(56 days)
The A&D Medical UA-851THW digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.
The A&D Medical UA-851THW digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
UA-851THW uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal electronic-controlled exhaust valve. There is a quick exhaust mechanism so that the pressure of the cuff can be completely released. There is a maximum pressure safety setting at 300mmHg. The culT will inflate higher than 300mmHg. The arm distribution range is from 5.1" to 17.7" (13 cm to 45 cm). At the end of the measurement, the result can be uploaded to a PC with ActiLink USB transceiver and viewed by the Wellness Connected software.
Here's an analysis of the provided 510(k) summary regarding the A&D Medical UA-851THW Digital Blood Pressure Monitor, focusing on its acceptance criteria and the study that proves its performance:
Based on the provided document, the UA-851THW Digital Blood Pressure Monitor is generally compared to its predicate devices for substantial equivalence, rather than a detailed study proving its meeting of specific acceptance criteria. The document highlights that the technological and operational characteristics are largely the same as the predicate devices, implying that the established accuracy of those predicates serves as the basis for the current device's performance.
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (UA-851THW) |
|---|---|
| Blood Pressure Accuracy | +/- 3mmHg or +/- 2% of measured value, whichever is greater |
| Pulse Rate Accuracy | +/- 5% (pulse) |
| Measurement Range (BP) | 20 to 280 mmHg |
| Measurement Range (Pulse) | 30 to 200 pulse/min |
Study Information:
The 510(k) summary does not contain a description of a specific new study performed for the UA-851THW to "prove" it meets these acceptance criteria directly. Instead, the core argument for substantial equivalence relies on the fact that these performance specifications are "No change – the same" as the predicate devices (UA-789 & UA-767PBT).
Therefore, the following information is not available or directly applicable from the provided text for the UA-851THW itself:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document implies reliance on previous testing of predicate devices.
- 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 provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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: Not applicable. This is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a standalone device (automated blood pressure monitor). However, specific performance studies of the algorithm itself are not detailed. Its performance is stated as "No change - the same" as the predicate devices.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, but for blood pressure monitors, ground truth is typically established using a reference standard (e.g., auscultatory method with a trained observer, or validated invasive measurements). The reliance on predicate devices suggests this was performed during their respective clearances.
- The sample size for the training set: Not applicable based on the information provided. The device uses an oscillometric method, and its core algorithm is essentially the same as previous, cleared devices. Specific "training set" for a new machine learning algorithm is not mentioned.
- How the ground truth for the training set was established: Not applicable based on the information provided.
Summary of the "Study" and Basis for Acceptance:
The "study" in this context is the comparison to predicate devices to demonstrate substantial equivalence, rather than a de novo clinical trial for the UA-851THW itself to establish its accuracy.
- The manufacturer states that the Measurement Method, Measurement Range, and Accuracy are "No change – the same" as the predicate devices (A&D LifeSource model UA-767PBT with FDA 510(k) K043217 and A&D LifeSource model UA-789 with FDA 510(k) K062027).
- The argument is that the major changes (radio replacement and plastic mold changes) "do not affect the devices' intended use or alter the device's fundamental scientific technology." Therefore, because the core technology and performance specifications are unchanged from devices already cleared by the FDA, the UA-851THW is deemed to meet the same acceptance criteria.
In essence, the acceptance criteria are met implicitly by proving substantial equivalence to previously cleared devices which themselves had demonstrated meeting such criteria. The document explicitly avoids describing new, independent testing data for the UA-851THW's accuracy against these criteria.
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Attachment (D) 510(k) Summary
1. DATE PREPARED
October 17, 2008
NOV 1 3 2008
2. CONTACT INFORMATION
A&D Engincering, Inc. Mr. Jerry Wang 1756 Automation Parkway, Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang(@andmedical.com
3. DEVICE NAME
| Proprietary Name: | A&D Medical UA-851THW Digital Blood PressureMonitor |
|---|---|
| Common/Usual Name: | Blood Pressure Monitor |
| Classification name: | Non-invasive blood pressure measurement System21 CFR 870-1130, Class II, 74DXN. |
4. DEVICE DESCRIPTION AND INTENDED USE
The A&D Medical UA-851THW digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
5. PREDICATE DEVICE
A&D LifeSource model UA-767PBT digital blood pressure monitor with FDA 510(k) K043217
A&D LifeSource model UA-789 digital blood pressure monitor with FDA 510(k) K062027.
Both devices are designed and manufactured by the same company and facility as the UA-851THW digital blood pressure monitor.
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TECHNOLOGICAL and OPERATIONAL CHARACTERISTICS 6.
UA-851THW uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal electronic-controlled exhaust valve. There is a quick exhaust mechanism so that the pressure of the cuff can be completely released. There is a maximum pressure safety setting at 300mmHg. The culT will inflate higher than 300mmHg. The arm distribution range is from 5.1" to 17.7" (13 cm to 45 cm). At the end of the measurement, the result can be uploaded to a PC with ActiLink USB transceiver and viewed by the Wellness Connected software.
7. SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Parameter | Predicate Devices(UA-789 & UA-767PBT) | UA-851THW |
|---|---|---|
| MeasurementMethod | Oscillometric Method | No change – the same |
| MeasurementRange | BP : 20 to 280 mmHgPulse : 30 to 200 pulse/min | No change – the same |
| Accuracy | BP : +/- 3mmHg or +/- 2% ofmeasured value, whichever isgreaterPulse : +/- 5 % (pulse) | No change – the same |
| PressurizationSource | Automatic internal pump | No change – the same |
| Cuff Deflation | Automatic constant speedmechanical exhaust valve | No change – the same |
| Data MemorySize with Time& Date | 40 memories for UA-767PBT60 memories for UA-789 | 51 memories |
| IrregularHeartbeatsDetection | More than +/-25% to the meaninterval of all pulse intervals | No change – the same |
| Power Source | 6V DC, 4x1.5V AA batteriesor AC adapter as an option | No change – the same |
| Battery Life | 4 months with dailymeasurement | No change – the same |
| OperatingEnvironment | 50°F (10°C) to 104°F (40°C) atless than 85% RH | No change – the same |
| StorageEnvironment | 14°F (-20°C) to 140°F (60°C)at less than 85% RH | No change – the same |
| Dimensions | 80(H) x 110(W) x 120(L) mm | 160(H) x 150(W) x 125(L) mm |
Product Specification Comparison
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| CuffAttachmentMethod | By plastic hose connected tomonitor | No change – the same |
|---|---|---|
| Arm Size | UA-767PBT – 5.1" to 17.7"(13 cm to 45cm)UA-789 – 9.4" to 23.6" (24 cmto 60 cm) | No change – the same as UA-767PBT |
| Weight | UA-767PBT – 920 g (2.03 lb)without batteriesUA-789 – 940 g (2.07 lb)without batteries | 930 g (2.05 lb) withoutbatteries |
| Display Type | Liquid crystal display | No change – the same |
Major changes from the predicate devices:
- Replace the radio in the UA-767PBT with a new one into UA-851THW .
- Change the plastic molds from UA-789 to UA-851THW .
These changes do not affect the devices' intended use or alter the device's fundamental scientific technology. There is no significant difference that affects the safety or effectiveness of the intended device as compared to the predicate devices.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2008
A & D Engineering, Inc. c/o Mr. Jerry Wang Director of Engineering 1756 Automation Parkway San Jose, CA 95131
Re: K082734
Trade/Device Name: A&D Medical LifeSource UA-851THW Digital Blood Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 17, 2008 Received: October 22, 2008
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, Frug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA). 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 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
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Page 2 - Mr. Jerry Wang
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 clectronic prochet radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter 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 10gally 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 (240) 276-0120. Also, please note the regulation entilled, "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 Suall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna D. Holmes
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
510(k) Number (if known): اِک ه ک ی 34
Device Name: A&D Medical LifeSource UA-851THW 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Varner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K082734
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).