The WatchPAT300 is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 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 WP300 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 WP300's PSTAGES and snoring level and body position provide supplemental information to its PRDIPAHIC. The WP300'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 subject WatchPAT300 (WP300) is identical in its intended use and indications for use to the cleared predicate WP200U (K203839) and the cleared predicate WP300 (K180775). The subject WP300 combines the software arrhythmia feature of the WP200U cleared predicate (K203839) into the WP300 cleared predicate (K180775).

The subject WP300 consists of: A wrist worn Control Unit, Actigraphy (in the Control Unit), Wrist Strap, Power Supply (battery), uPAT probe, Chest sensor (optional), Tamper-Proof Bracelet (optional), and Management and Analysis Software (SW).

The subject WP300, like the predicate WP200U and predicate WP300, uses the same offline Management and Analysis Software (SW). The 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 arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices. It provides the sleep physician with additional information to that of the WP300 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the WatchPAT300 (WP300) device, focusing on the addition of an arrhythmia detection feature previously cleared in the Watch-PAT200U (WP200U). The key argument for substantial equivalence is that the new software feature does not alter the technological characteristics or principles of operation, and hardware differences do not raise new safety or effectiveness concerns.

However, the document specifically states regarding performance data: "SW verification and validation was performed on the subject WP300 device with the SW containing the additional arrhythmia feature as per the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". It also mentions that "Bench testing was previously conducted on the predicate WP300 (in K180775) to show that the acquisition system of the WP300 and WP200U are generating the same input signals to the analysis algorithms. Specifically, the equivalence of the PAT and the actigraphy signals which are used in the newly added arrhythmia algorithm were tested. This testing provides evidence that the WP300 signals are equivalent to the WP200U signals."

The document focuses on demonstrating substantial equivalence based on the technological characteristics and intended use being largely the same as predicate devices, with the new arrhythmia feature adopting a previously cleared algorithm. It does not provide specific acceptance criteria or an explicit study proving that the device meets those acceptance criteria through clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the arrhythmia feature in a clinical setting. Instead, the argument relies on the equivalence of signals and the prior clearance of the arrhythmia algorithm in a different device.

Given the information provided in the document:

A table of acceptance criteria and the reported device performance:
The document mentions "The testing and acceptance criteria are the same as those in the predicate devices." However, it does not explicitly list these acceptance criteria or the reported performance data against them for the new arrhythmia feature in the WP300, beyond stating that signals are equivalent to a predicate device. The comparison table (page 6) highlights the identical intended use, user population, environment, and channels, and that the arrhythmia flagging output is "Same as WP200U". This implies that the performance of the arrhythmia feature is expected to be consistent with the WP200U, for which the algorithm was previously cleared.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not explicitly stated for the arrhythmia feature's performance with the WP300. The document indicates "SW verification and validation was performed" and "Bench testing was previously conducted", but details on sample size, data provenance (e.g., countries, retrospective/prospective nature of a clinical test set) are not provided for the arrhythmia performance specifically.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not provided. The document focuses on "SW verification and validation" and "Bench testing," not a clinical performance study with expert interpretation of ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not provided. This would typically be relevant for clinical studies establishing ground truth, which is not detailed for the arrhythmia feature's performance in the WP300 submission.
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:
No MRMC study is mentioned. The arrhythmia feature is described as "informational use only, to flag patients suspected of having arrhythmias," and "aiding the physician to decide if further arrhythmia investigation is needed," rather than a tool for direct improvement of human reader performance or diagnostic efficacy.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document states that "Bench testing was previously conducted... to show that the acquisition system of the WP300 and WP200U are generating the same input signals to the analysis algorithms." This implies a standalone evaluation of signal acquisition equivalence. For the arrhythmia algorithm itself, it's integrated software. The performance of the arrhythmia algorithm as cleared in the WP200U would have undergone standalone evaluation at that previous clearance, but specific standalone performance metrics for this particular submission (K222331) are not provided beyond the signal equivalence testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not explicitly stated for the arrhythmia feature's performance in this submission. For prior clearance of the algorithm in the WP200U, a ground truth would have been established (likely clinical diagnosis by experts for arrhythmia detection), but details are absent here for the WP300.
The sample size for the training set:
Not provided.
How the ground truth for the training set was established:
Not provided.

In summary, the provided FDA 510(k) submission primarily leverages the fact that the new arrhythmia software feature was already cleared in a predicate device (WP200U) and that the WP300's hardware can generate equivalent input signals for this algorithm. Therefore, the submission does not detail new clinical performance studies or specific acceptance criteria met for the performance of the arrhythmia feature itself within this specific application. It relies on the substantial equivalence principle, asserting that no new questions of safety or effectiveness are raised.

Summary

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September 14, 2022

Itamar Medical, Ltd % Jonathan Kahan Partner Hogan Lovells Us Llp 553 Thirteenth Street, NW Washington, District of Columbia 20004

Re: K222331

Trade/Device Name: WatchPAT300 (WP300) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: August 2, 2022 Received: August 2, 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.

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222331

Device Name WatchPAT300 (WP300)

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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510(k) SUMMARY

Applicant's Name:	Itamar Medical Itd.9 Halamish st.Caesarea 3088900, IsraelTel: +972 4 617 7000Fax: +972 4 627 5598
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Jonathan Kahan, Esq. Contact Person: 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
Date Prepared: August 2, 2022
Trade Name: WatchPAT300 (WP300)
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 Device:

. Watch-PAT200U ("WP200U") (Itamar Medical Ltd), cleared under K203839; product code MNR

Reference Device:

· Watch-PAT300 ("WP300") (Itamar Medical Ltd.) cleared under K180775; product code MNR

Purpose of the Special 510(k):

The subject WP300 combines the software arrhythmia feature of the WP200U cleared predicate (K203839) into the WP300 cleared predicate (K180775).

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Intended Use

The WatchPAT300 is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 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 WP300 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 WP300's PSTAGES and snoring level and body position provide supplemental information to its PRD/PAHI/PAHIc. The WP300'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. PAHlc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.

Device Description

Technological Characteristics

The subject WP300 has the same technological characteristics as the predicates WP300 and WP200U to which it has been modified.

Identically to WP200U and WP300, the subject WP300 device is a ventilatory effort recorder that utilizes Peripheral Arterial Tone (PAT) signal. It is a patient-worn device used at home for aiding in the diagnosis of sleep related breathing disorders based on the PAT signal. In all 3 systems, the controller part of the device is worn on the wrist and records the PAT signal and blood oxygen saturation levels in the distal part of the finger-mounted probe based on an optical plethysmographic method, and the wrist motion from an embedded actigraphy. The following report output information is provided by the cleared WP200U, cleared WP300,

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and the subject WP300 using the same offline SW and algorithms that analyze recorded data to present respiratory disturbance index (pRDI), Apnea Hypopnea Index (pAHI), Central Apnea Hypopnea Index (pAHIc), sleep stages (pSTAGES - REM Sleep, Light Sleep, Deep Sleep, Wake), snoring level and body position discrete states. The new arrhythmia information in the subject WP300's report is identical to the one in the cleared WP200U.

The subject WP300, identically to both predicates, consists of the same components: (1) Same unified PAT probe (uPAT) is used to measure the PAT and oximetry signals; (2) an embedded actigraph which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist: (3) Electronics, which include a microprocessor that records the information supplied by the uPAT finger probe, actigraph and chest movement; and (4) chest sensor (SBP/RESBP sensors same as in the predicates).

The SW characteristics of the subject WP300 and the predicate WP300 are the same except for the newly added SW algorithm that was cleared for use in the WP200U (K203839) to identify or 'flaq' the patient for further arrhythmia investigation (Atrial Fibrillation and Premature Beats). This additional SW algorithm is the proposed modification to the subject WP300.

The hardware (HW) of the subject WP300 is the same as the HW of the predicate WP300 (K180775). Further, the HW of the WP300 was designed to provide identical signals to that of the predicate WP200U. The differences in HW between the WP300 and the WP200U devices have been thoroughly discussed and found to be substantially equivalent in K180775.

The cleared arrhythmia SW alqorithm from the predicate WP200U added to the subject WP300 does not alter the technological characteristics of the device or its principles of operation.

Performance Data

SW verification and validation was performed on the subject WP300 device with the SW containing the additional arrhythmia feature as per the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The testing and acceptance criteria are the same as those in the predicate devices. Bench testing was previously conducted on the predicate WP300 (in K180775) to show that the acquisition system of the WP300 and WP200U are generating the same input signals to the analysis algorithms. Specifically, the equivalence of the PAT and the actigraphy signals which are used in the newly added arrhythmia algorithm were tested. This testing provides evidence that the WP300 signals are equivalent to the WP200U signals.

Substantial Equivalence

The subject WP300 has the same intended use as both previously cleared predicate devices, WP300 and WP200U. The WP300's new SW arrhythmia feature 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 and the differences in HW between the WP200U (in which the new SW feature for Arrhythmia detection was cleared) and the subject WP300 do not raise new questions of safety or effectiveness.

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	Subject WP300	WP200U (K203839)	WP300 (K180775)	Comparison
		(Primary Predicate)	(Reference device)
Intended Use	The Watch-PAT300 (WP300)device is a non-invasivehome care device for usewith patients suspected tohave sleep related breathingdisorders. The WP300 is adiagnostic aid for thedetection of sleep relatedbreathing disorders, sleepstaging (Rapid EyeMovement (REM) Sleep,Light Sleep, Deep Sleep andWake), snoring level andbody position. The WP200Ugenerates a peripheralarterial tonometry ("PAT")Respiratory DisturbanceIndex ("PRDI"), Apnea-Hypopnea index ("PAHI"),Central Apnea-Hypopneaindex ("PAHIc"), PAT sleepstaging identification(PSTAGES) and optionalsnoring level and bodyposition discrete states froman external integratedsnoring and body positionsensor. The WP300'sPSTAGES and snoring leveland body position providesupplemental information toits PRDI/PAHI/PAHI/PAHIc. TheWP300's PSTAGES andsnoring level and bodyposition are not intended tobe used as the sole orprimary basis for diagnosinqany sleep related breathingdisorder, prescribingtreatment, or determiningwhether additional diagnosticassessment is warranted.PAHIc is indicated for use inpatients 17 years and older.All other parameters areindicated for 12 years andolder	The Watch-PAT200U(WP200U) device is a non-invasive home care devicefor use with patientssuspected to have sleeprelated breathing disorders.The WP200U is a diagnosticaid for the detection of sleeprelated breathing disorders,sleep staging (Rapid EyeMovement (REM) Sleep,Light Sleep, Deep Sleep andWake), snoring level andbody position. The WP200Ugenerates a peripheralarterial tonometry ("PAT")Respiratory DisturbanceIndex ("PRDI"), Apnea-Hypopnea index ("PAHI"),Central Apnea-Hypopneaindex ("PAHIc"), PAT sleepstaging identification(PSTAGES) and optionalsnoring level and bodyposition discrete states froman external integratedsnoring and body positionsensor. The WP200U'sPSTAGES and snoring leveland body position providesupplemental information toits PRDI/PAHI/PAHI/PAHIc. TheWP200U's PSTAGES andsnoring level and bodyposition are not intended tobe used as the sole orprimary basis for diagnosingany sleep related breathingdisorder, prescribingtreatment, or determiningwhether additional diagnosticassessment is warranted.PAHIc is indicated for use inpatients 17 years and older.All other parameters areindicated for 12 years andolder	The Watch-PAT300 (WP300)device is a non-invasivehome care device for usewith patients suspected tohave sleep related breathingdisorders. The WP300 is adiagnostic aid for thedetection of sleep relatedbreathing disorders, sleepstaging (Rapid EyeMovement (REM) Sleep,Light Sleep, Deep Sleep andWake), snoring level andbody position. The WP200Ugenerates a peripheralarterial tonometry ("PAT")Respiratory DisturbanceIndex ("PRDI"), Apnea-Hypopnea index ("PAHI"),Central Apnea-Hypopneaindex ("PAHIc"), PAT sleepstaging identification(PSTAGES) and optionalsnoring level and bodyposition discrete states froman external integratedsnoring and body positionsensor. The WP300'sPSTAGES and snoring leveland body position providesupplemental information toits PRDI/PAHI/PAHI/PAHIc. TheWP300's PSTAGES andsnoring level and bodyposition are not intended tobe used as the sole orprimary basis for diagnosingany sleep related breathingdisorder, prescribingtreatment, or determiningwhether additional diagnosticassessment is warranted.PAHIc is indicated for use inpatients 17 years and older.All other parameters areindicated for 12 years andolder	Same
UserPopulation	Adult and adolescence (fromage 12)	Adult and adolescence (fromage 12)	Adult and adolescence (fromage 12)	Same
Intended UseEnvironment	Home Use	Home Use	Home Use	Same
Channels	PAT, Pulse rate, Oximetry,Actigraphy, Snoring, BodyPosition, Chest Movement	PAT, Pulse rate, Oximetry,Actigraphy, Snoring, BodyPosition, Chest Movement	PAT, Pulse rate, Oximetry,Actigraphy, Snoring, BodyPosition, Chest Movement	Same
	· Respiratory indices (pRDI,pAHI,pAHIc)	· Respiratory indices (pRDI,pAHI,pAHIc)	· Respiratory indices (pRDI,pAHI,pAHIc)	Same
	Subject WP300	WP200U (K203839)	WP300 (K180775)	Comparison
SW Analysisoutput	Sleep stages (REM, light, deep and wake) Snoring level Body position discrete states Heart rate statistics Oximetry statistics	Sleep stages (REM, light, deep and wake) Snoring level Body position discrete states Heart rate statistics Oximetry statistics	Sleep stages (REM, light, deep and wake) Snoring level Body position discrete states Heart rate statistics Oximetry statistics
	Arrhythmia flagging output: Suspected Atrial Fibrillation (AFib): Total duration in sleep Longest event duration Premature beats: Events per minute	Arrhythmia flagging output: Suspected Atrial Fibrillation (AFib): Total duration in sleep Longest event duration Premature beats: Events per minute	No Arrhythmia output	Same asWP200U
Input uPATProbe	Itamar proprietary probe only	Itamar proprietary probe only	Itamar proprietary probe only	Same
HWComponents	uPAT finger probe Smaller device with improved graphics, OLED screen Actigraph Controller Chest sensor (optional) External Tamper-Proof Bracelet (optional)	uPAT finger probe Device with LCD screen Actigraph Controller Chest sensor (optional) External Tamper-Proof Bracelet (optional)	uPAT finger probe Smaller device with improved graphics, OLED screen Actigraph Controller Chest sensor (optional) External Tamper-Proof Bracelet (optional)	Same asWP300. uPATprobe, Chestsensor, andTamper-ProofBracelet arethe same for all3 devices.
Power Supply	One OTS 1.5V Alkaline AAAbatteryOROne rechargeable AAA 1.2VNickel-metal hydride (NiMH)battery	Proprietary, rechargeableLithium Ion Battery	One OTS 1.5V Alkaline AAAbatteryOROne rechargeable AAA 1.2VNickel-metal hydride (NiMH)battery	Same asWP300
SensorsPlacement	Wrist, finger and chest(optional)	Wrist, finger and chest(optional)	Wrist, finger and chest(optional)	Same
Intended userof theArrhythmiaoutput	Physician	Physician	No Arrhythmia output	Same asWP200U
ArrhythmiaMonitoringperiod	During prescribedsleep study	During prescribedsleep study	No Arrhythmia output	Same asWP200U
Arrhythmiaoutputtechnologicalcharacteristic	PPG	PPG	No Arrhythmia output	Same asWP200U

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Conclusions

The subject WP300 has the same technological characteristics and principles of operation as its predicates and the new SW arrhythmia feature does not raise any new questions of safety or effectiveness. Substantial equivalence of the subject device has been proven towards both predicates, and the differences in HW between the WP200U (in which the new SW feature for Arrhythmia detection was cleared) and the subject WP300 do not raise new questions of safety or effectiveness. Based on the above Itamar Medical Ltd. concludes that the WP300 is substantially equivalent to its predicates and does not raise any new or different concerns about safety or effectiveness.

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).