(209 days)
The NX System is intended to be used as a monitoring device when time-critical care is not required. The peripheral devices compatible with the NX System are blood pressure, pulse, weight, oxygen saturation, glucose and PT/INR. The NX System enables the home-bound patient to retrieve data taken by the peripheral devices and forward them to an off-site central location for access by a health care professional.
The NX System is a Telemedicine Communications Module. It uses a custom PC platform for its patient station (NX Monitoring Station) and has more interface options to stand-alone medical device peripherals. The NX system uses wireless technology to connect to the stand-alone medical devices. It obtains readings from medical device peripherals and forwards those data to the system's Server. The NX System has no internal medical devices.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the American TeleCare NX System, detailing its intended use, classification, predicate devices, and a substantial equivalence determination by the FDA.
Therefore, I cannot provide the requested information in a table or describe a study based on this document. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting performance data against specific acceptance criteria for a new study.
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510(k) SUMMARY
American TeleCare's
NX System
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:
Pete Plucinak American TeleCare, Inc. Telephone: (952) 897-0000 Facsimile: (952) 941-2247
Date Prepared: August 15, 2003
Name of Device
NX System
Common or Usual Name
Telemedicine Communications Module
Classification Name
Powered Communication System
Predicate Devices
American TeleCare's Aviva 200 System
Indications for Use:
The NX System is intended to be used as a monitoring device when time-critical care is not required. The peripheral devices compatible with the NX System are blood pressure, pulse, weight, oxygen saturation, glucose and PT/INR. The NX System enables the home -bound patient to retrieve data taken by the peripheral devices and forward them to an off-site central location for access by a health care professional.
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Substantial Equivalence
The NX System and the predicate device (Aviva 200 System) listed above have the same intended use and very similar principles of operation and technological characteristics. These systems are intended for use as monitoring devices, whereby results from medical devices can be obtained by the NX System and forwarded to the Data Server/Web Server over the Internet. The NX System has no internal medical devices. Communicating through its standard interface ports using radio waves, the NX System can wirelessly connect to devices for measuring blood pressure, pulse, weight, oxygen saturation, glucose and PT/INR. These devices function independently in accordance with their own individual specifications and operation. None of the systems are intended to be used for diagnostic purposes.
In general, basic operation for both systems consists of: (1) obtaining readings for medical device peripherals and (2) forwarding those data to the system's Server.
The only difference from the predicate Aviva 200 System is that the NX System uses a custom PC platform for its patient station (NX Monitoring Station) instead of an off-the-shelf PC and the NX System has more interface options to stand-alone medical device peripherals. Further, the NX system uses wireless technology to connect to the stand-alone medical devices.
These minor variations to the predicate devices do not raise new questions of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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AUG 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
American TeleCare, Inc. c/o Mr. Charles R. Abbruscato Chief Technology Officer 7640 Golden Triangle Drive Eden Prairie, Minnesota 55344
K030222 Re: Trade Name: NX System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: May 19, 2003 Received: May 21, 2003
Dear Mr. Abbruscato:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Charles R. Abbruscato
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KO30222
NX System Device Name:
Indications for Use:
The NX System is intended to be used as a monitoring device when time-critical care is not required. The peripheral devices compatible with the NX System are blood pressure, pulse, weight, oxygen saturation, glucose and PT/INR. The NX System enables the home-bound patient to retrieve data taken by the peripheral devices and forward them to an off-site central location for access by a health care professional.
(Please Do Not Write Below This Line - Continue On Another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030222
OR
Prescription Use: X (Per CRF 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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).