The WATCH PATTM 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI"), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

The WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy.

Device Description

The WATCH-PAT200i System (WP200i) is a non-invasive home care device for use with patients suspected to having sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stag, based on Peripheral Arterial Tonometry (PAT); a noninvasive technology.

The WP200i System is a compact version of the WP100S System, both consist of: (1) a finger PAT probe, which is used to detect the PAT signal; (2) an embedded pulse oximeter using a second probe that is attached to another finger for measuring blood oxygen saturation; (3) an embedded actigraph which is used to determine periods of sleep based on the motion of the wrist; (4) Electronics which include a controller that records the information supplied by the PAT finger probe, oximeter, and actigraph; (5) the device software; and (6) a power supply.

The device is worn on the wrist, and continuously measures the relative state of the vasomotor activity in the distal part of the finger, by a finger-mounted probe based on a plethysmographic method. The measured signal is acquired from a self contained, optopneumatic sensor.

AI/ML Overview

This 510(k) summary (K081037) for the Itamar Medical Watch-PAT 200i (WP200i) makes a claim of substantial equivalence to its predicate device, the Watch-Pat 100S (WP100S) (K042916). The submission describes that the device is substantially equivalent in all aspects, including technological characteristics, mode of operation, performance characteristics, and intended use. The primary changes are minor hardware modifications for a more compact design and lower power consumption.

The information provided does not contain a detailed study proving the device meets specific acceptance criteria with quantifiable metrics, sample sizes, expert involvement for ground truth, or details on multi-reader studies. Instead, it relies on the assertion that the WP200i's performance is maintained due to its similarity to the predicate device and that general safety and performance testing was conducted.

Here's a breakdown of the requested information based on the provided text, recognizing the limitations of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) submission for the Watch-PAT 200i (WP200i) does not provide specific, quantifiable acceptance criteria or detailed reported device performance in a tabular format. The submission states that the WP200i is substantially equivalent to the predicate device, WP100S, and implies that the WP200i meets the same performance standards as the WP100S.

The submission mentions that a series of tests were performed "to demonstrate that the modified WP200i System does not raise any new questions of safety and efficacy." These tests include:

Electrical and electromagnetic testing
Software verification and validation
Electronics design verification test
Performance testing demonstrating the accuracy of the captured signals and device's reproducibility

However, no specific performance metrics (e.g., sensitivity, specificity, accuracy for PRDI or PREM scores) are provided for these tests, nor are there acceptance criteria for these metrics. The performance of the predicate device (WP100S) is also not explicitly detailed in this document.

Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance (Implied from Predicate Equivalence)
Maintain the safety and efficacy of the predicate device (WP100S)	Achieved through minor hardware modifications and verification/validation testing. No new safety or effectiveness issues identified.
Accuracy of captured signals	Demonstrated to be accurate through performance testing (no specific metrics provided).
Device reproducibility	Demonstrated through performance testing (no specific metrics provided).
Compliance with electrical and electromagnetic standards	Demonstrated through electrical and electromagnetic testing.
Software functionality and reliability	Demonstrated through software verification and validation.
Electronics design integrity	Demonstrated through electronics design verification test.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size used for any test set or the provenance (country of origin, retrospective/prospective) of any data. The submission relies on "performance testing" and "accuracy of captured signals and device's reproducibility" without providing granular details about the studies or data used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The submission does not mention the use of experts to establish ground truth for any test set. Given that the submission focuses on substantial equivalence based on hardware modifications and general verification testing, it does not describe clinical studies that would typically involve expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Since no information is provided regarding studies to establish ground truth with experts, there is no mention of an adjudication method (e.g., 2+1, 3+1, none) for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it mentioned in the provided text. The Watch-PAT 200i is described as a diagnostic aid that generates indices (PRDI and PREM); it is not presented as an AI assistance tool for human readers in the context of interpretation. Therefore, there is no discussion of human reader improvement with or without AI assistance or any effect sizes.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone diagnostic aid that generates specific indices (PRDI and PREM). While its primary function is to process physiological signals and output these indices, the submission does not describe a specific "standalone study" in the way it might be for an AI algorithm generating diagnoses. The performance testing mentioned likely refers to the accuracy and reproducibility of its signal capture and index generation, which can be considered its standalone performance. However, no specific study details are provided to quantify this. The intended use states it's a "diagnostic aid" and PREM is "not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder," implying a human-in-the-loop for final diagnosis based on its output.

7. The Type of Ground Truth Used

The submission does not explicitly state the type of ground truth used for any studies. For a device like this, ground truth would typically come from a full polysomnography (PSG) study, which is the gold standard for diagnosing sleep-related breathing disorders. However, the document provided does not detail any comparative studies against PSG or other forms of ground truth.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size. This device is presented more as a hardware and software system for signal processing and index generation, rather than a machine learning or AI algorithm that would typically require a distinct training set. The substantial equivalence claim is based on hardware changes and verification tests rather than a new algorithm requiring a training/validation paradigm.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied, there is no information on how ground truth for a training set was established.

Summary

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KOY1037

510(k) SUMMARY

JUN - 9 2008

Applicant's Name:	Itamar Medical Itd.2 Ha'eshel st.Caesarea 38900, IsraelTel: +972 4 617 7000Fax: +972 4 627 5598
Contact Person:	Jonathan Kahan, Esq.Hogan & Hartson, L.L.P.Columbia Square555 Thirteenth Street, NWWashington, DC 20004-1109Tel: (202)637-5794Fax: (202)637-5910
	andDorit Winitz, Ph. DBiomedical Strategy (2004) Ltd.Moshe Aviv Tower, 34th Floor,7 Jabotinsky StreetRamat Gan 52520, IsraelTel: +972-3-612-3281Fax: +972-3-612-3282dorit@ebms.co.il
Date Prepared:	March, 2008
Trade Name:	Watch-PAT 200i ("WP200i")
Common Name:	Ventilatory Effort Recorder

. 1

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Classification:

21 CFR 868.2375 Class:II MNR (Ventilatory Effort Recorder).

Classification Name: Breathing Frequency Monitor

Medical Specialty: Anesthesiology

Predicate Devices:

Watch-Pat100S ("WP100S") (Itamar Ltd), cleared under K042916; product code MNR (ventilatory effort recorder).

Device Description:

Intended Use:

The WATCH PAT™ 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI"), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy.

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Performance Data & Substantial Equivalence

The WP100i System is substantially equivalent in all aspects, including tcchnological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available WP100S System, cleared under K042916.

The principle changes between the devices include minor hardware modifications that were made to the controller components to enable more compact design and lower power consumption.

A series of safety and performance testing, including bench testing were performed to demonstrate that the modified WP200i System does not raise any new questions of safety and efficacy. These tests include:

트 Electrical and electromagnetic testing
l Software verification and validation
트 Electronics design verification test
트 Performance testing demonstrating the accuracy of the captured signals and device's reproducibility

Based on these tests results, Itamar Medical Ltd. believes that the WP200i System is substantially equivalent to the cleared WP100S System without raising new safety and/or effectiveness issues.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & 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. The seal is simple and monochromatic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2008

Itamar Medical Limited C/O Mr. Jonathan S. Kahan Regulatory Affairs Consultant Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109

Re: K081037

Trade/Device Name: Watch-PATTM 200i Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: May 13, 2008 Received: May 13, 2008

Dear Mr. Kahan:

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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Page 2 – Mr. Kahan

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 Office of Compliance at (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

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

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Indications for Use Statement

510(k) Number (if known): K081037

Device Name: WATCH PATTM 200i

Indications for Use:

The WATCH PATTM 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI'), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

The WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy.

Prescription Use X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number:	K08 1037
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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).