(82 days)
Model CH-432 Blood Pressure Meter intended use is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the Citizen Watch Company's Blood Pressure Meter, Model CH-432.
This letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory framework and responsibilities of the manufacturer. It does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, you would typically need to refer to the full 510(k) submission document or a summary thereof, which often includes details of performance testing and comparison to predicate devices, but these specifics are not present in the provided FDA letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2005
:
Citizen Watch Company. Ltd. c/o Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road Newtown, CT 06470
Re: K052046
Trade Name: Blood Pressure Meter, Model CII-432 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 06, 2005 Received: October 11, 2005
Dear Mr. Borsai:
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. I'DA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Tamas Borsai
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 sct 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 (240) 276-0295. 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,
Mesayng
for R. Zadeh, M.D.
Zuckerma Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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052046/s
Indications for Use
K052046 510(k) Number (if known):
Devise Name: Model CH-432 Blood Pressure Meter
Indications For Use: Model CH-432 Blood Pressure Meter intended use is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.
Prescription Use
CITIZEN
AND/OR
Over-The-Counter Use
Use
(PLEASE DP NOPT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (ODE)
Maces Aop
(Signature)
(Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of 1
510(k) Number K052046
11/4/1
§ 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).