The EndoPATx device is a non-invasive device intended for use as a diagnostic aid in the detection of coronary artery Endothelial Dysfunction (positive or negative) using a reactive hyperemia procedure.

The EndoPATx has been shown to be predictive of coronary artery Endothelial Dysfunction in the following patient population: patients with signs or symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but who lack angiographic evidence of obstructive coronary artery disease. The device is intended to be used in a hospital or clinic environment by competent health professionals.

The EndoPATx device is not intended for use as a screening test in the general patient population. It is intended to supplement, not substitute, the physician's decision-making process. It should be used in conjunction with knowledge of the patient's history and other clinical findings.

Device Description

The EndoPATx is a non-invasive system for assessing vascular endothelial function. It is based on the use of Peripheral Arterial Tone (PAT) technology which measures post-ischemic vascular response following arm blood flow occlusion.

It is intended for use as a diagnostic aid in the detection of presence coronary artery Endothelial Dysfunction using a reactive hyperemia procedure in the following patient population: patients with signs or symptoms of ischemic heart disease, who are indicated for coronary artery angiography, but who lack angiographic evidence of obstructive coronary artery disease. The device is intended to be used in a hospital or clinic environment by competent health professionals.

It is not intended for use as a screening test in the general patient population. It is intended to supplement, not substitute, the physician's decision-making process. It should be used in conjunction with knowledge of the patient's history and other clinical findings.

AI/ML Overview

The provided FDA 510(k) summary for the EndoPATx device does not contain a detailed study proving the device meets specific acceptance criteria in the manner typically presented for clinical performance studies of AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device (EndoPAT2000) through functional, safety, and performance testing, emphasizing that the underlying technology and algorithms are identical, with the EndoPATx being a "modern replica" with updated hardware and user interface.

Therefore, many of the requested elements (sample size for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance details, and specific acceptance criteria with reported performance) are not explicitly described in this document. This is common for 510(k) submissions where the device builds directly upon a previously cleared predicate and primarily involves hardware or usability updates, rather than a new clinical algorithm requiring extensive de novo validation.

However, based on the information provided, I can construct a response addressing what is present and noting what is absent.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Given that the EndoPATx device is seeking clearance through substantial equivalence to its predicate device (EndoPAT2000) and states that "The principles of operation of the EndoPATx are identical to those of the predicate... Both the predicate device and the subject device use the same analysis algorithms and the same scores are calculated in both devices," the acceptance criteria are implicitly tied to demonstrating that the changes in the EndoPATx do not negatively affect the performance or introduce new questions of safety or effectiveness compared to the already cleared predicate.

The "performance data" provided relates to this equivalency, rather than establishing de novo clinical performance metrics against a defined ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Summary from Document)
Functional Equivalence: The EndoPATx system (hardware and firmware) performs its intended functions correctly.	Passed: "Data Acquisition System (hardware (HW) and firmware (FW)) functional tests for the EndoPATx."
Electrical Safety: Device meets relevant electrical safety standards.	Passed: "Electrical Safety testing per AAM/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012."
Electromagnetic Compatibility (EMC): Device meets relevant EMC standards.	Passed: "Electromagnetic compatibility testing per IEC 60601-1-2:2014, 4th Edition."
Mechanical Integrity/Durability: Device can withstand transportation and use.	Passed: "Mechanical tests: transportation tests."
Software Verification & Validation (V&V): Software meets design specifications and functions correctly. Includes information security.	Passed: "Software verification and validation testing was performed to demonstrate that the software in the subject device meets design specifications." and "Information Security Tests (part of software (SW) test) to verify access control with username and password."
Performance Equivalency to Predicate (EndoPAT2000): Ensures that the core physiological signal acquisition and scoring algorithms yield comparable results to the predicate, demonstrating no degradation in diagnostic accuracy.	Passed: "Equivalency testing to verify that the performance of EndoPATx is substantially equivalent to its predicate device, EndoPAT2000. Technical equivalency tests are divided as follows: 1) PAT signal acquisition input/output equivalency tests; 2) Scoring equivalency tests."

The overall conclusion is that "The testing above demonstrated that the EndoPATx is substantially equivalent to its predicate and the proposed modifications do not raise any different questions of safety or effectiveness."

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

The document does not specify a sample size for a "test set" in the context of clinical performance evaluation with patient data. The equivalency testing mentioned ("PAT signal acquisition input/output equivalency tests; Scoring equivalency tests") refers to technical tests comparing the new device's output to the predicate's, likely using simulated or previously collected signals rather than a new clinical test set with human subjects.

Sample Size: Not specified.
Data Provenance: Not specified, but likely relates to internal technical validation data rather than a new clinical dataset from patients. Given the predicate's established use, it's implied that the original predicate's performance was proven with clinical data, and this submission leverages that.
Retrospective or Prospective: Not stated for this equivalency testing; however, if it involved patient data, it would likely be retrospective given the nature of demonstrating equivalence to an existing device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not specified. The ground truth for direct clinical performance is not explicitly established or re-established for this 510(k) submission, as the device is leveraging substantial equivalence. The claim is that the device's technical performance for PAT signal acquisition and scoring is equivalent to the predicate, which presumably had its own clinical validation and ground truth established during its initial clearance (K032519).

4. Adjudication Method for the Test Set

Not applicable/Not specified. There is no mention of a human-reviewed "test set" requiring adjudication in this 510(k) summary for the new device's clearance.

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

Not applicable. An MRMC study was not conducted for this 510(k) submission. This type of study is typically performed to evaluate the impact of an AI/ML device on human reader performance, which isn't the focus when demonstrating substantial equivalence of a device with identical algorithms to its predicate.

6. Standalone (Algorithm Only) Performance

The EndoPATx relies on the same core analysis algorithms as its predicate, EndoPAT2000. The document states: "Both the predicate device and the subject device use the same analysis algorithms and the same scores are calculated in both devices."
Therefore, its "standalone" performance is considered to be identical to that of the predicate. The document does not provide new standalone performance metrics for the EndoPATx, but implies it has the same standalone performance as the predicate due to identical algorithms.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for the equivalency testing. For the original EndoPAT2000, the "ground truth" for "coronary artery endothelial dysfunction" would typically be established via a gold standard clinical procedure, such as coronary artery angiography (as mentioned in the Indications for Use, "who lack angiographic evidence of obstructive coronary artery disease" implies correlation to angiographic findings for patient selection). However, for this 510(k), the "ground truth" for the equivalency study is implicitly the output of the predicate device (EndoPAT2000) for PAT signal acquisition and scoring, as the objective is to show the new device produces the same results.

8. Sample Size for the Training Set

Not applicable/Not specified. This 510(k) is for a device which uses established, identical algorithms as its predicate. There is no mention of a new "training set" for an AI/ML algorithm in this submission. The algorithms are already developed and proven via the predicate.

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

Not applicable/Not specified. As there is no new training set mentioned, the establishment of ground truth for a training set is not pertinent to this submission.

Summary

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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 29, 2022

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

Re: K211557

Trade/Device Name: EndoPATx Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: May 19, 2021 Received: May 19, 2021

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

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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,

Robert T. Kazmierski - S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K211557

Device Name

EndoPATx

Indications for Use (Describe)

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 Ltd.'s EndoPATx

1. Submitter's Identification

Itamar Medical Ltd. 9 Halamish Street Caesarea 3088900, Israel Tel: +972 4 617 7000 Fax: +972 4 627 5598

2. Contact Person

Jonathan Kahan, Esq. Hogan Lovells US LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910 Email: jonathan.kahan@hoganlovells.com

3. Date Prepared

November 30, 2022

4. Name of Device

Trade Name: EndoPATx Common or Usual Name: Computer, Diagnostic, Programmable Classification: 21 CFR 870.1425 Classification Name: Programmable Diagnostic Computer Regulatory Class: II Product Code: DQK Product Code Name: Computer, Diagnostic, Programmable

5. Predicate Device Information

Predicate: EndoPAT2000 ("EP2000") (Itamar Medical Ltd.), K032519; product code DQK (Programmable Diagnostic Computer)

6. Device Description

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7. Indications for Use

8. Summary of Technological Characteristics and Comparison

The clinical set-up, mode of operation and the output measurement of the subject device are identical to the proposed predicate (K032519). Both the predicate and the subject devices are noninvasive devices intended for use as a diaqnostic aid in the detection of coronary artery Endothelial Dysfunction using a reactive hyperemia procedure.

The principles of operation of the EndoPATx are identical to those of the predicate, also developed by Itamar Medical. Both devices use Peripheral Arterial Tone (PAT) Technology to measure postischemic vascular response following the release of blood flow occlusion of one arm while the other arm serves as control. In both devices the PAT probes are placed on the patient's index fingers on both hands, one on the occluding side and one on the control, sensing the finger pulsatile volume changes and the magnitude and dynamics of the PAT signal changes. Both the predicate device and the subject device use the same analysis algorithms and the same scores are calculated in both devices.

The technological characteristics of the subject device are similar to the predicate device. The hardware and the software algorithms of the subject device are similar to the predicate device and provide equivalent functionality and performance features.

The subject device is a modern replica of the predicate device, with several modifications replacing some of the old and obsolete hardware components and to introduce an updated user interface addressing enhanced usability (see comparison Table VII-1).

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Parameter	Subject Device	EndoPAT2000K032519	Comparison
Intended Use	The EndoPATx device isa non-invasive deviceintended for use as adiagnostic aid in thedetection of coronaryartery EndothelialDysfunction (positive ornegative) using areactive hyperemiaprocedure.The EndoPATx hasbeen shown to bepredictive of coronaryartery EndothelialDysfunction in thefollowing patientpopulation: patients withsigns or symptoms ofischemic heart disease,who are indicated forcoronary arteryangiography, but wholack angiographicevidence of obstructivecoronary artery disease.The device is intendedto be used in a hospitalor clinic environment bycompetent healthprofessionals.The EndoPATx device isnot intended for use asa screening test in thegeneral patientpopulation. It is intendedto supplement, notsubstitute, thephysician's decision-making process. Itshould be used inconjunction withknowledge of thepatient's history andother clinical findings.	The EndoPAT™2000device is a non-invasivedevice intended for useas a diagnostic aid in thedetection of coronaryartery EndothelialDysfunction (positive ornegative) using a reactivehyperemia procedure.The EndoPAT™2000Device has been shownto be predictive ofcoronary arteryEndothelial Dysfunction inthe following patientpopulation: patients withsigns or symptoms ofischemic heart disease,who are indicated forcoronary arteryangiography, but who lackangiographic evidence ofobstructive coronaryartery disease. Thedevice is intended to beused in a hospital or clinicenvironment bycompetent healthprofessionals.The EndoPAT™2000device is not intended foruse as a screening test inthe general patientpopulation. It is intendedto supplement, notsubstitute, the physician'sdecision-making process.It should be used inconjunction withknowledge of the patient'shistory and other clinicalfindings.	Identical
Class	II	II	Identical
Regulation	21 CFR 870.1425	21 CFR 870.1425	Identical
Code	DQK	DQK	Identical
510k number	N/A	K032519	N/A
DeviceComponents	• Two EndoPAT Probes• EndoPAT connectorcables (Pneumo-electric tubing)	• Two EndoPAT Probes• EndoPAT connectorcables (Pneumo-electric tubing)	The EndoPAtx hasnew Data AcquisitionSystem (DAS) withnewly developed
Parameter	Subject Device	EndoPAT2000K032519	Comparison
	EndoPATx Data Acquisition System (DAS) Standard, MS-Windows based personal computer (PC)	EndoPAT2000 Data Acquisition System (DAS) Standard, MS-Windows based personal computer (PC)	electronics by use of current / state of the art components. The improvement does not raise different questions of safety or effectiveness.
	EndoPAT accessories:-Finger Anchor-Arm Support-Cuff Set	EndoPAT accessories:-Finger Anchor-Arm Support-Cuff Set	The EndoPATx accessories are identical to the EndoPAT2000 accessories.
Environment	Hospital or clinic	Hospital or clinic	Identical
Prescription	Prescription Use Only	Prescription Use Only	Identical
ClinicalProcedure	Baseline Recording,Occlusion, Release andPost OcclusionRecording.	Baseline Recording,Occlusion, Release andPost Occlusion Recording.	Identical
System TLD(Top LevelDomain)	PAT Probes, connected to Data Acquisition System, connected and controlled by PC, patient data storage and patient database managed by the PC.	PAT Probes, connected to Data Acquisition System, connected and controlled by PC, patient data storage and patient database managed by the PC.	Identical
Scores	Reactive Hyperemia Index (RHI and LnRHI) Heart rate (HR)	Reactive Hyperemia Index (RHI) Heart rate (HR)	Usability improvement.In addition to the RHI that is presented in a linear scale, an optional presentation in a logarithmic scale (LnRHI) was added. The calculation remains the same.Heart rate: Identical
Analysisalgorithms		Identical
MainElectricalDesign (PCB)	New design that supports the use of the new digital output pressure sensors and USB communication with host computer.		Technical improvement.Use of current / state of the art components.
Power Supply	12VDC 2.50A (30W) internal medical-grade power supply	12VDC 2.00A (24W) external medical-grade power supply	Usability improvement.The internal Power Supply Unit (PSU) is an integral unit of the system, therefore
Parameter	Subject Device	EndoPAT2000K032519	Comparison
			different PSU isavoided and so is the risk of connecting anon-medical grade PSU.Increasing the power to 30W increases theworst-case power consumption margin.
LEDIndications	3 – ON, Error,Communication	2 – ON andCommunication	Usabilityimprovement.Additional errorindication on thedevice. Addition ofthe Error indicationdoes not raisedifferent questions ofsafety andeffectiveness.
Connectivity	USB	RS232 + USB adapter	Usabilityimprovement.Avoid the need for theUSB adapter.This improvementdoes not raisedifferent questions ofsafety andeffectiveness.
Finger Probe	Pneumatic PAT Probe forEndoPATx.Internal coating of theprobe made fromNeoprene; a standardmaterial used for surgicalgloves.	Pneumatic PAT Probe forEndoPAT2000.Internal coating of theprobe made from Latex.	Biocompatibilityimprovement.Internal coatingchanged to a materialwhich is lessallergenic than latex.The change does notraise differentquestions of safetyand effectiveness.
Cables	Electronic – Air LumenCable	Electronic – Air LumenCable	Identical
DataArchiving	In database and files	In files	TechnicalImprovement.Direct access to datawithout the need toparse data in files.
Parameter	Subject Device	EndoPAT2000K032519	Comparison
			Data is secured andthere is automaticbackup.Access control isseamlesslyimplemented byuser's role.This improvementdoes not raisedifferent questions ofsafety and efficacy.
SW UserInterface	New Graphical UserInterface (GUI):Same functionalityUser interface wasupdated	GUI	Usabilityimprovement.Use of current / stateof the art userinterface.This improvementdoes not raisedifferent questions ofsafety and efficacy.

Table VII-1: Comparison Table

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9. Summary of Performance Data

A series of safety and performance tests were performed to demonstrate that the EndoPATx is substantially equivalent to the predicate system. These tests include:

· Data Acquisition System (hardware (HW) and firmware (FW)) functional tests for the EndoPATx.
· Electrical Safety testing per AAM/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
· Electromagnetic compatibility testing per IEC 60601-1-2:2014, 4th Edition.
Mechanical tests: transportation tests.

· Software verification and validation testing was performed to demonstrate that the software in the subject device meets design specifications.

· Information Security Tests (part of software (SW) test) to verify access control with username and password.

• Equivalency testing to verify that the performance of EndoPATx is substantially equivalent to its predicate device, EndoPAT2000. Technical equivalency tests are divided as follows: 1) PAT signal acquisition input/output equivalency tests; 2) Scoring equivalency tests.

The testing above demonstrated that the EndoPATx is substantially equivalent to its predicate and the proposed modifications do not raise any different questions of safety or effectiveness.

10. Conclusions

Based on the comparison of intended use, indications for use, technological characteristics and performance testing, Itamar Medical Ltd. believes that the EndoPATx is substantially equivalent to its predicate.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).