(43 days)
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended for use of this over-the-counter device is for age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor
The provided document is a 510(k) cleared letter for a Non-invasive Blood Pressure Measurement System (HL168W Touch Screen). This type of document typically focuses on substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, study designs, sample sizes, or ground truth establishment as would be found in a clinical study report or a more comprehensive technical document.
Therefore, many of the requested details cannot be extracted from this letter.
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantified acceptance criteria or reported device performance metrics in a table format. The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance data against specific, pre-defined acceptance criteria within the clearance letter itself.
2. Sample sized used for the test set and the data provenance:
Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified in this document.
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:
Not applicable. This is a non-invasive blood pressure monitor, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a standalone device intended for direct human use. The performance is the device's measurement.
7. The type of ground truth used:
Not explicitly stated in this document. For a non-invasive blood pressure monitor, the "ground truth" would typically involve comparison to an invasive blood pressure measurement or another validated reference method, but the details are not provided here.
8. The sample size for the training set:
Not applicable or not specified. This is a conventional medical device, not an AI/ML algorithm that undergoes a "training" process in the same sense.
9. How the ground truth for the training set was established:
Not applicable or not specified.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
OCT 2 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul Yang General Manager Health & Life Co., Ltd. 6F, No. 407, Chung Shan Road Sec. 2. Chung Ho City Taipei Hsien TAIWAN R.O.C.
Re: K013033
Trade Name: HL168W Touch Screen Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 24, 2001 Received: October 1, 2001
Dear Mr. Yang:
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. Paul Yang
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 that I DA has made a associations administered by other Federal agencies. You must of any I edelal statutes and regulations and using, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, n.c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CFK Fatt 607), labeling (21 CFR Part 820), good if applicable, the electronic forul in the quality systems (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) I ms letter will anow you to ough mains of substantial equivalence of your device to a legally premaired predicated on: "The PDF intellight on 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 If you desire specific authority of your avitro diagnostic devices), please contact the Office of additionally 21 CT N Fall 607.10 for mirraally, for questions on the promotion and advertising of Compliance at (301) 594-4640. The Office of Compliance at (301) 594-4639. Also, please note the your device, prease ochiasonding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your respectional 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,
Dale Tell
~ James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) : K013033
Device Name: Full Automatic (NIBP) Blood Pressure Monitor
Trade Name : HL168W
Indications For Use
Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended for use of this over-the-counter device is for age 16 and above.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription USE ( (Per 21 CFR 801.109) OR
Over-The-Counter USE (V) (Optional Format 1-2)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013053
2
§ 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).