VPAP ST

K080131 · Resmed, Ltd. · BZD · Apr 1, 2008 · Anesthesiology

Device Facts

• Record ID: K080131
• Device Name: VPAP ST
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.

Device Story

VPAP ST is a noncontinuous ventilator (IPPB) providing CPAP, Bilevel, and VAuto therapy modes. Device uses a microprocessor-controlled blower system to generate airway pressures, maintaining an 'air splint' to treat OSA. System includes flow generator, HumidAire 4i humidifier, patient tubing, mask, Smart Card, and USB adapter. Used in hospital and home settings by patients under clinician guidance. Output consists of pressurized air delivered to the patient; healthcare providers use device features to manage therapy. Benefits include effective treatment of OSA through controlled airway pressure.

Clinical Evidence

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

Technological Characteristics

Microprocessor-controlled blower system; CPAP, Bilevel, and VAuto therapy modes; includes flow generator, humidifier, tubing, mask, Smart Card, and USB adapter. Complies with FDA guidance for ventilators and software.

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)
• Sullivan VPAP II ST (K961783)
• VPAP Auto (K071171)

Submission Summary (Full Text)

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RESMED

VPAP ST Traditional 510(k) Premarket Notification

# 510(k) Summary - VPAP ST

| Date Prepared | 14th Jan, 2008 |
|--------------------------|----------------------------------------------|
| | APR - 1 2008 |
| 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 ST |
| Predicate Device(s) | VPAP Malibu (K062291) - Primary |
| | S8 Pioneer (K041209) - Secondary |
| | Sullivan VPAP II ST (K961783) - Secondary |
| | VPAP Auto (K071171) - Secondary |
| Reason for submission | New Device |

### Intended for Use

The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air than oo ib (oo hg). "The optional megrated Prairial in device. The VPAP ST and HumidAire 4i are intended 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.

- ﺣﺮ ﺍ Similar intended use
- 公 Similar operating principle
- > Same technologies
- 公 Same manufacturing process

Design and Verification activities were performed on the VPAP ST as a result of the risk analysis and product requirements. All tests confirmed the VPAP ST 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:

- A 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)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) 公

#### Intended Use

The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.

#### Device Description

The VPAP ST is similar to the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171). The VPAP ST provides CPAP, Bilevel and VAuto 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 splint" for effective treatment of OSA.

The system comprises the Flow Generator, HumidAire 4i, patient tubing, mask (patient interface), Smart Card and USB Adapter.

The performance and functional characteristics of the VPAP ST includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171).

#### Conclusion

The VPAP ST is substantially equivalent to the VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2008

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

Re: K080131

Trade/Device Name: VPAP ST Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD, BTT Dated: January 14, 2008 Received: January 18, 2008

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,

Senate Y. Michie, M.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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## Indication for Use

510(k) Number (if known):

Device Name:

VPAP ST

#### Indication for Use

The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 41 are intended for use in the hospital and home.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR

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) | |
|--------------------------------------------------------|-------------|
| (Division Sign-Off) | Page 1 of 1 |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K040131 |

14" Jan, 2008

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