(36 days)
The A&D LifeSource UB-511 & UB-512 digital blood pressure monitors are 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 UB-511 & UB-512 digital blood pressure monitors are intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate. UB-511 & UB-512 use an inflated cuff which is wrapped around the wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method while the cuff is inflated. 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. The blood pressure results are compared with WHO (World Health Organization) BP classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. UB-511 & UB-512 measure blood pressure and pulse rate even when an irregular heartbeat occurs. After one minute without operation, UB-511 & UB-512 turns off automatically.
Here's a summary of the acceptance criteria and study information for the A&D LifeSource UB-511 & UB-512 Digital Blood Pressure Monitors, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Standard / Section) | Reported Device Performance |
|---|---|
| NIST/AAMI SP-10 Section 4.1.1 (General) | Conformed |
| NIST/AAMI SP-10 Section 4.1.2.1 (Device labeling) | Conformed |
| NIST/AAMI SP-10 Section 4.1.2.2 (Outer container) | Conformed |
| NIST/AAMI SP-10 Section 4.1.3 (Information manual) | Conformed |
| NIST/AAMI SP-10 Section 4.1.4.1 (Component replacement) | Conformed |
| NIST/AAMI SP-10 Section 4.1.4.2 (Power system labeling) | Conformed |
| NIST/AAMI SP-10 Section 4.1.4.3 (Labeling for battery-powered devices) | Conformed |
| NIST/AAMI SP-10 Section 4.2.1 (Storage conditions) | Conformed |
| NIST/AAMI SP-10 Section 4.2.2 (Operating conditions) | Conformed |
| NIST/AAMI SP-10 Section 4.2.3 (Vibration and shock) | Conformed |
| NIST/AAMI SP-10 Section 4.2.4.1 (Voltage range) | Conformed |
| NIST/AAMI SP-10 Section 4.2.4.2 (Life) | Conformed |
| NIST/AAMI SP-10 Section 4.3.1.1 (Maximum cuff pressure) | Conformed |
| NIST/AAMI SP-10 Section 4.3.1.2 (Cuff deflation) | Conformed |
| NIST/AAMI SP-10 Section 4.3.2 (Electrical safety) | Conformed |
| NIST/AAMI SP-10 Section 4.3.3 (Conductive components) | Conformed |
| NIST/AAMI SP-10 Section 4.4.1 (Pressure indicator accuracy) | Conformed |
| NIST/AAMI SP-10 Section 4.4.2 (Overall system efficacy) | Conformed |
| NIST/AAMI SP-10 Section 4.4.2.1 (Auscultatory method as the reference standard) | Conformed |
| NIST/AAMI SP-10 Section 4.4.2.2 (Intra-arterial method as the reference standard) | Not applicable |
| NIST/AAMI SP-10 Section 4.4.3 (Battery-powered devices) | Conformed |
| NIST/AAMI SP-10 Section 4.5 (Requirements for devices with manual inflation systems) | Conformed |
| FDA guidance "Non-invasive Blood Pressure (NIBP) Monitor Guidance" | Conformed |
Study Details
-
Sample size used for the test set and the data provenance:
The document states, "UB-511 & UB-512 are not clinically tested." This implies that there was no separate test set used for clinical validation of blood pressure accuracy from human subjects. The device's performance against the AAMI SP-10 and FDA guidance was reported as "Conformed" for various technical and safety aspects, which would involve testing the device itself, not necessarily on a human subject test set. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set on human subjects was conducted for this specific device. The device's equivalence was based on its identical software codes and pressure detection hardware to predicate devices. -
Adjudication method for the test set:
Not applicable, as no clinical test set on human subjects was conducted for this specific device. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. The device was "not clinically tested" and its substantial equivalence was based on technological characteristics and conformity to standards rather than comparative clinical effectiveness with human readers or devices. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document indicates that the UB-511 & UB-512 "use the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate." This implies that the algorithm's performance (specifically the oscillometric method) was relied upon based on the predicate devices' established performance. While not explicitly stated as a standalone study for this specific device, the technical conformity relies on the standalone performance of the underlying technology shared with the predicates. -
The type of ground truth used:
For the technical tests (e.g., pressure indicator accuracy, overall system efficacy), the ground truth would have been established by calibrated instruments and reference methods as dictated by the AAMI SP-10 standard (e.g., auscultatory method as a reference standard for overall system efficacy). For the general performance of the blood pressure measurement technology, the established performance of the predicate devices implicitly serves as the ground truth. -
The sample size for the training set:
Not applicable. As the device was not clinically tested, and its equivalence relies on predicate devices, there is no mention of a training set for an algorithm developed specifically for this device. The shared software codes and hardware indicate that any "training" (if applicable to the algorithm's development) would have occurred for the predicate devices. -
How the ground truth for the training set was established:
Not applicable, as no training set for a new algorithm was utilized for this device.
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DEC - 3 2004
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Attachment (D) 510(k) Summary
DATE PREPARED 1.
Oct. 20, 2004
2. SPONSOR INFORMATION
A&D Engincering, 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 UB-511 & UB-512 Digital Blood PressureMonitors | |
|---|---|---|
| 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 UB-511 & UB-512 digital blood pressure monitors are intended for use by adults for measuring the systolic and diastolic blood pressure and pulse rate.
PREDICATE DEVCIE 5.
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-328, FDA 510(k) K040229. Issued on June 30, 2004
TECHNOLOGICAL CHARACTERISTECS 6.
UB-511 & UB-512 use an inflated cuff which is wrapped around the wrist. The cuff is inflated automatically by the air pump. The systolic and diastolic blood pressures are determined by oscillometric method while the cuff is inflated. The pressure of the cuff
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<04-2967
P20-2
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. The blood pressure results are compared with WHO (World Health Organization) BP classifications, which are Sever Hypertension, Moderate Hypertension, Mild Hypertension, High Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. UB-511 & UB-512 measure blood pressure and pulse rate even when an irregular heartbeat occurs. After one minute without operation, UB-511 & UB-512 turns off automatically.
7. DEVICE TESTING
A&D LifeSource UB-511 & UB-512 digital blood pressure monitors meet 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-511 & UB-512 are 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 |
| inflation systems |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized emblem that resembles an abstract caduceus or a symbol representing health and human services. The emblem consists of three curved lines or strokes that converge at the bottom, creating a sense of unity and support.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
A&D Engineering, Inc. c/o Mr. Jerry Wang Director of Engineering & QA 1555 McCandless Drive Milpitas, CA 95035
Re: K042967
Trade Name: A&D Medical LifeSource UB-511 & UB-512 Digital Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: November 29, 2004 Received: November 30, 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.
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Page 2 -- Mr. Jerry Wang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession on the requirements of the Act
that FDA has made a determination that your device complies with on any must that FDA has made a decemmation that your administered by other Federal agencies. You must or any Federal Statutes and regulations administered of registration and listing (21)
comply with all the Act's requirements, including, but not limited to: ref comply with all the Act 3 requirements, morading practice requirements as set CFR Part 807); labeling (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if app 1000-1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decloils of Pecifice in your Section 510(k)
This letter will allow you to begin marketing your device of war device to logol I his letter will anow you to oegin manxalig your antial equivalence of your device to a legally premarket nothleadon. The PDA miding of backand on 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 If you desire specific advice for your ac not on one one and the regulation entitled, conlact the Office of Comphanes at (2017) the Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) view difference "Misbranding by relefence to premaries noville is a may be obtained from the Other general information on your responsional 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,
Bhimima for
am 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):
Device Name: A&D Medical LifeSource UB-511 & UB-512 Digital Blood Pressure Monitors
Indications for Use:
Measure blood pressure (systolic and diastolic) and pulse rate.
Or
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B Summa
§ 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).