(78 days)
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.
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.
The provided document is a 510(k) Summary for the A&D LifeSource UA-704 Digital Blood Pressure Monitor. It describes the device, its intended use, and its substantial equivalence to predicate devices. The document highlights that the device was tested against the NIST/AAMI SP-10 standard and FDA guidance for Non-invasive Blood Pressure (NIBP) Monitors.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
The device's acceptance criteria are based on meeting the NIST/AAMI SP-10 standard for non-invasive blood pressure monitors. The "Test Results & Comments" column in the table indicates whether the device "Conformed" to each section of the standard.
| SP-10 Section # | Section Title | Test Results & 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 |
Study Details:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a sample size for a clinical test set. It explicitly states: "UA-704 is not clinically tested." Testing was conducted against the SP-10 standard, which involves technical and performance evaluation, not a human subject study for efficacy in the same way a diagnostic AI would be tested.
- Data Provenance: Not applicable as no clinical test set using human data is mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Since there was no clinical testing on human subjects, there was no need for experts to establish ground truth in this context. The standard itself defines accuracy requirements.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set involving human subjects requiring adjudication is mentioned.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The device is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is relevant to this device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The testing against the SP-10 standard evaluates the device's technical performance in a standalone manner, ensuring its accuracy and adherence to specifications without direct human intervention in the measurement process (beyond operating it as intended). The statement "UA-704 uses the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate" further supports its standalone operational capability mirroring previous approved devices.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Overall system efficacy" (Section 4.4.2), the standard specifies the "Auscultatory method as the reference standard" (Section 4.4.2.1). This means the ground truth for blood pressure measurements would be derived from simultaneous measurements taken by a trained observer using a stethoscope and sphygmomanometer, which is the traditional clinical gold standard for non-invasive blood pressure. The other reference standard, "Intra-aeterial method," was "Not applicable."
-
The sample size for the training set:
- Not applicable. The document does not describe the use of machine learning or AI that would require a distinct "training set." The device relies on established oscillometric principles and "identical software codes and pressure detection related hardware as the predicate devices."
-
How the ground truth for the training set was established:
- Not applicable. As no training set for a machine learning model is mentioned, the method for establishing its ground truth is also not applicable.
{0}------------------------------------------------
Attachment (D) 510(k) Summary
1/2
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 System21 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
{1}------------------------------------------------
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 |
{2}------------------------------------------------
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.
{3}------------------------------------------------
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
{4}------------------------------------------------
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
§ 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).