(197 days)
Not Found
Not Found
No
The summary does not contain any mention of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML in medical devices. The intended use is a standard physiological measurement.
No.
The device measures blood pressure and pulse rate, which are diagnostic measurements for monitoring health, not for treating a condition.
Yes
The device measures blood pressure (systolic and diastolic) and pulse rate, which are physiological parameters used to assess and monitor a person's health status, fitting the definition of a diagnostic device.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. Without this information, it's impossible to definitively classify the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Measure blood pressure (systolic and diastolic) and pulse rate." This is a physiological measurement taken directly from the body, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information about a disease or condition based on sample analysis
Blood pressure monitors are considered medical devices, but they fall under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Measure blood pressure (systolic and diastolic) and pulse rate.
Product codes
74 DXN
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
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health, featuring a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2002
Mr. Jerry P. Wang Director of Engineering & QA A & D Engineering, Inc. 1555 McCandless Dr. Milpitas, CA 95035
Re: K012472
Trade Name: A & D Medical Lifesource UA-787, UA-787H, UA-787V, UA-787PC, and UA-787T Digital Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: 74 DXN Dated: November 16, 2001 Received: November 19, 2001
Dear Mr. Wang:
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 for associated in the encreated 976, the enactment date of the Medical Device Amendments, or to conniner of First to File) 2011-07-12, in accordance with the provisions of the Federal Food, DDI (A do noos that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , ateres, mains 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 If your device 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.
1
Page 2 - Mr. Jerry P. Wang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase oc advised that I Driv issualited our device complies with other requirements of the Act that I Dr Has Internes and regulations administered by other Federal agencies. You must of any I coleral statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rord in and quind) of the revisions (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 premailed predicated 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 11 you declie specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Far 3646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 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 Oinci general 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,
K. Quin Till
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular And Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): __ K O | 2 4 7 2
Device Name: A&D Medical LifeSource UA-787, UA-787H, UA-787V, UA-787V, UA-787PC, & UA-787T Digital Blood Pressure Monitors
Indications for Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K02472 |
|---|---|
| --------------- | -------- |
| Prescription Use | or | Over-The-Counter Use X |
|---|---|---|
| ------------------ | ---- | -------------------------- |
(Optional Format 1-2-96)