VPAP AUTO WITH H3I

K071171 · Resmed, Ltd. · BZD · Jul 10, 2007 · Anesthesiology

Device Facts

• Record ID: K071171
• Device Name: VPAP AUTO WITH H3I
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indicated for humidification of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 31 are intended for use in the hospital and home.

Device Story

VPAP Auto System is a noncontinuous ventilator (IPPB) for OSA treatment; provides CPAP, Bilevel, and Vset therapy modes. System includes flow generator, HumidAire 3i humidifier, patient tubing, mask, Smart Card, and USB adapter. Operates via microprocessor-controlled blower system generating airway pressures to maintain effective treatment. Used in hospital and home settings by patients under clinician guidance. Clinicians use device output to monitor therapy effectiveness; patient benefits from automated pressure adjustments for OSA management.

Clinical Evidence

Bench testing only. Design and verification activities were performed based on risk analysis and product requirements; all tests confirmed the system met predetermined acceptance criteria.

Technological Characteristics

Microprocessor-controlled blower system; CPAP, Bilevel, and Vset therapy modes. Includes integrated humidifier, Smart Card, and USB adapter. Complies with FDA guidance for ventilators and software. Connectivity via Smart Card/USB for data management.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea (OSA) in patients weighing > 66 lb (30 kg).

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

• VPAP Malibu (K062291)
• S8 Pioneer (K041209)
• S7 Elite CPAP System (K013909)

Submission Summary (Full Text)

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L071171

# RESMED

VPAP Auto Traditional 510(k) Premarket Notification

# 510(k) Summary - VPAP Auto System

| Date Prepared | 19 ^th April, 2007 |
|---------------|------------------------------|
|---------------|------------------------------|

JUL 10 2007

| Official Contact | Dr Lionel King |
|--------------------------|----------------------------------------------|
| | V.P., Quality Assurance & Regulatory Affairs |
| | ResMed Ltd |
| | 1 Elizabeth Macarthur Drive |
| | Bella Vista, NSW 2153 |
| | Australia |
| | Tel: [phone] |
| | Fax: [phone] |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | 73 BZD |
| Common/Usual Name | Noncontinuous ventilator (IPPB). |
| Proprietary Name | VPAP Auto System |
| Predicate Device(s) | VPAP Malibu (K062291) - Primary |
| | S8 Pioneer (K041209) - Secondary |
| | S7 Elite CPAP System (K013909) - Secondary |
| Reason for submission | New Device |

Intended for Use

The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indicated for humidification of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 31 are infonded for use in the hospital and home.

.

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## Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device.

- A Similar intended use
- 产 Similar operating principle
- ﺧﺮ Same technologies
- ﺗﯜ Same manufacturing process

Design and Verification activities were performed on the VPAP Auto System as a result of the risk analysis and product requirements. All tests confirmed the VPAP Auto System met the predetermined acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate devices. The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:

- > FDA Draft Reviewer Guidance for Ventilators (July 1995)
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical /A Devices (May 11, 2005)
- 洪 FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)

#### Intended Use

The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indicated for humidification of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 3i are intended for use in the hospital and home.

#### Device Description

The VPAP Auto System is similar to the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909). The VPAP Auto provides CPAP, Bilevel and Vset therapy modes to adult patients with OSA. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air sployout" for effective treatment of OSA.

The system comprises the Flow Generator, HumidAire 3i, patient tubing, mask (patient interface), Smart Card and USB Adapter.

The performance and functional characteristics of the VPAP Auto system includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909).

#### Conclusion

The VPAP Auto is substantially equivalent to the VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

JUL 1 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited C/O Mr. David D'Cruz Vice President, US Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K071171

Trade/Device Name: VPAP Auto System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 19, 2007 Received: April 27, 2007

Dear Mr. D'Cruz:

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. D'Cruz

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 (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.

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.

Sumite H. Michie MD

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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### Indication for Use

510{k) Number (if known):

Device Name:

VPAP Auto System

#### Indication for Use

The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indication of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 31 are intended for use in the hospital and home.

Prescription Use X

ANDIOR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 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)

Page 1 of_____________________________________________________________________________________________________________________________________________________________________

ission Sign-Off)

I Mision of Anesthesiology, General Hospital, Control, Dental Devices

510(k) Number: k071121/