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.

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.

AI/ML Overview

This document describes the AUTOSET SPIRIT CPAP System, a device for treating Obstructive Sleep Apnea (OSA). The information provided is primarily focused on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices in the US. This type of submission relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with pre-defined acceptance criteria based on performance metrics.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, as it would apply to a novel device or a device requiring a specific performance study, is not explicitly present in the provided text. The submission focuses on compliance with standards and a comparison to predicate devices, rather than a standalone performance study with specific effectiveness endpoints.

However, I can extract information related to the device description, indications for use, and the regulatory pathway.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:

Acceptance Criteria and Study for AUTOSET SPIRIT CPAP System

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

Acceptance Criteria: Not explicitly stated as performance metrics in this regulatory filing. The "acceptance criteria" here are implicitly being "substantially equivalent" to predicate devices and meeting relevant safety and electrical standards.
Reported Device Performance: No specific performance metrics (e.g., AHI reduction, adherence rates, specific pressure delivery accuracy under varying conditions) are reported in clinical study format in this summary. The performance is implied to be equivalent to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (K980721 and K971260)	Demonstrated through detailed descriptions and testing results (as stated in the summary)
Compliance with EN 60601-1 (General Safety)	Tested
Compliance with EN 60601-1-2 (Electromagnetic Compatibility)	Tested
Compliance with IEC 529:1989 (Degrees of Protection)	Tested
Compliance with ISO 8185:1997 (Humidifiers)	Tested
Compliance with PrEN ISO 17510 (Sleep Apnoea Therapy Devices)	Tested
Compliance with FDA Reviewer Guidances	Considered in the submission

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a "test set" of patients for evaluating device effectiveness. The "testing" mentioned refers to compliance with engineering and safety standards, not a patient-based performance study.
Data Provenance: Not applicable.

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. There is no mention of experts establishing ground truth for a clinical test set in this document. The "ground truth" for this submission revolves around technical compliance and equivalence to predicate devices, assessed by regulatory bodies and internal engineering teams.

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

Not applicable. There is no clinical test set requiring adjudication in 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

This device (CPAP system) is not an AI-based diagnostic tool that relies on "human readers." Therefore, no MRMC study, AI assistance data, or effect size is relevant or mentioned.

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

Not applicable. This is a medical device for treatment, not an algorithm. The "Auto-titrating (AutoSet) Mode" has an algorithmic component, but its performance is demonstrated through comparison to a predicate device and compliance with standards, not a standalone algorithm study with specific metrics in this document.

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

For the purpose of this 510(k) submission, the "ground truth" is largely established by:
- Regulatory Standards: Compliance with established medical device standards (EN 60601-1, ISO 8185, etc.).
- Predicate Device Performance: The established safety and effectiveness of the ResMed Sullivan AutoSet CPAP System (K980721) and the ResMed Sullivan HumidAire Heated Humidifier (K971260). The new device demonstrates "substantial equivalence" to these.
- Engineering and Bench Testing: Implicit in the statement "This submission presents the results of this testing, and together with detailed descriptions demonstrate Substantial Equivalence..."

8. The sample size for the training set

Not applicable. This document does not describe a machine learning algorithm that requires a "training set."

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

Not applicable. This document does not describe a machine learning algorithm or a training set.

Summary of Device and Approval Process:

The AUTOSET SPIRIT CPAP System is a non-invasive Continuous Positive Airway Pressure (CPAP) system for treating Obstructive Sleep Apnea (OSA) in adults. Its approval via the 510(k) pathway was based on demonstrating "Substantial Equivalence" to two predicate devices: the ResMed Sullivan AutoSet CPAP System (K980721) and the ResMed Sullivan HumidAire Heated Humidifier (K971260). The submission included:

Detailed descriptions of the device, highlighting shared design features with predicate devices.
Results from testing against a series of international and FDA-recognized standards for medical electrical equipment, electromagnetic compatibility, enclosure protection, humidifiers, and sleep apnea therapy devices.

The FDA's finding of substantial equivalence (K013843) on July 16, 2002, indicates that the agency determined the AUTOSET SPIRIT CPAP System to be as safe and effective as its predicate devices, based on the provided technical and regulatory compliance information, rather than a new clinical effectiveness study with defined performance acceptance criteria.

Summary

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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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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

Page 9

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).