PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER

K061200 · Resmed, Ltd. · BZD · Jul 20, 2006 · Anesthesiology

Device Facts

• Record ID: K061200
• Device Name: PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.

Device Story

PRESTIGE CPAP System provides continuous positive airway pressure (4-20 cmH2O) to treat obstructive sleep apnea; functions as an 'air splint' to maintain airway patency. System includes flow generator, patient tubing, mask, and humidifier. Micro-processor controlled blower system generates pressure. Intended for home use by patients. Healthcare providers use device output to manage OSA therapy. Benefits include effective treatment of OSA symptoms.

Clinical Evidence

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

Technological Characteristics

Micro-processor controlled blower system; generates CPAP 4-20 cmH2O. System components: flow generator, patient tubing, mask, humidifier. Complies with FDA guidance for ventilators and software. No specific material standards or connectivity details provided.

Indications for Use

Indicated for treatment of obstructive sleep apnea (OSA) in patients weighing >30 kg (66 lb). Intended for home 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

• S8 Prime (K013909)
• S7 Elite (K033841)

Submission Summary (Full Text)

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**RESMED**

PRESTIGE Traditional 510(k) Premarket Notification

| Date Prepared | 10th April, 2006 | JUL 20 2006 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Official Contact | Dr Lionel King<br>V.P., Quality Assurance & Regulatory Affairs<br>ResMed Ltd<br>97 Waterloo Road<br>North Ryde, NSW 2113<br>Australia<br>Tel: [phone]<br>Fax: [phone] | |
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | 73 BZD | |
| Common/Usual Name | Non continuous ventilator (IPPB). | |
| Proprietary Name | PRESTIGE CPAP System | |
| Predicate Device(s) | S8 Prime (K013909)<br>S7 Elite (K033841) | |
| Reason for submission | New Device | |

# 510(k) Summary - PRESTIGE CPAP System

Intended for Use

The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.

.

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## Substantial Equivalence

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

- ﺮ ﺍ Similar intended use
- Same operating principle ﺮ ﺍ
- Similar technologies ﺮ ﺍ
- -Same manufacturing process

Design and Verification activities were performed on the PRESTIGE CPAP System as a result of the risk analysis and product requirements. All tests confirmed the product met the acceptance criteria. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment of patients with Obstructive Sleep Apnoea (OSA) who weighing more than 66 lb (>30 kg). The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:

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

#### Intended Use

The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.

### Device Description

The PRESTIGE CPAP System is similar to the predicate devices, (S8 Prime and S7 Elite CPAP System with H2i) with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHo as required to maintain an "air splint" for effective treatment of OSA. The system comprises the Flow Generator, patient tubing, mask (patient interface) and humidifier.

The performance and functional characteristics of the PRESTIGE CPAP system includes all the clinician and user friendly features of the predicate devices, S8 Prime and S7 Elite CPAP System.

#### Conclusion

The PRESTIGE CPAP System is substantially equivalent to the Predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 20 2006

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

Re: K061200

Trade/Device Name: Prestige CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 10, 2006 Received: May 1, 2006

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 Eederal 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 vour 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.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# RESMED

### Indication for Use

510(k) Number (if known):

PRESTIGE CPAP System Device Name:

Indication for Use

The PRESTIGE CPAP system is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 66 lb (>30 kg). It is intended for use at home.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X Over-The-Counter Use_

(Part 21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

AND/OR

Concurrence of CDRH; Office of Device Evaluation (ODE)

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10tt April, 2006

Auy Shalom

Page 13

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Cuon Control, Dental Devices

Number. K0612