WatchPAT200U (WP200U)

K203839 · Itamar Medical , Ltd. · MNR · Mar 21, 2022 · Anesthesiology

Device Facts

• Record ID: K203839
• Device Name: WatchPAT200U (WP200U)
• Applicant: Itamar Medical , Ltd.
• Product Code: MNR · Anesthesiology
• Decision Date: Mar 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2375
• Device Class: Class 2
• Attributes: Pediatric

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, 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 Story

Watch-PAT200U (WP200U) is a non-invasive home-use diagnostic aid for sleep-related breathing disorders. Input signals include peripheral arterial tonometry (PAT) and oximetry from a finger probe, actigraphy from a wrist-worn controller, and optional snoring/body position/chest movement data from a chest sensor. The device processes these signals to generate respiratory indices (pRDI, pAHI, pAHIc), sleep stages, and cardiac arrhythmia flags (Atrial Fibrillation and Premature Beats). The system is operated by patients at home; data is analyzed by physicians to supplement clinical history and diagnostic information. The arrhythmia feature flags suspected events for physician review; it is not a diagnostic device for cardiac arrhythmia and does not replace traditional diagnostic methods. The device benefits patients by providing supplemental cardiac and respiratory information during sleep studies, aiding in the identification of patients requiring further investigation.

Clinical Evidence

Clinical performance evaluated in 157 subjects during overnight sleep studies. The device's capability to identify arrhythmic events (atrial fibrillation and premature beats) was compared against cardiologist-scored ECG channels from a polysomnography (PSG) system. Results demonstrated acceptable performance for detecting clinically relevant arrhythmic events as supplemental information.

Technological Characteristics

Wrist-worn controller with actigraphy; unified finger PAT probe (optical plethysmography); optional chest sensor (snoring, body position, chest movement). Uses PAT technology with a uniform pressure field to improve signal dynamic range. Software-based arrhythmia detection algorithm. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients 12 years and older suspected of sleep-related breathing disorders; PAHIc parameter indicated for patients 17 years and older. Used as a diagnostic aid for sleep-related breathing disorders, sleep staging, snoring level, and body position.

Regulatory Classification

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.

Predicate Devices

• Watch-PAT200U (WP200U) (K161579)

Reference Devices

• Compumedics Somté PSG System (K072201)
• Melys Atrial Fibrillation Monitor (K132206)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

March 21, 2022

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

Re: K203839

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: February 17, 2022 Received: February 17, 2022

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K203839

Device Name Watch-PAT200U (WP200U)

#### Indications for Use (Describe)

The WatchPAT™200U (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"), 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/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.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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."

{3}------------------------------------------------

### K203839 - 510(K) SUMMARY

- Applicant's Name: Itamar Medical Itd. 9 Halamish st. Caesarea 3088900, Israel Tel: [phone] Fax: [phone]
- Contact Person: Jonathan Kahan, Esq. Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: March 21, 2022

Trade Name: Watch-PAT200U (WP200U)

Common or Usual Name: Ventilatory Effort Recorder

Classification Name: Breathing Frequency Monitor

Medical Specialty: Anesthesiology

Product Code: Ventilatory Effort Recorder, MNR

Device Class: Class II

Regulation Number: 868.2375

Panel: Anesthesiology

#### Predicate Devices:

- Primary predicate: Watch-PAT200U ("WP200U") (Itamar-Medical), cleared under ● K161579; product code MNR (ventilatory effort recorder).
- . Reference device: Compumedics Somté PSG System (Compumedics), cleared under K072201; product code MNR (ventilatory effort recorder)
- Reference device: Melys Atrial Fibrillation Monitor (Advanced Fluidics), cleared ● Receivers, K132206; product coode DXH (Transmitters and under Electrocardiograph, Telephone)

{4}------------------------------------------------

## Intended Use / Indication for 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, 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 (pRDI), apnea - hypopnea index (pAHI), central apnea - hypopnea index (pAHIc) and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. In accordance with physician discretion, the WP200U may be connected to a chest sensor for measuring snoring level, body position states and chest movements.

The WP200U device consists of the following: (1) unified finger PAT probe to measure PAT and oximeter signals; (2) actigraph, which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) chest sensor to measure snoring level, body position and chest movements (optional); (4) electronics, which include a controller that records the signals provided by the uPAT finger probe, actigraph and chest sensor; (5) tamper-Proof Bracelet (Optional); (6) power supply; (7) Wrist strap and (8) Management and Analysis Software Program.

The subject WP200U introduces new algorithms to its software allowing the identification of arrhythmia events occurred during the night - Atrial Fibrillation and Premature Beats.

{5}------------------------------------------------

Beside the introduction of the new arrhythmia information, the SW provides identical output information as that previously provided for the predicate.

The additional arrhythmia information presented by the modified WP200U device follows the AASM (American Academy of Sleep Medicine) guidelines to provide the sleep physician with information regarding cardiac events occurred during the night. The WP200U arrhythmia feature is to be used for informational use only, to flag patients suspected of having arrhythmias, thereby aiding the physician to decide if further arrhythmia investigation is needed. The device is not intended to be used as a diagnostic device for cardiac arrhythmia and it is not intended to replace traditional methods of diagnosis. The WP200U's arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices.

The new analysis provides the sleep physician with additional information to that of the WP200U cleared capabilities of detecting sleep disorders, to be considered in conjunction with the physician's knowledge of patient background, clinical history, symptoms, and other diagnostic information.

## Substantial Equivalence:

## Intended Use

The intended use of the subject Watch-PAT200U ("WP200U") remains exactly the same as the intended use of its predicate, the WP200U (K161579) as a home device for diagnosis of sleep related breathing disorders.

The WP200U's new analysis of cardiac arrhythmia is offered as supplemental information to its sleep information. The device is not intended to be used as a diagnostic device for any cardiac arrhythmia. All other information supplied, is the same as the information supplied by the predicate device.

For the added capability of identifying arrythmia during sleep, the company selected a reference device, Somté PSG System, cleared under K072201 intended for recording physiological parameters to aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians. The-Somté includes an analysis package for arrhythmia detection and classification ('ECG Analysis package'). It also provides ECG statistics during respiratory events and R-R interval (heart rate).

The intended use statement as previously cleared in K161579 was not changed and this capability of providing information regarding the cardiac arrythmia events is specified in the labeling of the subject device and does not raise additional or new questions of safety or effectiveness.

{6}------------------------------------------------

| | Itamar Medical's | Primary predicate - | Reference - | Reference - Melys | Comparison |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Watch-PAT200U | Itamar Medical's | Compumedics's | atrial fibrillation | |
| | (Subject device) | Watch-PAT200U | Somté | monitor | |
| | | (K161579) | (K072201) | (K132206) | |
| Product Code | MNR | MNR | MNR | DXH | |
| Manufacturer | Itamar Medical | Itamar Medical | Compumedics | Advanced Fluidics, | |
| | | | | LLC | |
| Indications | The Watch-PAT200U | The Watch-PAT200U | The Somté PSG is | The Melys Atrial | Substantially |
| for Use | (WP200U) device is a | (WP200U) device is a | intended for use in | Fibrillation Monitor | Equivalent to |
| | non-invasive home | non-invasive home | the recording, | is indicated for self- | the predicate |
| | care device for use | care device for use | displaying, analysis, | testing by patients, | (Watch- |
| | with patients | with patients | printing and storage | who have been | PAT200U) - the |
| | suspected to have | suspected to have | of human biological | diagnosed with, or are | intended use |
| | sleep related | sleep related | parameters such as | susceptible to | remains a |
| | breathing disorders. | breathing disorders. | heart and muscle | developing, atrial | diagnostic |
| | The WP200U is a | The WP200U is a | activity, eye | fibrillation and who | device to detect |
| | diagnostic aid for the | diagnostic aid for the | movement, breathing | would like to monitor | sleep related |
| | detection of sleep | detection of sleep | and body movements | and record their heart | breathing |
| | related breathing | related breathing | to assist in the | rhythms on an | disorders. |
| | disorders, sleep | disorders, sleep | diagnosis of various | intermittent basis. | For the added |
| | staging (Rapid Eye | staging (Rapid Eye | sleep disorders or | | capabilities of |
| | Movement (REM) | Movement (REM) | sleep related | | arrhythmia |
| | Sleep, Light Sleep, | Sleep, Light Sleep, | respiratory or cardiac | | output, as |
| | Deep Sleep and | Deep Sleep and | disorders. The Somté | | specified in the |
| | Wake), snoring level | Wake), snoring level | PSG is designed for | | labeling, the |
| | and body position. | and body position. | ambulatory and | | WP200U is |
| | The WP200U | The WP200U | mobile operation and | | equivalent to the |
| | generates a peripheral | generates a peripheral | can be used in either | | reference device |
| | arterial tonometry | arterial tonometry | the patient's home, | | - Somté system. |
| | ("PAT") Respiratory | ("PAT") Respiratory | the hospital or other | | |
| | Disturbance Index…