(19 days)
Manual inflate type blood pressure monitor for measurement of 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 24-44cm (approx. 9.4" to 17.5").
Manual inflate type blood pressure monitor for measurement of human's systolic, diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
This looks like a 510(k) clearance letter for a non-invasive blood pressure monitor. Such letters generally do not contain detailed information about acceptance criteria or specific study results as they primarily confirm substantial equivalence to a predicate device.
Therefore, the requested information cannot be extracted from the provided text.
Here is a summary of why the information is unavailable:
- Acceptance Criteria and Device Performance: The document is a clearance letter, which determines substantial equivalence. It does not contain performance data, clinical trial results, or specific acceptance criteria. These would typically be found in the 510(k) submission itself, not the clearance letter.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set, etc.: All these categories relate to a detailed study design and results, which are not part of the FDA's clearance decision letter. The letter confirms the device is substantially equivalent to a predicate, based on information provided in the original 510(k) submission, but does not reiterate or summarize the study specifics.
To obtain this information, one would need to access the full 510(k) submission for K043186, which is usually a much more extensive document.
{0}------------------------------------------------
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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 2004
Health & Life Co., Ltd. c/o Mr. Paul Hung Manager 9F. No. 186. Jian Yi Road Chung Ho City, Taipen Hsien TAIWAN R.O.C.
Re: K043186
Trade Name: H&L (NIBP) Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: November 08, 2004 Received: November 17, 2004
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 for association 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, de necs that have been resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aroney mains 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 rr your device 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 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,
Blumman for
R. D. Zalesky, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
<043186
510(k) Number (if known) :
Device Name : H&L (NIBP) Blood Pressure Monitor
Trade Name : HL888EM
Indications For Use
Manual inflate type blood pressure monitor for measurement of 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 24-44cm (approx. 9.4" to 17.5")."
Prescription USE( (Per 21 CFR 801 109)
OR
Over-The-Counter Use( √ ) ( Optional Format 1-2)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blumena
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K013/86
Card Devices
§ 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).