(298 days)
Not Found
No
The document explicitly states that the ECG Analysis Program is a "software algorithm only" and does not mention AI, ML, or related terms. The performance studies focus on standard software verification and validation, not AI/ML model training or testing.
No.
The device is described as a "diagnostic ECG examination system" and an "electrocardiograph." Its intended use is to "conduct an electrocardiogram," "measure and interpret 12-lead EGGs," and "provide waveform parameters and ECG analysis for healthcare provider interpretation." These functions are for diagnosis and monitoring, not for treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The PhysioGlove ES Model I is a reusable 12-lead diagnostic ECG examination system" and "When used with a 12-lead cable, it is intended for use in resting diagnostic electrocardiograph examination of adults." The "Device Description" also refers to it as a "diagnostic electrocardiograph."
No
The device description explicitly states the system consists of an "electronics data acquisition unit" and "software that runs on a medical grade PC," and uses either a standard cable or the "PhysioGlove" to obtain data. This indicates the system includes hardware components beyond just software.
Based on the provided text, the PhysioGlove ES Model I is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- PhysioGlove ES Model I Function: The PhysioGlove ES Model I is a diagnostic ECG system. It directly measures electrical activity of the heart from the patient's body using electrodes (either via a standard cable or the PhysioGlove device). It does not analyze specimens taken from the body.
The device is a diagnostic electrocardiograph, which is a type of medical device used for in-vivo (within the living body) measurement and analysis of physiological signals.
N/A
Intended Use / Indications for Use
The PhysioGlove ES Model I is a reusable 12-lead diagnostic ECG examination system. The system can be used with 12-lead cables or the PhysioGlove device. When used with the PhysioGlove, it is intended to conduct an electrocardiogram. The diagnostic and automatic measurement features are not available. When used with a 12-lead cable, it is intended for use in resting diagnostic electrocardiograph examination of adults. The PhysioGlove ES Model I is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device provides waveform parameters and ECG analysis for healthcare provider interpretation.
The PhysioGlove ES Model I ECG Analysis Program assists the physician in measuring and interpreting 12-lead EGGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
Product codes
DPS, MHX
Device Description
The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system consists of an electronics data acquisition unit and software that runs on a medical grade PC. The system uses either a standard, FDA-cleared, 10electrode EGG cable, or the PhysioGlove to obtain ECG data from the patient. The electronics performs analog processing and analog to digital conversion of a 12 lead diagnostic ECG.
The digital packets from the front-end enter the PC via the USB port. The software for the PC performs a variety of functions, including patient registration, ECG display, and storage.
In addition the system provides ECG analysis. The ECG Analysis Program is a software algorithm only. When the system is used with the PhysioGlove, the ECG Analysis Program is not available.
The PhysioGlove ES Module I is intended to be marketed in two configurations.
- Configuration 1 standard ES Model I without ECG analysis. .
- . Configuration 2 - standard ES Model I with ECG analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities.
Intended User / Care Setting
Physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. Hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
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)
Summary of Non-Clinical testing:
There are no recognized consensus standards applicable to the EGG Analysis System algorithm. The EGG Analysis Program and its applications comply with the Guidances and/or Special Controls as outlined below and detailed in Section 16 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- *Requirements Reviews .
- *Risk Analvsis .
- *Software Verification and Validation .
- *Performance testing .
The device was tested according to the following performance standards:
- Usability testing was done to demonstrate the efficacy of the PhysioGlove in its . intended environment.
- IEC 60601-1-4 Programmable Electrical Medical Systems .
- IEC 62304 Software Life Cycle for Medical Devices .
- IEC 60601-2-51 Particular requirements for safety of electrocardiographs .
In all instances, the device functioned as intended.
Summary of clinical testing:
The modifications made to the PhysioGlove ES Model I with ECG analysis did not require clinical testing to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
510(k) Summary
Commwell Ltd. PhysioGlove ES Model I with ECG Analysis
510(k) Number K103791
Date:
October 18, 2011
Submitter:
Commwell Ltd. Rechov Yad Harutzim 4 Kfar Saba, Israel 44641
Contact Person:
Irving Levy Commwell Ltd. · Rechov Yad Harutzim 4 Kfar Saba, Israel 44641 T: (972) 9-766-8094 F: (972) 9-766-8099
Device Trade Name:
PhysioGlove ES Model I with ECG Analysis
Common Name:
12-lead Diagnostic System with ECG Analysis Program
Classification:
Electrocardiograph System
Product Code:
DPS, MHX
Class:
ll
CFR Reference:
21 CFR 870.2340
Predicate Devices:
1
Intended Use / Indications for Use:
The PhysioGlove ES Model I is a reusable 12-lead diagnostic ECG examination system. The system can be used with 12-lead cables or the PhysioGlove device. When used with the PhysioGlove, it is intended to conduct an electrocardiogram. The diagnostic and automatic measurement features are not available. When used with a 12-lead cable, it is intended for use in resting diagnostic electrocardiograph examination of adults. The PhysioGlove ES Model I is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device provides waveform parameters and ECG analysis for healthcare provider interpretation.
The PhysioGlove ES Model I ECG Analysis Program assists the physician in measuring and interpreting 12-lead EGGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
Device Description:
The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system consists of an electronics data acquisition unit and software that runs on a medical grade PC. The system uses either a standard, FDA-cleared, 10electrode EGG cable, or the PhysioGlove to obtain ECG data from the patient. The electronics performs analog processing and analog to digital conversion of a 12 lead diagnostic ECG.
The digital packets from the front-end enter the PC via the USB port. The software for the PC performs a variety of functions, including patient registration, ECG display, and storage.
In addition the system provides ECG analysis. The ECG Analysis Program is a software algorithm only. When the system is used with the PhysioGlove, the ECG Analysis Program is not available.
The PhysioGlove ES Module I is intended to be marketed in two configurations.
- Configuration 1 standard ES Model I without ECG analysis. .
- . Configuration 2 - standard ES Model I with ECG analysis.
Technological Characteristics - Components and Safety Features:
The PhysioGlove ES Model I with ECG analysis is for recording and analyzing diagnostic 12-lead ECG signals. The system is intended to be used with either a standard patient cable or the cleared PhysioGlove device (K083677). When used
2
with the PhysioGlove, the ECG analysis functionality is disabled. The system employs the same functional scientific technology as its predicate devices.
Determination of Substantial Equivalence:
The PhysioGlove ES Model I with ECG analysis has been modified from the predicate version (K050674) to include additional features to enhance performance and usability of the device, and to provide additional functionality with the introduction of the ECG analysis package (General Electric (GE) 12SL ECG Analysis Program approved under (K092369)). There have been no changes to the fundamental scientific technology of the system.
Summary of Non-Clinical testing:
There are no recognized consensus standards applicable to the EGG Analysis System algorithm. The EGG Analysis Program and its applications comply with the Guidances and/or Special Controls as outlined below and detailed in Section 16 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- *Requirements Reviews .
- *Risk Analvsis .
- *Software Verification and Validation .
- *Performance testing .
The device was tested according to the following performance standards:
- Usability testing was done to demonstrate the efficacy of the PhysioGlove in its . intended environment.
- IEC 60601-1-4 Programmable Electrical Medical Systems .
- IEC 62304 Software Life Cycle for Medical Devices .
- IEC 60601-2-51 Particular requirements for safety of electrocardiographs .
In all instances, the device functioned as intended.
Summary of clinical testing:
The modifications made to the PhysioGlove ES Model I with ECG analysis did not require clinical testing to support substantial equivalence.
Conclusion:
The summary above shows there are no new questions of safety and effectiveness issues associated with the PhysioGlove ES Model I with ECG analysis when compared to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 1 2011
Crommwell Ltd. c/o Mr. Irving Levy Vice President Rechov Yad Harutzim4 Kfar Saba ISRAEL 44641
Re: K103791
Trade/Device Name: PhysioGlove ES Model I with ECG Analysis Program Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: September 21, 2011 Received: September 21, 2011
Dear Mr. Levy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have betely promance holdication of intent to market the device
for use stated in the enclosure) to locally market is substantially equivalent (for the i 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 the Federal Food, Drug,
You may, therefore, market the device, subicat to You may, therefore, market the device, subject to the general controls provisions of the Act. The Act. The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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.
4
Page 2 - Mr. Irving Levy
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Rev. D. Zacharias, M.P.
Bram D. 2 uckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number: K103791
Device Name:
PhysioGlove ES Model I with ECG Analysis Program
Indications for Use:
The PhysioGlove ES Model I is a reusable 12-lead diagnostic ECG examination system. The system can be used with 12-lead cables or the PhysioGlove device. When used with the PhysioGlove, it is intended to conduct an electrocardiogram. The diagnostic and automatic measurement features are not available. When used with a 12-lead cable, it is intended for use in resting diagnostic electrocardiograph examination of adults. The PhysioGlove ES Model I is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device provides waveform parameters and ECG analysis for healthcare provider interpretation.
The PhysioGlove ES Model I ECG Analysis Program assists the physician in measuring and interpreting resting 12-lead EGGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.
Prescription Use (Per 21 CFR 801.109 subpart D)
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Qffice of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K103791