(90 days)
CMS-2000 is intended to be used in the recording of ECG in an ambulatory mode for the diagnosis of various cardiac disorders, which principally include cardiac arrhythmia and myocardial ischemia. This recorder will document and compress the electrocardiograph signal into a memory card during 24 hours recording period with a patient.
Not Found
This is an FDA 510(k) clearance letter for the CMS-2000 device, a medical device for recording ECGs. The provided text does not contain specific acceptance criteria, details of a study proving the device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or information about MRMC studies.
The letter explicitly states: "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."
This indicates that the clearance is based on a demonstration of substantial equivalence to a predicate device, not on a new clinical study with specific acceptance criteria as you've outlined. 510(k) submissions typically compare the new device's performance, technological characteristics, and intended use to a legally marketed predicate device to demonstrate that it is as safe and effective.
Therefore, I cannot populate the table or answer the specific questions you've asked because the provided document does not contain that level of detail for this type of clearance.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine, with a staff and two snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 10 1998
Mr. Chang Hsu General Director Center for Measurement Standards BLDG 16, 321 Kuang Fu RD, Sec 2 Hsinchu, Tiawan, R.O.C.
Re : K982843 CMS-2000 Regulatory Class: II (TWO) Product Code: MWJ Dated: August 10, 1998 Received: August 12, 1998
Dear Mr. Hsu:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation
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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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR 807.97). Other qeneral 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,
Thomas J. Callahan
Thomas J. Callanan, 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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Page __ 1 ____________________________________________________________________________________________________________________________________________________________________
510(k) Number : ______________________________________________________________________________________________________________________________________________________________ Device Name : CMS-2000_
Indications For Use:
CMS-2000 is intended to be used in the recording of ECG in an ambulatory mode for the diagnosis of various cardiac disorders, which principally include cardiac arrhythmia and myocardial ischemia. This recorder will document and compress the electrocardiograph signal into a memory card during 24 hours recording period with a patient.
Hsu, Chang General Director Center for Measurement Standards Industrial Technology Research Institute
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ` IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. Da. B. T. L. M.
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K982843
D. T. C.m.m.m.m. H.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).