TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM

K020537 · Tensys Medical, Inc. · DXN · Aug 15, 2002 · Cardiovascular

Device Facts

• Record ID: K020537
• Device Name: TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
• Applicant: Tensys Medical, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 15, 2002
• Decision: SESE
• Submission Type: Traditional
• 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

TL10 Tensymeter is a non-invasive blood pressure monitor; utilizes single-patient-use pressure sensor placed on wrist over radial artery; electronic interface module processes signals. Proprietary algorithms analyze radial artery pressure waveform; device displays diastolic, systolic, mean blood pressure, and pulse rate. Used by medically trained personnel in clinical settings. Provides continuous monitoring; assists clinicians in hemodynamic assessment; benefits patients by enabling real-time blood pressure tracking without invasive arterial lines.

Clinical Evidence

Clinical testing performed to validate accuracy against AAMI Standard SP-10-1992. Results met or exceeded accuracy requirements for non-invasive blood pressure measurement systems.

Technological Characteristics

Semiconductor pressure-sensing element; wrist-worn form factor; electronic interface module. Patient contact materials compliant with ISO 10993-1. Electrical safety per IEC 60601-1; electromagnetic compatibility per IEC 60601-1-2.

Indications for Use

Indicated for adult patients with a palpable pulse requiring continuous monitoring of diastolic, systolic, mean blood pressure, and pulse rate in a clinical setting.

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.

Predicate Devices

• Colin Medical Instruments Corp. CBM-7000 Blood Pressure System (K900247)

Submission Summary (Full Text)

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# 510k Summary

# 510k Summary for the TL10 Tensymeter Non-invasive Blood Pressure Monitor

#### -Submitter:

Tensys Medical, Inc. 5825 Oberlin Drive Suite 100 San Diego, CA 92121 Phone [phone] Fax

### Contact:

/

Stuart L. Gallant, President

Date prepared:

Trade Name:

### TL10 Tensymeter Non-invasive Blood Pressure Monitor

#### Common name:

Non-invasive blood pressure measurement system.

## Classification:

Class II per 21 CFR 870.1130 Non-invasive blood pressure measurement system.

## Predicate Device:

Tensys Medical, Inc. believes that the TL10 Tensymeter is substantially equivalent to the Colin Medical Instruments Corp.CBM-7000 Blood Pressure System (K900247)

Image /page/0/Picture/17 description: The image shows the logo for Tensys Medical. The logo features the word "Tensys" in a bold, sans-serif font, with a stylized line above the word. Below "Tensys" is the word "Medical" in a smaller, sans-serif font. The logo is black and white.

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## Device Description:

The TL10 Tensymeter is a non-invasive blood pressure monitor that utilizes a single patient use non-invasive pressure sensor placed on the wrist, over the radial artery, and an electronic interface module. The device uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, mean blood pressure, pulse rate and a pressure waveform.

## Intended Use:

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

# Comparison of Technological Characteristics of New Device to Predicate Device(s):

The design of the TL10 Tensymeter utilizes a semiconductor pressure-sensing element applied to the wrist, over the radial artery, to obtain a pressure waveform in the same manner as the predicate device.

## Clinical Tests:

Clinical test were performed which show test results which meet or exceed the accuracy requirements of AAMI Standard SP-10 -1992

## Non-Clinical Tests:

Patient Contact Materials ISO 10993-1

Electrical Safety IEC 60601-1

# Electromagnetic Compatibility

IEC 60601-1-2

Image /page/1/Picture/14 description: The image shows the word "Tensys" in a stylized font. There is a line above the word that has a peak in the middle. There are also dots below the word.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three stylized lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2002

Tensys Medical, Inc. c/o Mr. Stuart L. Gallant President and Chief Operating Officer 5825 Oberlin Drive, Suite 100 San Diego, CA 92121

Re: K020537

Trade Name: TL10 Tensymeter Blood Pressure Monitoring System Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: June 6, 2002 Received: June 7, 2002

Dear Mr. Gallant:

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 such 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.

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Page 2 - Mr. Stuart L. Gallant

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours

ths. D.M.z. Sr.

Bruce R. Zuchman, M.D.

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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# Statement of Indications for Use

KO20537 510(k) Number:

Device Name: TL10 Tensymeter 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
(Per 21 CFR 801.109)

Yes

Illan Hoff for Bram Jucker

(Division Sign-Off)
Division of Cardiovascular

8/14

Division of Cardiovascular
and Respiratory Devices

510(k) Number K02

**Tensys**