The Watch-PAT200S-2 (WP200S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP200S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP200S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP200S-2's PSTAGES 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.

Device Description

The WATCH-Pat200-2 System (WP200S-2) is a non-invasive home care device for use with patients suspected to having sleep related breathing disorders. The WP200S-2 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) Sleep, Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT); a non-invasive technology. a, based on Peripheral Arterial Tonometry (PAT); a non-invasive technology.

The WP200S-2 System is a compact version of the WP100S-2 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

The provided FDA 510(k) document for the Itamar Medical Ltd Watch PAT200S-2 System does not contain a detailed study proving the device meets specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (Watch-Pat100S-2, K080427) and a device with identical hardware (Watch-Pat200i, K081037). The “Performance Data & Substantial Equivalence” section explicitly states:

"The WP200S-2 System is substantially equivalent in all aspects, including technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available WP100S-2 System, cleared under K080427 and in respect of its hardware is also substantially equivalent to the WP200i System cleared under K081037."

Therefore, the acceptance criteria are implicitly those that defined the substantial equivalence of the predicate devices, and the "study" is largely a comparison to these predicates and engineering verification/validation rather than a new clinical performance study with defined acceptance thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As a new clinical study with specific performance acceptance criteria for the WP200S-2 was not conducted or reported in this document, such a table cannot be directly generated from the provided text. The "acceptance criteria" for the WP200S-2's clearance were its substantial equivalence to the WP100S-2 (for all aspects, including performance and software) and WP200i (for hardware).

The document mentions that the WP200i/WP200S-2 hardware was subjected to:

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

And the software underwent:

Comprehensive software verification and validation activities to ensure it meets all software requirement specifications.

Essentially, the reported performance is that it performs equivalently to the predicate devices. No specific numerical metrics (e.g., accuracy, sensitivity, specificity for RDI/AHI, or sleep staging against a gold standard) are provided for the WP200S-2 itself from a new clinical study in this document.

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

Test Set Sample Size: Not specified in this document. The submission relies on the performance data of the predicate devices and engineering tests for the new device.
Data Provenance: Not explicitly stated for any clinical data specifically related to the WP200S-2 or its predicates in this document. The K080427 and K081037 submissions for the predicate devices would contain this information.

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

This information is not available in the provided document, as a new clinical study with a defined test set for performance evaluation against a ground truth was not detailed.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No, an MRMC comparative effectiveness study for human readers with and without AI assistance is not mentioned in this document. The device is a diagnostic aid, and the primary focus of this 510(k) is substantial equivalence based on prior device clearances.
Effect Size: Not applicable, as no such study was reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done? A standalone clinical performance study with specific metrics (e.g., sensitivity, specificity, accuracy against a gold standard like polysomnography) for the WP200S-2 itself is not detailed in this document. The document states: "Performance testing demonstrating the accuracy of the captured signals and device's reproducibility" was done for the hardware, and "comprehensive software verification and validation activities" were conducted. These are engineering and software tests, not typically clinical performance studies against a medical ground truth (like physician diagnosis or pathology). The substantial equivalence claim implies that its standalone performance is similar to its predicates, but no new study data is presented here.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified in this document as a new clinical performance study against a specific ground truth for RDI/AHI or sleep staging was not detailed for the WP200S-2. For devices detecting sleep disorders, the typical gold standard ground truth is Polysomnography (PSG) readings interpreted by a sleep specialist. The substantial equivalence claim implies that the predicate devices demonstrated acceptable performance against such a standard.

8. Sample Size for the Training Set

Training Set Sample Size: This information is not available in the document. The document refers to the device's software as being the same as the WP100S-2, which implies that any "training" (if an AI/ML component was used, which is not explicitly stated but implied by "diagnostic aid" and algorithm-based indices) would have occurred during the development of the predicate's software.

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

How Ground Truth Established: This information is not available in the document. As stated above, any ground truth used for developing the algorithms (if applicable) would have been established during the development of the predicate device's software.

Summary

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1081982

Itamar Medical Ltd Watch PAT200S-2 System

AUG 1 4 2008

Applicant's Name:
	Itamar Medical Itd.
	2 Ha'eshel st.
	Caesarea 38900, Israel

	Tel: +972 4 617 7000
	Fax: +972 4 627 5598
Contact Person:
	Jonathan Kahan, Esq.
	Hogan & Hartson, L.L.P.
	Columbia Square
	555 Thirteenth Street, NW

	Washington, DC 20004-1109
	Tel: (202)637-5794
	Fax: (202)637-5910
	and
	Dorit 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:	July 11, 2008
Trade Name:	Watch-PAT 200S-2 ("WP200S-2")
Common Name:	Ventilatory Effort Recorder

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

Classification Name: Breathing Frequency Monitor

Medical Specialty: Anesthesiology

Predicate Devices:

" Watch-Pat100S-2 ("WP100S-2") (Itamar Ltd), cleared under K080427; product code MNR (ventilatory effort recorder).
Watch-Pat200i ("WP200i") (Itamar Ltd), cleared under K081037; product code . MNR (ventilatory effort recorder).

Device Description:

Intended Use:

The Watch-PAT200S-2 (WP200S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP200S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP100S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP100S-2's PSTAGES is not intended to be used as the sole or

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primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

The WP100S-2 is not indicated for children less than 17 years old.

Performance Data & Substantial Equivalence:

The WP200S-2 System is substantially equivalent in all aspects, including technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available WP100S-2 System, cleared under K080427 and in respect of its hardware is also substantially equivalent to the WP200i System cleared under K081037.

The principle changes between the WP100S-2 and the WP200S-2 systems include minor hardware modifications that were made to the controller components to enable more compact design and lower power consumption. The hardware of the WP200S-2 system is identical to the hardware of the WP200i, both are compact versions of the Watch Pat system. This WP200i/WP200S-2 hardware was subjected to the following testing (K081037):

Electrical and electromagnetic testing 로
해 Electronics design verification test
보 Performance testing demonstrating the accuracy of the captured signals and device's reproducibility

The software of the WP200S-2 is the same software as the WP100S-2, allowing for the detection of sleep related breathing disorders and presentation of both the PRDI and PAHI indices and PAT sleep staging identification; PSTAGES (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). A comprehensive software verification and validation activities were conducted to ensure that the software meets all software requirement specifications.

Based on the design verification and validation processes, performed as a result of risk analysis assessment, Itamar Medical Ltd. believes that the WP200S-2 System is substantially equivalent to the cleared WP100S-2 System without raising new safety and/or effectiveness issues.

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Image /page/3/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 symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement. The text is in all caps and is evenly spaced around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Itamar Medical Limited C/O Mr. Jonathan S. Kahan Regulatory Counsel Hogan & Hartson L.L.P 555 Thirtcenth Street, NW Washington, DC 20004

AUG 1 4 2008

Re: K081982

Trade/Device Name: Watch-PAT200S-2 (WP200S-2) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: July 11, 2008 Received: July 11, 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 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 vours.

Th. Schmuls-Pend, m.D.

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):

Device Name:

Indications for Use:

The WP200S-2 is not indicated for children less than 17 years old.

M. Thel

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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)

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).