(85 days)
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 provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a typical medical device study would.
Instead, the document is a 510(k) summary for the Aviva SLX Systems, which focuses on demonstrating substantial equivalence to a predicate device, not on proving new performance characteristics through independent studies with defined acceptance criteria.
Here's why the requested information cannot be extracted from this document:
- No acceptance criteria or performance study reported: The document states that the new device has "minor modifications" and "does not raise new questions of safety or effectiveness." This implies that extensive new performance studies (like those requiring acceptance criteria, sample sizes, ground truth, etc.) were not deemed necessary because the device is substantially equivalent to an already approved device.
- Focus on substantial equivalence: The core of this 510(k) filing is to show that the Aviva SLX System has the "same intended use and very similar principles of operation and technological characteristics" as the predicate device.
- Device purpose: The device is a "Telemedicine Communications Module" intended for monitoring and gathering basic physiological data (blood pressure, pulse, heart/lung sounds, glucose readings), not for diagnostic purposes. This type of device relies more on the accuracy and reliability of its integrated components (like blood pressure meters and stethoscopes which are often already cleared) and its communication capabilities, rather than a novel diagnostic algorithm that would require extensive clinical validation against a gold standard.
Therefore, I cannot populate the table or provide answers to most of your questions because the information is not present in the provided 510(k) summary.
Disclaimer: Without a formal performance study detailed in a 510(k) summary, specific acceptance criteria as you've outlined for diagnostic AI devices are not typically presented. Regulatory clearance for devices like the Aviva SLX often relies on demonstrating that the modifications do not negatively impact safety or effectiveness compared to a legally marketed predicate device.
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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: (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.
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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 (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)
§ 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).