(77 days)
Not Found
No
The description focuses on standard telemedicine components (blood pressure meter, stethoscope, communication circuit) and explicitly states the devices have "very similar principles of operation and technological characteristics" to predicate devices, with the only difference being a video phone upgrade. There is no mention of AI or ML capabilities for analysis or interpretation of the collected data.
No
The device is described as a "monitoring device" for gathering readings and sounds, not for providing therapy or treatment.
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state, "None of the devices are intended to be used for diagnostic purposes."
No
The device description explicitly states that the device consists primarily of a blood pressure meter, a telephonic stethoscope, and a communications circuit, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for "monitoring" and gathering information like blood pressure, pulse, and heart/lung sounds from a remote location. It also explicitly states, "None of the devices are intended to be used for diagnostic purposes."
- Device Description: The description reinforces the monitoring function and the components (blood pressure meter, telephonic stethoscope, communications circuit) are consistent with remote monitoring, not in vitro testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
Therefore, the device's purpose and description clearly indicate it is a remote patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DRG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart and lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professional can, from a remote location, communicate with the patient
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
American TeleCare's Personal Telemedicine Module, American TeleCare's Digital Personal Telemedicine Module, American TeleCare's Personal Telemedicine System (3)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: (612) 897-0000 Facsimile: (612) 941-2247
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)
1
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.
2
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.
3
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IP NEEDED)
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)