(89 days)
Not Found
No
The description mentions "proprietary algorithms" but does not explicitly state or imply the use of AI or ML. The performance studies reference a standard (AAMI SP-10) focused on accuracy, not typically associated with AI/ML validation in this context.
No.
The device is strictly for monitoring and displaying physiological parameters (blood pressure and pulse rate) and does not provide any therapy or treatment.
Yes
The device monitors and displays blood pressures and pulse rate, providing physiological information that can be used to assess a patient's health status. While it doesn't diagnose specific diseases, the continuous monitoring of vital signs is a form of diagnostic information gathering used by medical personnel to evaluate a patient's condition for diagnostic purposes.
No
The device description explicitly mentions a "single patient use non-invasive pressure sensor placed on the wrist" and an "electronic interface module," indicating hardware components are part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TL100 Tensymeter is a non-invasive device that measures blood pressure and pulse rate directly from the patient's wrist. It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring physiological parameters (blood pressure and pulse rate) in a clinical setting, not analyzing biological samples for diagnostic purposes.
Therefore, the TL100 Tensymeter falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
DXN
Device Description
The TL100 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, over the radial artery
Indicated Patient Age Range
adult patients
Intended User / Care Setting
medically trained personnel in a clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical test were performed which show test results which meet or exceed the accuracy requirements of AAMI Standard SP-10 -1992
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
KC022783
NOV 1 9 2002
510k Summary
510k Summary for the TL100 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:
TL100 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 TL100 Tensymeter is substantially equivalent to the Tensys Medical Inc. TL10 Tensymeter(K020537)
Image /page/0/Picture/17 description: The image shows the logo for Tensys Medical. The logo features the word "Tensys" in a bold, italicized font. Above the word "Tensys" is a line that resembles a heart rate monitor. Below the word "Tensys" is the word "medical" in a smaller font.
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Device Description:
The TL100 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 TL100 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/13 description: The image shows the logo for Tensys Medical Inc. The logo is black and white and features the word "Tensys" in a bold, stylized font. Below the word "Tensys" is the word "Medical, Inc." in a smaller font. Above the word "Tensys" is a line that resembles a heart rate monitor.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. 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
NOV 1 9 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: K022783
Trade Name: TL100 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: August 21, 2002 Received: August 22, 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 (OS) 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), 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,
Dna Humulu for
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M. 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
510(k) Number:
Device Name: TL100 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.
Division of Cardiovascular & Respiratory Devices
510(k) Number K022783
DSF 11/1/02
Image /page/4/Picture/6 description: The image shows the logo for Tensys Medical. The logo features the word "Tensys" in a bold, sans-serif font, with a line above the word that resembles a heartbeat. Below the word "Tensys" are the words "medical inc.", in a smaller font.