(90 days)
Not Found
Not Found
No
The provided text only describes the recording and compression of ECG signals and does not mention any AI or ML capabilities.
No
The device is used for diagnosis and recording of ECG signals, not for treatment or therapy.
Yes
The Intended Use section states that the device is "intended to be used in the recording of ECG in an ambulatory mode for the diagnosis of various cardiac disorders." This explicitly indicates a diagnostic purpose.
No
The description explicitly states the device is a "recorder" that "document[s] and compress[es] the electrocardiograph signal into a memory card." This implies the presence of hardware components for signal acquisition, recording, and storage, which is inconsistent with a software-only device.
Based on the provided information, the CMS-2000 is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "recording of ECG in an ambulatory mode for the diagnosis of various cardiac disorders." This involves collecting physiological signals from the patient's body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Nature of the Device: The description indicates it's a recorder that documents and compresses an electrocardiograph signal. This is a device that interacts directly with the patient to measure electrical activity of the heart.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The CMS-2000 falls under the category of a medical device that directly measures physiological parameters from the patient.
N/A
Intended Use / 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.
Product codes
MWJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.