The Watch-PAT200U (WP200U) device 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, sleep staging (Rapid Eye Movement (REM) 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"), 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 WP200U's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200U'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.

The WP200U is indicated for use in patients 12 years of age or greater.

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 motion of the wrist; (3) external integrated snoring and body position sensor — SBP (Optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP; (5) the device software; and (6) a power supply.

AI/ML Overview

The provided text describes the Watch-PAT200U (WP200U) device and outlines its substantial equivalence to a predicate device, primarily focusing on the expansion of its intended use to include an adolescent population (12 to 17 years old). The document highlights performance data and clinical studies used to support this expanded indication.

Here's an attempt to extract the requested information, understanding that certain details like specific acceptance criteria numerical values for RDI/AHI or the number of experts for polysomnography scoring are not explicitly stated in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Adolescent Population)
PAHI Correlation (vs. PSG AHI)	High correlation required for diagnostic aid.	R = 0.92, p < 0.0001 (highly correlated)
Sensitivity for SDB (Threshold 10)	High sensitivity for detecting sleep-disordered breathing.	100.0% (for SDB with AHI threshold of 10)
Specificity for SDB (Threshold 10)	High specificity for detecting sleep-disordered breathing.	100.0% (for SDB with AHI threshold of 10)
Sleep Stage Agreement (vs. PSG)	Reasonable agreement required for supplemental information.	Overall agreement of 64.6% with PSG. Kappa agreement = 0.51 (95% CI: 0.499 to 0.519).
Use Assessment (Ease of Sensor Placement/Removal)	Acceptable ease of use in pediatric patients.	Evaluated in a form-fit-function study. (Specific results not detailed)
Fit of Sensor/Strap	Acceptable fit on pediatric patients.	Evaluated in a form-fit-function study. (Specific results not detailed)
Physiological Effects (Discomfort, Sweating, Pressure Marks)	Minimal physiological effects on pediatric patients.	Evaluated in a form-fit-function study. (Specific results not detailed)
SpO2 Accuracy	Comparability to a control (transfer standard pulse oximeter).	Evaluated in a form-fit-function study. (Specific results not detailed)

Notes on Acceptance Criteria: The document implies that the device is acceptable if its performance in the adolescent population is comparable to its already cleared performance in adults, and demonstrates accuracy suitable for a "diagnostic aid." The specific numerical thresholds for "high correlation" or "reasonable agreement" are not explicitly defined as acceptance criteria but are demonstrated by the reported study results.

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

Test Set Sample Size: "Data from adolescence patients (12 to 17 years old) was pooled from 3 prospective clinical studies sponsored by Itamar of a broader age range population." The precise number of adolescent patients (12-17 years old) is not explicitly stated from the total 'broader age range population' in these 3 prospective studies. However, a separate published study mentioned prior to the main clinical studies analyzed 17 children with OSA (age range 5 to 17 years old), but this appears to be a separate smaller study contributing to the literature review, not the primary "test set" for the current submission.
Data Provenance: Prospective clinical studies sponsored by Itamar. The country of origin is not specified, but Itamar Medical, Ltd. is based in Caesarea, Israel.

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

The ground truth for the test set was established by Polysomnography (PSG) manual scoring. The document states: "The purpose of the studies was to compare the efficacy of the WP to the manual scoring of the PSG for aiding in the diagnosis of SDB."

Number of Experts: Not specified.
Qualifications of Experts: The document refers to "manual scoring of the PSG," which implies scoring by trained polysomnography technologists or sleep medicine physicians, but their specific qualifications (e.g., years of experience, certifications) are not detailed.

4. Adjudication Method for the Test Set

The document states "manual scoring of the PSG," but it does not specify an adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies in PSG scoring if multiple scorers were involved.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not explicitly described in the provided text. The study focused on the standalone performance of the device (WP200U) against PSG as the gold standard.

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

Yes, a standalone performance study was conducted. The clinical studies described compared the WP200U's output (PRDI, PAHI, and sleep stages) directly against the manual scoring of simultaneous in-lab polysomnography (PSG). This assesses the algorithm's performance without direct human intervention in the device's diagnostic output generation or interpretation, beyond the initial use setup.

7. Type of Ground Truth Used

The primary ground truth used was expert-scored Polysomnography (PSG). The studies compared the WP200U's sleep indices and sleep stages with those "generated by the manual scoring of the PSG."

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The clinical study details describe a "test set" used for evaluating the device's performance in adolescent patients. Given that no modifications were made to the algorithm (the "PAT technology or the algorithm for the detection of sleep related breathing disorders" was identical to the predicate K133859), it's highly probable that the training of the algorithm occurred much earlier, prior to the K133859 submission, and is not detailed here. This submission focuses on validating the existing algorithm for an expanded age group.

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

This information is not provided in the document. As mentioned above, the algorithm itself was part of the predicate device (K133859) and its training data and ground truth establishment would have been detailed in that prior submission. The current document focuses on validating the existing algorithm for a new patient population.

Summary

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

July 26, 2016

Itamar Medical, Ltd. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, D.C. 20004

Re: K153070

Trade/Device Name: Watch-PAT200U ("WP200U") Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: July 5, 2016 Received: July 5, 2016

Dear Jonathan 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, PhD. 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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Indications for Use

510(k) Number (if known) K153070

Device Name Watch-PAT200U ("WP200U")

Indications for Use (Describe)

The WP200U is indicated for use in patients 12 years of age or greater.

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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510(k) SUMMARY

Itamar Medical's Watch-PAT200U

Submitter Information:

Applicant:	Itamar Medical, Ltd.9 Halamish St.Caesarea 3088900, IsraelPhone: +972 4 617 7000Fax: +972 4 627 5598
Contact Person:	Jonathan KahanHogan Lovells US LLP555 Thirteenth Street, NWWashington, DC 20004Phone: (202) 637-5794Fax: (202) 637-5910
Date Prepared:	July 13, 2016

Subject Device:

Device Name:	Watch-PAT200U ("WP200U")
Common Name:	Ventilatory Effort Recorder
Classification Name:	Breathing Frequency Monitor
Regulation:	Class II, 21 C.F.R. § 868.2375
Product Code:	MNR

Predicate Devices:

Primary Predicate:	Itamar Medical's Watch-PAT200U (K133859)
Reference Device:	Embla Systems' Embletta MPR Sleep Data Recording System (K122516)

Indications for Use:

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position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200U's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200U'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.

The WP200U is indicated for use in patients 12 years of age or greater.

Device Description

Substantial Equivalence

Intended Use

The Watch-PAT200U is substantially equivalent to the primary predicate device K133859. Both devices have the same intended use as non-invasive, home-care devices for use with patients suspected to have sleep-related breathing disorders. The indications for use is identical to the predicate except for the modification of the device's intended use population to include patients 12 years of age or greater. FDA has cleared reference device Embla Systems' Embletta MPR Sleep Data Recording System (K122516) for the identification of sleep-related disorders in similar pediatric patient population.

Comparison of Technological Characteristics

The technological characteristics and principles of operation are identical between the subject device and the primary predicate device WP200U (K133859). They have identical hardware, software, materials, and components. There were no modifications to the PAT technology or the algorithm for the detection of sleep related breathing disorders in the predicate device for

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the expanded pediatric patient population. The subject and primary predicate devices include the same recording channels: PAT, pulse rate, oximetry, actigraphy, optional snoring level, and 5 discrete body position states. The reference device (K122516) measures Electrocardiogram (EKG), Electroencephalogram (EEG), Electromyography (EMG), Electrooculogram (EOG), Resp, Thermistor and Pressure channels. The PAT technology was already cleared in the primary predicate device K133859 for the same intended use.

The subject device, primary predicate and reference device provide information concerning sleep-related disorders using sleep disordered breathing (SDB) indices – Respiratory Disturbance index (RDI) and Apnea/Hypopnea index (AHI), while the reference device provides also respiratory events classification. The supplementary functions of the reference device do not affect the safety and effectiveness of the subject device for its intended use.

Performance Data

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

IEC 60601-1:2005 +C1:2006 +C2:2007 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 +CISPR11:2009 +A1:2010 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
. IEC 60601-1-11:2010 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
. ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
. Software verification and validation testing was performed to demonstrate that the software in the subject device meets design specifications.

Also, no additional biocompatibility testing is required because the patient contacting materials are identical to the predicate.

A form-fit-function study was conducted to evaluate the WP200U in pediatric patients age range from 12 through 17 years old. The following were evaluated in the study:

Use assessment (ease of sensor's placement and removal)
. Fit of sensor/strap
Physiological effects on the measurement site (discomfort, sweating, pressure marks)
SpO2 accuracy compared to control (Transfer Standard Pulse Oximeter)

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Clinical Data

ltamar has performed a clinical data assessment in the adolescent population to assure there are no new safety issues or performance concerns when including adolescent population in the WatchPAT's intended use. This assessment included the following activities:

1. Literature review. Itamar performed a broad search and analyzed peer reviewed articles and international guidelines concerning sleep medicine in the age group of 12 to 17 years old.
1. Published study. A published abstract assessing the WP device in children was identified. Seventeen children with OSA (age range from 5 to 17 years old; 11 males and 6 females) underwent simultaneous recording of in-lab polysomnography and WatchPAT sleep study.
1. Clinical studies to evaluate the subject device on adolescent patients. Data from adolescence patients (12 to 17 years old) was pooled from 3 prospective clinical studies sponsored by Itamar of a broader age range population. The purpose of the studies was to compare the efficacy of the WP to the manual scoring of the PSG for aiding in the diagnosis of SDB. The effectiveness of the WP was determined by evaluating the correlation between the WP sleep indices and similar indices generated by the manual scoring of the PSG. The sensitivity and specificity of SDB were evaluated using the threshold of 10. The effectiveness of the WP's sleep stages was determined by evaluating its agreement to the sleep stages generated by the PSG. A subgroup analysis was performed on the relevant subjects' records. Their results were compared to the corresponding results in adult subjects gathered in a separate clinical study which had been previously submitted to the agency under 510(K) submission number K080427. Results showed that the PAHI in the adolescence population was highly correlated with the AHI measured by the PSG with R = 0.92, p < 0.0001. Using a threshold of 10 for PSG, sensitivity and specificity of the WP for adolescence were both 100.0%. The accuracy of sleep stages generated by the WP in the adolescence population showed an overall agreement of 64.6% versus the PSG. Kappa agreement was 0.51 (95% Cl: 0.499 to 0.519) in the adolescence population.

Conclusions

ltamar believes that the subject device is substantially equivalent to the primary predicate device K133859. Both devices have intended use and indications for use with the exception of the expanded adolescent patient population. FDA has already cleared reference device Embla's Embletta MPR (K122516) for this pediatric population. Itamar did not make any modifications to the hardware or software of the primary predicate device. A formfit-function study and clinical data demonstrated that the subject device has substantially equivalent performance in monitoring sleep disorders. Therefore, the subject device is substantially equivalent to the primary predicate device.

A summary of comparison between the subject and predicate devices is provided below.

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	Subject Device:Itamar Medical's Watch-PAT200U	Primary Predicate Device:Itamar Medical's Watch-PAT200U(K133859)	Reference Device:Embla's Embletta MPR(K122516)
Indications forUse	The Watch-PAT200U (WP200U)device is a non-invasive home caredevice for use with patientssuspected to have sleep relatedbreathing disorders. The WP200U isa diagnostic aid for the detection ofsleep related breathing disorders,sleep staging (Rapid Eye Movement(REM) Sleep, Light Sleep, Deep Sleepand Wake), snoring level and bodyposition. The WP200U generates aperipheral arterial tonometry("PAT") Respiratory DisturbanceIndex ("PRDI"), Apnea-Hypopneaindex ("PAHI"), PAT sleep stagingidentification (PSTAGES) andoptional snoring level and bodyposition discrete states from anexternal integrated snoring andbody position (SBP) sensor. TheWP200U's PSTAGES and SBP providesupplemental information to itsPRDI/PAHI. The WP200U's PSTAGESand SBP are not intended to be usedas the sole or primary basis fordiagnosing any sleep relatedbreathing disorder, prescribingtreatment, or determining whetheradditional diagnostic assessment iswarranted.The WP200U is indicated for use inpatients 12 years of age or greater.	The Watch-PAT200U (WP200U)device is a non-invasive home caredevice for use with patientssuspected to have sleep relatedbreathing disorders. The WP200U isa diagnostic aid for the detection ofsleep related breathing disorders,sleep staging (Rapid Eye Movement(REM) Sleep, Light Sleep, Deep Sleepand Wake), snoring level and bodyposition. The WP200U generates aperipheral arterial tonometry("PAT") Respiratory DisturbanceIndex ("PRDI"), Apnea-Hypopneaindex ("PAHI"), PAT sleep stagingidentification (PSTAGES) andoptional snoring level and bodyposition discrete states from anexternal integrated snoring andbody position (SBP) sensor. TheWP200U's PSTAGES and SBP providesupplemental information to itsPRDI/PAHI. The WP200U's PSTAGESand SBP are not intended to be usedas the sole or primary basis fordiagnosing any sleep relatedbreathing disorder, prescribingtreatment, or determining whetheradditional diagnostic assessment iswarranted.	The Embletta MPR is a digitalrecording device designed tobe used under the direction ofa physician or trainedtechnician but may be appliedby a layperson. The Emblett aMPR records multiplephysiological parameters froma sleeping patient for thepurpose of simultaneous orsubsequent display of theparameters. The displayeddata assists in theidentification of sleep-relatedmedical disorders by trainedpersonnel.The Embletta MPR is intendedto be used for adult andpediatric (excluding infantsand neonatal) studies. Thedevice is not equipped withalarms and is not intended tobe used as a monitor.The intended environmentsinclude any clean, dry, dustfree environment suitable for apatient's relative comfort.The device does not monitoror diagnose the patient anddoes not issue any alarms.
UserPopulation	Adult and adolescence (age rangegreater than 12 years old)	Adult patients suspected to havesleep related breathing disorders	Adult and pediatric (excludinginfants and neonatal)
Intended UseEnvironment	Home Use	Home Use	Sleep clinics and home
recordingsignalcapabilities	PAT, pulse rate, oximetry,actigraphy and an optional snoringlevel, 5 discrete body position states	PAT, pulse rate, oximetry,actigraphy and an optional snoringlevel, 5 discrete body position states	EKG, EEG, EMG, EOG, Pulse,Resp (ABD, Thorax),Thermistor, Oximetry,Pressure, Actigraphy, BP,Snore
Sleep-disorderedbreathing(SDB) indices	• pRDI (17 years of age and older)• pAHI	• pRDI• pAHI	• RDI• AHI (Obstructive / centraland mixed)• Cheyne-Stokes Breathing
	Subject Device:Itamar Medical's Watch-PAT200U	Primary Predicate Device:Itamar Medical's Watch-PAT200U(K133859)	Reference Device:Embla's Embletta MPR(K122516)
AdditionalSleepparametersoutput	• Sleep stages• Snoring level• Five Body position discrete states	• Sleep stages• Snoring level• Five Body position discrete states	• Sleep stages• Snoring• Five Body position discretestates• PLM• Arousal
Components	• uPAT finger probe• actigraph• Controller• Microphone• Accelerometer• ZzzPAT software• External SBP sensor (optional)• External Tamper-Proof Bracelet(optional)	• uPAT finger probe• actigraph• Controller• Microphone• Accelerometer• ZzzPAT software• External SBP sensor (optional)• External Tamper-Proof Bracelet(optional)	• Unit recorder• Recorder• oximeter• Thermistor and nasalcanula• Sensors (snoring, bodyposition)• respiratory effort belts• electrodes (EEG, EOG, EMG,EKG)• RemLogic Softwaresoftware
Power Supply	Proprietary, rechargeable Li IonBattery	Proprietary, rechargeable Li IonBattery	Battery operated (2 AA)

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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).