(46 days)
Not Found
No
The description details a standard oscillometric blood pressure monitor with automatic inflation and deflation, and mentions using identical software and hardware as predicate devices, with no indication of AI/ML algorithms for measurement or analysis.
No
The device measures blood pressure and pulse rate but does not provide any therapeutic intervention.
Yes
Explanation: The device measures blood pressure (systolic and diastolic) and pulse rate, which are physiological parameters used to assess a patient's health status. Determining these measurements is a form of diagnosis to identify potential health issues or monitor existing conditions.
No
The device description explicitly details hardware components like an inflated cuff, air pump, mechanical valve, and LCD display, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The A&D LifeSource UB-328 measures blood pressure and pulse rate directly from the body (specifically, the upper wrist) using a physical method (oscillometric). It does not analyze samples taken from the body.
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The A&D LifeSource UB-328 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)
74DXN
Device Description
The A&D LifeSource UB-328 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
UB-328 uses an inflated cuff which is wrapped around the upper wrist. The cuff is inflated automatically by the air pump. 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. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, UB-328 turns off automatically. UB-328 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 wrist
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 UB-328 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. UB-328 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.
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.
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
MAR 1 9 2004
K040229/S1
page 1 of 2
Attachment (D) 510(k) Summary
DATE PREPARED 1.
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(@andmedical.com
3. DEVICE NAME
| Proprietary Name: | A&D LifeSource UB-328 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 UB-328 digital blood pressure monitor is intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
PREDICATE DEVCIE ਨ.
It is substantially equivalent to the following three devices: A&D UB-401, FDA 510(k) K002115. Issued on July 25, 2000
A&D UA-787, FDA 510(k) K012472. Issued on Feb. 15, 2002
TECHNOLOGICAL CHARACTERISTECS 6.
UB-328 uses an inflated cuff which is wrapped around the upper wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are
1
K040229/51
page 2 of 2
determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for one minute. After one minute without operation, UB-328 turns off automatically. UB-328 measures blood pressure and pulse rate even when an irregular heartbeat occurs.
DEVICE TESTING 7.
A&D LifeSource UB-328 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. UB-328 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 # | 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 inflation systems | Conformed |
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2004
A&D Engineering, Inc. c/o Mr. Jerry Wang Director of Engineering & QA 1555 McCandless Drive Milpitas, CA 95035
K040229 Re:
Trade Name: A&D Lifesource UB-328 Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: January 30, 2004 Reccived: February 02, 2004
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 complics with other requirements of the Act
3
Page 2 -- Mr. Jerry Wang
or any Federal statutes and regulations administered by other Federal agencies. You must or any I catales and 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 Of It Fat 8017; accems (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. product thankled on begin marketing your device as described in your Section 510(k) I mis letter will and in yourse of substantial equivalence of your device to a legally promance notifications of caresults 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 11 you abon office of Compliance at (301) 594-4648. 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 other general minimational and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ashley B. Beane
Bram D. Zuckerman, M.D. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Director
Enclosure
4
Indications for Use
510(k) Number (if known):__K040229
Device Name: _A&D Medical LifeSource UB-328 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashley B. Evans
510(K) Number K040229 (SM. IQ
Page 1 of -