TELE TRENS TM 10

K960884 · Life Sensing Instrument Company, Inc. · DSI · Sep 12, 1997 · Cardiovascular

Device Facts

• Record ID: K960884
• Device Name: TELE TRENS TM 10
• Applicant: Life Sensing Instrument Company, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Sep 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended 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.

Device Story

TeleTrens TM10 is a multi-parameter patient monitor; performs non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature, and respiration. Used in hospital and clinical settings; operated by healthcare professionals. Device processes physiological signals to provide real-time patient data; output displayed for clinician review to support clinical decision-making and patient monitoring. Intended to assist in tracking patient status; requires use of specified accessories to ensure accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-parameter patient monitor for non-invasive physiological sensing (ECG, BP, SpO2, temperature, respiration). Form factor is a clinical monitor unit. Connectivity and specific material standards not disclosed in provided text.

Indications for Use

Indicated for non-invasive monitoring of ECG, blood pressure, pulse rate, pulse oximetry, temperature, and respiration in hospital or clinical environments. Prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 12 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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Page 1 of 1

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)


Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)