EndoPATx

{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, 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 {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 (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 {2}------------------------------------------------ 510(k) Number (if known) K211557 Device Name #### EndoPATx Indications for Use (Describe) 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. | Type of Use ( <i>Select one or both, as applicable</i> ) | |-------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> <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}------------------------------------------------ # 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 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. {4}------------------------------------------------ # 7. Indications for Use 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. # 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). {5}------------------------------------------------ | Parameter | Subject Device | EndoPAT2000<br>K032519 | Comparison | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The EndoPATx device is<br>a non-invasive device<br>intended for use as a<br>diagnostic aid in thedetection of coronary<br>artery Endothelial<br>Dysfunction (positive or<br>negative) using a<br>reactive hyperemia<br>procedure.<br>The EndoPATx has<br>been shown to be<br>predictive of coronary<br>artery Endothelial<br>Dysfunction in the<br>following patient<br>population: patients with<br>signs or symptoms of<br>ischemic heart disease,<br>who are indicated for<br>coronary artery<br>angiography, but who<br>lack angiographic<br>evidence of obstructive<br>coronary artery disease.<br>The device is intended<br>to be used in a hospital<br>or clinic environment by<br>competent health<br>professionals.<br>The EndoPATx device is<br>not intended for use as<br>a screening test in the<br>general patient<br>population. It is intended<br>to supplement, not<br>substitute, the<br>physician's decision-<br>making process. It<br>should be used in<br>conjunction with<br>knowledge of the<br>patient's history and<br>other clinical findings. | The EndoPAT™2000<br>device is a non-invasive<br>device intended for use<br>as a diagnostic aid in the<br>detection of coronary<br>artery Endothelial<br>Dysfunction (positive or<br>negative) using a reactive<br>hyperemia procedure.<br>The EndoPAT™2000<br>Device has been shown<br>to be predictive of<br>coronary artery<br>Endothelial Dysfunction in<br>the following patient<br>population: patients with<br>signs or symptoms of<br>ischemic heart disease,<br>who are indicated for<br>coronary artery<br>angiography, but who lack<br>angiographic evidence of<br>obstructive coronary<br>artery disease. The<br>device is intended to be<br>used in a hospital or clinic<br>environment by<br>competent health<br>professionals.<br>The EndoPAT™2000<br>device is not intended for<br>use as a screening test in<br>the general patient<br>population. It is intended<br>to supplement, not<br>substitute, the physician's<br>decision-making process.<br>It should be used in<br>conjunction with<br>knowledge of the patient's<br>history and other clinical<br>findings. | 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 | | Device<br>Components | • Two EndoPAT Probes<br>• EndoPAT connector<br>cables (Pneumo-electric tubing) | • Two EndoPAT Probes<br>• EndoPAT connector<br>cables (Pneumo-electric tubing) | The EndoPAtx has<br>new Data Acquisition<br>System (DAS) with<br>newly developed | | Parameter | Subject Device | EndoPAT2000<br>K032519 | 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:<br>-Finger Anchor<br>-Arm Support<br>-Cuff Set | EndoPAT accessories:<br>-Finger Anchor<br>-Arm Support<br>-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 | | Clinical<br>Procedure | Baseline Recording,<br>Occlusion, Release and<br>Post Occlusion<br>Recording. | Baseline Recording,<br>Occlusion, Release and<br>Post Occlusion Recording. | Identical | | System TLD<br>(Top Level<br>Domain) | 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.<br>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.<br>Heart rate: Identical | | Analysis<br>algorithms | | Identical | | | Main<br>Electrical<br>Design (PCB) | New design that supports the use of the new digital output pressure sensors and USB communication with host computer. | | Technical improvement.<br>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.<br>The internal Power Supply Unit (PSU) is an integral unit of the system, therefore | | Parameter | Subject Device | EndoPAT2000<br>K032519 | Comparison | | | | | different PSU is<br>avoided and so is the risk of connecting a<br>non-medical grade PSU.<br>Increasing the power to 30W increases the<br>worst-case power consumption margin. | | LED<br>Indications | 3 – ON, Error,<br>Communication | 2 – ON and<br>Communication | Usability<br>improvement.<br>Additional error<br>indication on the<br>device. Addition of<br>the Error indication<br>does not raise<br>different questions of<br>safety and<br>effectiveness. | | Connectivity | USB | RS232 + USB adapter | Usability<br>improvement.<br>Avoid the need for the<br>USB adapter.<br>This improvement<br>does not raise<br>different questions of<br>safety and<br>effectiveness. | | Finger Probe | Pneumatic PAT Probe for<br>EndoPATx.<br>Internal coating of the<br>probe made from<br>Neoprene; a standard<br>material used for surgical<br>gloves. | Pneumatic PAT Probe for<br>EndoPAT2000.<br>Internal coating of the<br>probe made from Latex. | Biocompatibility<br>improvement.<br>Internal coating<br>changed to a material<br>which is less<br>allergenic than latex.<br>The change does not<br>raise different<br>questions of safety<br>and effectiveness. | | Cables | Electronic – Air Lumen<br>Cable | Electronic – Air Lumen<br>Cable | Identical | | Data<br>Archiving | In database and files | In files | Technical<br>Improvement.<br>Direct access to data<br>without the need to<br>parse data in files. | | Parameter | Subject Device | EndoPAT2000<br>K032519 | Comparison | | | | | Data is secured and<br>there is automatic<br>backup.<br>Access control is<br>seamlessly<br>implemented by<br>user's role.<br><br>This improvement<br>does not raise<br>different questions of<br>safety and efficacy. | | SW User<br>Interface | New Graphical User<br>Interface (GUI):<br>Same functionalityUser interface was<br>updated | GUI | Usability<br>improvement.<br><br>Use of current / state<br>of the art user<br>interface.<br><br>This improvement<br>does not raise<br>different questions of<br>safety and efficacy. | # Table VII-1: Comparison Table {6}------------------------------------------------ {7}------------…