RESMED S8 PIONEER CPAP SYSTEM

K041209 · Resmed, Ltd. · BZD · Jul 1, 2004 · Anesthesiology

Device Facts

• Record ID: K041209
• Device Name: RESMED S8 PIONEER CPAP SYSTEM
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP). The S8 Pioneer system is intended for home and hospital use.

Device Story

S8 Pioneer CPAP System provides continuous positive airway pressure (4-20 cmH2O) to maintain airway patency (air splint) for OSA treatment. System includes flow generator, patient tubing, mask, and data module (Smart Card or DB9 adapter). Operates in AutoSet (self-adjusting) or fixed-pressure CPAP modes, with optional Expiratory Pressure Relief (EPR) for comfort. Used in home or hospital settings by patients under clinician guidance. Micro-processor controlled blower adjusts pressure based on patient needs. Data module facilitates clinical monitoring and therapy management. Benefits include effective OSA treatment and improved patient compliance via EPR.

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; pressure range 4-20 cmH2O. Modes: AutoSet, fixed-pressure CPAP, CPAP with EPR. Connectivity: Smart Card module or DB9 adapter for data transfer. Form factor: compact flow generator. Power: electrical. Software: microprocessor-based control.

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea (OSA) in adult patients. Intended 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

• AutoSet Spirit (K013843)
• S8 Prime (K033841)
• VPAP III (K030843)

Submission Summary (Full Text)

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K 041209

# 510(k) Summary - S8 Pioneer CPAP System

| Date Prepared | Tuesday, May 4th, 2004 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | BZD - Non-Continuous Ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | S8™ Pioneer CPAP System |
| Predicate Device(s) | AutoSet Spirit (K013843)<br>S8 Prime (K033841)<br>VPAP III (K030843) |
| Reason for submission | New Device |
| Indications for Use | The S8 Pioneer self-adjusting sleep apnea system is indicated for<br>the treatment of Obstructive Sleep Apnea (OSA) in adult patients.<br>The S8 Pioneer self-adjusting sleep apnea system has two<br>treatment modes (AutoSet and fixed-pressure CPAP).<br>The S8 Pioneer system is intended for home and hospital use. |

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# Substantial Equivalence

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

- Same intended use ﺮ ﻣﻌ
- r Similar operating principle
- Similar technologies ﺮ ﻣﺤ
- -Same manufacturing process

Design and Verification activities were performed on the S8 Pioneer 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 OSA in adults. The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:

- FDA Reviewer Guidance for Premarket Notifications, November 1993 ﺮ
- FDA Draft Reviewer Guidance for Ventilators (July 1995) . ﺗ
- FDA reviewer's and industry, Guidance for the content of premarket submissions for software . V contained in medical devices, May 1998

### Intended Use

The S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP).

The S8 Pioneer system is intended for home and hospital use.

## Device Description

The S8 Pioneer CPAP System is similar to the predicate devices, (AutoSet Spirit, S8 Prime and VPAP III) it is smaller, with a new and improved micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmH2O as required to maintain an "air splint" for effective treatment of OSA. Treatment modes are self-adjusting, CPAP and CPAP with Expiratory Pressure Relief (EPR). CPAP with EPR provides a comfort to patients who experience difficulty in breathing out aqainst CPAP during the expiratory phase.

The system comprises the Flow Generator, patient tubing, mask (patient interface) and Smart Card (SC) Module or DB9 Adapter for receiving and sending data.

The performance and functional characteristics of the S8 Pioneer CPAP system includes all the clinician and user friendly features of the predicate devices, Autoset Spirit, S8 Prime and VPAP III.

Llfk

Dr Lionel King V.P., Quality Assurance & Regulatory Affairs ResMed.

Tuesday, May 04, 2004

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 1 2004

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

Re: K041209

Trade/Device Name: ResMed S8 Pioneer CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 4, 2004 Received: May 10, 2004

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 (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 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,

Qiu Ls

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:

S8 Pioneer

#### Indications for Use:

The S8 Pioneer self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The S8 Pioneer self-adjusting sleep apnea system has two treatment modes (AutoSet and fixed-pressure CPAP).

The S8 Pioneer system is intended for home and hospital use.

Ciny Suliom

(Division Sign Division of Anesthesiology. General Hospital, Infection Control, Dental Device 510(k) Number:

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)

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Tuesday, May 04, 2004