K Number

Device Name

Watch-PAT200U

Manufacturer

ITAMAR MEDICAL, LTD.

Date Cleared

2016-07-26

(278 days)

Product Code

MNR

Regulation Number

868.2375

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133859

Reference Devices

K122516

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI or ML, and the description of the device and performance studies focuses on traditional signal processing and statistical analysis.

Therapeutic

The device is described as a "diagnostic aid for the detection of sleep related breathing disorders" and provides "supplemental information to its PRDI/PAHI," indicating its primary function is diagnostic, not therapeutic.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging...". The "Device Description" also refers to it as a "diagnostic aid for the detection of sleep related breathing disorders."

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components including probes, sensors, electronics, and a power supply, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Watch-PAT200U (WP200U) device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
WP200U Function: The WP200U is a non-invasive device that measures physiological signals directly from the patient's body (PAT signal, blood oxygen saturation, wrist motion, snoring, body position). It does not analyze samples taken from the body.
Intended Use: The intended use clearly states it's a "non-invasive home care device" and a "diagnostic aid for the detection of sleep related breathing disorders." This aligns with a device that monitors physiological parameters, not one that analyzes biological samples.

Therefore, the WP200U falls under the category of a medical device that monitors physiological signals in vivo (within the living body), rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

MNR

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

12 years of age or greater.

Intended User / Care Setting

Home Care

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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)

Itamar 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Results showed that the PAHI in the adolescence population was highly correlated with the AHI measured by the PSG with R = 0.92, p

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).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with a series of human profiles facing to the right.

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

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

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, Israel
Phone: +972 4 617 7000
Fax: +972 4 627 5598 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jonathan Kahan
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington, DC 20004
Phone: (202) 637-5794
Fax: (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:

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

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)

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