June 3, 2024

Sibel Health Inc.

Sarah Coughlin
Regulatory Affairs Manager
2017 N Mendell
Unit 2SE
Chicago, Illinois 60614

Re: K240251
Trade/Device Name: ANNE Chest
Regulation Number: 21 CFR 870.2910
Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver
Regulatory Class: Class II
Product Code: DRG, FLL, MWJ, KMI, BZQ, MWI
Dated: May 10, 2024
Received: May 10, 2024

Dear Sarah Coughlin:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above
and have determined the device is substantially equivalent (for the indications for use stated in the enclosure)
to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment
date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the
provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general controls
provisions of the Act. Although this letter refers to your product as a device, please be aware that some
cleared products may instead be combination products. The 510(k) Premarket Notification Database
available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.10
Silver Spring, MD 20993
www.fda.gov
K240251 - Sarah Coughlin Page 2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and
approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for
devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart
A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections
531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer W. Shih -S
Jennifer Shih Kozen
Assistant Director
Division of Cardiac Electrophysiology,
Diagnostics and Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 07/31/2026
Indications for Use See PRA Statement below.

Submission Number (ifknown)

K240251
I
Device Name

I ANNE Chest

Indications for Use (Describe)

The ANNE Chest is a wearable, wireless sensor intended for the measurement of
electrocardiography (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body
position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure
respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor
communicates with compatible software applications for the display, storage, and analysis of data.
The device is intended to provide continuous physiological information as an aid to diagnosis and
treatment by healthcare professionals in general care patients who are 12 years of age or older in
clinical and home environments. The device is not intended for use on critical care patients.

Type of Use (Select one or both, as applicable)

ZPrescription Use (Part 21 CFR 801 Subpart D) ]Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
 510(K) Summary

I. Submitter:

Sibel Health Inc.

2017 N Mendell St. Suite 2SE Chicago, IL 60614
Tel: (224) 251-8859

Official Correspondent:
Sarah Coughlin, Regulatory Affairs Manager
2017 N Mendell St. Suite 2SE Chicago, IL 60614
Tel: (224) 251-8859

Date Prepared: 05/09/2024

II. Device Information

Name of Device: ANNE Chest

510K Number: K240251
Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver
Regulation: 21 CFR §870.2910
Regulatory Class: Class II
Product Classification Code: DRG, FLL, MWJ, KMI, BZQ, MWI

III. Predicate Device

Primary Predicate
Trade Name: ANNE One
510(k): K223711
Device Manufacturer: Sibel Health Inc.

Secondary Predicate
Trade Name: Portrait Mobile Monitoring Solution
510(k) Number: K230626
Manufacturer: GE Medical Systems Information Technologies, Inc.

IV. Device Description

The ANNE Chest Sensor is a skin-mounted, bio-integrated sensor that collects real-time
biosignals including electrocardiography (ECG), 3-axis accelerometry, and temperature to
measure vital signs such as heart rate, respiratory rate, body position, fall detection, and skin
temperature. The sensor communicates via Bluetooth to the Sibel SDK, which may be
integrated within software applications for the display and storage of data. The ECG signal

510(k) Summary Page 1 of 7

K240251
obtained by the ANNE Chest sensor is not intended for manual discrimination of any
arrhythmias or cardiac conditions.

V. Indications for Use

The ANNE Chest is a wearable, wireless sensor intended for the measurement of
electrocardiography (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body
position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure
respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest
sensor communicates with compatible software applications for the display, storage, and
analysis of data. The device is intended to provide continuous physiological information as an
aid to diagnosis and treatment by healthcare professionals in general care patients who are 12
years of age or older in clinical and home environments. The device is not intended for use on
critical care patients.

VI. Performance Data

The following consensus standards and bench testing were used to evaluate the substantial
equivalence of ANNE Chest:
● Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI
ES60601-1:2005/(R) 2020 and IEC 60601-1-2:2014 standards. Electrical safety testing in
the home healthcare environment per IEC 60601-1-11:2015.
● Biocompatibility testing according to ISO 10993-5:2009, ISO 10993-10:2021, and ISO
10993-23:2021 for patient contacting materials.
● Wireless coexistence testing according to ANSI IEEE C63.27-2017.
● Software verification and validation testing according to IEC 62304:2015 and the FDA
guidance document, Content of Premarket Submissions for Software Contained in
Medical Devices.
● Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC
60601-2-47:2012.
● Defibrillation testing according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012
● Shelf life testing of the adhesive to demonstrate performance over the intended device
life cycle.
● Bench testing to demonstrate the mechanical durability of the sensors.
● Usability testing in accordance with the FDA guidance document, Applying Human
Factors and Usability Engineering to Medical Devices.
● Performance testing of heart rate, respiratory rate, skin temperature, activity, and posture.
● Cybersecurity evaluation according to the FDA guidance document, Cybersecurity in
Medical Devices: Quality System Considerations and Content of Premarket Submissions

510(k) Summary Page 2 of 7

K240251
VII. Clinical Studies

Respiratory Rate Accuracy: A clinical validation study was conducted in n=40 healthy adult and
adolescent subjects to evaluate respiratory rate measurements with the ANNE Chest sensor
against an End Tidal Carbon Dioxide (EtCO2) monitor reference. Testing encompassed a range
of patient demographics including age, gender, and BMI. Participants were asked to breathe
along with a metronome at 8, 13, 23, 27, and 35 breaths per minute. The test also evaluated
respiratory rate at different body positions and before and after motion activities. The mean
absolute error (MAE) between the ANNE Chest sensor and capnography was 1.27 breaths per
minute.

VIII. Conclusion

The results of the substantial equivalence assessment, taken together with safety and
performance testing data, demonstrate that ANNE Chest’s performance characteristics are
substantially equivalent to the predicate device in both technology and intended use.

510(k) Summary Page 3 of 7

K240251
 Subject device Primary Predicate device Secondary Predicate Variances / Equivalence
Sibel Health Inc. Sibel Health Inc. GE Medical Systems
Information
Technologies, Inc.

Trade ANNE Chest ANNE One Portrait Mobile Monitoring

Name Solution

510(k) K240251 K223711 K230626

Number

Class II II II Equivalent

Product DRG, FLL, KMI, MWJ, DRG, MWI, FLL, DQA, MHX, MSX, DRG, BZQ, Equivalent
Code BZQ, MWI MWJ, KMI DQA BZQ is a product code in
the subject device that
was not present in the
predicate device.
However, the predicate
device did monitor
breathing frequency. The
K230626 secondary
predicate is used to
support the BZQ product
code.

Regulation 870.2910 870.2910 870.1025 Equivalent

Number Transmitters and Transmitters and Arrhythmia Detector and
and Receivers, Physiological Receivers, Physiological Alarm (Including
Regulation Signal, Radiofrequency Signal, Radiofrequency ST-Segment Measurement
Name and Alarm)

Indications The ANNE Chest is a ANNE One is a wireless Portrait Mobile Monitoring Similar
for Use wearable, wireless sensor monitoring platform Solution: The Portrait The subject device utilizes
intended for the indicated for the Mobile Monitoring Solution the same ANNE Chest
measurement of measurement of is intended to acquire, sensor for the monitoring
electrocardiography (ECG) electrocardiography (ECG) store, calculate, display of ECG, heart rate,
waveforms, heart rate, waveforms, heart rate, and export patient respiratory rate, body
respiratory rate, activity, respiratory rate, functional monitoring data as well as position, activity, and skin
fall detection, body oxygen saturation of provide real time alarming temperature as the
position, and skin arterial hemoglobin for monitoring adult and predicate device ANNE
temperature. The ANNE (SpO2), pulse rate, activity, pediatric patients (3 years One. The ANNE One
Chest sensor is not body position, fall of age and older, and predicate has additional
intended to monitor or detection, skin weighing more than 10 outputs including SpO2,
measure respiratory rate temperature, and body kg). pulse rate, body
while the patient temperature by qualified temperature, and
undergoes significant healthcare professionals in non-invasive blood
motion or is active. The home and healthcare Physiological parameters pressure. This difference
ANNE Chest sensor settings. ANNE One is and waveforms supported does not affect safety or
communicates with compatible with third-party, are: effectiveness of the output
compatible software FDA-cleared devices for • Pulse oximetry parameters indicated for
applications for the display, noninvasive blood (SpO2/pulse rate) use in the subject device.
storage, and analysis of pressure, SpO2, pulse • Respiration rate (RR)
data. The device is rate, and body
Continuous pulse oximetry
intended to provide temperature
and respiration rate
continuous physiological measurements. The
monitoring may be used
information as an aid to device is indicated for
for patients at risk of
diagnosis and treatment monitoring ECG

510(k) Summary Page 4 of 7

K240251
 by healthcare waveforms and heart rate cardiorespiratory and
professionals in general on ambulatory patients. infectious complications.
care patients who are 12 The device is not intended
years of age or older in to monitor or measure
clinical and home respiratory rate, SpO2, The Portrait Mobile
environments. The device pulse rate, or noninvasive Monitoring Solution is
is not intended for use on blood pressure while the intended for use under the
critical care patients. patient undergoes direct supervision of a
significant motion or is licensed practitioner, or by
active. personnel trained in proper
use of the equipment in a
ANNE One continuously professional healthcare
monitors the orientation of facility.
patients to aid in the
prevention of pressure This device is not an
ulcers for at-risk patients. Apnea monitor (i.e., do not
The system provides rely on the device for
visual notification when the detection or alarm for the
patient’s position has not cessation of breathing).
changed from a preset
threshold of time.
This device should not be
The device is intended for used for life
use on general care sustaining/supporting
patients who are 12 years purposes. The Portrait
of age or older as a Mobile Monitoring Solution
general patient monitor to is not intended for use in a
provide continuous controlled Magnetic
physiological information Resonance (MR)
as an aid to diagnosis and environment.
treatment. The data from
ANNE One are transmitted
wirelessly for display,
storage, and analysis. The
device is not intended for
use on critical care
patients.

Target 12 years of age and older 12 years of age and older 3 years of age and older, Equivalent
Population weighing more than 10 kg

Use Home and healthcare Home and healthcare Professional healthcare Equivalent
Environme settings settings facility
nt

Reprocessi Multiple patient reusable Single patient reusable Semi-disposable Different

ng The subject device is
reusable on multiple
patients. Validation of the
cleaning process and
mechanical testing
demonstrate that this
difference does not impact
safety or effectiveness.

Sensor Chest Finger and Chest Portrait Wearable Equivalent

Placement Respiration Rate Sensor Placement location of the
and Portrait RR Electrode ANNE Chest sensor is the
Patch: same between the subject

510(k) Summary Page 5 of 7

K240251
 Chest and predicate devices.
The predicate device
includes an additional
sensor, the ANNE Limb
Sensor, that is worn on the
finger. The ANNE Limb
Sensor is not part of the
scope of the subject
device.

Heart Rate 30 - 270 bpm 30-270 bpm N/A Equivalent

(the greater of ±10% or (the greater of ± 10% or ±
±5bpm) 5 bpm)

Respiratory Accelerometer and ECG Accelerometer-derived Derived from impedance Similar

Rate derived 8 - 30 bpm (± 3 bpm and biopotential signals The range for respiratory
8 - 35 bpm (±3 bpm RMSE) rate has been extended in
RMSE) Accuracy range from 4 to the subject device from the
60 breaths/minute (± 3 K223711 predicate. The
bpm RMSE) range is less than the
K230626 secondary
predicate. Respiratory rate
over the output range for
the subject device meets
the same accuracy
specification as both
predicates.

Skin 73.4°F - 109.4°F (±0.54°F) 73.4°F - 109.4°F (±0.54°F) N/A Equivalent

Temperatur 23°C - 43°C (±0.3°C) 23°C - 43°C (±0.3°C)
e

Body Not Applicable ± 0.05 °C ( ± 0.1 °F ) N/A Different

Temperatur during 35.00 °C ~38.00°C The subject device does
e (95.00 °F ~100.40°F) ± not have body temperature
0.1°C ( ± 0.2 °F ) during functionality.
T<35.00°C (95.00°F) or
T>38.00°C (100.40°F)
with use of an optional
compatible thermometer

SpO2 Not Applicable ARMS ≤ 3% (range ARMS ≤ 2% (range Different

70-100%) 70-100%) The subject device does
Low perfusion: ARMS ≤ 3% not have SpO2
With motion: ARMS ≤ 3% functionality.

Pulse Rate Not Applicable 30-300 bpm 30-250 bpm Different

(the greater of ± 10% or ± <= 2bpm (30 to 250 bpm) The subject device does
5 bpm) With motion: <=5bpm not have pulse rate
functionality.

Activity Accelerometer Accelerometer N/A Equivalent

Posture Body Position Body Position N/A Equivalent

Non-Invasiv Not Applicable 0 - 300 mmHg (± 3 mmHg) N/A Not Applicable

e Blood
Pressure

510(k) Summary Page 6 of 7

K240251
(NIBP) with use of an optional The subject device does
compatible blood pressure not have NIBP
cuff functionality.

ECG Compliant to IEC Compliant to IEC N/A Equivalent

Waveform 60601-2-27 60601-2-27
Compliant to IEC Compliant to IEC
60601-2-47 60601-2-47

ECG ECG Sampling Frequency: ECG Sampling Frequency: N/A Equivalent

Sampling 512 Hz 512 Hz
Frequency Streaming Frequency: 256 Streaming Frequency: 256
Hz Hz

ECG 18 bit 18 bit N/A Equivalent

Resolution

Data Data is transmitted Data is transmitted Data is transmitted Similar

wirelessly via Bluetooth wirelessly via Bluetooth wirelessly from the Portrait The subject device allows
from the sensor to the from the sensors to a Sensor Battery to the communication with
mobile device. Data may Portrait Mobile Patient compatible software
Sibel SDK, which may be
be downloaded for later Monitor over a wireless applications for the display,
integrated within software storage and analysis. Medical Body Area storage, and analysis of
applications for the display Network (MBAN) using a data.
and storage of data. proprietary protocol.

Notification No notification ability. Provides visual notification Real time alarming Similar
on patient orientation. The subject device
provides a visual
notification on patient
orientation.

Motion Respiratory rate Respiratory rate, SpO2, Ambulatory monitoring Equivalent

measurements should not and pulse rate Equivalent for applicable
be taken during motion. measurements should not parameters
be taken during motion.
Heart rate and ECG may
be taken during motion. Heart rate and ECG may
be taken during motion.

Measureme Continuous measurements Continuous measurements Continuous measurements Equivalent

nt modality

Monitoring Real time monitoring Real time monitoring Real time monitoring Equivalent
type
Data storage for later
analysis

Apnea Not an apnea alarm Not an apnea alarm Not an apnea alarm Equivalent
Claims

510(k) Summary Page 7 of 7

K240251