(29 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 use of this over-the counter device is for adult patients whose arm circumference is between 24-32cm (approx. 9.4" to 12.6").
H&L Full Automatic (NIBP) Blood Pressure Monitor
The provided text is a 510(k) premarket notification letter from the FDA for a non-invasive blood pressure measurement system (HL888BA). It confirms substantial equivalence but does not contain details about specific acceptance criteria, study design, or performance metrics beyond the general function of measuring blood pressure and heart rate.
Therefore, most of the requested information cannot be extracted from the given document.
Here's what can be gathered, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be determined from the provided text. The document states the device measures systolic, diastolic blood pressure, and heart rate, but it does not specify performance metrics (e.g., accuracy, precision) or acceptance criteria for those metrics.
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 determined from the provided text.
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)
- Not applicable/Cannot be determined from the provided text. This type of device (non-invasive blood pressure monitor) typically does not rely on expert consensus for "ground truth" in the same way an imaging AI device would. Its accuracy is usually validated against a reference standard (e.g., a mercury sphygmomanometer) and not expert interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Cannot be determined from the provided text. No adjudication method would be relevant for this type of device's validation.
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/Cannot be determined from the provided text. This is a standalone diagnostic device. There is no "human reader" component or AI assistance involved in the measurement process itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. A blood pressure monitor fundamentally operates as a standalone device to measure blood pressure and heart rate. Its performance evaluation would be based on its ability to accurately measure these parameters without human interpretation during the actual measurement. However, the results of such a study are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be determined from the provided text. For a blood pressure monitor, the ground truth would typically be established by a validated reference method, such as a mercury sphygmomanometer or an invasive arterial line, which is then used to compare the device's readings. The document does not specify this.
8. The sample size for the training set
- Not applicable/Cannot be determined from the provided text. This is a non-AI medical device; therefore, there isn't a "training set" in the context of machine learning. The device is based on established oscillometric principles.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
{0}------------------------------------------------
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2003
Health & Life Co. Ltd c/o Mr. Paul Hung QA Division 9F, No. 186, Jian Yi Road Chung Ho City, Taipei Hsien (235) Taiwan, RO.C.
Re: K032839
Trade Name: HL888BA Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 5, 2003 Received: September 11, 2003
Dear Mr. Hung:
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.
{1}------------------------------------------------
Page 2 - Mr. Paul Hung
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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
стефанотер
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known) : K032839
Device Name : H&L Full Automatic (NIBP) Blood Pressure Monitor
Trade Name : HL888BA
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 use of this over-the counter device is for adult patients whose arm circumference is between 24-32cm (approx. 9.4" to 12.6").
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription USE ( )
(Per 21 CFR 801.109)
OR
Over-The
(Optional
",
Over-The-Counter Use( ) ( Optional Format 1-2)
510(k) Number K032839
7
§ 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).