Philips Respironics BiPAP C Series Request for Additional Information

with Oximetry Module

510(k) Summary
MAR 2 4 2011
Administrative Information and Device Identification

Name and address of the manufacturer Manufacturer:

and sponsor of the 5 10(k) submission:
Philips Respironics
1001 Murry Ridge Lane
Murrysville, PA 15668
Fax: (724) 387-4216

Sponsor:

Philips Respironics
1740 Golden Mile Highway
Monroeville, PA 15146
Office: 724-387-7562
Fax: 724-387-7490

FDA registration number of the 2518422

manufacturer of the new device:
Official contact person for all Elaine Larkin
correspondence: Regulatory Affairs Engineer
Philips Respironics
1740 Golden Mile Highway
Monroeville, PA 15146
Office: 724-387-5350
Fax: 724-387-7490
Email: elaine.larkin(Wphilips.com

Classification Reference 21 CFR 868.5895

a) Identification. A continuous ventilator

(respirator) is a device intended to mechanically
control or assist patient breathing by delivering a
predetermined percentage of oxygen in the
breathing gas. Adult, pediatric, and neonatal
ventilators are included in this generic type of
device.

_______________________________(b) Classifcation. Class II (performance standards).

Panel Code: MN S - ventilator, continuous, non-life supporting

Classification Panel: Anesthesiology

CommonlUsual Name Ventilatory Support System
Philips Respironics BiPAP C Series Request for Additional Information
with Oximetry Module

Proprietary name of new device: Philips Respironics BiPAP C Series (BiPAP

AVAPS - BiPAP SIT) with Oximetry Module
System
Predicate Device Namne(s) and 5 10(k) I1. Respironics BiPAP AVAPS Ventilatory
numbers: Support System (cleared under K0928188-
date of concurrence: January 22, 2010).
2. DeVilbiss DV5M SmartLink System
(cleared under K082209 - date of
concurrence: October 28, 2008).
3. Resmed S7 Elite and AutoSet Spirit CPAP
Systems with ResLink (cleared under
K024191 - date of concurrence: July 7,
2003).

Reason for submission: IDevice modifications and additional accessories

Philips Respironics BiPAP C Series Request for Additional Information
with Oximetry Module

Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate
devices:
ol Same intended use.
ol Same operating principle.
ol Same technology.
ol Same manufacturing process.

Design verification tests were performed on the Respironics BIPAP AVAPS C Series System
as a result of the risk analysis and product requirements. All tests were verified to meet the
required acceptance criteria. Respironics has determined that the modifications have no
impact on the safety and effectiveness of the device. In summary, the device d scribed in this
submission is substantially equivalent to the predicate devices.

The modified device complies with the applicable standards referenced in the Guidance for
FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for
Software Contained in Medical Devices," May 2006. (See Section 8.0 Substantial
Equivalence Discussion of the original submittal, K102465)

Intended Use
The Nonin Xpod Oximetry Module can be used with Philips Respironics BiPAP C Series
therapy devices (BiPAP AVAPS and BiPAP SIT) to measure functional oxygen saturation of
arterial hemoglobin (%SpO2) and pulse rate for adult and pediatric patients. The Oximetry
Module may be used in a hospital or home care environment.

The Respironics BiPAP C Series Ventilatory System is intended to provide non-invasive

ventilatory support to treat adult and pediatric (> 7 years of age; > 40 Ibs) patients with
obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C Series
Ventilatory System may be used in the hospital or home.

Device Description
The BiPAP AVAPS C Series device with Oximetry provides access to patient therapy
information through the two-way transfer of data between patient devices and clinicians through
the appropriate software including therapy efficacy and device setting as requested by the
attending physician.
Philips Respironics BiPAP C Series Request for Additional Information
with Oximetry Module

The Respironics Oximetry Module is designed for use with Respironics BiPAP AVAPS C Series
and Respironics BiPAP SIT C Series flow generators to help the clinician monitor the end user's
sleep and ensure that optimal treatment is provided.

When connected to the flow generator, the Oximetry module records treatment and pulse
oximetry data during therapy. The data is stored on a secure digital card. After treatment, the
secure digital card containing the data can be removed from the device and sent to the clinician
for review.

Both Respironics BiPAP C-Series with Oximetry Module devices are microprocessor controlled
blower based positive pressure systems with integrated heated humidifier, like the predicate
cleared in K09281 8. The Respironics BiPAP C-Series System with Oximetry Module also
delivers two positive pressure levels (IPAP/EPAP), like the predicate cleared in K0928 18. The
dual pressure levels provide a more natural means of delivering pressure support therapy to the
patient resulting in improved patient comfort. In addition, the BiPAP C-Series System includes
CPAP mode in which a fixed pressure is delivered. Four bi-level operating modes, S, SIT, T &
PC, are also offered which determine how the changes between IPAP and EPAP pressure are
made. All therapy modes are unchanged from the previously cleared K0928 18.

A user interface displays clinical data and enables the operator to set and adjust certain clinical
parameters. The therapy device will provide the following indications as to the status of the
Oximetry module.

The BiPAP C-Series with Oximetry System is fitted with alarms to alert the user to changes that
will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.
(Unchanged from K0928 18) These alarms are specific to the ventilator and are not related to
oximetry measurements.

Like its predicates, the BiPAP C-Series with Oximetry System is intended for use with a patient
circuit that is used to connect the deviceto the patient interface device (mask). A typical patient
circuit consists of a six-foot disposable or reusable smooth lumen 19mm tubing, an exhalation
device, and a patient interface device.

Device Modifications:
Modifications to the BiPAP AVAPS and BiPAP SIT C Series Ventilatory devices consist of the
following:

" Revised labeling (Refer to the request for Additional Information Packet 1, Attachment A)
" Updated BiPAP C Series software to enable the flow generator and Link module to
communicate and to provide additional display messages of the flow generator LCD to
provide feedback to the use on correct connection of the Link Module
" Inclusion of the Oximetry Module System (used as an accessory to the previously cleared
BiPAP C Series Devices, K0928 18) is a device designed for use with BiPAP C Series
Devices to aid the clinician/provider in monitoring oximetry data during therapy. The data is
Philips Respironics BiPAP C Series Request for Additional Information
with Oximetry Module

displayed real time and stored on a memory card (SD Card). The SD Card containing the
data can be removed from the Oximetry Module System device and sent to a
clinician/provider for review.

The Oximetry Module System consists of the:

" Nonin'& Xpod(& Oximeter Cable

" Nonincg Oximeter Sensor
" Philips Respironics Link Module
* Carrying Case
" SD Card and Mailer

*Link Module is a communication device that attaches to the BiPAP C Series device and
collects oximetry data. The module transfers information to and from the Nonin oximeter sensor
and the device via a data card and card reader.

* SD Card is a portable memory card that carries information from one data transfer device to
another. In this system, the data card is a Secure Digital (SD) card that carries therapy
information between the Link module on the BiPAP C Series device and the Encore and Direct
View Series software.

* Nonin Oximetry cable and sensors provide a non-invasive measurement of the oxygen
saturation levels of hemoglobin.

The BiPAP C Series device with Oximetry Module System provides access to patient therapy
information through the two-way transfer of data between patient devices, the Link Module and
both Encore and DirectView Patient Management Software (patient data management software).

Non-Clinical Testing:

This device has been tested to appropriate ISO, ASTM, and IEC standards and other
applicable requirements passing all test protocols. The Respironics BiPAP C-Series with
Oximetry System was designed and tested according to guidance outlined in:

1. FDA's Draft Reviewer Guidance for Premarket Notification Submissions -

Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular,
Respiratory, and Neurological Devices (November 1993);

2. FDA's Draft Reviewer Guidance for Ventilators July 1995; and

3. FDA "Guidance for the Content of Premarket Submissions for Software

Contained in Medical Devices" (May 11, 2005).

As suggested by FDA's November 1993 publication entitled "Reviewer Guidance for

Premarket Notification Submissions - Anesthesiology and Respiratory Devices Branch;
Philips Respironics BiPAP C Series Request for Additional Information
with Oximetry Module

Division of Cardiovascular, Respiratory, and Neurological Devices" the Respironics BiPAP C-

Series with Oximetry System was tested in accordance with the applicable voluntary standards.
The BiPAP C-Series with Oximetry System met the required performance criteria and functioned
as intended.

See Section 16.7 Traceability Analysis provided with the original submittal (K 102465),
Response # 2, Verification and Validation Testing Documentation, included with this request for
additional information packet, Section 9.3 Electromagnetic Compatibility and Electrical Safety
provided with the original submittal (K 102465), and Attachment A - BiPAP C-Series with
Oximetry System Product Requirements Document provided with the original submittal
(K] 02465).

Statement of Safety and Effectiveness:

Analysis of comparison of design, function and features of the BiPAP C-Series with Oximetry
System to the Respironics BiPAP AVAPS device (K0928 18), the DeVilbiss DV5M SmartLink
System (K082209) and ResMed S7Elite and AutoSet Spirit CPAP Systems with ResLink
(K02419 1); together with the results of testing demonstrates the device to be substantially
equivalent to the predicate devices in terms of meeting performance criteria and functioning as
intended.

Conclusion:

The Respironics BiPAP C-Series with Oximetry System is substantially equivalent to the
predicate devices listed in this Summary and the device, as changed, does not raise any new
issues of safety and effectiveness.
4DEPARTMENT OF HEALTH & HUMAN SERVICES PublIic IIca Itli Scervi ce

Hood and Thug Administration

10903 New I lampsh ire Aven tic
Document Control Room -WV066-0609
Silver Spring. NID 20993-000)

Ms. Elaine Larkin

Regulatory Affairs Engineer
Respironics, Incorporated
1740 Golden Mile Highway
Monroeville, Pennsylvania 15146 MA h 2 4 2"'

Re: K102465
Trade/Device Name: BiPAP AVAPS with Oxinietry Module
Reguilation Number: 21 CER 868.5895
Regulation Name: Continuous Ventilator
Regulatory Class: 11
Product Code: MNS
Dated: March 18, 2011
Received: March 21, 2011

Dear Ms. Larkin:

We have reviewed your Section 5 10(k) premnarket 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 (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. 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 11 (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, Pants 800 to 898. In
addition, FDA may publish further announcements concerning your device in the Federal
Relgister.
Page 2- Ms. H-arris

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 CER Part 807); labeling (21 CER Part 80 1); medical device reporting
(reporting of medical device-related adverse events) (21 CER 803); good manufacturing
practice requirements as set forth in the quality systems (QS) regulation (21 CER Part 820);
and if applicable, the electronic product radiation control provisions (Sections 53 1-542 of
the Act); 21 CER 1000- 105 0.

If you desire specific advice for your device on our labeling reg ulation (21 CFR Part 801),
please go to
http://www.fda.y~ov/AboutFDA/CentersOffices/CDRE-/CDRJ-HOffiCeS/ICIcn 115809.htmi for
the Center for Devices and Radiological Health's (CDRFI's) Office of Compliance. Also,
please note the regulation entitled, "Misbranding by reference to premarket notification"
(21CER Part 807.97). For questions regarding the reporting of adverse events under the
MDR regulation (21 CFR Part 803), please go to
lhttp://wxvxv.fda.ipov/MedicalDevices/Safety/RepoilaProbleii/defatilt.]itn for the CDR-L's
Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities uinder the Act from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free
number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://wwvw.fda.grov/MedicalDevices/ResourcesforYouiIiiduiStry,/defaulthltmn

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A.

Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
K 102465 Respironics BiPAP C Series Oximetry Kit Request for Additional Information

Section 6.0 Indications for Use

Indications for Use

5 10(k) Number (if known): _______

Device Name: BiPAP AVAPS with Oximetry Module

The Nonin Xpod Oximetry Module can be used with Philips Respironics BiPAP C Series
therapy devices (BiPAP AVAPS and BiPAP SIT) to measure functional oxygen saturation of
arterial hemoglobin (%SpO 2 ) and pulse rate for adult and pediatric patients. The Oximetry
Module may be used in a hospital or home care environment.

The Respironics BiPAP C Series Ventilatory System is intended to provide non-invasive

ventilatory support to treat adult and pediatric (> 7 years of age; > 40 Ibs) patients with
obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C
Series Ventilatory System may be used in the hospital or home.

Prescription Use _X AND/OR Over-The-Counter Use _ _

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device APN.,General HOsPaS

InfectOn Control, uental Devices

10 9
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