(119 days)
The AMC SYSTEM is indicated when a physician wants to periodically measure data of chronically-ill home r nt reason it me monitoring devices connected via wired or wireless facilities to a central station, where parts can be generated and viewed via a Web browser by authorized personnel (e.g. physicians, care givers, and patients). The system is not intended to provide real-time data or real-time monitoring.
The AMC System receives data from cleared home measurement devices via an intermediary organization, stores the information in databases, and produces reports for patients and physicians that can be viewed on the Internet by means of secure transmission methods. The AMC system has no direct interface with patients or patients' measuring devices.
The AMC system performs no diagnosis. It stores the received data in the patient's file as received from intermediate organizations, and generates reports in the form of diagrams, data sheets, histograms and scatter diagrams (where applicable).
The AMC system allows the patient and his doctor to access the patient's data via the Internet by use of secured password-protected access codes. These codes (User name and password) are assigned by the AMC system ..
This document is a 510(k) summary for the AMC System by Advanced Monitored Caregiving Inc. It describes a central station for home medical parameters measurement devices and a transtelephonic digital transmission system.
Based on the provided text, the AMC System is a data management and reporting system; it does not perform any diagnosis or have a direct interface with patients or measurement devices. Because of this, the submission indicates that no clinical tests were required. The 510(k) submission highlights that "The AMC system uses the same technology as the predicate devices, and thus no clinical tests are required. All home measurement devices are FDA-cleared." This implies that the device's performance does not rely on a direct clinical evaluation.
Given the information, the following points can be extracted:
-
Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Software Validation Testing Undergone extensive validation testing Interface Compatibility Interfaces with intermediary organizations are all tested for compatibility Equivalence to Predicate Devices Uses the same technology as legally marketed predicate devices, ensuring equivalent safety and efficacy. -
Sample size used for the test set and the data provenance:
- Not applicable/Not mentioned, as no clinical tests were required.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned, as no clinical tests were required.
-
Adjudication method for the test set:
- Not applicable/Not mentioned, as no clinical tests were required.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not mentioned. The device is a data management system, not an AI-assisted diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned for standalone clinical performance. The "algorithm" (software) underwent non-clinical validation.
-
The type of ground truth used:
- For software validation, the 'ground truth' would be defined by predefined functional and performance specifications. For regulatory clearance, the ground truth for equivalence was the legally marketed predicate devices.
-
The sample size for the training set:
- Not applicable/Not mentioned. No machine learning training set is indicated.
-
How the ground truth for the training set was established:
- Not applicable/Not mentioned. No machine learning training set is indicated.
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Page A1 OCT 7 - 2005
Advanced Monitored Caregiving Inc. 510(k) submission AMC System Overview and Product Description June 3, 2005
510(k) summary
1. Submitter Information
Name: Advanced Monitored Caregiving Inc.
Address:
1729 E. 12th St Brooklyn NY 11229
Telephone Number: 718-645-2273 Fax Number : 718-998-9247
Contact person:
Dr. George Myers Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Tel.: 201-727-1703 Fax: 201-727-1708
Date prepared: June 3, 2005
2. Name of Device
Trade Name: AMC System
Common Name: Central station for home medical parameters measurement devices and transtelephonic digital transmission system
Classification name: Telephone Electrocardiographic transmitter and receiver (870.2920/74DXH)
3. Equivalent legally- marketed devices:
Aerotel MPM, K041854 RemoteNurse, K041308 Cybernet Medstar K020534
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4. Description
The AMC System receives data from cleared home measurement devices via an intermediary organization, stores the information in databases, and produces reports for patients and physicians that can be viewed on the Internet by means of secure transmission methods. The AMC system has no direct interface with patients or patients' measuring devices.
The AMC system performs no diagnosis. It stores the received data in the patient's file as received from intermediate organizations, and generates reports in the form of diagrams, data sheets, histograms and scatter diagrams (where applicable).
The AMC system allows the patient and his doctor to access the patient's data via the Internet by use of secured password-protected access codes. These codes (User name and password) are assigned by the AMC system ..
5. Intended Use
The Advanced Monitored Care ("AMC") AMC System is intended to be used in conjunction with home patient measuring devices to send the measured parameters from a patient's home to a central computer via an intermediary organization, where reports can be generated for the physician and data can be reviewed over the Internet by physicians and patients.
6. Performance Data
Non – clinical tests
The software for this product has undergone extensive validation testing. The interfaces with the intermediary organizations are all tested for compatibility.
Clinical tests
The AMC system uses the same technology as the predicate devices, and thus no clinical tests are required. All home measurement devices are FDA-cleared..
7. Conclusion
The AMC System monitoring system is equivalent in safety and efficacy to the legally-marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2005
Advanced Monitoring Caregiving Inc. c/o Mr. George Myers Medsys, Inc. 377 Route 17S Hasbrouck Heights, NJ 070604
Re: K051544
Trade Name: Vital Caregiving System Regulation Number: 21 CFR 870.2920 Regulation Name: Transmitters and Receivers, Electrocardiograph. Telephone Regulatory Class: Class II Product Code: DXH Dated: September 09, 2005 Received: September 12, 2005
Dear Mr. Myers:
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.
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Page 2 – Mr. George Myers
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that i Dr o resuarted essour device complies with other requirements of the Act that I DA has made a dolorized administered by other Federal agencies. You must or any I cuchares and roganizents, including, but not limited to: registration and listing Comply with and rice b requirements, as a manufacturing practice requirements as scl (21 CFR Part 807), laboring (21 CFR Part 820); and if applicable. the electronic forth in the quality bytvelles (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (Seeting your device as described in your Section 510(k) I mis icher will anow you to begin mainenes , .
premarket notification. The FDA finding of substantial equivalence of your device to a legally premative notineation. The sure 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 If you desire specific advised at (240) 276-0295. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMhoranum of reference to your responsibilities under the Act may be obtained from the Other general mionnation on your mernational 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/dsma/dsmamain.html
Sincerely yours,
Ashley B. Bovair
for
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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K051544 510(k) Number (if known):
Indications for Use Form
Device Name: AMC System
Indications for Use:
The AMC SYSTEM is indicated when a physician wants to periodically measure data of chronically-ill home r nt reason it me monitoring devices connected via wired or wireless facilities to a central station, where parts can be generated and viewed via a Web browser by authorized personnel (e.g. physicians, care givers, and patients). The system is not intended to provide real-time data or real-time monitoring.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adule Boan
510(k) Number K051544
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).