The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. TheWP200U 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 WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP200U's PSTAGES and snoring level and body position 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.

PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

Device Description

The Watch-PAT200U System (WP200U) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U 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 WP200U may be connected to an external integrated snoring and body position (SBP) sensor.

The WP200U device consists of the following: (1) a unified PAT and pulse oximeter probe which is used to detect the PAT signal and to measure blood oxygen saturation; (2) an embedded actigraph, which is used to determine periods of sleep based on the wrist: (3) external integrated snoring and body position sensor – SBP/RESBP (optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP/RESBP; (5) the device software; and (6) a power supply.

The subject WP200U introduces the RESBP sensor - an additional Snoring and Body Position (SBP) integrated sensor which also includes chest movement signal.

Another change in the subject WP200U is the introduction of new sleep disorder parameter - central apnea/hypopnea index (pAHIc).

AI/ML Overview

The provided document gives information about the Watch-PAT200U device, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not explicitly state acceptance criteria in a structured table or provide detailed information about a study that proves the device meets specific acceptance criteria in the format requested.

The document discusses a clinical study conducted to evaluate the WP200U's capability to identify central sleep apnea and Cheyne-Stokes Respiration, but it only briefly mentions "Test results demonstrated substantially equivalent performance" without detailing specific performance metrics or acceptance thresholds.

Given the limitations of the provided text, I will construct the answer based on the information that is available, and explicitly state where information is missing or not provided in the requested format.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not provide a table of explicit acceptance criteria with specific performance thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, it states that "Test results demonstrated substantially equivalent performance" for the clinical study. This implies that the performance was deemed comparable to the predicate device or a clinical gold standard, but the numerical targets for such equivalence are not given.

Therefore, a table as requested cannot be fully constructed.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: 72 subjects
Data Provenance: The document states "72 subjects were evaluated in an overnight sleep study". It does not explicitly mention the country of origin or whether it was retrospective or prospective, but the description of an "overnight sleep study" suggests a prospective collection of data for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that the comparison was made against "polysomnographic (PSG) manual scoring."

Number of experts: Not specified.
Qualifications of experts: While it implicitly refers to qualified professionals performing PSG manual scoring (likely sleep physicians or trained sleep technologists), their specific qualifications (e.g., years of experience, board certification) are not detailed.

4. Adjudication method for the test set

The document mentions "polysomnographic (PSG) manual scoring" as the reference standard but does not specify any adjudication method (e.g., 2+1, 3+1, none) for disagreements among scorers, implying either a single scorer or an established standard procedure.

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

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any evaluation of human readers with or without AI assistance. The study described focuses on the standalone performance of the Watch-PAT200U device against PSG.

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

Yes, a standalone performance evaluation was done. The clinical study evaluated the "WP200U's capability to identify central sleep apnea and Cheyne-Stokes Respiration" by comparing its output directly to polysomnographic manual scoring. This indicates testing of the device's algorithms without human intervention in the diagnostic process.

7. The type of ground truth used

The ground truth used was polysomnographic (PSG) manual scoring. PSG is considered the gold standard for diagnosing sleep disorders.

8. The sample size for the training set

The document does not provide information regarding the sample size used for the training set or development of the device's algorithms. It only describes the clinical study for evaluation/validation.

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

Since information about a training set is not provided, how its ground truth was established is also not available in the document.

Summary

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

February 24, 2017

Itamar Medical, Ltd. % Jonathan Kahan Partner Hogan Lovells US LLP 555 13th Street, NW Washington, District of Columbia 20004-1109

Re: K161579

Trade/Device Name: Watch-PAT200U Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: January 23, 2017 Received: January 23, 2017

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. 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K161579

Device Name

Watch-PAT200U

Indications for Use (Describe)

PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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5.1 Applicant's Name: Itamar Medical Itd. 9 Halamish st. Caesarea 3088900, Israel Tel: +972 4 617 7000 Fax: +972 4 627 5598 5.2 Contact Person: Jonathan Kahn, Esq. 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: February 23, 2017
Watch-PAT 200U ("WP200U") 5.4 Trade Name:
5.5 Common or Usual Name: Ventilatory Effort Recorder
Classification Name: Breathing Frequency Monitor 5.6
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:

Primary Predicate Device: Watch-PAT200U ("WP200U") (Itamar Ltd), cleared under K133859: product code MNR (ventilatory effort recorder)
Additional Predicate Device: Embla Systems' Embletta MPR Sleep Data Recording System ● (K122516)

5.13 Intended Use / Indication for Use:

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provide supplemental information to its PRD/PAHI/PAHIc. The WP200U's PSTAGES and snoring level and body position 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.

PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

5.14 Device Description:

The subject WP200U introduces the RESBP sensor - an additional Snoring and Body Position (SBP) integrated sensor which also includes chest movement signal.

Another change in the subject WP200U is the introduction of new sleep disorder parameter - central apnea/hypopnea index (pAHIc).

5.15 Substantial Equivalence:

Intended Use

The intended use of the subject Watch-PAT200U ("WP200U") is similar to the intended use of its predicate, the Watch-PAT200U (Itamar Ltd). The only difference is that the subject device provides new sleep disorder parameter - central apnea/hypopnea index (pAHIc). All other information supplied, are exactly the same as the predicate device. The additional information in the subject device does not alter the intended diagnostic use of the WP200U.

For the added capability of identification of central ApnealHypopnea events, the company selects additional predicate device - Embla Systems' Embletta MPR Sleep Data Recording System (K122516) intended to assist in the identification of sleep-related medical disorders, including Central Sleep Apnea Syndrome.

Comparison of Technological Characteristics

The technological characteristics and principles of operation of the subject device are identical to the predicate device. The subject WP200U, like its predicate, is a ventilatory effort recorder that utilizes PAT technology. Specifically, the hardware and the subject device are similar to that of the primary predicate device, except the following modifications:

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1. RESBP sensor an additional Snoring and Body Position (SBP) integrated sensor which also includes chest movement signal.
1. The algorithms of the primary predicate are further developed in the subject device to provide the information regarding central Apnea/Hypopnea events.

Please note that the pAHIc is presented only when the patient uses the RESBP sensor in the sleep study.

The subject device also has similar technological characteristics to the additional predicate Embletta. Although the subject device uses PAT signal to measure physiological parameters, this difference does not raise different types of safety and effectiveness questions. Specifically, the agency has cleared PAT signal in the primary predicate device.

The subject WP200U principle of operation is identical to the cleared WP200U principles of operation.

Performance Testing

Since there were no modifications to the WP200U predicate device K133859, consensus standards conducted on the predicate device is applicable to the subject device. The following consensus standards were used to evaluate the predicate device:

. Electrical safety and Electromagnetic compatibility testing per IEC 60601-1:2005 +01:2006 +C2:2007 +AM1:2012, IEC 60601-1-2:2014, and 60601-1-11:2015
. Software verification and validation
. Bench testing to show that the snore intensity in decibels and body position discrete states measured by the new respiratory effort snore and body position (RESBP) sensor is the same as that measured by the cleared snore and body position (SBP) sensor.
. Clinical study was conducted to evaluate the WP200U's capability to identify central sleep apnea and Cheyne-Stokes Respiration. 72 subjects were evaluated in an overnight sleep study using the subject device and polysomnographic (PSG) manual scoring. Test results demonstrated substantially equivalent performance.

All these tests demonstrate that the WP200U is substantially equivalent to its predicate without raising any different issues of safety or effectiveness.

Summary

Based on the performance testing results, including the electromagnetic testing, clinical study, software verification and validation process and bench test, Itamar Ltd, believes that the WP200U System is substantially equivalent to its predicates.

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).

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

K161579

Watch-PAT200U

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

5.12 Predicate Devices:

5.13 Intended Use / Indication for Use:

5.14 Device Description:

5.15 Substantial Equivalence:

Intended Use

Comparison of Technological Characteristics

Performance Testing

Summary

§ 868.2375 Breathing frequency monitor.

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