(34 days)
The Personal Telemedicine is intended to be used solely as a monitorium device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, and to listen to the patient's heart and lung sounds.
The PTM 1 consists of a blood pressure meter, a telephonic stethoscope and a speaker/microphone circuit. Both the blood pressure meter and telephonic stethoscope have been cleared by FDA. Neither device has been altered for use with the PTM 1. Instead, they have been placed in a common enclosure for the convenience of the patient. The principal differences between the PTM 1 and the PTS are: (1) the removal of the videophone; (2) the addition of the speaker/microphone circuitry, and (3) the modification of the enclosure.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for American Telecare, Inc.'s Personal Telemedicine Module, focusing on its substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request for the following information:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily discusses the device's intended use, its components (blood pressure meter, telephonic stethoscope, and speaker/microphone circuit), and justifies its substantial equivalence by highlighting that its core components were previously cleared by the FDA and the modifications do not raise new safety or effectiveness concerns. It mentions that the company "has conducted testing which demonstrates the compatibility of this device in the new enclosure," but provides no details about this testing, its criteria, or results.
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K964<554
510(k) Summary
American Telecare, Inc.'s
Personal Telemedicine Module
or
Submitter's Name, Address, and Telephone Number
American Telecare, Inc. 7680 Golden Triangle Drive Eden Prairie, MN 55344-3732 (612) 897-0000 Telephone: (612) 944-2247 Facsimile:
Contact Persons
C. Richard Abbruscato American Telecare, Inc. 7680 Golden Triangle Drive Eden Prairie, MN 55344-2247 (612) 897-0000 Telephone: (612) 944-2247 Facsimile:
Gerard J. Prud'homme, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109 Telephone: (202) 637-5735 Facsimile: (202) 637-5910 (as Regulatory Counsel to American Telecare, Inc.)
Date Prepared
November 8, 1996
Name of Device Personal Telemedicine Module
Classification Name
Powered Communication System
Common Name
Telemedicine Communications Module
Product Code ILC
Predicate Device American Telecare Inc. 's Personal Telemedicine System (K952882)
Intended Use
American Telecare, Inc.'s Personal Telemedicine Module ("PTM 1") is intended to be used solely Anneround device, whereby a health care professional can comminicate with the patient
116
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between visits to gather blood pressure and pulse readings, and to listen to the patient's heart and lung sounds.
Substantial Equivalence
The PTM 1 is used by the patient in conjunction with a videophone, PC-based video conferencing system or other means for the health care professional to talk with the patient or attending nurse. The patient or attending nurse uses the PTM 1's blood measure meter and display to take the patient's blood pressure and pulse rate. The patient or attending nurse reads the blood pressure and pulse valves from the display and repeats them into the PTM 1's microphone for the health care professional to hear at his/her end. The patient or attending nurse places the chest piece on the appropriate body region to pick up either heart, lung, or bowel sounds. The sounds are transmitted to the health care professional who has the receiving end unit of American Telecare's cleared CareTone I telephonic stethoscope. The health care professional advises the patient or attending nurse as to the placement of the chest piece over the communications line ending at the PTM I's speaker. The PTM 1 operates with many off-the shelf desk top PC-based video conferencing systems ("video system") through the video system's audio interface.
The PTM 1 consists of a blood pressure meter, a telephonic stethoscope and a speaker/microphone circuit. Both the blood pressure meter and telephonic stethoscope have been cleared by FDA. Neither device has been altered for use with the PTM 1. Instead, they have been placed in a common enclosure for the convenience of the patient. The principal differences between the PTM 1 and the PTS are: (1) the removal of the videophone; (2) the addition of the speaker/microphone circuitry, and (3) the modification of the enclosure.
The removal of the videophone does not raise new issues of safety or effectiveness because: (1) there is no change in the method of transmitting the blood pressure, pulse or stethoscope sounds from the patient to the physician; and (2) the modification is made merely to permit use with any other compatible PC-based video conferencing system. The use of the speaker/microphone circuitry also does raise new issues of safety or effectiveness because the circuitry uses technology very similar to the speaker phone on the PTS which is well understood. Finally, the minor difference in enclosure dimensions also does not raise any new issues of safety or effectiveness because the Company has conducted testing which demonstrates the compatibility of this device in the new enclosure.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEC 1 7 1996
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. C. Richard Abbruscato American TeleCare, Inc. 7680 Golden Triangle Drive Eden Prairie, Minnesota 55344-3732
- Re : K964554 Personal Telemedicine Module Regulatory Class: II (two) Product Code: 74 DRG Dated: September 12, 1996 Received: September 13, 1996
Dear Mr. Abbruscato:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any cbligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. C. Richard Abbruscato
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
D. Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _
Personal Telemedicine Module Device Name:
Indications For Use:
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indications For Ose.
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device, whereby a health care professional can communicate with the patient The Personal Telementine are professional can comminicate with the productions of the productions of the former to
between visits to gather blood pressure and pulse readings, between visits to gather of
the patient's heart and lung sounds.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Reckard P. Oliphin
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Respiratory, Division of Cological Devices 41455 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).