AUTOSET SPIRIT SYSTEM

K032480 · Resmed, Ltd. · BZD · Oct 16, 2003 · Anesthesiology

Device Facts

• Record ID: K032480
• Device Name: AUTOSET SPIRIT SYSTEM
• Applicant: Resmed, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AUTOSET SPIRIT self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The AUTOSET SPIRIT self-adjusting sleep apnea system has two treatment-modes (auto-titrating and fixed-pressure CPAP). The optional integrated humidifier (HUMIDAIRE 2i) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT self-adjusting sleep apnea System and HUMIDAIRE 2i are for home and hospital use.

Device Story

Microprocessor-controlled, blower-based CPAP system; delivers air pressure (4-20 cmH2O) to maintain airway patency (air splint) for OSA treatment. System comprises flow generator, patient tubing, mask, and optional integrated humidifier (HUMIDAIRE 2i). Used in home and hospital environments by adult patients. Device automatically adjusts pressure based on patient needs. Healthcare providers use device output to manage OSA therapy. Benefits include effective treatment of sleep apnea through pressure titration.

Clinical Evidence

No clinical data provided. Bench testing only (referenced from predicate).

Technological Characteristics

Microprocessor-controlled blower-based system; pressure range 4-20 cmH2O. Includes integrated humidifier. Class II device (21 CFR 868.5905).

Indications for Use

Indicated for treatment of Obstructive Sleep Apnea (OSA) in adult patients. Used in home and hospital settings. Includes auto-titrating and fixed-pressure CPAP modes.

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

• ResMed, AutoSet® Spirit™ CPAP System (K013843)

Submission Summary (Full Text)

{0}------------------------------------------------

| Date Prepared | 17th September, 2003 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Lionel King<br>Director, 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 | AutoSet® Spirit™ System. |
| Predicate Device(s) | ResMed, AutoSet® Spirit™ CPAP System (K013843) |
| Reason for submission | Updated Indication for Use |
| Indications for Use | "The AUTOSET SPIRIT self-adjusting sleep apnea system<br>is indicated for the treatment of Obstructive Sleep Apnea<br>(OSA) in adult patients. The AUTOSET SPIRIT self-<br>adjusting sleep apnea system has two treatment-modes<br>(auto-titrating and fixed-pressure CPAP).<br><br>The optional integrated humidifier (HUMIDAIRE 2i) is<br>indicated for the humidification and warming of air from the<br>AUTOSET SPIRIT flow generator device. The AUTOSET<br>SPIRIT self-adjusting sleep apnea System and<br>HUMIDAIRE 2i are for home and hospital use." |

A155641.doc

ার প্রায় প্রায়

{1}------------------------------------------------

## Device Description

The AutoSet Spirit (K013843) CPAP System is a microprocessor controlled blower-based system that self-adjusts the pressure from 4-20 cmH O as required to maintain an "air splint" for effective treatment of Obstructive Sleep Apnea (OSA) in adult patients. The system includes the flow generator, patient tubing, integrated humidifier and a mask (patient interface).

## Device Modification

Modification to the Indication for Use was made in the User's and Clinician's Manuals to more accurately reflect the terminology used in ISO 17510-1:2002, Sleep Apnoea breathing therapy devices under section 3, Terms and Definitions, sub section 3.16, self-adjusting sleep apnoea breathing therapy devices. The Indication for Use from the predicate submission (K013843) has only been rephrased. This change does not alter the fundamental Indication for Use as cleared by the FDA for the predicate device.

# Substantial Equivalence

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

- O Same Intended Use
- o Same Operating Principle
- o Same Technologies
- O Same Manufacturing Process

The only changes that were made relate to revised wording for the Indications for Use. Therefore, design Verification and Validation were not performed on the AutoSet Spirit System as there are no engineering changes required to the device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus-like symbol with three wavy lines representing the human services aspect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. The text is in uppercase letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 6 2003

Mr. David D'Cruz V.P. U.S. Clinical & Regulatory Affairs Resmed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K032480

Trade/Device Name: Autoset Spirit System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: July 25, 2003 Received: August 12, 2003

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.

{3}------------------------------------------------

## 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/dsma/dsmamain.html

Sincerely yours,

Susan Runge

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

{4}------------------------------------------------

Sponsor: ResMed

AutoSet Spirit Special 510(k) Premarket Notification

510(k) Number (if known): J

Device Name:

AutoSet® Spirit™ System

Indications for Use:

"The AUTOSET SPIRIT self-adjusting sleep apnea system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The AUTOSET SPIRIT selfadjusting sleep apnea system has two treatment modes (auto-titrating and fixedpressure CPAP).

The optional integrated humidifier (HUMIDAIRE 2i) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT self-adjusting sleep apnea System and HUMIDAIRE 2i are for home and hospital use."

Sanderlin

ision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: k032480

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)