TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM

K121141 · Tensys Medical Systems, Inc. · DXN · May 15, 2012 · Cardiovascular

Device Facts

• Record ID: K121141
• Device Name: TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
• Applicant: Tensys Medical Systems, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: May 15, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

This device is intended for use by medically trained personnel in a clinical setting to continually monitor and display diastolic, systolic, and mean blood pressures and pulse rate. The device is intended for use on adult patients with a palpable pulse.

Device Story

TL-200 T-Line® is a non-invasive blood pressure monitoring system; provides continuous monitoring of systolic, diastolic, mean blood pressure, and pulse rate. Operates via applanation tonometry sensor applied to patient radial artery; transforms arterial pressure waveforms into numerical blood pressure values. Used in clinical settings by medically trained personnel. Output displayed on monitor for real-time clinical decision-making; enables continuous hemodynamic assessment in adult patients with palpable pulse. Benefits include non-invasive, beat-to-beat blood pressure tracking without arterial catheterization.

Clinical Evidence

No clinical data provided in the document. Substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Non-invasive blood pressure monitoring system; utilizes applanation tonometry sensing principle. Class II device (21 CFR 870.1130). Product code: DXN. Designed for continuous monitoring of adult patients.

Indications for Use

Indicated for continuous monitoring and display of diastolic, systolic, mean blood pressure, and pulse rate in adult patients with a palpable pulse. For use by medically trained personnel in clinical settings.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 5 2012

Tensys Medical Systems, Inc. c/o Mr. Jamie M. Sulley 5825 Oberlin Drive Suite 100 San Diego, CA 92121

Re: K121141

> Trade/Device Name: TL200 T-Line® Non-invasive Blood Pressure Monitoring System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Codes: DXN Dated: April 12, 2012 Received: April 16, 2012

Dear Mr. Sulley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not.mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 -- Tensys Medical Systems, Inc. c/o Mr. Jamie M. Sulley

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

R. Z. skinner, MD

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Appendix B

## Indications for Use Statement

510(k) Number (if known):

Device Name: TL-200 T-Line® Non-invasive Blood Pressure Monitoring System

#### Indications for Use:

This device is intended for use by medically trained personnel in a clinical setting to continually monitor and display diastolic, systolic, and mean blood pressures and pulse rate. The device is intended for use on adult patients with a palpable pulse.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrepee of CDRH, Office of Device Evaluation (ODE)

## (Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K121141

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(Posted November 13, 2003)