BIPAP AUTOSV

K090248 · Respironics Inc., Sleep & Home Respiratory Group · MNS · Mar 4, 2009 · Anesthesiology

Device Facts

• Record ID: K090248
• Device Name: BIPAP AUTOSV
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: MNS · Anesthesiology
• Decision Date: Mar 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIPAP AutoSV is intended to provide non-invasive ventilatory subport to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Device Story

Microprocessor-controlled, blower-based bi-level positive pressure system; delivers IPAP/EPAP levels to provide non-invasive ventilatory support. Flow and pressure sensors in patient airway feed data to microprocessor; controller regulates blower assembly to normalize ventilation during sleep-disordered breathing events. Device delivers minimum pressure support via EPAP and IPAP Min controls; automatically adjusts inspiratory pressure between IPAP Min and IPAP Max. Used in clinical or home settings; operated by patient or clinician. User interface displays clinical data and allows parameter adjustment. Includes alarms for treatment changes. Connects to patient via circuit (tubing and mask). Benefits patients by providing natural pressure support to treat central/mixed apneas and periodic breathing.

Clinical Evidence

Bench testing only. Design verification tests performed to meet acceptance criteria; no clinical data provided.

Technological Characteristics

Microprocessor-controlled blower; bi-level positive pressure (IPAP/EPAP). Sensors: flow and redundant pressure sensors. Connectivity: user interface for clinical data display and parameter configuration. Software: microprocessor-based control system. Complies with FDA software guidance (May 2006).

Indications for Use

Indicated for adult patients with obstructive sleep apnea (OSA) and respiratory insufficiency caused by central and/or mixed apneas and periodic breathing. Prescription use only.

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 AutoSV (K063540)
• Respironics BiPAP Synchrony (K020777)

Submission Summary (Full Text)

{0}------------------------------------------------

10248

# MAR 4 2009 SAFETY & LEFFECTIVE

| Official Contact | Zita A. Yurko<br>Director, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[e-mail]<br>724-387-4120 t<br>724-882-4120 c<br>724-387-4216 f |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Reference | 21 CFR 868.5895 |
| Product Code | MNS – Non-Continuous ventilator |
| Common/Usual Name | Ventilator, continuous, non-life supporting |
| Proprietary Name | Respironics BiPAP AutoSV |
| Predicate Device(s) | Respironics BiPAP AutoSV (K063540)<br>Respironics BiPAP Synchrony (K020777) |
| Reason for submission | modified device |

{1}------------------------------------------------

# Substantial Equivalence

The BiPAP AutoSV has the following similarities to the previously cleared predicate device:

- a Same intended use.
- Same operating principle. o
- Same technology. ם
- O Same manufacturing process.

The BiPAP AutoSV was cleared in K063540. The BiPAP Synchrony with Bi-Flex was cleared in K020777. Design verification tests were performed on the Respironics BIPAP AutoSV 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 described 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 in Medical Devices," May 2006.

#### Intended Use

The BIPAP AutoSV is intended to provide non-invasive ventilatory subport to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

### Device Description

The Respironics BIPAP AutoSV 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 therapy to 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.

The BiPAP AutoSV pressure control that contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the EPAP and IPAP Min controls. The device may automatically provide additional pressure support with inspiratory pressures between IPAP Min and IPAP Max to normalize patient ventilation during sleep

{2}------------------------------------------------

.

disordered breathing events. Note: When EPAP < IPAP Min = IPAP Max, this is equivalent to traditional bi-level therapy.

The BIPAP AutoSV 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 AutoSV 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.

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black against a white background.

4 2009 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090248

> Trade/Device Name: BiPAP AutoSV Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: January 30, 2009 Received: February 2, 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 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.

{4}------------------------------------------------

# 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Qudite Y. Michine Dms.

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known):

Device Name: BiPAP AutoSV

The BiPAP AutoSV is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Prescription Use Over-The-Counter Use X Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (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)

Susan Rimon

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

510(k) Number: _