The Watch-PAT200S-3 (WP200S-3) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200S-3 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200S-3's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200S-3's PSTAGES and SBP are 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.

Device Description

The Watch-PAT200S-3 System (WP200S-3) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 is a diagnostic aid for the detection of sleep related breathing disorders [Respiratory disturbance index (RDI), apnea – hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200S-3 may be connected to an external integrated snoring and body position (SBP) sensor.

The WP200S-3 device is worn on the wrist and consists of the following: (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) external integrated snoring and body position sensor - SBP (Optional); (5) electronics, which include a controller that records the information supplied by the PAT finger probe, oximeter, actigraph and SBP, (6) the device software; and (7) a power supply.

The Watch-PAT200S-3 is identical to the already cleared Watch-PAT200S-2 with the addition of an optional snoring level and body position sensor and the required electronic and software modification. The integrated sensor (SBP) is an optional external hardware which can be connected to the WP200S-3 device and attached to the patient's chest right under the sternal notch for recording snoring and body position signals.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Watch-PAT200S-3, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics against specific criteria (e.g., sensitivity, specificity thresholds). Instead, the performance testing demonstrated substantial equivalence to predicate devices and focused on the addition of the SBP sensor. The general "acceptance criteria" can be inferred to be successful completion of the described performance tests to demonstrate safety and efficacy.

Acceptance Criteria (Inferred)	Reported Device Performance
Electrical and Electromagnetic Testing	Successfully completed, demonstrating the WP200S-3 does not raise new issues of safety or efficacy.
Software Verification and Validation	Successfully completed, demonstrating the WP200S-3 does not raise new issues of safety or efficacy.
Clinical Study	Successfully completed, supporting the claim of measuring snoring level and body position, and demonstrating the WP200S-3 does not raise new issues of safety or efficacy. Specifically referenced as supporting the claim of measuring snoring level in decibels and body position.
Substantial Equivalence to Predicates	Demonstrated through performance testing, indicating the WP200S-3 is as safe and effective as its predicates.

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

The document mentions "a clinical study" was performed and that "supportive clinical data" was used. However, it does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth in the clinical study.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used (e.g., 2+1, 3+1, none) for the test set in the clinical study.

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

The document does not mention or describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is described as a diagnostic aid that generates indices (PRDI, PAHI, PSTAGES) and provides supplemental information. The focus of the clinical study mentioned was on supporting the snoring level and body position claims.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the device (Watch-PAT200S-3) as a diagnostic aid that generates PRDI, PAHI, PSTAGES, and optionally snoring level and body position discrete states, operates in a standalone manner. The clinical study and performance testing would have evaluated the standalone performance of the device's algorithms to support its claims. The document implies an algorithm-only performance assessment where the device's outputs (PRDI, PAHI, etc.) are compared against a ground truth.

7. The Type of Ground Truth Used

The document explicitly states that the clinical study was conducted to support "the claim of measuring snoring level in decibels and body position." While not explicitly stated, it is highly probable that the ground truth for these measurements would have been established by reference devices or expert observation/recording (e.g., simultaneous polysomnography (PSG) recording for body position and sound level meters for snoring, or expert scoring of PSG data). For PRDI/PAHI and sleep staging, the typical ground truth in such studies is concurrently recorded, expertly scored polysomnography (PSG) data.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of any algorithms within the device.

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

The document does not provide information on how the ground truth for the training set (if any was used for algorithm development) was established.

Summary

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510(K) SUMMARY

510(k) Number K102567

Itamar Medical Itd. 5.1 Applicant's Name: 9 Halamish st. Caesarea 38900, Israel Tel: +972 4 617 7000 Fax: +972 4 627 5598
Jonathan Kahn, Esq. 5.2 Contact Person: Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202)637-5794 Fax: (202)637-5910 Email: jonathan.kahan@hoganlovells.com
5.3 Date Prepared: June 2011
Watch-PAT 200S-3 ("WP200S-3") 5.4 Trade Name:
5.5 Common or Usual Name: Ventilatory Effort Recorder
5.6 Classification Name: Breathing Frequency Monitor
5.7 Medical Specialty: Anesthesiology
5.8 Product Code: Ventilatory Effort Recorder, MNR
5.9 Device Class: Class II
5.10 Regulation Number: 868.2375
5.11 Panel: Anesthesiology
5.12 Predicate Devices:
- Watch-PAT200S-2 ("WP200S-2") (Itamar Ltd), cleared under K081982; product . code MNR (ventilatory effort recorder)
- Ultima Snoring Mike, model 0540 (Braebon Medical Corporation), cleared under . K020312; product code MNR (ventilatory effort recorder).

ﺔ

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Embla Polysomnography system (PSG), cleared under K971813; product code . GWQ (electroencephalograph).

5.12 Intended Use / Indication for Use:

The Watch-PAT200S-3 (WP200S-3) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eve Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200S-3 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200S-3's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200S-3's PSTAGES and SBP are 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.

5.13 Device Description:

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5.14 Substantial Equivalence:

Intended Use

The intended use of the WP200S-3 is substantial equivalence to the combination of the intended use of its predicates Watch-PAT200S-2 ("WP200S-2") (Itamar Ltd), Ultima Snoring Mike, model 0540 (Braebon Medical Corporation) and Embla Polysomnography system (PSG) and any minor differences do not alter the intended diagnostic value of the WP200S-3. The claim of measuring snoring level in decibels and body position, were supported by both software verification and validation activities and a clinical study.

Technological Characteristics and Mode of Operation

The WP200S-3, like its predicate the WP200S-2, is a ventilatory effort recorder that utilizes PAT technology.

The integrated snoring and body position sensor can be attached to the patient's chest right under the sternal notch for recording snoring intensity in decibels and body position signals.

The WP200S-3's software modification done to include the new algorithm which allows for further processing of the external integrated signals of snoring and body position raise no new issue of effectiveness, as demonstrated through software verification and validation and supportive clinical data.

The WP200S-3's principles of operation and technology are the same as the cleared WP200S-2's except for the operation and technology of the SBP sensor. This SBP sensor is similar in operation and technology to those of the WP200S-3 predicate devices.

Performance Testing

A series of safety and performance testing were performed to demonstrate that the WP200S-3 does not raise any new issues of safety and efficacy. These tests include:

Electrical and electromagnetic testing .
Software verification and validation .
Clinical study .

All these tests demonstrate that the WP200S-3 is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

Summarv

Based on the performance testing results, including software verification and validation process, Electrical and electromagnetic testing, clinical study, Itamar Ltd. believes that the WP200S-3 System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jonathan Kahn Itamar Medical, Limited Hogan Lovells Us LLP 555 Thirteenth Street NW Washington, District of Columbia 20004-1109

JUN - 2 2011

Re: K102567

Trade/Device Name: Watch-PAT 200S-3 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: May 13, 2011 Received: May 13, 2011

Dear Mr. Kahn:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kahn

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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

510(k) Number (if known): K102567

Device Name: Watch-PAT200S-3 (WP200S-3)

Indications for Use:

Prescription Use V V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Arl. M.D.

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

510(k) Number: K102567

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).