(71 days)
The UA-767PC is designed to be used by end users who are eighteen (18) years and older at home and doctoring office to montor their blood pressure (systolic and diastolic and pulse rate. At the end of each measurement, the results will be stored in the UA-767PC memory. UA-767PC through its communication port can also transfer the measurements stored in nemory to other electronic devices, such as a PC, a modem, or a printer. The end user should not have common arthythmias, such as atrial or ventricular the measurement It is not designed for sul the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
UA-767PC Digital Blood Pressure Monitor
The provided text is a 510(k) clearance letter for the A&D Medical UA-767PC Digital Blood Pressure Monitor. It does not contain information regarding detailed acceptance criteria, the specific study design, or performance metrics beyond a statement of substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document's primary purpose is to confirm the device's clearance based on substantial equivalence, and it outlines the intended use and general regulatory requirements. It does not delve into the specifics of the clinical or performance studies conducted to demonstrate that equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1999
A&D Engineering, Inc. c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298
K982481 Re: A&D Medical UA-767PC Digital Blood Pressure Monitor Regulatory Class: II (Two) Product Code: DXN Dated: September 11, 1998 Received: September 14, 1998
Dear Mr. Mosenkis:
This letter corrects our substantially equivalent letter of This letter corrects our baserantially equivalent letter September 25, 1998 and our carding the indications for use statement.
We have reviewed your Section 510(k) notification of intent to market We nave review your above and we have determined the device is the device released [(for the indications for use stated in the SubScancearly by arketed 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 Medical Bevice iment provisions of the Federal Food, Drug, and Cosmetic accordance with blog processore, market the device, subject to the nee (neeronment provisions of the Act. The general controls general concrolo pact include requirements for annual registration, provisions of the nee od manufacturing practice, labeling, and probibitions against misbranding and adulteration.
li your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such echibit) of birds. Existing major regulations affecting your device ann be tound in the Code of Federal Regulations, Title 21, Parts 800 ean be rou substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements
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Page 2 - Mr. Robert Mosenkis
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to continue marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: UA-767PC Digital Blood Pressure Monitor
Indications for Use:
The UA-767PC is designed to be used by end users who are eighteen (18) years and older at home and doctoring office to montor their blood pressure (systolic and diastolic and pulse rate. At the end of each measurement, the results will be stored in the UA-767PC memory. UA-767PC through its communication port can also transfer the measurements stored in nemory to other electronic devices, such as a PC, a modem, or a printer. The end user should not have common arthythmias, such as atrial or ventricular the measurement It is not designed for sul the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K982481 |
| Prescription Use | |
|---|---|
| ------------------ | -- |
or
| Over-The-Counter Use | ✓ |
|---|---|
| ---------------------- | --- |
(Optional Format 1-2-96)510(K) 7-1/JW
§ 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).