(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 for use of this over-the-counter device is for age 16 and above.
Full Automatic (NIBP) Blood Pressure Monitor
Here's an analysis of the provided text regarding acceptance criteria and device performance:
No specific acceptance criteria or study details are provided in the given document.
The document is a 510(k) clearance letter from the FDA for the device "HL168R" (a Full Automatic (NIBP) Blood Pressure Monitor). This letter grants clearance for the device based on a finding of "substantial equivalence" to a legally marketed predicate device.
The FDA's decision of substantial equivalence often relies on performance data submitted by the manufacturer, but this specific letter does not contain those data or the acceptance criteria used. It refers to the manufacturer's 510(k) premarket notification as the source of the information that led to the determination.
Therefore, I cannot fulfill the request for a table of acceptance criteria, study details, and specific performance metrics based solely on the provided text.
To answer your request, I would need access to the actual 510(k) submission document for K031695, not just the FDA clearance letter. That document would contain the detailed studies conducted, their methodologies, and the acceptance criteria applied.
{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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL I 2003
Health & Life Coporation, Ltd. c/o Mrs. Susan Chen 9F, No. 186, Jian Yi Road Chung Ho City, Taipei, Hsien China (Taiwan) 235
Re: K031695
Trade Name: HL168R Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: May 2, 2003 Received: June 2, 2003
Dear Mrs. Chen:
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.
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
{1}------------------------------------------------
Page 2 - Mrs. Susan Chen
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,
Elisa Diaz for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known) :
Device Name : Full Automatic (NIBP) Blood Pressure Monitor
Trade Name : HL168R
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)
Prescription Use Only
OR
7
Over-The-Counter Use( √ ( Optional Format 1-2)
Oharles D. Hatcher BDA 7/1/03
/(Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K0316
§ 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).