(75 days)
Not Found
No
The summary describes a system for collecting and transmitting physiological data, with no mention of AI or ML for data analysis or interpretation.
No
The device is described as a system for collecting and transmitting physiological information and for remote physiological data measurement, transmission, processing, storage, and display. This indicates a monitoring and communication function, not a therapeutic one. The description does not mention any function that treats, prevents, or mitigates a disease or condition.
No
The device is intended to collect and transmit physiological information for monitoring, not for diagnosing medical conditions. The "Intended Use" states it's for "use by the patient or a healthcare professional" to review collected data, which aligns with monitoring rather than diagnosis.
No
The device description explicitly mentions "optional hardware" and the performance studies include testing for "EMC/Electrical safety" and "environmental testing," which are indicative of a system that includes hardware components beyond just software.
Based on the provided information, the Medic4All Telemedicine System Model VMS-01 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect and transmit physiological information, such as weight," and for "interactive, remote, physiological data measurement, transmission, processing, storage and display of data." This focuses on collecting and managing in vivo (within the living body) physiological data, not in vitro (outside the living body) diagnostic testing.
- Device Description: The description reinforces the focus on monitoring physiological data from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing diagnostic tests on these samples, which are the hallmarks of IVD devices.
The device is a telemedicine system designed for remote physiological monitoring, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as weight, via standard telephone lines or the internet to local or remote computer systems for use by the patient or a healthcare professional.
Product codes
DRG
Device Description
Medic4All's VMS-01 telemedicine system (VMS-01) is a wireless telephonic/internet-based physiologic monitoring system, designed for care of patients requiring periodic monitoring. It is designed for interactive, remote, physiological data measurement, transmission, processing, storage and display of data. Additionally, the system allows optional verbal and video conferencing between a care giver and a patient through common telephone lines or the internet and optional hardware.
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
Not Found
Intended User / Care Setting
patient or a healthcare professional / local or remote computer systems
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)
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the telemedicine system. Testing involved EMC/Electrical safety; unit testing; integration testing; data integrity testing; usability testing; environmental testing; compatibility testing; performance testing. system testing, and load/performance testing for the whole telemedicine system. In all instances, the VMS-01 functioned as intended.
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
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).
0
5 510(K) SUMMARY
NOV 2 1 2006
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. § 807.92.
Submitter:
Medic4All (Israel) LTD.
10 Hamefalsim Street, POB 4222 Petach Tikva, Israel 49000 Phone number: +972-3-9226610 Fax number: +972-3-9226615
Contact Person:
Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109
Phone: (202) 637-5794
Date Prepared: September 7, 2006
Name of the Device:
Medic4All Telemedicine System VMS-01
Predicate Devices:
The VMS-01 is substantially equivalent to:
- The Philips Medical Systems M3810A TeleMonitoring System with . M3812B TeleStation (K023749).
- The BL-Healthcare, Inc. Remote Care Management System (K051470). .
1
1062662
Intended Use / Indications for Use
The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as weight, via standard telephone lines or the internet to local or remote computer systems for use by the patient or a healthcare professional.
Technological Characteristics
Medic4All's VMS-01 telemedicine system (VMS-01) is a wireless telephonic/internet-based physiologic monitoring system, designed for care of patients requiring periodic monitoring. It is designed for interactive, remote, physiological data measurement, transmission, processing, storage and display of data. Additionally, the system allows optional verbal and video conferencing between a care giver and a patient through common telephone lines or the internet and optional hardware.
Performance Data
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the telemedicine system. Testing involved EMC/Electrical safety; unit testing; integration testing; data integrity testing; usability testing; environmental testing; compatibility testing; performance testing. system testing, and load/performance testing for the whole telemedicine system. In all instances, the VMS-01 functioned as intended.
Substantial Equivalence
The VMS-01 system is substantially equivalent to the Philips Medical Systems M3810A TeleMonitoring System with M3812B TeleStation (K023749) and the BL-Healthcare, Inc. Remote Care Management System (K051470). The VMS-01 has the same intended uses and substantially similar indications, technological characteristics, and principles of operation as these predicate devices. The minor differences in indications for use and technology between the VMS-01 and the predicate devices raise no new issues of safety or effectiveness, as demonstrated by performance test data.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2005
Medic4All (Israel) LTD. c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K062662
Trade Name: Medic4All Telemedicine System VMS-01 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: September 7, 2006 Received: September 7, 2006
Dear Mr. 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. 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.
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 - Mr. Jonathan S. Kahan
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 not moan 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 litting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice rearinements 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 100-100. 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) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blyminima of
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 4
| 510(k) Number (if known): | Ko Willele |
|---|---|
| --------------------------- | ------------ |
Device Name: Telemedicine System Model VMS-01
Indications for Use:
The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as weight, via standard telephone lines or the internet to prrycler ground in computer systems for use by the patient or a healthcare professional.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Blammena
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