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The NX System is intended to be used as a monitoring device when time-critical care is not required. The peripheral devices compatible with the NX System are blood pressure, pulse, weight, oxygen saturation, glucose and PT/INR. The NX System enables the home-bound patient to retrieve data taken by the peripheral devices and forward them to an off-site central location for access by a health care professional.

The NX System is a Telemedicine Communications Module. It uses a custom PC platform for its patient station (NX Monitoring Station) and has more interface options to stand-alone medical device peripherals. The NX system uses wireless technology to connect to the stand-alone medical devices. It obtains readings from medical device peripherals and forwards those data to the system's Server. The NX System has no internal medical devices.

The Aviva SLX System is intended for use as a monitoring device, 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.

The Aviva SLX System and the predicate device (Aviva System) listed above have the same intended use and very similar principles of operation and technological characteristics. Specifically, both devices consist primarily of a blood pressure meter, a telephonic stethoscope, and a communications circuit. These 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, basic operation of the devices consists of: (1) establishing voice/video communication; (2) establishing communication between the sending and receiving units of a telephonic stethoscope to obtain heart and lung sounds; and (3) obtaining blood pressure and pulse readings. The only difference from the predicate Aviva System is that the Aviva SLX System has the capability to 1) transmit the blood pressure/pulse readings from the Patient Station to the Central Station and clear the readings from the blood pressure/pulse meter; and 2) obtain glucose readings from an off-the-shelf glucose meter plugged into the data port of the Patient Station and transmit those readings to the Central Station, as well as to clear the readings from the glucose meter. The Aviva SLX Systems use the same blood pressure meter and the same telephonic stethoscope as the predicate device.

The PIM Systems are intended for use as a monitoring device, 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.

The Aviva Systems and the predicate devices listed above have the same intended use and very similar principles of operation and technological characteristics. Specifically, all three devices consist primarily of a blood pressure meter, a telephonic stethoscope, and a communications circuit. These 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. None of the devices are intended to be used for diagnostic purposes. In general, operation of the devices consists of: (1) establishing voice/video communication: (2) establishing communication between the sending and receiving units of a telephonic stethoscope; (3) obtaining and conveying a blood pressure and pulse reading; and (4) obtaining and transmitting heart or lung sounds. The only difference from the Personal Telemedicine System is that the Aviva Systems contain a standards based (H.324) video phone instead of an older proprietary video phone. The difference from the PTM and Digital PTM is that the Aviva Systems include a video phone to be used with the PTM and Digital PTM. The Aviva Systems use the same blood pressure meter and the same telephonic stethoscopes as the predicate devices.

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.

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.

The intended use of American Telecare, Inc.'s CareTone II is to conduct a stethoscope examination of a patient by a nurse or physician at another location using a communications line.

To use the CareTone, a patient plugs the sending unit's telephone cable into a telephone wall outlet and the examiner plugs the receiving unit's telephone cable into a telephone wall outlet. The examiner dials the patient's telephone number to connect the receiving unit and sending unit over the telephone line. When the connection is made, the patient places the stethoscope chest piece on his/her chest. The sounds captured by the chest piece are transmitted to the patient end unit of the sending unit by a microphone located within the chest piece. The signal is processed within the circuitry of the patient end unit and transmitted over the telephone line to the receiving unit and through headphones to the examiner.

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 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.

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.