(107 days)
Not Found
No
The summary describes a system for collecting, transmitting, and displaying physiological data, but there is no mention of AI or ML being used for data analysis, interpretation, or decision support. The performance studies focus on system functionality and reliability, not on the performance of an AI/ML algorithm.
No.
The device is intended to collect and transmit physiological information for monitoring, not to treat or cure a disease or condition.
Yes
The device collects and transmits "physiological information, such as glucose levels" for use by a healthcare professional, implying the data could be used for assessment and diagnosis. The term "monitoring" used in the device description often precedes diagnostic activities.
No
The device description explicitly states it is a "wireless telephonic/internet-based physiologic monitoring system" and mentions "interactive, remote, physiological data measurement". The performance studies include "EMC/Electrical Safety" and "environmental testing", which are typically associated with hardware components, not solely software. The predicate devices are also described as "TeleMonitoring System" and "Remote Care Management System", implying hardware components for data acquisition.
Based on the provided information, the Medic4All Telemedicine System Model VMS-01 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to collect and transmit physiological information, specifically mentioning glucose levels, but the system itself is not performing the diagnostic test on the sample. It's collecting data from a separate device (presumably a glucose meter) and transmitting it.
- Device Description: The description focuses on the system's function as a monitoring and transmission system for physiological data. It doesn't describe any components or processes that would involve testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, etc.)
- Using reagents or assays
- Providing a diagnostic result based on the analysis of a sample
The system acts as a data collection and transmission platform for physiological data, which is a different category of medical device than an IVD. The glucose level data it transmits is likely generated by a separate IVD device (a glucose meter).
N/A
Intended Use / Indications for Use
The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as glucose levels, 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.
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
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, 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
K061502
page 1 of 2
SEP 15 2006
5 510(K) SUMMARY
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: May 30, 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). .
Intended Use / Indications for Use
The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as glucose levels, via standard telephone lines or the internet to local or remote computer systems for use by the patient or a healthcare professional.
1
K041502
page 2 of 2
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.
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, 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
Public Health Service
Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2006
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: K061502
Trade Name: Telemedicine System Model 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: August 30, 2006 Received: August 30, 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmmer for
Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4 INDICATIONS FOR USE STATEMENT
14041502 510(k) Number (if known):
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 glucose levels, via standard telephone lines or the internet to local or remote computer systems for use by the patient or a healthcare professional.
Prescription Use
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 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
Ondell
(Division Sian-Off) Division of Cardiovascular Devices 510(k) Number KO6 502