(89 days)
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.
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.
The provided text only briefly mentions that "Clinical test were performed which show test results which meet or exceed the accuracy requirements of AAMI Standard SP-10 -1992" for the TL100 Tensymeter Non-invasive Blood Pressure Monitor. However, it does not provide the specific acceptance criteria from AAMI SP-10-1992 or the reported device performance in a table format. It also lacks detailed information about the study design, sample sizes, ground truth establishment, or expert involvement.
Therefore, many sections of your request cannot be fulfilled based on the information provided in the document.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (from AAMI Standard SP-10 -1992): Not explicitly stated in the document.
- Reported Device Performance: Not explicitly stated in the document.
- What is mentioned: "Clinical test were performed which show test results which meet or exceed the accuracy requirements of AAMI Standard SP-10 -1992." This is a general statement of compliance, not a detailed performance report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
- What is mentioned: "Clinical test were performed..."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- What is mentioned: The device is intended "for use by medically trained personnel." This implies medical professionals were involved in its intended use, but doesn't detail their role in a clinical study's ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not mentioned. The device is a blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study in this context is unlikely or not applicable to its primary function as described.
- Effect Size of Human Readers with AI: Not applicable based on the device description.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The device is described as "utilizes proprietary algorithms to analyze the radial artery pressure and display diastolic, systolic, mean blood pressure, pulse rate and a pressure waveform." The "clinical tests" mentioned likely evaluated the accuracy of these algorithms in conjunction with the device's hardware, implying a standalone performance evaluation of the system as a whole against a reference standard. However, explicit details of a "standalone" study (algorithm only) without human intervention in the loop of that specific test's outcome are not provided. The device itself is designed for continuous monitoring and display, which is inherently an "algorithm only" (plus hardware) performance for the actual measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not specified. For blood pressure devices, the ground truth is typically established by a reference standard measurement (e.g., intra-arterial blood pressure or another validated non-invasive method) rather than expert consensus or pathology in the typical sense.
8. The sample size for the training set
- Training Set Sample Size: Not specified. The document does not discuss a "training set" as it would for a machine learning model. While proprietary algorithms exist, the details of their development and any associated training data are not disclosed in this summary.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not specified. (See point 8).
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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
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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
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§ 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).