(29 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.
TL200 T-Line® Non-invasive Blood Pressure Monitoring System
The provided text is a 510(k) clearance letter from the FDA for the Tensys Medical Systems, Inc. TL200 T-Line® Non-invasive Blood Pressure Monitoring System. It mainly focuses on regulatory approval and does not contain the detailed performance study information, acceptance criteria, or ground truth establishment relevant to the questions asked.
Therefore, most of the requested information cannot be extracted from this document. I can only confirm what is explicitly stated or can be inferred from the context of a 510(k) submission for a non-invasive blood pressure monitor.
Here's a breakdown of what can and cannot be answered based only on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document mentions the device is "substantially equivalent" to predicate devices, but it does not provide specific performance metrics or acceptance criteria for that equivalence. For a non-invasive blood pressure measurement system, typical acceptance criteria would be based on standards like ISO 81060-2 (e.g., mean difference and standard deviation between the device and a reference measurement), but these are not present in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. This information is typically found in the clinical study report, which is not part of this 510(k) clearance letter.
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)
- Cannot be extracted. For a blood pressure monitoring device, ground truth is usually established via a reference method (e.g., intra-arterial measurement or a validated oscillometric device) rather than expert consensus on images. The document does not provide details on how ground truth was established for any performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. Adjudication methods are typically relevant for subjective assessments, often in imaging studies. For a blood pressure monitor, the "ground truth" is a measured value, not an interpretation that requires adjudication.
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
- Cannot be extracted. MRMC studies are specific to imaging and AI-assisted interpretation, where human readers evaluate cases with and without AI. This device is a non-invasive blood pressure monitor, not an imaging AI diagnostic aid. Therefore, an MRMC study would not be applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be extracted definitively, but likely "yes" as a primary test. For a blood pressure monitor, the algorithm is the device's core function. Its performance is typically evaluated in a standalone manner against a reference standard. While a clinical study would involve human subjects, the device itself operates "standalone" in generating the blood pressure readings. The document does not explicitly state this, but it's implied by the nature of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be extracted definitively from the text. However, for non-invasive blood pressure devices, the ground truth is typically obtained from a highly accurate reference measurement, such as intra-arterial blood pressure or another validated non-invasive method (e.g., mercury sphygmomanometer with auscultation by trained observers), often following standards like ISO 81060-2.
8. The sample size for the training set
- Cannot be extracted. The document does not mention any training sets, which are typically associated with machine learning or AI algorithms. While the device likely has algorithms, the document refers to its clinical performance for regulatory approval, not its development or training data.
9. How the ground truth for the training set was established
- Cannot be extracted. As there's no mention of a training set, there's no information on how its ground truth would have been established.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, rendered in black lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird. The text is in all capital letters and is also black.
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 (800) 638-2041 or (301) 796-7100 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
Page 1 of 1
(Posted November 13, 2003)
§ 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).