AUTOSET SPIRIT CPAP SYSTEM

K013843 · Resmed Corp · BZD · Jul 16, 2002 · Anesthesiology

Device Facts

• Record ID: K013843
• Device Name: AUTOSET SPIRIT CPAP SYSTEM
• Applicant: Resmed Corp
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AUTOSET SPIRIT CPAP System is indicated 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 AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.

Device Story

Non-invasive CPAP system; includes flow generator, humidifier, mask, and tubing. Flow generator uses blower, sensors, and processing electronics to deliver pressurized air. Two modes: fixed-pressure CPAP mode or auto-titrating (AutoSet) mode, which adjusts pressure based on patient breathing patterns. Clinical Interface (AutoScan) software allows clinicians to adjust parameters and view stored treatment data via PC. Used in home or hospital settings to treat OSA; helps maintain airway patency.

Clinical Evidence

Bench testing only. Device tested against EN 60601-1 (safety), EN 60601-1-2 (EMC), IEC 529 (enclosure protection), ISO 8185 (humidifiers), and PrEN ISO 17510 (sleep apnea therapy devices). No clinical trial data presented.

Technological Characteristics

Flow generator with blower (motor/fan), sensors, and processing electronics. Integrated humidifier. Connectivity via PC for data download. Standards: EN 60601-1, EN 60601-1-2, IEC 529, ISO 8185, PrEN ISO 17510.

Indications for Use

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

• ResMed Sullivan AutoSet CPAP System (K980721)
• ResMed Sullivan HumidAire Heated Humidifier (K971260)

Submission Summary (Full Text)

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### SAFETY AND EFFECTIVENESS (SUMMARY) 2.

#### 2.1 Indications for Use

The AUTOSET SPIRIT CPAP System is indicated 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 AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.

#### 2.2 Brief Device Description

The AUTOSET SPIRIT CPAP System is a non-invasive Continuous Positive Airway Pressure (CPAP) system. It includes the following system components:

- Flow generator device,
- . Humidifier
- Mask and air tubing.
- . Clinical Interface (AutoScan) Software.

The flow generator device incorporates a blower (motor/fan assembly), sensors and processing electronics. The blower supplies pressurized air to the patient via the air tubing and a mask.

The AUTOSET SPIRIT flow generator has two (2) modes of operation:

- (i) CPAP Mode
In this mode the flow generator provides a single fixed-pressure as set by the clinician.

- Auto-titrating (AutoSet) Mode (ii)
In this mode the pressure is automatically set in response to the patient's breathing patterns.

The AutoScan software allows adjustment of parameter settings and viewing of flow generator-stored treatment data via a PC.

#### 2.3 Substantial Equivalence

This submission demonstrates Substantial Equivalence of the AUTOSET SPIRIT CPAP System (including the integrated humidifier) with the predicate ResMed Sullivan AutoSet CPAP System (K980721) and the predicate ResMed Sullivan HumidAire Heated Humidifier (K971260). (The Sullivan AutoSet CPAP System was cleared for use with the Sullivan HumidAire Heated Humidifier.)

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The AUTOSET SPIRIT flow generator and the HUMIDAIRE 2i integrated humidifier are developments from the predicate Sullivan AutoSet flow generator and Sullivan HumidAire devices and share many design features.

The AUTOSET SPIRIT CPAP System has been tested to the following standards and guidance documents:

- Medical electrical equipment. Part 1: General requirements for . EN 60601-1 safety.
- Medical electrical equipment Part 1: General requirements for . EN 60601-1-2 safety - 2. Collateral standard: Electromagnetic compatibility.
- Degrees of protection provided by enclosures (Code IP). . IEC 529: 1989
- Humidifiers for medical use General requirements. . ISO 8185:1997
- Sleep Apnoea Therapy Devices (1998). PrEN ISO 17510 ●
- . Reviewer Guidance for Premarket Notification Submissions, November 1993, ARDB, CDRH, FDA.
- FDA Heated Humidifier Review Guide, Shelf # 780, 8/30/91 (applicable requirements) .

This submission presents the results of this testing, and together with detailed descriptions demonstrate Substantial Equivalence of the AUTOSET SPIRIT CPAP System to the predicate devices.

## END -- Traditional 510(k) Summary of Safety and Effectiveness

16 November 2001

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three horizontal lines above it, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 6 2002

Mr. Roger Kotter Senior Director of QA/RA ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K013843

Trade/Device Name: AUTOSET® CPAP System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 16, 2002 Received: April 19, 2002

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.

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.

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Page 2 - Mr. Kotter

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Tim 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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#### 3.2 Indications for Use

510(k) Number (if known): _KO| 3843

AUTOSET® SPIRIT™ CPAP System Device Name:

Indications for Use:

The AUTOSET SPIRIT CPAP System is indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMDAIRE® 2[™) is indicated for the humidification and warming of air from the AUTOSET SPIRIT flow generator device. The AUTOSET SPIRIT CPAP System and HUMIDAIRE 2i are for home and hospital use.

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

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

n Sign-Off)
Page **_ of _**
of Dental, Infection Control,
eral Hospital Devices K013843
Jumber

Concurrence of CDRH, Office of Device Evaluation (ODE)

16 November 2001

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