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 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).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the AutoSet® Spirit™ System. This submission is for an updated indication for use, not for a new device or significant performance claims requiring extensive new studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and comparative effectiveness studies is largely not applicable in the context of this specific submission.

Here's an explanation based on the provided document:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This 510(k) submission is for a modification to the "Indication for Use" statement, not for a change that would require new performance acceptance criteria or a new performance study. The device itself (AutoSet Spirit CPAP System) was previously cleared (K013843), and its performance would have been established at that time. The current submission explicitly states: "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. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No new test set data was generated for this specific submission because there were no engineering changes to the device or new performance claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As no new performance testing was conducted, there was no test set requiring ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set, no adjudication method for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. The AutoSet® Spirit™ System is a CPAP system, a therapeutic device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. The AutoSet® Spirit™ System is a self-adjusting CPAP device; it is not an algorithm that operates in a standalone diagnostic or analytical capacity. Its "self-adjusting" capability refers to the mechanical adjustment of pressure, not an AI algorithm analyzing data for diagnostic purposes.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable. As no new performance studies were conducted, no new ground truth was established for this submission.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device that would require a "training set."

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/machine learning device that would require a "training set" or its associated ground truth establishment.

In summary: The provided document is a 510(k) for a minor modification (rephrasing of the Indication for Use) of an already cleared device. This type of submission does not typically involve new clinical studies or performance data, hence most of the requested information is not relevant to this specific regulatory filing. The "study" here is essentially the internal review by the manufacturer to confirm that a wording change does not alter the fundamental safety or effectiveness of the device, and the FDA's review of this assessment for substantial equivalence.

Summary

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

Date Prepared	17th September, 2003
Official Contact	Lionel KingDirector, Regulatory AffairsResMed Ltd97 Waterloo RoadNorth Ryde, NSW 2113AustraliaTel: +61 (2) 9886 5443Fax: +61 (2) 9878 5564
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 systemis 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) isindicated for the humidification and warming of air from theAUTOSET SPIRIT flow generator device. The AUTOSETSPIRIT self-adjusting sleep apnea System andHUMIDAIRE 2i are for home and hospital use."

A155641.doc

ার প্রায় প্রায়

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

Device Description

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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).

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)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
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.(b)
Classification. Class II (performance standards).