(34 days)
No
The description focuses on combining existing, cleared devices (blood pressure meter, telephonic stethoscope) into a new enclosure for convenience and adding speaker/microphone circuitry. There is no mention of AI, ML, image processing, or any data analysis beyond basic vital sign collection and audio transmission. The performance studies focus on compatibility in the new enclosure, not algorithmic performance.
No.
The device is described as a "monitorium device" used to gather blood pressure and pulse readings and listen to heart and lung sounds, which are diagnostic or monitoring functions, not therapeutic.
No
The device is used to gather readings and sounds for a healthcare professional and does "not" diagnose or process any of the information gathered.
No
The device description explicitly states it consists of hardware components: a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit, all placed in a common enclosure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "monitorium device" for a health care professional to communicate with a patient, gather blood pressure and pulse readings, and listen to heart and lung sounds. This involves monitoring physiological parameters directly from the patient's body.
- Device Description: The components are a blood pressure meter, a telephonic stethoscope, and a speaker/microphone circuit. These are devices that interact with the patient's body or facilitate communication, not analyze samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a disease or condition based on such analysis. IVDs are specifically designed for testing samples in vitro (outside the body).
The device is clearly focused on remote patient monitoring and communication of physiological data obtained in vivo (within the body).
N/A
Intended Use / Indications for 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 between visits to gather blood pressure and pulse readings, and to listen to the patient's heart and lung sounds.
Product codes
ILC, DRG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's heart and lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional
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)
The Company has conducted testing which demonstrates the compatibility of this device in the new enclosure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
American Telecare Inc. 's Personal Telemedicine System (K952882)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K964