BIPAP AVAPS VENTILATORY SUPPORT SYSTEM

K102465 · Respironics, Inc. · MNS · Mar 24, 2011 · Anesthesiology

Device Facts

• Record ID: K102465
• Device Name: BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
• Applicant: Respironics, Inc.
• Product Code: MNS · Anesthesiology
• Decision Date: Mar 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Nonin Xpod Oximetry Module can be used with Philips Respironics BiPAP C Series therapy devices (BiPAP AVAPS and BiPAP S/T) 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 lbs) 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 Story

BiPAP C Series is a microprocessor-controlled, blower-based positive pressure system providing non-invasive ventilatory support (IPAP/EPAP, CPAP, S, S/T, T, PC modes). Device integrates with Nonin Xpod Oximetry Module via a Link Module to monitor SpO2 and pulse rate. Inputs include patient respiratory flow and oximetry sensor signals. Data is stored on an SD card for transfer to Encore or DirectView software for clinician review. Used in hospital or home environments by patients under physician direction. Clinicians use output data to assess therapy efficacy and adjust device settings. Benefits include improved patient comfort via dual-pressure support and enhanced monitoring of sleep therapy.

Clinical Evidence

Bench testing only. Device tested against applicable ISO, ASTM, and IEC standards, including electromagnetic compatibility and electrical safety. Performance verified per FDA guidance for ventilators and software in medical devices. No clinical data presented.

Technological Characteristics

Microprocessor-controlled blower-based positive pressure system. Includes integrated heated humidifier. Connectivity via SD card for data transfer to management software. Oximetry module uses Nonin Xpod sensor. Software-enabled communication between flow generator and Link module. Complies with IEC/ISO/ASTM standards for respiratory devices.

Indications for Use

Indicated for adult and pediatric patients (>7 years, >40 lbs) with obstructive sleep apnea (OSA) and respiratory insufficiency requiring non-invasive ventilatory support. Oximetry module indicated for monitoring SpO2 and pulse rate in these populations in hospital or home settings.

Regulatory Classification

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.

Predicate Devices

• Respironics BiPAP AVAPS Ventilatory Support System (K092818)
• DeVilbiss DV5M SmartLink System (K082209)
• Resmed S7 Elite and AutoSet Spirit CPAP Systems with ResLink (K024191)

Submission Summary (Full Text)

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## 510(k) Summary

MAR 2 4 2011

## Administrative Information and Device Identification

| Name and address of the manufacturer<br>and sponsor of the 510(k) submission: | Manufacturer:<br>Philips Respironics<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>Fax: [phone]<br><br>Sponsor:<br>Philips Respironics<br>1740 Golden Mile Highway<br>Monroeville, PA 15146<br>Office: 724-387-7562<br>Fax: [phone] |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA registration number of the<br>manufacturer of the new device: | 2518422 |
| Official contact person for all<br>correspondence: | Elaine Larkin<br>Regulatory Affairs Engineer<br>Philips Respironics<br>1740 Golden Mile Highway<br>Monroeville, PA 15146<br>Office: 724-387-5350<br>Fax: [phone]<br>Email: [e-mail] |
| Classification Reference | 21 CFR 868.5895<br><br>a) <i>Identification</i> . A continuous ventilator<br>(respirator) is a device intended to mechanically<br>control or assist patient breathing by delivering a<br>predetermined percentage of oxygen in the<br>breathing gas. Adult, pediatric, and neonatal<br>ventilators are included in this generic type of<br>device.<br><br>(b) <i>Classification</i> . Class II (performance standards).<br>MNS – ventilator, continuous, non-life supporting |
| Panel Code: | MNS – ventilator, continuous, non-life supporting |
| Classification Panel: | Anesthesiology |
| Common/Usual Name | Ventilatory Support System |

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| Proprietary name of new device: | Philips Respironics BiPAP C Series (BiPAP<br>AVAPS – BiPAP S/T) with Oximetry Module<br>System |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device Name(s) and 510(k)<br>numbers: | 1. Respironics BiPAP AVAPS Ventilatory<br>Support System (cleared under K092818 –<br>date of concurrence: January 22, 2010). |
| | 2. DeVilbiss DV5M SmartLink System<br>(cleared under K082209 – date of<br>concurrence: October 28, 2008). |
| | 3. Resmed S7 Elite and AutoSet Spirit CPAP<br>Systems with ResLink (cleared under<br>K024191 – date of concurrence: July 7,<br>2003). |
| Reason for submission: | Device modifications and additional accessories |

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# Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate devices:

- O Same intended use.
- D Same operating principle.
- O Same technology.
- O 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 S/T) 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 lbs) 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.

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The Respironics Oximetry Module is designed for use with Respironics BiPAP AVAPS C Series and Respironics BiPAP S/T 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 K092818. The Respironics BiPAP C-Series System with Oximetry Module also delivers two positive pressure levels (IPAP/EPAP), like the predicate cleared in K092818. 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, S/T, 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 K092818.

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 K092818) 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 device.to 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 S/T 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, K092818) 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

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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 t
- Nonin® Oximeter Sensor .
- Philips Respironics Link Module ●
- Carrying Case t
- 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;

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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 (K102465), 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 (K102465), and Attachment A - BiPAP C-Series with Oximetry System Product Requirements Document provided with the original submittal (K102465).

### 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 (K092818), the DeVilbiss DV5M SmartLink System (K082209) and ResMed S7Elite and AutoSet Spirit CPAP Systems with ResLink (K024191): 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.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Elaine Larkin Regulatory Affairs Engineer Respironics, Incorporated . 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

MAR 2 4 201

Re: K102465

Trade/Device Name: BiPAP AVAPS with Oximetry Module Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: March 18, 2011 Received: March 21, 2011

Dear Ms. Larkin:

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 (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 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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

hr for

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

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Section 6.0 Indications for Use

#### Indications for Use

510(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 S/T) 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 lbs) 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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K102465 |
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