(36 days)
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No
The description details a standard oscillometric blood pressure monitor and makes no mention of AI or ML. The comparison to WHO classifications is a simple rule-based system, not AI/ML.
No.
The device measures blood pressure and pulse rate, which are diagnostic indicators, but it does not treat or provide therapy for any condition.
Yes.
The device measures blood pressure and pulse rate, which are used to determine classifications like "Sever Hypertension" and "Optimal," indicating its use in diagnosing health conditions related to blood pressure.
No
The device description explicitly details hardware components like an inflated cuff, air pump, and LCD display, indicating it is a physical device with integrated software, not a software-only device.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The A&D LifeSource UB-511 & UB-512 digital blood pressure monitors measure blood pressure and pulse rate directly from the body (specifically, the wrist) using a physical method (oscillometric). They do not analyze samples taken from the body.
Therefore, this device falls under the category of a non-invasive medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
wrist
Indicated Patient Age Range
adults
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
DEC - 3 2004
Image /page/0/Picture/1 description: The image shows the number K042967 in bold font. Below the number is the text 'P 1 of 2' in a smaller, handwritten font. The 'P' is capitalized, and the '1' and '2' are separated by the words 'of'.
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 Pressure
Monitors | |
|----------------------|-------------------------------------------------------------------------------------|--|
| 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-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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