PERSONAL TELEMEDICINE SYSTEM
K952882 · American Telecare, Inc. · DXN · Sep 9, 1996 · Cardiovascular
Device Facts
| Record ID | K952882 |
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| Device Name | PERSONAL TELEMEDICINE SYSTEM |
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| Applicant | American Telecare, Inc. |
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| Product Code | DXN · Cardiovascular |
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| Decision Date | Sep 9, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 870.1130 |
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| Device Class | Class 2 |
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Intended Use
The American TeleCare, Inc. Personal Telemedicine System (PTS) is intended to be used to transmit medical information between a patient at one location, typically in their home, and a medical practitioner at another location, typically a home care nurse at a central nursing station. Information is transmitted over normal residential telephone lines and utilizes two-way video and voice communication.
Device Story
Personal Telemedicine System (PTS) acts as a communication hub for remote patient monitoring; integrates existing FDA-cleared medical devices (e.g., blood pressure monitors, stethoscopes) into a single housing with videophone and speakerphone capabilities. Used in home settings by patients; operated by medical practitioners at central nursing stations. Input includes visual data via camera with magnifying lens and auditory data from medical devices; transmitted over standard residential telephone lines. Practitioner conducts 'video-visits' to perform diagnostic tests, replacing or augmenting physical visits. Output consists of real-time two-way audio/video communication; allows practitioner to receive verbal test results and perform visual examinations. Facilitates clinical decision-making by enabling remote assessment of patient status; benefits patients by providing access to care without requiring physical travel.
Clinical Evidence
No clinical data. The device is an assembly of previously cleared medical products used for their original intended purposes; substantial equivalence is based on the integration of existing cleared components and telecommunications hardware.
Technological Characteristics
Assembly of FDA-cleared medical devices housed with a videophone and speakerphone. Utilizes standard residential telephone lines for data transmission and standard household energy sources. Includes a magnifying lens for camera-based visual examination. No specific materials or software algorithms described.
Indications for Use
Indicated for patients in home health care settings requiring remote medical examination and monitoring by a medical practitioner or home care nurse.
Regulatory Classification
Identification
A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.
Predicate Devices
- Digital Blood Pressure Monitor (A & D Medical)
- TelePhonic Stethoscope (American TeleCare, Inc.)
- Image Management System (Corabi International Telemetrics, Inc.)
- Corabi DX2000 Dynamic Module (Apollo Software, Inc.)
Related Devices
- K040581 — MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM · Vitel Net · May 27, 2004
- K973873 — DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 · American Telecare, Inc. · Dec 29, 1997
- K022274 — CARECOMPANION PATIENT STATION & NURSE STATION · Neptec Design Group, Ltd. · May 29, 2003
- K981533 — AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 · American Telecare, Inc. · Jul 15, 1998
- K031863 — CARESTATION 126S VIDEOPHONE · Motion Media Technology, Inc. · Oct 10, 2003
Submission Summary (Full Text)
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K952882
Page 15 PTS 510(k)
SEP - 9 1996
510(k) Summary of Safety and Effectiveness
| Submitter: | American TeleCare, Inc.
7680 Golden Triangle Drive
Eden Prairie, MN 55344-3732 |
| --- | --- |
| Phone: | 612/897-0000 |
| Fax: | 612/944-2247 |
| Contact: | Charles R. Abbruscato |
| Date of Summary: 6/22/95 |
| --- |
Product: Classification Name: Powered Communications Product (21 CFR 890.3710)
Generic Name: Telemedicine Communication Product
Trade/Proprietary Name: Personal Telemedicine System
Substantially Equivalent Products:
Digital Blood Pressure Monitor as manufactured by A & D Medical TelePhonic Stethoscope as manufactured by American TeleCare, Inc.
Image Management System and Corabi DX2000 Dynamic Module as manufactured by Corabi International Telemetrics, Inc. and Apollo Software, Inc.
Description: The Personal Telemedicine System (PTS) is an assembly of medical products, each of which was previously cleared by the FDA for commercial distribution to patients for their in home use. These products are assembled into a housing which incorporates a videophone and speakerphone and thereby allows a medical practitioner to communicate directly with a patient in a remote location, both verbally and visually, to perform an examination.
Use of the PTS begins by either the medical practitioner placing a call to the patient's videophone or the patient pushing the "CALL" button on the PTS unit to notify the medical practitioner to call them. The medical practitioner then determines the patient's status through questions and answers, through visual examination via the videophone, and through use of the medical products. Visual examination is enhanced by the patient placing themselves in relation to the camera portion of the videophone and by use of a specially made magnifying lens placed in front of the camera portion of the videophone. The medical practitioner walks the patient through use of the medical products and the results of each test are presented verbally to the medical practitioner.
The medical products in the PTS unit are being used for the same purposes for which they received 510(k) clearance. The unit as a whole, however, has never been submitted to the FDA for clearance.
Intended Use: The American TeleCare, Inc. Personal Telemedicine System (PTS) is intended to be used to transmit medical information between a patient at one location, typically in their home, and a medical practitioner at another location, typically a home care
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Page 16 PTS 510(k)
nurse at a central nursing station. Information is transmitted over normal residential telephone lines and utilizes two-way video and voice communication.
The PTS is typically used in home health care situations as an augment to home care nursing.
In essence, the PTS allows a medical practitioner to make a "video-visit"™ to the patient rather than a physical visit. In this "video-visit," the medical practitioner can conduct many of the same diagnostic tests that would be performed in a physical visit.
Comparison to Substantially Equivalent Products:
The American TeleCare, Inc. Personal Telemedicine System (PTS) is equivalent to the medical equipment from which it is assembled, with the addition of the telecommunications equipment. This additional equipment is equivalent to the Corabi/Apollo equipment in that it conveys the medical information gathered at a remote site to a central location for diagnostic evaluation. Both use specialized hardware to accomplish this task, and convey the information using standard household energy sources and telephone equipment.
The Corabi/Apollo equipment uses a personal computer while the PTS does not. The PTS uses several pieces of home use medical equipment while the Corabi/Apollo does not. The PTS conveys some auditory as well as visual information while the Corabi/Apollo conveys only visual information.
