(59 days)
By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.
Blood-pressure meter, Model BPW128
This document is a 510(k) clearance letter from the FDA for a blood pressure monitor (Model BPW128) and largely focuses on regulatory approval rather than a detailed study report with acceptance criteria. As such, most of the requested information cannot be extracted from the provided text.
Here is what can be determined from the document:
- Device: Blood-pressure Meter, Model BPW128
- Intended Use: "By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel. The intended for use of this device is for age 15 and above."
The document does not contain the following information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
In summary, this document is an FDA clearance letter confirming substantial equivalence to a predicate device, which implies the device meets certain safety and effectiveness standards, but it does not provide the specific details of performance data and study methodologies that would typically be included in a technical report or scientific publication.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2002
IDT Technology Ltd. c/o Dr. Lily Li Biomedical Specialist Block C, 9/F., Kaiser Estate, Phase 1 41 Man Yue Street Hunghom, Hong Kong CHINA
Re: K021252
Trade Name: Blood-pressure Meter, Model BPW128 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: April 8, 2002 Received: April 19, 2002
Dear Dr. Li:
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 - Dr. Lily Li
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.
N. D. Tiller, Ph.D.
onna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Blood-pressure meter, Model BPW128
Indications for Use:
By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.
The intended for use of this device is for age 15 and above.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) 01 - 1 (三国四一 (二十 )
Concurence of CDRH, Office of Device Evaulation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR ... ..
Over-the-Counter Use
(Optional Format 3-10-98)
Qalla Tull
Division of Cardiovascular & Respiratory Devices
510(k) Number K021252
§ 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).