The ApneaLink™ Plus device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. Apneal ink Plus recred the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation.

Device Description

The performance and functional characteristics of ApneaLink Plus includes all the user-friendly features of the predicate devices. The ApneaLink Plus is a further development of the previously submitted device Apneal.ink (K070263). This submission addresses the expanded Indications for Use of Apnealink by including AASM criteria for detecting hypopneas and a respiratory effort sensor to differentiate between central, obstructive and mixed apneas.

The ApneaLink Plus recorder is a 3-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Plus provides recordings of respiratory pressure, respiratory effort, pulse rate and oxvaen saturation during sleep. The phvsician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may perform the recording at home by himself. The ApneaLink Plus recorder and the respiratory effort sensor must be fastened with the re-usable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal cannula, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the ApneaLink Plus recorder and fixed at the patient's nose. The oximetry sensor is connected to the XPOD and fixed at the patient's finger. The XPOD is connected to the ApneaLink Plus recorder. The respiratory effort sensor is connected to the ApneaLink Plus recorder and held in place by the belt. After recording, the ApneaLink Plus recorder must be returned to the physician. With the ApneaLink Plus Software installed on a personnel computer the physician can generate a report with the recorded and analyzed data to aid in the diagnosis of sleep disordered breathing. The recordings and the report can be sent via email to further clinical investigation.

AI/ML Overview

The provided 510(k) summary for KOS-3575 (ApneaLink Plus) does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the indications for use.

While it states "All tests confirmed the predetermined acceptance criteria," it does not provide the specific criteria or the results of these tests. It also lacks information regarding the sample size, data provenance, ground truth establishment for test and training sets, expert qualifications, adjudication methods, or MRMC studies.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here is a summary of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

Missing: The document states "All tests confirmed the predetermined acceptance criteria," but does not list these criteria or the specific performance metrics achieved.

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

Missing: No information regarding the sample size or provenance of data used for testing is provided.

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)

Missing: No information on experts or ground truth establishment for a test set is provided.

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

Missing: No information on adjudication methods is provided.

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

Missing: There is no mention of an MRMC comparative effectiveness study. The device is intended to "aid in the diagnosis," implying it produces a report for a healthcare professional, but there's no study on human reader improvement with the device.

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

Missing: While the device analyzes data and produces a report, the document does not present a standalone performance study in terms of diagnostic accuracy against a ground truth. Its role is described as aiding diagnosis by a healthcare professional.

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

Missing: No information regarding the type of ground truth used for any testing is provided.

8. The sample size for the training set

Missing: No information regarding a training set sample size is provided. The document describes the device's functionality rather than a machine learning model's training.

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

Missing: No information regarding ground truth establishment for a training set is provided.

Information that is available (from the prompt, not directly in the requested format):

Device: ApneaLink Plus
Intended Use: To aid in the diagnosis of sleep-disordered breathing for adult patients by recording respiratory nasal airflow, snoring, blood oxygen saturation, pulse, and respiratory effort during sleep, and producing a report for healthcare professionals.
Expanded Indications: The submission addresses expanded indications by including AASM criteria for detecting hypopneas and a respiratory effort sensor to differentiate between central, obstructive, and mixed apneas.
Predicate Devices: ApneaLink (K070263) and Respironics Stardust II (K021845).
Compliance: The device complies with various standards and regulations (e.g., FDA Guidance, IEC, ISO).

Summary

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KOS-3575

510(k) Summary – ApneaLink Plus

MAR 1 9 2009

Date Prepared

28" November 2008

Official Contact	David D'Cruz
	V.P., Clinical & Regulatory Affairs
	ResMed Corp.
	14040 Danielson St,
	Poway CA 92064-6857
	USA
	Tel: +1 858-746-2238
	Fax: +1 858-746-2915
Classification Reference	21 CFR 868.2375
Product Code	MNR - Ventilatory Effort Recorder
Common/Usual Name	Ventilatory Effort Recorder
Proprietary Name	ApneaLink Plus
Predicate Devices	ApneaLink (K070263)
	Respironics Stardust II (K021845)
Reason for submission	Expanded Indications

28th November, 2008

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Substantial Equivalence

The new device has the following similarities to the previously cleared devices:

产 Intended use Similar
公 Operating principle Same
必 Technologies Same
产 Manufacturing process Same

Design and Verification activities were performed on the ApneaLink Plus as a result of the risk analysis and product requirements. All tests confirmed the predetermined acceptance criteria. ResMed has determined that the ApneaLink Plus is Substantially Equivalent to the predicate devices. The ApneaLink complies with the applicable standards and requirements referenced in the following:

ア FDA Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices (May 11, 2005)
ﻨﺰ FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
ﺗﺮ FDA General Principles of Software Validation (January 11, 2002)
ﮨﺰ IEC 60601-1 (Medical Electrical Equipment Part 1: General requirements for safety)
ﺮ IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests)
IEC 60601-1-4 (Medical Electrical Equipment Part 1-4: General requirements for safety Collateral ﺰ Standard: Programmable electrical medical systems)
A IEC 60068-2-1/ and the following (Environmental testing)
ISO 10993-1 (Biological evaluation of medical devices -- Part 1 Evaluation and testing) A
ﺗﺮ EN ISO 14971 (Medical Devices - Application of risk management to medical devices)

Intended Use

The Apneal.ink Plus device is indicated for use by Heath Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. Apnealink Plus records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation.

Device Description

280 November, 2008

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

MAR 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K083575

Trade/Device Name: ApneaLink Plus Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: March 3, 2009 Received: March 5, 2009

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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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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suven Runnes

Ginette Y. Michaud. M.D. Acting 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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510(k) Number (if known):

Device Name:

ApneaLink Plus

Indication for Use

Prescription Use ... ..........................

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)

Susan Soares

Concurrence of CDRH; Office of Device Evaluation (ODE)

(Division Sian-Off) Division of Anesthesiology. General Hospital Intection Control, Dental Devices

510(k) Number. K083375

28th November, 2008

Page 1 of__ 1

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).