(444 days)
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No
The summary describes a telemedicine system for remote communication and examination using existing cleared medical devices, with no mention of AI or ML capabilities for analysis or interpretation.
No.
The device is described as a telemedicine system that transmits medical information and allows for remote communication and examination, rather than directly providing therapy.
No
The device is a telemedicine system intended to transmit medical information and facilitate remote examinations using previously cleared medical products. It is not, in itself, a diagnostic device, but rather a platform that enables diagnostic activities to be performed remotely. The text explicitly states, "The medical products in the PTS unit are being used for the same purposes for which they received 510(k) clearance," implying that the diagnostic capabilities reside within those individual components, not the PTS itself as a standalone diagnostic tool.
No
The device description explicitly states that the Personal Telemedicine System (PTS) is an "assembly of medical products" and is "assembled into a housing which incorporates a videophone and speakerphone." This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the American TeleCare, Inc. Personal Telemedicine System (PTS) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- PTS Function: The PTS is described as a system for transmitting medical information, enabling remote visual and verbal communication between a patient and a medical practitioner, and facilitating the use of pre-cleared medical devices for examination.
- Lack of Sample Analysis: The description does not mention the PTS performing any analysis on samples taken from the patient's body. The medical products included are used for direct examination (like a blood pressure monitor or stethoscope), not for analyzing biological samples.
- Focus on Communication and Remote Examination: The primary function is to allow a "video-visit" and conduct diagnostic tests that would typically be performed during a physical examination, which does not involve in vitro analysis.
Therefore, the PTS falls under the category of a telemedicine system that facilitates remote medical examinations and communication, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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" TM 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.
Product codes
MSF
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Typically a home care nurse at a central nursing station.
Typically in their home.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).
0
SEP - 9 1996
510(k) Summary of Safety and Effectiveness
Date of Summary: 6/22/95 Submitter: American TeleCare, Inc. 7680 Golden Triangle Drive Eden Prairie, MN 55344-3732 612/897-0000 Phone: Fax: 612/944-2247 Contact: Charles R. Abbruscato
Classification Name: Powered Communications Product (21 CFR 890.3710) Product:
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
1
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" TM 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 TeleČare, 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.