AVIVA SYSTEM, MODEL SL1010

K993550 · American Telecare, Inc. · DRG · Jan 13, 2000 · Cardiovascular

Device Facts

• Record ID: K993550
• Device Name: AVIVA SYSTEM, MODEL SL1010
• Applicant: American Telecare, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

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.

Device Story

Aviva SLX System facilitates remote patient monitoring between clinical visits. System components include blood pressure meter, telephonic stethoscope, and data port for off-the-shelf glucose meter. Healthcare professional at Central Station communicates with patient at Patient Station via voice/video. Device captures blood pressure, pulse, heart/lung sounds, and glucose readings; transmits data from Patient Station to Central Station. System allows clearing of readings from connected meters. Used by clinicians to gather patient data; not for diagnostic purposes. Benefits include remote access to patient physiological data, enabling monitoring without in-person visits.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

System comprises a blood pressure meter, telephonic stethoscope, and communications circuit. Includes a data port for integration with off-the-shelf glucose meters. Operates as a remote communication and data transmission system. No specific materials or software architecture details provided.

Indications for Use

Indicated for use by healthcare professionals to remotely monitor patients between visits by collecting blood pressure, pulse, heart sounds, lung sounds, and glucose readings. Not intended for diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• American TeleCare's Personal Telemedicine Module
• American TeleCare's Digital Personal Telemedicine Module
• American TeleCare's Personal Telemedicine System

Submission Summary (Full Text)

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## 510(k) SUMMARY

## American TeleCare's

# Aviva SLX Systems

# 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: [phone] Facsimile: [phone]

Date Prepared: October 19, 1999

# Name of Device

Aviva SLX Systems

## Common or Usual Name

Telemedicine Communications Module

#### Classification Name

Powered Communication System

## Predicate Devices

- (1) American TeleCare's Personal Telemedicine Module
- (2) American TeleCare's Digital Personal Telemedicine Module
- American TeleCare's Personal Telemedicine System (3)

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## Substantial Equivalence

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. These minor modifications to the predicate devices do not raise new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2000

Mr. Charles Richard Abbruscato American Telecare, Inc. 7640 Golden Triangle Drive Eden Prairie, Minnesota 55344

Re: K993550 Aviva SLX System Model SL1010 Requlatory Class: II (two) Product Code: DRG Dated: October 19, 1999 Received: October 20, 1999

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 legally marketed predicate 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 regulations.

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Page 2 - Mr. Charles 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K993550

Aviva SLX System Device Name:_

Indications For Use:

The Aviva SLX System is intended for use as a monitoring device, whereby a health care professional can, from a remote location, with the with the patient between visits to gather blood communicate with the pacese readings, as well as to listen to the patient's heart and lung sounds.

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Concurrence of CDRH, Office of Device Evaluation

Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Off) Division of Cardiovas and Neurological D 510(k) Numbe

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