BIPAP SYNCHRONY WITH AVAPS

K070328 · Respironics Inc., Sleep & Home Respiratory Group · MNS · May 8, 2007 · Anesthesiology

Device Facts

• Record ID: K070328
• Device Name: BIPAP SYNCHRONY WITH AVAPS
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: MNS · Anesthesiology
• Decision Date: May 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Synchrony may be used in the hospital or home. The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

Device Story

Microprocessor-controlled, blower-based Bi-level positive pressure system; delivers IPAP/EPAP pressure levels. Inputs: flow and pressure data from airway sensors. Operation: microprocessor regulates blower assembly based on sensor feedback to provide ventilatory support. AVAPS (Average Volume Assured Pressure Support) feature adjusts pressure to maintain target tidal volume. Output: non-invasive ventilatory support; clinical data displayed on user interface. Used in hospital or home; operated by clinicians or patients. Alarms alert users to treatment changes. Benefits: improved patient comfort and assured volume delivery for respiratory insufficiency.

Clinical Evidence

Clinical study conducted to compare therapy with AVAPS versus therapy without AVAPS. Results demonstrated that AVAPS is as effective as therapy without AVAPS. Additional evidence provided via comprehensive bench testing, including waveform performance, triggering, alarms, and event detection, confirming equivalence to predicate.

Technological Characteristics

Microprocessor-controlled blower system; dual-level positive pressure (IPAP/EPAP). Sensors: flow and pressure. Connectivity: user interface for clinical data display. Alarms: fixed and user-adjustable. Patient interface: nasal or full-face masks via 22mm tubing. Software: microprocessor-based control logic.

Indications for Use

Indicated for adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency requiring non-invasive ventilatory support in home or hospital 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 HC (K992530)
• Respironics BiPAP Synchrony S/T (K012323/K020777)

Submission Summary (Full Text)

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Traditional 510(k) Tab 5 – 510(k) summary

<070328

### TAB 5

#### 2007 MAY 8 -

# 510(K) SUMMARY

| Date of Submission | 31 January 2007 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Zita A. Yurko<br>Manager, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[e-mail] |
| | 724-387-4120 t<br>724-882-4120 c<br>724-387-4216 f |
| Classification Reference | 21 CFR 868.5895 |
| Product Code | MNS - Continuous ventilator |
| Common/Usual Name | Ventilator, continuous, non-life supporting |
| Proprietary Name | Respironics BiPAP Synchrony with AVAPS Ventilatory Support System |
| Predicate Device(s) | Respironics BiPAP Synchrony HC (K992530) |
| | Respironics BiPAP Synchrony S/T (K012323/K020777) |
| Reason for submission | new device (built on an existing cleared device platform) |

# Substantial Equivalence

The BiPAP Synchrony with AVAPS has the following similarities to the previously cleared predicate device:

- □ Same intended use.
- Same operating principle. ០
- Q Same technology.
- D Same manufacturing process.

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The BiPAP Synchrony was cleared in K992530/K012323/K020777. To establish a basis for effectiveness of the Average Volume Assured Pressure Support ventilation therapy feature, Respironics performed clinical study to assure therapy provided with AVAPS was equivalent to or better than existing therapy provided without AVAPS. Results from this study determined that AVAPS is as effective as that of therapy without AVAPS. Further, a risk analysis to identify the consideration of using the existing BiPAP Synchrony electromechanical platform with the Average Volume Assured Pressure Support Ventilation therapy feature to treat adult patients with OSA and Respiratory Insufficiency. To determine equivalence between the Respironics BiPAP Synchrony with AVAPS and the Respironics BiPAP Synchrony, comprehensive bench testing was performed. This testing including collecting waveform performance data, triggering data, alarms data, and overall event diction and control data for comparison. Bench testing has confirmed that the BiPAP Synchrony with AVAPS performs equivalently to the device predicate BiPAP Synchrony (K992530/K012323/K020777). All tests were verified to meet the required acceptance criteria.

### Intended Use

The BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Synchrony may be used in the hospital or home.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

### Environment of Use/Patient Population

For use in the home or hospital/institutional environment on adult patients.

## Device Description

The Respironics BiPAP Synchrony with AVAPS is a microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support the patient resulting in improved patient comfort. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.

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The AVAPS feature is professionally selected and rides on top of the existing modality provided by the BiPAP Synchrony. The BiPAP Synchrony with AVAPS pressure control that contains various controls which are used to configure positive pressure therapies.

The BiPAP Synchrony with AVAPS 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.

The BiPAP Synchrony with 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 22mm tubing, a method of venting exhaled gases and a patient device (mask).

(End of Tab.)

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is facing to the right, and the text is arranged around the circle.

MAY 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K070328

Trade/Device Name: BiPAP Synchrony with AVAPS Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: April 30, 2007 Received: May 1, 2007

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 (sec 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 - 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 legally marketed 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). please contact the Office 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 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 yours.

Chiu Lin, Ph.D.

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): K070328

Device Name: _________________________________________________________________________________________________________________________________________________________________

#### Intended Use/Indications for Use

The BiPAP Synchrony with Average Volume Assured Pressure Support (AVAPS) is intended to provide non-invasive ventilatory support to treat adult patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Synchrony may be used in the hospital or home.

The Synchrony is intended for use with nasal masks and full-face masks as recommended by Respironics.

#### Environment of Use/Patient Population

For use in the home or hospital/institutional environment on adult patients.

Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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