(119 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the system's functionality (data storage, report generation) does not suggest the use of AI/ML.
No
The device is a system for collecting, storing, and reporting data from home measurement devices, not for providing therapy. It explicitly states it performs no diagnosis and does not provide real-time data or monitoring for therapeutic intervention.
No
Explanation: The "Device Description" explicitly states that "The AMC system performs no diagnosis." Its function is to receive, store, and report data from other measurement devices.
Yes
The device description explicitly states that the system receives, stores, and produces reports from data received from cleared home measurement devices. It has no direct interface with patients or measuring devices and performs no diagnosis. The performance studies focus on software validation and interface compatibility, not hardware. This strongly indicates a software-only device that processes data from external hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The AMC System receives, stores, and reports data from external home monitoring devices. It does not directly interact with or analyze biological specimens from the patient.
- Intended Use: The intended use is for periodic measurement data of chronically-ill home patients and generating reports for viewing. It explicitly states it is not intended to provide real-time data or monitoring, and it performs no diagnosis.
- Device Description: The description confirms it receives data from cleared home measurement devices and stores/reports it. It has no direct interface with patients or their measuring devices.
The system acts as a data management and reporting tool for information gathered by other devices, rather than performing diagnostic tests on biological samples itself.
N/A
Intended Use / Indications for 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.
The AMC SYSTEM is indicated when a physician wants to periodically measure data of chronically-ill home patients using measuring and monitoring devices connected via wired or wireless facilities to a central station, where reports 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.
Product codes
DXH
Device 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.
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
Physicians, care givers, and patients and home medical parameters measurement.
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)
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.
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
§ 870.2920 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).
0
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
1
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.
2
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.
3
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
4
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