VPAP III

K030843 · Resmed, Ltd. · BZD · Aug 15, 2003 · Anesthesiology

Device Facts

• Record ID: K030843
• Device Name: VPAP III
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VPAP III™ is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 2I™) is indicated for the humidification and warming of air from the VPAP III™ flow generator. The VPAP III™ flow generator and HUMIDAIRE 2I™ are for home and hospital use.

Device Story

VPAP III is a microprocessor-controlled, blower-based positive airway pressure flow generator; treats Obstructive Sleep Apnea (OSA) in adults. Device delivers bi-level positive airway pressure to provide pressure relief during exhalation. Used with patient tubing and mask; optional integrated HUMIDAIRE 2i humidifier provides air warming/humidification. Operated in home or hospital settings. Healthcare providers use device output to manage OSA therapy; device benefits patients by maintaining airway patency during sleep.

Clinical Evidence

Bench testing only. Design verification and validation tests performed in accordance with risk analysis and product requirements confirmed safety and effectiveness.

Technological Characteristics

Microprocessor-controlled blower-based flow generator. Bi-level pressure delivery. Integrated humidifier option. Home and hospital use. Software-controlled.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea (OSA) in adult patients. Optional humidifier indicated for humidification and warming of air. For home and hospital use.

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

• S7 Elite CPAP System (K013909)
• VPAP II ST Nasal VPAP System (K961783)

Submission Summary (Full Text)

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| K030843 | RESMED |
|---------|--------|
|---------|--------|

# 510(k) SUMMARY— VPAP III

Date Prepared

10" March 2003

VPAP III™

Official Contact

Dr Lionel King ResMed Ltd 97 Waterloo Road North Ryde NSW 2113 Australia

Tel: + 61 (2) 9886 5000

Fax: + 61 (2) 9878 5517

| Device Trade Name | VPAP III™ |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name | CPAP and Bi-level Flow Generator |
| Classification Name | BZD Noncontinuous Ventilator |
| Predicate Devices | S7 Elite CPAP System (K013909) |
| | VPAP II ST Nasal VPAP System (K961783) |
| Reason for Submission | Modified design, additional therapy mode |
| Indications for use | The VPAP III™ is intended for the treatment of<br>Obstructive Sleep Apnea (OSA) in adult patients. The<br>optional integrated humidifier (HUMIDAIRE® 2I™) is<br>indicated for the humidification and warming of air from<br>the VPAP III™ flow generator. The VPAP III™ flow<br>generator and HUMIDAIRE 2I™ are for home and hospital<br>use. |

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## Device Description

The VPAP III is a microprocessor-controlled blower-based positive airway pressure flow generator for the treatment of OSA. The device is based on the S7 Elite with an additional therapy mode (bi-level), derived from the VPAP II ST, to provide pressure relief during exhalation. The flow generator is used in combination with patient tubing and a mask. For additional humidification, an optional integrated humidifier, the HUMIDAIRE 2i, is compatible with the flow generator.

#### Substantial Equivalence

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

- ച Same Intended Use
- J Same Operating Principle
- Same Technologies
- Same Manufacturing Line า

Design Verification and Validation tests were performed on the VPAP III flow generator, in accordance with the risk analysis and product requirements. All tests confirmed that the modifications have had no impact on the safety or effectiveness of the device. In summary, the device in this submission is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

AUG 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited Senior Director of QA/RA C/O Roger Kotter 14040 Danielson Street Poway, California, 92064-6857

Re: K030843

Trade/Device Name: VPAP III Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 13, 2003 Received: June 16, 2003

#### Dear Mr. Kotter:

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. Kotter

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/dsma/dsmamain.html

Sincerely yours,

Susan Runs

Susan Runner, DDS, MA Interim 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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RESMED

VPAP III™

510(k) Number (if known):

KD30843

Device Name:

VPAP |||"*

Indications for Use:

The VPAP III™ is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 21™) is indicated for the humidification and warming of air from the VPAP III™ flow generator. The VPAP III™ flow generator and HUMIDAIRE 21™ are for home and hospital use.

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Concurrence of CDRH; Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| 510(k) Number: | K030 843 |
|----------------|----------|
|----------------|----------|

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Optional Format 1-2-96)