(85 days)
Not Found
No
The description focuses on basic data transmission and communication functionalities, with no mention of AI/ML terms or capabilities like analysis, interpretation, or learning from data.
No
The device is described as a "monitoring device" to gather data, not to provide therapy or treatment.
No
The "Intended Use / Indications for Use" section and "Device Description" section explicitly state that "Neither device is intended to be used for diagnostic purposes." It is described as a monitoring device.
No
The device description explicitly states it consists of hardware components: a blood pressure meter, a telephonic stethoscope, and a communications circuit.
Based on the provided information, the Aviva SLX System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is a "monitoring device" for gathering blood pressure, pulse readings, and listening to heart and lung sounds. It also explicitly states, "Neither device is intended to be used for diagnostic purposes."
- Device Description: The description reinforces its function as a monitoring device for collecting physiological data (blood pressure, pulse, heart/lung sounds, and glucose readings).
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The Aviva SLX System does not perform analysis on such specimens. While it can obtain glucose readings from an off-the-shelf glucose meter (which is an IVD), the Aviva SLX System itself is simply transmitting that data.
Therefore, the Aviva SLX System falls under the category of a remote patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
DRG
Device Description
The Aviva SLX System consists primarily of a blood pressure meter, a telephonic stethoscope, and a communications circuit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professional, remote location
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)
K993550, (1) American TeleCare's Personal Telemedicine Module, (2) American TeleCare's Digital Personal Telemedicine Module, (3) American TeleCare's Personal Telemedicine System
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
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: (612) 897-0000 Facsimile: (612) 941-2247
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.
2
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 (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/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
(Optional Format 3-10-98)