BIPAP AVAPS VENTILATORY SUPPORT SYSTEM

K092818 · Respironics, Inc. · MNS · Jan 22, 2010 · Anesthesiology

Device Facts

• Record ID: K092818
• Device Name: BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
• Applicant: Respironics, Inc.
• Product Code: MNS · Anesthesiology
• Decision Date: Jan 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Respironics BiPAP AVAPS Ventilatory Support 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. BiPAP AVAPS Ventilatory Support System may be used in the hospital or home.

Device Story

Microprocessor-controlled, blower-based positive pressure ventilator with integrated heated humidifier; provides non-invasive ventilatory support. Operates in CPAP, Spontaneous/Timed, Timed, and Pressure Control modes; includes Bi-Flex or AVAPS therapy features. Used in hospital or home environments; operated by clinicians or patients. Connects to patient via circuit (tubing, exhalation device, mask). Graphical user interface displays settings and data; integrated alarm system alerts users to treatment changes. Device modifications verified through design testing to ensure safety and effectiveness equivalent to predicates.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Microprocessor-controlled blower-based positive pressure system; integrated heated humidifier. Modes: CPAP, S/T, Timed, Pressure Control. Features: Bi-Flex, AVAPS. Connectivity: Graphical user interface for data/settings. Alarms: Fixed and user-adjustable. Software: Complies with FDA guidance for software in medical 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 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 Synchrony 2 Ventilatory Support System (K071509)
• Respironics REMstar Q Series Auto with AFLEX CPAP System (K091319)

Submission Summary (Full Text)

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| 510(K) SUMMARY OF SAFETY & EFFECTIVENESS |
|------------------------------------------|
|------------------------------------------|

| Official Contact | Zita A. Yurko<br>Director, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 | K092818<br>JAN 22 2010 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | 724-387-4120<br>724-387-7490 (fax)<br>Email: Zita. [e-mail] | |
| Establishment Registration # | 2518422 | |
| Classification Reference | 21 CFR 868.5895 | |
| Product Code | MNS - ventilator, continuous, non-life supporting | |
| Common/Usual Name | Ventilatory Support System | |
| Proprietary Name | Respironics BiPAP AVAPS Ventilatory Support System | |
| Predicate Device(s) | Respironics BIPAP Synchrony 2 Ventilatory Support System<br>(K071509)<br>Respironics REMstar Q Series Auto with AFLEX CPAP System<br>(K091319) | |
| Reason for submission | Modified design. | |

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# Substantial Equivalence

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

- ට Same intended use.
- 0 Same operating principle.
- Same technology.
- Same manufacturing process. ට

Design verification tests were performed on the Respironics BiPAP AVAPS 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.

## Intended Use

The Respironics BiPAP AVAPS Ventilatory Support 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. BiPAP AVAPS Ventilatory Support System may be used in the hospital or home.

## Device Description

The Respironics BiPAP AVAPS Ventilatory Support System is a microprocessor controlled blower based positive pressure ventilatory system with integrated heated humidifier. The device platform being used as the key topic for this submission was previously cleared in K091319. The same ventilation modalities and therapy features, previously cleared in K071509 is also included in the BiPAP AVAPS Ventilatory Support System, which is the topic of this submission. These modes and therapy features include: CPAP, Spontaneous/Timed, Timed, Timed, Pressure Control modes with Bi-Flex or AVAPS therapy features available if enabled by the health care professional.

A Graphical user interface displays device data and device settings.

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The BiPAP AVAPS Ventilatory Support 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.

Like its predicates, the BiPAP AVAPS Ventilatory Support 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 tubing, an exhalation device, and a patient interface device.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Zita A. Yurko Director, Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

JAN 2 2 2010

Re: K092818

Trade/Device Name: Respironics BiPAP AVAPS Ventilatory System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilators Regulatory Class: II Product Code: MNS Dated: September 11, 2009 Received: October 26, 2009

Dear Ms. 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 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 - Ms. 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 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

h fac

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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### Indications for Use

510(k) Number (if known):

Device Name: _____Respironics BiPAP AVAPS Ventilatory System_

The Respironics BiPAP AVAPS 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 AVAPS Ventilatory System may be used in the hospital or home.

Prescription Use AND/OR. (Part 21 CFR 801 Subpart D)

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

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

Concurrence of GDRH, Office of Device Evaluation (ODE)

L. Lw/thers

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

510(k) Numbe

000064