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 and pulse rate. The device is intended for use on adult patients with a palpable pulse.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TL10 Tensymeter Non-invasive Blood Pressure Monitor, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy requirements of AAMI Standard SP-10 -1992	"Clinical test were performed which show test results which meet or exceed the accuracy requirements of AAMI Standard SP-10 -1992"

Note: The provided text affirms that the device meets the AAMI SP-10 standard, but it does not provide the specific numerical accuracy requirements of that standard, nor does it provide the specific numerical results from the Tensymeter's performance in the clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the text. The study references AAMI SP-10, which typically involves a reference method (e.g., intra-arterial measurement or auscultation by trained observers), but the specific details of how ground truth was established for this particular study are not given.

4. Adjudication Method

This information is not provided in the text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not mentioned. The study described is an accuracy study against a standard, not a comparison of human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, the clinical tests described are a standalone performance study, as they assess the accuracy of the algorithm itself against a recognized standard (AAMI SP-10 -1992). The device is a "non-invasive blood pressure monitor" that "uses proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, mean blood pressure, pulse rate and a pressure waveform." The clinical tests directly evaluate the output of these algorithms against the specified accuracy standard.

7. Type of Ground Truth Used

The text indicates the device meets or exceeds the accuracy requirements of AAMI Standard SP-10. This implies that the ground truth would have been established using a validated reference method for blood pressure measurement, such as direct intra-arterial measurement or a standardized auscultatory method, as specified by the AAMI SP-10 standard. The specific method used in this study is not detailed, but it would align with the standard.

8. Sample Size for the Training Set

This information is not provided in the text. The text does not explicitly mention a "training set" or "test set" in terms of machine learning terminology, but rather "clinical tests."

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the text. As above, no explicit mention of a "training set" is made.

Summary

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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 858-552-1941 858-552-1944 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:

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 (301) 594-4646. 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 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).