(27 days)
Not Found
No
The device description details a manual, auscultatory method for blood pressure measurement with mechanical controls and a simple counter. There is no mention of automated analysis, pattern recognition, or learning algorithms.
No
The device is solely intended for measuring blood pressure and pulse rate, which is a diagnostic function, not a therapeutic one.
No
Explanation: A diagnostic device identifies a disease or condition. This device measures blood pressure and pulse rate, which are physiological parameters, not a diagnosis in themselves. While these measurements can be used in making a diagnosis, the device itself doesn't perform the diagnosis.
No
The device description clearly outlines a physical blood pressure monitor with a cuff, manual inflation, mechanical valve, and a "MARK" button, indicating it is a hardware device, not software-only.
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 patient's body.
- Device Description: The device uses an inflated cuff on the upper arm and the auscultatory method to determine blood pressure. This is a non-invasive method of measuring a physiological parameter.
- 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.
This device measures a physiological parameter in vivo (within the living body), not in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The A&D Medical UM-101 digital blood pressure monitor is intended for use by medical professionals for measuring the systolic and diastolic blood pressure and pulse rate.
Indications For Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
Product codes
DXN
Device Description
The A&D Medical UM-101 digital blood pressure monitor is intended for use by medical professionals for measuring the systolic and diastolic blood pressure and pulse rate.
UM-101 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated manually by the medical professionals. The systolic and diastolic blood pressures are determined by auscultatory method. The deflation rate is regulated by a mechanical valve controlled by the medical professionals. There is a quick release valve so that the pressure of the cuff can be completely released at any time during the measurement. During the deflation, the systolic and diastolic can be marked by the medical professionals through a "MARK" button. UM-101 has an internal counter so it remembers the number of measurements. The information can be retrieved by holding the "MARK" button.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
K06145.6
Attachment (D) 510(k) Summary
DATE PREPARED 1.
May 23, 2006
SPONSOR INFORMATION 2.
A&D Engineering, Inc. Mr. Jerry Wang 1555 McCandless Drive, Milpitas, CA 95035 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang@andmedical.com
DEVICE NAME 3.
| Proprietary Name: | A&D Medical UM-101 Digital Blood Pressure Monitor |
|---|---|
| Common/Usual Name: | Blood Pressure Monitor |
| Classification name: | Non-invasive blood pressure measurement System |
| 21 CFR 870-1130, Class II, 74DXN. |
DEVICE DESCRIPTION AND INTENDED USE 4.
The A&D Medical UM-101 digital blood pressure monitor is intended for use by medical professionals for measuring the systolic and diastolic blood pressure and pulse rate.
PREDICATE DEVCIE 5.
A&D LifeSource model UA-704 digital blood pressure monitor with FDA 510(k) K032499.
TECHNOLOGICAL CHARACTERISTICS 6.
UM-101 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated manually by the medical professionals. The systolic and diastolic blood pressures are determined by auscultatory method. The deflation rate is regulated by a
1
mechanical valve controlled by the medical professionals. There is a quick release valve so that the pressure of the cuff can be completely released at any time during the measurement. During the deflation, the systolic and diastolic can be marked by the medical professionals through a "MARK" button. UM-101 has an internal counter so it remembers the number of measurements. The information can be retrieved by holding the "MARK" button.
7. DEVICE TESTING
A&D Medical UM-101 digital blood pressure monitor meets the following standards:
- . ANSI/AAMI SP-10 standard
- European Directive 93/42 EEC for Medical Products .
- . EN60601 General Safety Provisions
- . EN60601-2-30 Particular Requirements for the Safety of BP Monitor
- EN60601-1-2 and EN55011 Electromagnetic Compatibility .
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The eagle is stylized with three distinct lines forming its body and wings. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 1 2006
A&D Engineering, Inc. c/o Jerry Wang Director of Engineering & QA 1555 McCandless Drive Milpitas, CA 959035
Re: K061456
Trade Name: UM-101 Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 24, 2006 Received: May 25, 2006
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 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.
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
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Page 2 -- Mr. Jerry Wang
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), please contact the Office of Compliance at (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bhimiman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K061456 510(k) Number (if known):
Device Name: A&D Medical UM-101 Digital Blood Pressure Monitor
Indications For Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blymmema
Sign-Off) Division of Cardloyascular Devices 510(k) Number
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