(80 days)
No
The description focuses on standard telemedicine components (blood pressure meter, stethoscope, speaker/microphone) and explicitly states they are not interconnected by hardware or software, which is inconsistent with typical AI/ML integration. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is described as a "monitoring device" used to gather readings and listen to sounds, but it does not claim to treat or cure any condition.
No
Explanation: The device is described as a "monitoring device" used to gather readings and listen to sounds, not to diagnose medical conditions. Additionally, the description states it is "intended to be used solely as a monitoring device."
No
The device description explicitly states that the device consists of hardware components: a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit, even though they are not interconnected by hardware or software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for monitoring blood pressure, pulse, and heart/lung sounds. This involves collecting physiological data directly from the patient's body.
- Device Description: The components listed (blood pressure meter, telephonic stethoscope, speaker/microphone) are all designed to interact with the patient's body or collect sounds from within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) in vitro (outside the body) to provide diagnostic information. IVDs typically involve reagents, assays, or other methods for analyzing biological samples.
The device is a telemedicine monitoring tool that facilitates remote communication and data collection from the patient's body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Digital Personal Telemedicine Module is intended to be used solely as a monitoring device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung · sounds.
Product codes
74 DRG
Device Description
The Digital Telemedicine Module ("Digital PTM") and the predicate devices listed above have the same intended use and principles of operation and very similar technological characteristics. Specifically, both the Digital PTM and the Personal Telemedicine Module ("PTM") consist primarily of a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit; these three components are placed in a common housing but are not interconnected by hardware or software. Both devices are intended for use as monitoring devices, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds. Neither device is intended to be used for diagnostic purposes. In general, operation of either device consists of: 1) connecting the device to a video system; 2) establishing voice/video communication; 3) establishing communication between the sending and receiving units of a telephonic stethoscope; 4) obtaining a blood pressure and pulse reading; and 5} obtaining and transmitting to heart or lung sounds.
The only difference between the two devices is that the PTM contains American TeleCare's CareTone Telephonic Stethoscope ("CareTone"), while the Digital PTM contains American TeleCare's CareTone II/LBR Telephonic Stethoscope ("CareTone II/LBR"). the second generation model of American TeleCare's CareTone II Telephonic This minor modification to the technological Stethoscope ("CareTone II"). characteristics of the Digital PTM does not raise new questions of safety or effectiveness, because 1) the Digital PTM is a kit that provides the telephonic stethoscope in a common enclosure with the blood pressure monitor and the microphone/speaker circuit for the convenience of the patient: 2) the telephonic stethoscope is not interconnected with the other components of the Digital PTM; and 3.) the modifications made to the CareTone II/LBR, when compared with the CareTone II's characteristics, do not raise new questions or effectiveness regarding the stethoscope. Thus, the Digital PTM is substantially equivalent to the predicate devices.
With regard to the telephonic stethoscopes, the primary differences between the CareTone II and the CareTone II/LBR are: 1) the method used to encode the auscultatory sounds from the analog signal to a digital binary signal; 2) the process by which data are received at the receiving end unit of the telephonic stethoscope. These technological differences do not raise new questions of safety or effectiveness; bench testing and clinical studies demonstrate that these modifications do not adversely affect the quality of the transmitted signal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart and lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professional (remote location)
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)
Bench testing and clinical studies demonstrate that these modifications do not adversely affect the quality of the transmitted signal.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
1
510K SUMMARY
American TeleCare's Digital Personal Telemedicine Module
DEC 2 9 1997
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
American TeleCare, Inc. 7640 Golden Triangle Drive Eden Prairie, MN 55344-3732
Contact Person:
C. Richard Abbruscato American TeleCare, Inc. Telephone: (612) 897-0000 Facsimile: (612) 944-2247
Date Prepared: October 9, 1997
Name of Device
Digital Personal Telemedicine Module
Common or Usual Name
Telemedicine Communications Module
Classification Name
Powered Communication System
Predicate Devices
-
- American TeleCare's Personal Telemedicine Module (K964554); and
-
- American TeleCare's CareTone II Telephonic Stethoscope (K963678)
1
Substantial Equivalence
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The Digital Telemedicine Module ("Digital PTM") and the predicate devices listed above have the same intended use and principles of operation and very similar technological characteristics. Specifically, both the Digital PTM and the Personal Telemedicine Module ("PTM") consist primarily of a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit; these three components are placed in a common housing but are not interconnected by hardware or software. Both devices are intended for use as monitoring devices, whereby a health care professional can, from a remote location, communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to the patient's heart and lung sounds. Neither device is intended to be used for diagnostic purposes. In general, operation of either device consists of: 1) connecting the device to a video system; 2) establishing voice/video communication; 3) establishing communication between the sending and receiving units of a telephonic stethoscope; 4) obtaining a blood pressure and pulse reading; and 5} obtaining and transmitting to heart or lung sounds.
The only difference between the two devices is that the PTM contains American TeleCare's CareTone Telephonic Stethoscope ("CareTone"), while the Digital PTM contains American TeleCare's CareTone II/LBR Telephonic Stethoscope ("CareTone II/LBR"). the second generation model of American TeleCare's CareTone II Telephonic This minor modification to the technological Stethoscope ("CareTone II"). characteristics of the Digital PTM does not raise new questions of safety or effectiveness, because 1) the Digital PTM is a kit that provides the telephonic stethoscope in a common enclosure with the blood pressure monitor and the microphone/speaker circuit for the convenience of the patient: 2) the telephonic stethoscope is not interconnected with the other components of the Digital PTM; and 3.) the modifications made to the CareTone II/LBR, when compared with the CareTone II's characteristics, do not raise new questions or effectiveness regarding the stethoscope. Thus, the Digital PTM is substantially equivalent to the predicate devices.
With regard to the telephonic stethoscopes, the primary differences between the CareTone II and the CareTone II/LBR are: 1) the method used to encode the auscultatory sounds from the analog signal to a digital binary signal; 2) the process by which data are received at the receiving end unit of the telephonic stethoscope. These technological differences do not raise new questions of safety or effectiveness; bench testing and clinical studies demonstrate that these modifications do not adversely affect the quality of the transmitted signal.
Thus, the CareTone II/LBR is substantially equivalent to the CareTone II; therefore, as described above, the Digital PTM is substantially equivalent to the 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 features a stylized eagle with three profiles forming its body, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
DEC 2 9 1997
Mr. C. Richard Abbruscato Vice President, Engineering and Manufacturing Operations American TeleCare, Inc. 7640 Golden Triangle Drive Eden Prairie, MN 55344
Re: K973873 Digital Personal Telemedicine Module Trade Name: Requlatory Class: II (two) Product Code: 74 DRG Dated: October 9, 1997 October 10, 1997 Received:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 obligation 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 requlations.
3
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) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
:10(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Digital Personal Telemedicine Module )evice Name:_
ndications For Use:
..
scription Use
7 21 CFR 801.109)
The Digital Personal Telemedicine Module is intended to be used solely as a monitoring device, whereby a health care professional can communicate with the patient between visits to gather blood pressure and pulse readings, as well as to listen to 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 (C
V. Oanh Tiller
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number
Over-The-Counter/Use
(Optional Formal 1-2-96)
OR