AVIVA SYSTEMS MODEL NUMBERS 1010, 2020

K981533 · American Telecare, Inc. · DRG · Jul 15, 1998 · Cardiovascular

Device Facts

• Record ID: K981533
• Device Name: AVIVA SYSTEMS MODEL NUMBERS 1010, 2020
• Applicant: American Telecare, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jul 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

Intended Use

The PIM Systems are intended for use as a monitoring device, whereby a health care professional can, from a remote location, commicate with the patient between care professional can, from a readings, comments as also as any por of the patient's heart and lung sounds.

Device Story

Aviva Systems function as a telemedicine communications module for remote patient monitoring. Device inputs include blood pressure readings, pulse readings, and acoustic heart/lung sounds captured via telephonic stethoscope. System facilitates voice and video communication between patient and healthcare professional. Operation involves establishing communication links between sending (patient) and receiving (clinician) units to convey physiological data. System utilizes H.324 standards-based video phone technology. Healthcare providers use output to monitor patient status between visits; output is not for diagnostic purposes. System benefits patients by enabling remote clinical oversight.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes blood pressure meter, telephonic stethoscope, and H.324 standards-based video phone. Operates as a powered communication system for remote data transmission. Connectivity via telephonic/video link.

Indications for Use

Indicated for remote patient monitoring by healthcare professionals to gather blood pressure, pulse readings, and heart/lung sounds between patient visits. 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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JUL 1 5 1998

## 510(k) SUMMARY

## American TeleCare's

Aviva 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: April 28, 1998

#### Name of Device

Aviva 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 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. 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 U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 1998

Mr. Charles Richard Abbruscato American Telecare, Inc. 7640 Golden Triangle Drive Eden Prarie, MN 55344

K981533 Re: American TeleCare, Inc. Aviva Systems Requlatory Class: II (two) Product Code: DRG Dated: April 28, 1998 Received: April 29, 1998

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 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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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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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1981533 510(k) Number (if known):

Aviva Systems Device Name:_

# Indications For Use:

The PIM Systems are intended for use as a monitoring device, whereby a health care professional can, from a remote location, commicate with the patient between care professional can, from a readings, comments as also as any por of the patient's heart and lung sounds.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

McCalla Tuch

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Pressiption User (Per 21 CFR 801.109)

: -

OR

Over-The-Counter Use

(Optional Formal 1-2-96)