(589 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the underlying PAT technology and signal processing, not AI/ML algorithms.
No.
The device is described as a non-invasive diagnostic aid for detecting coronary artery Endothelial Dysfunction, not for treating or providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The EndoPATx device is a non-invasive device intended for use as a diagnostic aid in the detection of coronary artery Endothelial Dysfunction".
No
The device description and performance studies clearly indicate the presence of hardware components (Data Acquisition System (hardware (HW) and firmware (FW)), electrical safety testing, electromagnetic compatibility testing, mechanical tests) in addition to software.
Based on the provided information, the EndoPATx device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD typically involves the examination of specimens such as blood, urine, tissue, etc., outside of the body.
- The EndoPATx is a non-invasive device. It measures physiological responses (Peripheral Arterial Tone) directly from the patient's fingers without taking any samples.
- The device description focuses on a physical measurement. It describes the use of PAT technology to measure a post-ischemic vascular response.
Therefore, the EndoPATx falls under the category of a medical device that performs a diagnostic function in vivo (within the living body), rather than in vitro (in glass/outside the body).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DOK, DQK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
competent health professionals. / hospital or clinic environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
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 ( 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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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
K032519 | Comparison |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The EndoPATx device is
a non-invasive device
intended for use as a
diagnostic aid in thedetection 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. | The EndoPAT™2000
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 EndoPAT™2000
Device 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 EndoPAT™2000
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. | 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
Components | • Two EndoPAT Probes
• EndoPAT connector
cables (Pneumo-electric tubing) | • Two EndoPAT Probes
• EndoPAT connector
cables (Pneumo-electric tubing) | The EndoPAtx has
new Data Acquisition
System (DAS) with
newly developed |
| Parameter | Subject Device | EndoPAT2000
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:
-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 |
| Clinical
Procedure | Baseline Recording,
Occlusion, Release and
Post Occlusion
Recording. | Baseline Recording,
Occlusion, Release and
Post Occlusion Recording. | Identical |
| System TLD
(Top Level
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.
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 |
| Analysis
algorithms | | Identical | |
| Main
Electrical
Design (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 | EndoPAT2000
K032519 | Comparison |
| | | | different PSU is
avoided and so is the risk of connecting a
non-medical grade PSU.
Increasing the power to 30W increases the
worst-case power consumption margin. |
| LED
Indications | 3 – ON, Error,
Communication | 2 – ON and
Communication | Usability
improvement.
Additional error
indication on the
device. Addition of
the Error indication
does not raise
different questions of
safety and
effectiveness. |
| Connectivity | USB | RS232 + USB adapter | Usability
improvement.
Avoid the need for the
USB adapter.
This improvement
does not raise
different questions of
safety and
effectiveness. |
| Finger Probe | Pneumatic PAT Probe for
EndoPATx.
Internal coating of the
probe made from
Neoprene; a standard
material used for surgical
gloves. | Pneumatic PAT Probe for
EndoPAT2000.
Internal coating of the
probe made from Latex. | Biocompatibility
improvement.
Internal coating
changed to a material
which is less
allergenic than latex.
The change does not
raise different
questions of safety
and effectiveness. |
| Cables | Electronic – Air Lumen
Cable | Electronic – Air Lumen
Cable | Identical |
| Data
Archiving | In database and files | In files | Technical
Improvement.
Direct access to data
without the need to
parse data in files. |
| Parameter | Subject Device | EndoPAT2000
K032519 | Comparison |
| | | | Data is secured and
there is automatic
backup.
Access control is
seamlessly
implemented by
user's role.
This improvement
does not raise
different questions of
safety and efficacy. |
| SW User
Interface | New Graphical User
Interface (GUI):
Same functionalityUser interface was
updated | GUI | Usability
improvement.
Use of current / state
of the art user
interface.
This improvement
does not raise
different questions of
safety and efficacy. |
Table VII-1: Comparison Table
6
7
8
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.