(15 days)
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Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
The device is used to monitor blood pressure and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device monitors blood pressure and pulse rate, which are physiological parameters used to assess health status, fitting the definition of a diagnostic device.
No
The device description explicitly states "UB-322 Watch Style Wrist Digital Blood Pressure Monitor," indicating it is a hardware device with a watch-style form factor, not solely software. It also mentions using the "oscillometric method," which is a hardware-based measurement technique.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- UB-322 Function: The UB-322 is a blood pressure monitor that measures blood pressure and pulse rate directly from the body (specifically, the wrist) using an oscillometric method. It does not analyze samples taken from the body.
Therefore, based on the provided information, the UB-322 falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UB-322 is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UB-322 is using oscillometric method to conduct the measurement. It is not designed for ambulatory use. The wrist circumference range shall be within 5.3 inches to 7.7 inches.
Product codes
DPW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
eighteen (18) years and older
Intended User / Care Setting
end users / at home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a staff entwined by a serpent, representing health and medicine. The seal is presented in black and white.
MAR 1 9 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A&D Engineering, Inc. c/o Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298
K980824 Re : A&D UB-322 Watch Style Wrist Digital Blood Pressure Monitor Regulatory Class: II (Two) Product Code: DPW Dated: March 3, 1998 Received: March 4, 1998
Dear Mr. Mosenkis:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
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Page 2 - Mr. Robert Mosenkis
This letter will allow you to begin 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
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: UB-322 Watch Style Wrist Digital Blood Pressure Monitor
Indications for Use:
The UB-322 is designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. The end user should not have common arrhythmias, such as atrial or ventricular premature beats or atrial fibrillation. UB-322 is using oscillometric method to conduct the measurement. It is not designed for ambulatory use. The wrist circumference range shall be within 5.3 inches to 7.7 inches.
(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 | K980824 |
Prescription Use __________ or Over-The-Counter Use X
(Optional Format 1-2-96)