(406 days)
Not Found
No
The document explicitly states "The device only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations," and there are no mentions of AI, DNN, or ML in the provided text.
No
The device is described as a "diagnostic" ECG examination system, intended for obtaining and displaying "waveform parameters for healthcare provider interpretation." It does not provide any form of therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system." The "Device Description" also refers to it as a "diagnostic electrocardiograph."
No
The device description explicitly states that the system consists of an "electronics data acquisition unit" and uses a "standard, FDA-cleared, 10-electrode ECG cable," indicating the presence of hardware components beyond just software.
Based on the provided information, the PhysioGlove ES Model I is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- PhysioGlove ES Model I Function: The PhysioGlove ES Model I is a diagnostic ECG system. It directly measures electrical activity from the patient's body (specifically, the heart) using electrodes placed on the skin. It does not analyze specimens taken from the body.
Therefore, the PhysioGlove ES Model I falls under the category of a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system. It is intended for use in resting diagnostic electrocardiograph examination of adults. It 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 only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations.
Product codes
DPS
Device Description
The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system has been tested to a variety of performance standards.
The PhysioGlove ES Model I consists of an electronics data acquisition unit and software that runs on a medical grade PC.
The PhysioGlove ES Model I uses a standard, FDA-cleared, 10-electrode ECG cable 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. Users may also vary ECG acquisition parameters.
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
adults
Intended User / Care Setting
physician or similarly qualified healthcare professional. It is intended for use in physician offices, hospitals, outpatient clinics, or similar settings.
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)
Not Found
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
で、のに、・・・・
COMMWELL LTD.'s PHYSIOGLOVE ES MODEL I
General Information A.
- Submitter's Name: 1.
-
- Address:
-
- Telephone Number:
-
- Fax number:
-
- Contact Person:
-
- Date Prepared:
COMMWELL Ltd.
Rechov Yad Harutzim 4 Kfar Saba, Israel 44641 9729-766-8094 9729-766-8099 Irving Levy January 31, 2005
B. Device
- PHYSIOGLOVE ES MODEL I 1. Name: 2. Trade Name: PHYSIOGLOVE ES MODEL I 3. Common Name: 12-Lead Diagnostic ECG system 4. Classification Name: Electrocardiograph system 5. Product Code: DPS 6. Class: II Regulation Number: 7. 21CFR 870.2340
C. Description of the Device
The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system has been tested to a variety of performance standards.
The PhysioGlove ES Model I consists of an electronics data acquisition unit and software that runs on a medical grade PC.
The PhysioGlove ES Model I uses a standard, FDA-cleared, 10-electrode ECG cable 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. Users may also vary ECG acquisition parameters.
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1
D. Intended Use Statement
The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system. It is intended for use in resting diagnostic electrocardiograph examination of adults. It 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 only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations.
Components D.
- Electronic Unit
- . USB Cable
- . Software and driver CD
- User Guide
F. Discussion of Substantial Equivalence
The PhysioGlove ES Model I has a substantially similar intended use and indications for use as the QRS Diagnostic's EKGCard (K030535), and uses substantially similar technology. None of the minor differences between the devices raise new questions of safety or effectiveness. Accordingly, the PhysioGlove ES Model I is substantially equivalence to the EKGCard.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending from the head, representing growth and development.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 1003
Commwell, Inc. c/o Dr. John Smith Hogan & Hartson, LLP 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K050674 Trade Name: PhysioGlove ES Model I Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: March 7, 2006 Received: March 7, 2006
Dear Dr. Smith:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 such 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.
3
Page 2 - Dr. John Smith
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); 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. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bfimmmafn
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K050674
Device Name: PhysioGlove ES Model I
Indications for Use:
The PhysioGlove ES Model I is a reusable 12-Lead diagnostic ECG examination system. It is intended for use in resting diagnostic electrocardiograph examination of adults. It 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 only provides waveform parameters for healthcare provider interpretation and does not itself provide suggested interpretations.
Prescription Use _XX (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Hemmerma
on Simm-
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