(203 days)
The TZ Medical "FM Demodulator" (4 or 12 lead) is an interface between an event recorder and ECG machine which takes FM frequency received from a heart monitor and translates it back into an electronic signal which can then be read by an ECG machine to provide ECG traces. The device is used with ECG machines which do not have built in "translators".
The TZ Medical "FM Demodulator" (4 or 12 lead) is an interface between an event recorder and ECG machine which takes FM frequency received from a heart monitor and translates it back into an electronic signal which can then be read by an ECG machine to provide ECG traces.
I am sorry but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an "FM Demodulator" device. It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory information.
The document does not contain any information about:
- Acceptance criteria or reported device performance in a table.
- Details of a study, including sample sizes, data provenance, number or qualifications of experts, adjudication methods.
- Whether MRMC or standalone studies were performed, or any effect sizes.
- The type of ground truth used.
- Training set sample sizes or how ground truth was established for a training set.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Mr. Byron Zahler Secretary TZ Medical, Inc. 15858 S.W. Upper Boones Ferry Road Lake Oswego, OR 97035
Re: K982228 FM Demodulator-4 Lead Model #8500-05 and FM Demodulator-12 Lead Model #8500-25 Regulatory Class: II (two) Product Code: DXH December 16, 1998 Dated: December 18, 1998 Received:
Dear Mr. Zahler:
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 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
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Page 2 - Mr. Byron Zahler
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.
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, 2Misbranding by reference to premarket notification? (21CFR 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,
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)_
Device Name:
FM Demodulator
Indications For Use:
The TZ Medical "FM Demodulator" (4 or 12 lead) is an interface between an event recorder and ECG machine which takes FM frequency received from a heart monitor and translates it back into an electronic signal which can then be read by an ECG machine to provide ECG traces. The device is used with ECG machines which do not have built in "translators".
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence Of CDRH, Office OF Device Evaluation (ODE)
Vayk Tille
(Division Sign-Off) Division of Cardiovascular, Respi and Neurological Devices 510(k) Number
Prescription Use
X
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).