(90 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is a standard Holter ECG recorder.
No
The device is used for diagnosis (recording ECGs for cardiac disorders), not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used in the recording of ECGs in an ambulatory mode for the diagnosis of various cardiac disorders."
No
The device description explicitly states "TES-20 Holter ECG Recorder," which implies a hardware component for recording ECGs.
Based on the provided information, the TES-20 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "recording of ECGs in an ambulatory mode for the diagnosis of various cardiac disorders." This describes a device that measures electrical signals from the body, not a device that examines specimens (like blood, urine, or tissue) outside of the body.
- Device Description: The description "Holter ECG Recorder" further confirms it's a device for recording physiological signals directly from the patient.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Using reagents or assays.
- Providing results based on the analysis of samples.
Therefore, the TES-20 is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TES-20 is intended to be used in the recording of ECGs in an ambulatory mode for the diagnosis of various cardiac disorders. These disorders principally include cardiac arrhythmia.
Product codes
MWJ
Device Description
Tes Electrical Electronic Corp. TES-20 Holter ECG Recorder
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is enclosed within a circular border. 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
OCT 1 9 1999
Mr. Mike Z. Chen TES Electrical Electronic Corporation 57 Jen Ai Road, Sec. 2 Taipei, Taiwan 300, ROC.
K992425 Re: TES-20 Requlatory Class: II (two) Product Code: MWJ Dated: July 20, 1999 Received: July 21, 1999
Dear Mr. Chen:
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 leqally 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 aqainst 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 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 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 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. Mike Z. Chen
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, "Misbranding 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,
Wolf Sapirstein, M.D.
Wolf Sapirstein, M.D. Acting 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 of 1
510(k) Number: K992425
Device Name: Tes Electrical Electronic Corp. TES-20 Holter ECG Recorder
Indications For Use:
The TES-20 is intended to be used in the recording of ECGs in an ambulatory mode for the diagnosis of various cardiac disorders. These disorders principally include cardiac arrhythmia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
ﺔ، "
.
(Optional Format 1-2-96)
Dallas Tull
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number