(557 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, or related concepts. The description focuses on standard physiological monitoring parameters.
No
The device is strictly for non-invasive monitoring of physiological parameters and does not provide any treatment or therapy.
Yes
The device is used for "non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature and respiration," which are measurements used to diagnose a patient's condition.
No
The intended use describes monitoring of multiple physiological parameters (ECG, blood pressure, pulse rate, pulse oximetry, temperature, and respiration) which typically requires hardware sensors and components to acquire the raw data. The summary does not mention the device being software-only or how these parameters are obtained without hardware.
Based on the provided information, the TeleTrens device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature and respiration". These are all physiological measurements taken directly from the patient's body, not from samples of bodily fluids or tissues in vitro (outside the body).
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. The TeleTrens does not perform such tests.
Therefore, the TeleTrens is a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The TeleTrens is intended for use in the non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature and respiration in the hospital/clinic environment.
The TeleTrens is intended to be used in accordance with accepted hospital and clinical protocols and instructions contained in this operators manual. Use of the TeleTrens for applications not specified in this manual may result in inaccurate patient information. Use of the TeleTrens with other than recommended or supplied accessories or parts may result in inaccurate patient information or damage to the monitor.
Federal law restricts this device to sale by or on the order of a physician.
Product codes
74 DSI
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
hospital/clinic environment
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 1997
Mr. B. Q. Cutshaw Life Sensing Instrument Company, Inc. 329 West Lincoln Street Tullahoma, Tennessee 37388
Re: K960884 TeleTrens Model Number TM10 Regulatory Class: III (three) Product Code: 74 DSI Dated: April 22, 1997 Received: April 23, 1997
Dear Mr. Cutshaw:
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 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.
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Page 2 - Mr. B. Q. Cutshaw
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" (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/dsmamain.html".
Sincerely yours,
Thomas J. Callshan
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): K960884
Device Name: TELE TRENS TM 10
Indications For Use:
The TeleTrens is intended for use in the non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature and respiration in the hospital/clinic environment.
The TeleTrens is intended to be used in accordance with accepted hospital and clinical protocols and instructions contained in this operators manual. Use of the TeleTrens for applications not specified in this manual may result in inaccurate patient information. Use of the TeleTrens with other than recommended or supplied accessories or parts may result in inaccurate patient information or damage to the monitor.
Federal law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. Payne
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K960884
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)