(463 days)
The Home Health Monitoring System is intended for use as a monitoring device, whereby a health care professional can view and communicate with the patient between offices visits to collect readings of patient blood pressure, the manage, pulse, temperature, and listen to sounds emanating from the bowel, heart and lungs.
The system is contraindicated for two populations. Patient's and/or caregivers that are physically unable to use this device. Patients' and/or caregivers who's cognitive and or language skills are impaired to such an extent as to preclude communication with medical personnel or effectively operate the device
This device should not be used for continuos monitoring.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Kodak LifeView Telemonitoring System. It does not contain information regarding detailed acceptance criteria, device performance studies, sample sizes for testing or training sets, expert qualifications, or ground truth establishment methods typically found in clinical study reports or pre-market approval applications.
Therefore, I cannot provide the requested information based on the input text. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines regulatory obligations.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2000
Mr. Donald R. Ellis Eastman Kodak Company 901 Elmgrove Road Rochester, NY 14653
Re: K983928 Kodak LifeView Telemonitoring System (Model 110 Patient Station and Model 1000 Nurse Station) Requlatory Class: II (two) 74 MWI, DRG, and DXN Product Code: Dated: December 22, 1999 Received: December 23, 1999
Dear Mr. Ellis:
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.
{1}------------------------------------------------
Page 2 - Mr. Donald R. Ellis
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 Also, please note the regulation entitled, (301) 594-4639. "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,
fe arnold Wietstockus fon
elia 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
Enclosure
{2}------------------------------------------------
"INDICATIONS FOR USE"
510(K) Number: K983928
Device Name: KODAK LifeView
Indication of use: The Home Health Monitoring System is intended for use as a monitoring device, whereby a health care professional can view and communicate with the patient between offices visits to collect readings of patient blood pressure, the manage, pulse, temperature, and listen to sounds emanating from the bowel, heart and lungs.
The system is contraindicated for two populations. Patient's and/or caregivers that are physically unable to use this device. Patients' and/or caregivers who's cognitive and or language skills are impaired to such an extent as to preclude communication with medical personnel or effectively operate the device
This device should not be used for continuos monitoring.
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | OR | Over-The-Counter | |||
|---|---|---|---|---|---|
| ------------------ | -- | ---- | -- | ------------------ | -- |
| 2/4/00 | |
|---|---|
| B. Clary |
Division Sign-Off
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number _
35
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).