The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as non-invasive blood pressure, via standard telephone lines or the internet to local or remote computer systems for use by the patient or a healthcare professional.

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.

AI/ML Overview

The provided text describes the "Medic4All Telemedicine System VMS-01" in the context of a 510(k) submission to the FDA. However, it does not include detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics.

Instead, the document focuses on:

Substantial Equivalence: Comparing the VMS-01 to predicate devices (Philips Medical Systems M3810A TeleMonitoring System and BL-Healthcare, Inc. Remote Care Management System) for intended use, indications, technological characteristics, and principles of operation.
Performance Data (General): A general statement that "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."

Therefore, many of the requested details about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, and expert involvement are not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific quantitative criteria not provided in the document.	"In all instances, the VMS-01 functioned as intended" for various testing activities (EMC/Electrical safety, unit testing, integration testing, data integrity testing, usability testing, environmental testing, compatibility testing, performance testing, system testing, and load/performance testing).

Explanation: The document states that performance testing was conducted and the device "functioned as intended," but it does not specify what those "intentions" or quantitative criteria were (e.g., specific accuracy levels for blood pressure measurements, data transmission reliability percentages, etc.).

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not specified.
Qualifications of experts: Not specified.

4. Adjudication method for the test set

Adjudication method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC study done: No. The device is a telemedicine system for collecting and transmitting physiological information, not an imaging device typically subject to MRMC studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone study done: The performance testing mentioned ("unit testing; integration testing; data integrity testing; usability testing; environmental testing; compatibility testing; performance testing, system testing, and load/performance testing") would likely encompass standalone performance aspects. However, a dedicated "standalone performance" study in the context of an AI algorithm is not explicitly detailed, nor is there mention of a specific algorithm (beyond a general "telemedicine system"). The device's primary function is data collection and transmission.

7. The type of ground truth used

Type of ground truth: Not specified. For a system that collects physiological information like non-invasive blood pressure, the "ground truth" would typically refer to the accuracy of the measurements compared to a reference standard, or the reliability of data transmission. The document only generally mentions "data integrity testing" and "performance testing."

8. The sample size for the training set

Sample size for training set: Not applicable based on the information provided. The VMS-01 is described as a telemedicine system for data collection and transmission, not an AI/machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

How ground truth for training set was established: Not applicable, as there's no mention of a training set for an AI/ML algorithm.

Summary

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5 510(K) SUMMARY

Image /page/0/Picture/1 description: The image shows the text "K062127 pg 1 of 2" written in black ink on a white background. The text appears to be handwritten. The text "K062127" is on the top line, and the text "pg 1 of 2" is on the bottom line.

NOV - 8 2005

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: July 21, 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). .

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K062127
pg 2 of 2

Intended Use / Indications for Use

Technological Characteristics

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-on 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.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2006

Medic4All Ltd. c/o Mr. Jonathan S. Kahan Partner Hogan & Hartson 555 Thirteenth St. NW Washington D.C. 20004

Re: K062127

Trade Name: Wireless Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: October 24, 2006 Received: October 24, 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.

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

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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,

Bram D/Zuckerman, M.D.

Bram D /Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT 4

510(k) Number (if known): K002 \27

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 noninvasive blood pressure, 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

(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

Division Sign-Off

Division of Cardio
510(k) Number K062127

Regulation Number and Section

§ 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).