BIPAP AUTO

K050759 · Respironics, Inc. · BZD · Jun 15, 2005 · Anesthesiology

Device Facts

• Record ID: K050759
• Device Name: BIPAP AUTO
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BiPAP Auto delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. The device is for use in the home or hospital/institutional environment on adult patients.

Device Story

BiPAP Auto is a microprocessor-controlled, blower-based bi-level positive airway pressure system. It delivers two distinct pressure levels (IPAP/EPAP) to provide pressure support therapy. The device features an Auto Bi-Level mode that automatically adjusts IPAP and EPAP levels based on patient needs, and a Split Night Auto Bi-Level mode that limits pressure during initial diagnostic recording before transitioning to auto-adjusting therapy. It may also utilize a Bi-Flex feature for pressure relief during exhalation. The device is used in home or hospital environments by adult patients. Healthcare providers use the device to treat Obstructive Sleep Apnea; the auto-adjusting pressure capability aims to maintain therapeutic efficacy while improving patient comfort and compliance. The system connects to a patient interface (mask) via a standard patient circuit (tubing and exhalation device).

Clinical Evidence

Clinical efficacy study demonstrated that the Auto Bi-Level mode is as effective as manually titrated bi-level positive airway pressure. Performance indicators showed that Auto Bi-Level therapy maintains lower average treatment pressures (IPAP/EPAP) compared to fixed-pressure therapy, and AHI remained below 10 during polysomnography.

Technological Characteristics

Microprocessor-controlled blower-based bi-level system. Delivers IPAP/EPAP. Includes Bi-Flex pressure relief. Complies with IEC 60601-1, IEC 60601-1-2, ISO 10993-1, and IEC 68-2 series (vibration/shock). Software life cycle processes comply with ANSI/AAMI SW-68:2001.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea requiring positive airway pressure therapy. For use in home or hospital/institutional settings.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Respironics BiPAP Pro 2 with Bi-Flex (K043607)
• Respironics REMstar Auto with C-Flex (K041010)

Submission Summary (Full Text)

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K050759

JUN 1 5 2005

BiPAP Auto

Traditional 510(k) Tab 10 – 510(K) Summary

#### TAB 10

| Official Contact / Address<br>of Manufacturing facility | Zita A. Yurko<br>Manager, Regulatory Affairs<br>Respironics Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | BiPAP Auto |
| Common/Usual Name | Ventilator, Non-Continuous (Respirator) |
| Classification Reference | 21 CFR 868.5905 |
| Classification | Class II |
| Appropriate Classification Panel | Anesthesiology |
| Product Code | BZD |
| Predicate Devices | Respironics BiPAP Pro 2 with Bi-Flex (K043607) |
| | Respironics REMstar Auto with C-Flex (K041010) |
| Reason for submission | Modified design |

## Substantial Equivalence

This premarket notification submission demonstrates that the BiPAP Auto is substantially equivalent to the combination of the Respironics BiPAP Pro 2 with Bi-Flex (K043607) and the Respironics REMstar Auto with C-Flex (K041010). Design modifications have been made to the BiPAP Pro 2 with Bi-Flex for this submission, including the incorporation of several REMstar Auto with C-Flex device features, to create the BiPAP Auto. None of the modifications affect the safety or effectiveness of the device.

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The following changes have been made:

- The Auto therapy algorithm present in the REMstar Auto with C-Flex CPAP System (K041010) has been added to the device to create the Auto Bi-level mode that automatically adjusts the IPAP and EPAP levels to meet the patient's needs.
- The Split Night mode (split night study feature) has been added to the device. The Split Night . mode limits the pressure during the first portion of the night to allow diagnostic recording; thereafter the pressure responds to the patient's needs to provide an assessment of therapeutic requirements. The Split Night mode (split night study feature) is based on the Split Night Auto CPAP mode (split night study feature) currently cleared by the FDA in K041010 (REMstar Auto with C-Flex CPAP System).

#### Indications for Use

The BiPAP Auto-aystem delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea-eelly: The device is for use in the home or hospital/institutional environment on adult patients.

#### Device Description

The Respironics BiPAP Auto is a microprocessor controlled blower based bi-level positive pressure system that delivers two different positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. Two modes are being introduced, which include the Auto Bi-Level mode and Split Night Auto Bi-Level mode. Bi-Level therapy with automatically adjusting IPAP and EPAP levels is delivered in the Auto Bi-Level mode. The Split Night Auto Bi-Level mode limits the pressure during the first portion of the night to allow diagnostic recording; thereafter the pressure responds to the patient's needs to provide an assessment of therapeutic requirements. Pressure relief upon exhalation (Bi-Flex feature) may be enabled during Auto Bi-Level therapy.

The BiPAP Auto 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 22mm tubing, an exhalation device, and a patient interface device.

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## Performance testing

An extensive collection of tests has been conducted and successfully completed, including clinical efficacy, safety, performance and comparative tests. Declarations of conformance to the FDA Recognized list of consensus standards have been provided in support of the safety and effectiveness of the BiPAP Auto. This list of performance testing included in the submittal is as follows:

- IEC 60601-1: 1988 + A1: 1991 + A2: 1995 Medical Electrical Equipment -- Part 1: General . Requirements for Safety
- IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic . Compatibility - Requirements and tests
- ISO 10993-1: 1997 Biological Evaluation of Medical Devices -- Evaluation and Testing .
- IEC 68-2-6: 1995 Environmental Testing Part 2: Tests Test Fc: Vibration (Sinusoidal) .
- IEC 68-2-27: 1987 Environmental Testing Part 2: Tests Test Ea and Guidance: Shock .
- IEC 68-2-34: 1993 Environmental Testing Part 2: Test Fd: Random Vibration Wide Band .
- Bench Testing BiPAP Auto vs. REMstar Auto with C-Flex; assessed the event detection and . control capability of the BiPAP Auto.
- System Design Verification Test Procedure/Report; assessed the features of the BiPAP Auto to . ensure compliance with the system level requirements and assesses compliance of the BiPAP Auto to the Operational and Storage test conditions stated in the 1993 FDA Reviewers Guidance.
- Clinical Efficacy Study; demonstrated that the Auto Bi-Level Mode (auto-adjusting bi-level positive . airway pressure) of the BiPAP Auto device is as effective at determining optimal pressures as manually titrated, bi-level positive airway pressure. The following performance indicators additionally demonstrate the clinical efficacy of the Auto Bi-Level therapy: Auto Bi-Level therapy maintains lower average treatment pressures (as defined by average IPAP and average EPAP as compared to manually titrated fixed pressure bi-level therapy), and the AHI will remain below 10 during polysomnography.

Additional testing has been performed to ensure safety & effectiveness of the BIPAP Auto. This testing involves the unit, module, and functional testing of the software of the device (firmware). Since we are able to declare compliance to ANSI/AAMI: SW-68:2001 Medical Device software life cycle processes, these test protocols and reports are not required to be included as part of this submittal, but are available upon request. Additionally, the following set of standards and guidance documents have been used in the design of the BiPAP Auto. These include:

- ANSI/AAMI SW-68: 2001 Medical Device Software Software Life Cycle Processes. .
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical . Devices, May 1998
- FDA Reviewer's Guidance General Principles of Software Validation; Final Guidance for Industry . and FDA Staff, January 2002

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#### Traditional 510(k)

Tab 10 – 510(K) Summary

- FDA Reviewer's Guidance (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISO-. 10993
- FDA Reviewer's Guidance for Premarket Notification Submissions, Appendix A, November 1993 .

## Conclusion

It is the conclusion of Respironics that the BiPAP Auto is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns of safety or effectiveness.

(End of Tab.)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2005

Mr. Zita A. Yurko Manager, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K050759

Trade/Device Name: BiPAP Auto Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 17, 2005 Received: May 19, 2005

Dear Mr. Yurko:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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#### Page 2 - Mr. Yurko

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 moun that 1 27 mm made statutes and regulations administered by other Federal agencies. or the ret of all the Act's requirements, including, but not limited to: registration 1 ou intelst compry was as a mart 801); labeling (21 CFR Part 801); good manufacturing practice and if the (22 ) = = = = forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a premarket hotelled predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you decire spie of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylvie G. Michael Davis

Chiu Lin, Ph.D. 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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# Indications for Use

510(k) Number (if known): K050759

BiPAP Auto Device Name:

Indications for Use:

The BiPAP Auto delivers positive airway pressure therapy for the treatment of The Bir Ar Auto dolivere positive is for use in the home or hospital/institutional environment on adult patients.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

4

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suyti Y. Michien D.M.D

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic

510(k) Number: K050759