(78 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor with manual inflation and mechanical deflation control. There is no mention of AI or ML in the device description, performance studies, or key metrics. The device relies on established methods and identical software/hardware to predicate devices.
No
The device is a diagnostic tool used to measure blood pressure and pulse rate, not to provide therapy or treatment.
Yes
Explanation: The device measures blood pressure and pulse rate, which are physiological parameters used to diagnose conditions like hypertension.
No
The device description explicitly details hardware components such as an inflated cuff, manual inflation bulb, mechanical valve, quick exhaust valve, and LCD display. It also mentions pressure detection related hardware. This indicates it is a physical medical device with integrated software, not a software-only device.
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. They are used to examine these samples outside of the body.
- Device Function: The A&D LifeSource UA-704 blood pressure monitor measures blood pressure and pulse rate directly from the user's upper arm. It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure physiological parameters (blood pressure and pulse rate) directly from the living body.
Therefore, based on the provided information, this device falls under the category of a non-invasive medical device used for monitoring physiological signs, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The A&D LifeSource UA-704 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The A&D LifeSource UA-704 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
UA-704 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by pressing a bulb manually by the user. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff by pressing the quick exhaust valve. The measurement results are displayed on the LCD. UA-704 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
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
adults
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)
A&D LifeSource UA-704 digital blood pressure monitor meets NIST/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance". UA-704 is not clinically tested. It uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate. Test results for various sections of SP-10 are listed as "Conformed" or "Not applicable".
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.
A&D UA-711, FDA 510(k) K871718, A&D UA-767PC, FDA 510(k) K982481, A&D UA-787, FDA 510(k) K012472
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).
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
Attachment (D) 510(k) Summary
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1. DATE PREPARED
July 29, 2003
2. SPONSOR INFORMATION
A&D Engineering, Inc. Mr. Jerry Wang 1555 McCandless Drive, Milpitas, CA 95035 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang@aandmedical.com
3. DEVICE NAME
| Proprietary Name: | A&D LifeSource UA-704 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 LifeSource UA-704 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
5. PREDICATE DEVCIE
It is substantially equivalent to the following three devices: A&D UA-711, FDA 510(k) K871718. Issued on June 24, 1987
A&D UA-767PC, FDA 510(k) K982481. Issued on Jan. 13, 1999
A&D UA-787, FDA 510(k) K012472. Issued on Feb. 15, 2002
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TECHNOLOGICAL CHARACTERISTECS 6.
UA-704 uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by pressing a bulb manually by the user. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff by pressing the quick exhaust valve. The measurement results are displayed on the LCD. UA-704 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
7. DEVICE TESTING
A&D LifeSource UA-704 digital blood pressure monitor meets NIST/AAMI SP-10 standard and FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance". Please refer to the table below for the list of AAMI SP-10 tests. UA-704 is not clinically tested. It uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate.
| SP-10 | Section Title | Test Results & |
|---|---|---|
| Section # | Comments | |
| 4.1.1 | General | Conformed |
| 4.1.2.1 | Device labeling | Conformed |
| 4.1.2.2 | Outer container | Conformed |
| 4.1.3 | Information manual | Conformed |
| 4.1.4.1 | Component replacement | Conformed |
| 4.1.4.2 | Power system labeling | Conformed |
| 4.1.4.3 | Labeling for battery-powered devices | Conformed |
| 4.2.1 | Storage conditions | Conformed |
| 4.2.2 | Operating conditions | Conformed |
| 4.2.3 | Vibration and shock | Conformed |
| 4.2.4.1 | Voltage range | Conformed |
| 4.2.4.2 | Life | Conformed |
| 4.3.1.1 | Maximum cuff pressure | Conformed |
| 4.3.1.2 | Cuff deflation | Conformed |
| 4.3.2 | Electrical safety | Conformed |
| 4.3.3 | Conductive components | Conformed |
| 4.4.1 | Pressure indicator accuracy | Conformed |
| 4.4.2 | Overall system efficacy | Conformed |
| 4.4.2.1 | Auscultatory method as the reference standard | Conformed |
| 4.4.2.2 | Intra-aeterial method as the reference standard | Not applicable |
| 4.4.3 | Battery-powered devices | Conformed |
| 4.5 | Requirements for devices with manual | Conformed |
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, framing the emblem.
OCT 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
A & D Engineering, Inc. c/o Mr. Jerry P. Wang Director of Engineering & QA 1555 McCandless Drive Milpitas, CA 95035
Re: K032499
Trade Name: LifeSource UA-704 Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 29, 2003 Received: September 30, 2003
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.
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Page 2 - Mr. Jerry P. Wang
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 Jetter 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Ona Heischur for
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment (B) Indications for Use Statement
510(k) Number (if known): K032499
Device Name: A&D Medical LifeSource UA-704 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)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Dora Heemlu
(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K032499