(126 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
UA-1200BLE of digital blood pressure monitor has the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. After the user starts the blood pressure measurement, the cuff is inflated automatically by an internal pump. The systolic and diastolic blood pressures are also determined by oscillometric method. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released immediately. There is a maximum pressure safety setting at 299 mmHg. UA-1200BLE UltraConnect Digital Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. UA-1200BLE will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the OLED and transmitted via Bluetooth wireless module to the connected app. The cuff is also deflated automatically to 0 mmHg at the same time. If the monitor receives no further action from the user for 1 minute, it will automatically turn off by itself.
The provided text describes the clinical validation of the A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor, which is a non-invasive blood pressure measurement system. The study aims to demonstrate that the device meets the acceptance criteria for accuracy.
Here's an analysis of the acceptance criteria and study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The clinical test summary is based on AAMI/ANSI/ISO 81060-2 Second Edition 2013-05-01 standards.
| Item | Standard Requirements | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Clinical Study Requirements | |||
| Number of Subjects | 85 or more | 85 | Pass |
| Number of Measurements | 3 times or more | 3 times | Pass |
| Observers | 2 | 2 | Pass |
| Observer Difference | +/-4 mmHg or less | +/- 4 mmHg less | Pass |
| Subject Demographics | |||
| Gender: Male | 30% or more | 69.4% (59 subjects) | Pass |
| Gender: Female | 30% or more | 30.6% (26 subjects) | Pass |
| Age | Older than 12 years: 100% | 100.0% (85 subjects) | Pass |
| Arm Circumference: 22.0-32.0 cm | 40% or more | 57.6% (49 subjects) | Pass |
| Arm Circumference: 32.1-42.0 cm | 40% or more | 42.4% (36 subjects) | Pass |
| Arm Circumference: 22.0-27.0 cm | 20% or more | 32.9% (28 subjects) | Pass |
| Arm Circumference: 37.0-42.0 cm | 20% or more | 20.0% (17 subjects) | Pass |
| BP Range Distribution | |||
| SBP < 100mmHg | 5% or more | 7.5% (19 measurements) | Pass |
| SBP > 160mmHg | 5% or more | 5.9% (15 measurements) | Pass |
| SBP < 140mmHg | 20% or more | 20.0% (51 measurements) | Pass |
| DBP < 60mmHg | 5% or more | 8.2% (19 measurements) | Pass |
| DBP > 100mmHg | 5% or more | 9.0% (23 measurements) | Pass |
| DBP > 85mmHg | 20% or more | 34.1% (87 measurements) | Pass |
| Measurement Result (Accuracy) | |||
| Average Difference (mean error) | +/-5mmHg or less | SBP: -2.66mmHgDBP: +0.90mmHg | Pass |
| Standard Deviation (Criteria 1) | 8mmHg or less | SBP: 6.90mmHgDBP: 6.63mmHg | Pass |
| Standard Deviation (Criteria 2) | 8mmHg or less | SBP: 5.35mmHgDBP: 6.12mmHg | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: 85 subjects.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical validation studies for medical devices are typically prospective. The standard referenced, AAMI/ANSI/ISO 81060-2, outlines a methodology for prospective clinical validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: 2 observers (presumably trained clinical professionals, though specific qualifications like "radiologist with 10 years of experience" are not specified).
- Qualifications of Experts: The document states "Observer: 2" and "Observer Difference: +/-4 mmHg or less," which implies that the observers are trained and their measurements are consistent with each other within standard limits. However, detailed qualifications (e.g., years of experience, specific medical profession) are not provided in this summary. For a blood pressure monitor, these would typically be trained clinicians (e.g., nurses, physicians, or technicians) competent in auscultatory blood pressure measurement.
4. Adjudication Method for the Test Set
The document states "Observer: 2" and "Observer Difference: +/-4 mmHg or less," which indirectly suggests a comparison or consensus method involving two observers. For blood pressure measurement, the standard typically involves simultaneous auscultatory measurements by two trained observers, with their readings averaged or compared. The "Observer Difference" criteria implies that their readings must be in close agreement, which is a form of internal validation or adjudication on the ground truth measurement process. It doesn't specify a 2+1 or 3+1 structure, but rather that two observers produced the reference measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study, which typically compares human reader performance with and without AI assistance, was not performed based on the provided summary. This study is a standalone clinical validation for the device's accuracy against a recognized standard.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, a standalone performance study was conducted. The clinical test summary directly assesses the accuracy of the UA-1200BLE device (algorithm only, as it's an automated device) against a "ground truth" established by human observers according to the AAMI/ANSI/ISO 81060-2 standard. The results for "Measurement Result (Accuracy)" (Average Difference and Standard Deviation) directly refer to the device's performance.
7. Type of Ground Truth Used
The ground truth used was based on expert consensus/reference measurements. Specifically, it was established by two human observers performing reference blood pressure measurements (likely auscultatory, which is the gold standard for validating automated devices) in accordance with the AAMI/ANSI/ISO 81060-2 standard. The "Observer Difference" criterion supports this, indicating the two observers' measurements formed the reference.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size for a training set. This summary focuses on the validation of the final device, not on the development or training of its internal algorithms.
9. How the Ground Truth for the Training Set Was Established
As no information about a training set is provided, there is no information on how its ground truth was established.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 03, 2017
A&D Company, Ltd % Jerry Wang Director of Engineering 1756 Automation Parkway San Jose, California 95131
Re: K163683
Trade/Device Name: A&D Medical UA-1200BLE Ultraconnect Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 31, 2017 Received: April 3, 2017
Dear Jerry 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Hillemann
for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163683
Device Name
UA-1200BLE UltraConnect Digital Blood Pressure Monitor
Indications for Use (Describe)
Measure blood pressure (systolic and diastolic) and pulse rate.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
മ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary
This summary of 510(k) safety and effective information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1. Date Prepared
December 23, 2016
2. Submitter's Information
A&D Engineering, Inc. Mr. Jerry Wang 1756 Automation Parkway, San Jose, CA 95131 Tel: 408-518-5113 Fax: 408-635-2313 Email: jwang@andonline.com
3. Device Information
Proprietary Name:
Regulation Number: Regulation Name: Regulatory Class: Product Code:
A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor 21 CFR 870.1130 Noninvasive Blood Pressure Measurement System Class II DNX
4. Information for he 510(k) Cleared Devices (Predicate Devices)
- A&D Medical UA-651 Digital Blood Pressure Monitor with 510(k) number K141160 .
- A&D Medical UA-767PBT Digital Blood Pressure Monitor with 510(k) number . K043217
Both predicate devices are designed and manufactured by the same company and facilities as the modified device.
ട. Indications for Use
Measure blood pressure (systolic and diastolic) and pulse rate
6. Intended Use
A&D LifeSource UA-1200BLE digital blood pressure monitor is designed for adult at home or clinic use. It measures systolic, diastolic, and pulse rate. UA-1200BLE uses the oscillometric method to determine blood pressure. If the user has a massive body movement or irregular heartbeats, a heart symbol will be shown on the app display. At the end of the measurement, the blood pressure results are compared with JNC VII hypertension classification. The rating is also displayed. UA-1200BLE has Bluetooth® low energy wireless (BLE) communication capability with Smart devices. UA-1200BLE fits arm size from 22 to 42 cm.
7. Device Description - Technological and Operational Characteristics Comparison
UA-1200BLE of digital blood pressure monitor has the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. After the user starts the blood pressure measurement, the cuff is inflated automatically by an internal pump. The systolic
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K163683
and diastolic blood pressures are also determined by oscillometric method. The deflation rate is controlled by an internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released immediately. There is a maximum pressure safety setting at 299 mmHg. UA-1200BLE UltraConnect Digital Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. UA-1200BLE will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the OLED and transmitted via Bluetooth wireless module to the connected app. The cuff is also deflated automatically to 0 mmHg at the same time. If the monitor receives no further action from the user for 1 minute, it will automatically turn off by itself.
Summary of Substantial Equivalence 8.
Modifications made from the predicate devices:
- · Remove the plastic host between the cuff and main BP monitor. Basically, UA-1200BLE is a hoseless BP monitor comparing with the predicate devices. We also changed the plastic molds so the UA-1200BLE digital blood pressure monitors have a new appearance.
- · Enable user ID so up to six users can use the UA-1200BLE.
- · Increase the memory size to 100 per user except in the visitor mode.
- · Change upper limit of the arm size from 17.7 inches (45 cm) to 16.5 inches (42 cm).
- · Change pressure sensor from static electricity capacity type to semiconductor type
| Predicate Devices | Modified Device | ||
|---|---|---|---|
| Model | UA-767PBT | UA-651 | UA-1200BLE |
| MeasurementMethod | Oscillometric Method | Oscillometric Method | No change |
| MeasurementRange | BP : 20 - 280mmHgPulse : 40 - 200beats perminute | BP : 0 - 299mmHgPulse : 40 - 180beatsper minute | No change from UA-651 |
| MeasurementAccuracy | BP : +/- 3mmHg or +/-2% of measured value,whichever is greaterPulse : +/- 5% (pulse) | BP : +/- 3mmHgPulse : +/- 5% (pulse) | No change from UA-651 |
| MinimumDisplayResolution | 1 mmHg | 1 mmHg | No change |
| Pressuresensor | Static electricity capacitytype sensor | Static electricitycapacity type sensor | Semiconducting typesensor |
| Pressurization Source | Automatic internal pump | Automatic internalpump | No change |
| CuffDeflationMethod | Automatic constant speedmechanical exhaust valve | Automatic constantspeed mechanicalexhaust valve | Solenoid valve for rapidexhaust |
| Display Type | Liquid crystal display | Liquid crystal display | OLED display |
| CuffAttachmentMethod | By plastic hose connectedto monitor | By plastic hoseconnected to monitor | Integrated (hoseless) |
| IHB | Enabled | Enabled | No change |
| %IHB | No | Enabled. %IHB isdisplayed as frequencyof IHB detected | No change from UA-651 |
| Power Source | 6V DC, 4x1.5V AAbatteries or AC adaptoras an option | 6V DC, 4x1.5V AAbatteries or ACadaptor as an option | 3.7V Li-ion batteriesor AC adaptor as anoption |
| Protectionagainstelectricalshock | Class I, Type B | Class I, Type B | No change |
| Battery Life | 6 months with onemeasurement dairy | 6 months with onemeasurement dairy | 3 months with onemeasurement daily |
| OperatingEnvironment | 50°F(10°C) to104°F(40°C)at less than 85%RH | 50°F(10°C) to104°F(40°C)15%RH to 85%RH | No change |
| StorageEnvironment | -4°F(-20°C) to140°F(60°C)at less than 85%RH | -4°F(-20°C) to140°F(60°C)10%RH to 95%RH | No change |
| DataMemory Size | Last 40 measurements ofsystolic, diastolic, andpulse rate | Last 60 measurementsfor each of the fouruser | Last 100 measurementsfor each of the five user |
| Dimensions | 163.7(H)x111(W)x66.7(L) mm | 140(W)x60(H)x105(D) mm | 40(W)x126(H)x26(D)mm |
| Weight | 320g without batteries | 255g without batteries | 205g without batteries |
| Cuff Design | D-ring cuff with plastichose | D-ring cuff withplastic hose | D-ring cuff(Integrated)Hoseless |
| Arm Size | 13 to 45 cm | 22 to 45 cm | 22 to 42 cm |
| Clock(Time/Date) | Yes (By App) | Yes | No change from UA-767PBT |
| AM/PM | No | Yes | No change from UA-651 |
| PressureIndicator | Yes | Yes | No change |
| WirelessRadioConnectivity | Bluetooth wireless | No | No change from UA-767PBT |
| Field service | Not allowed | Not allowed | No change |
| AutomaticZero at"START" | Yes | Yes | No change |
| Manual ZeroAdjustment | Not allowed | Not allowed | No change |
| Calibration | Not allowed in the field | Not allowed in thefield | No change |
| Sterilization | Not needed | Not needed | No change |
| BloodPressureReadingClassificationCriteria | USA JNC VII | WHO ClassificationCriteria | No change from UA-767PBT |
Product Specification Comparison Table:
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Key Features Comparison
| Parameter | Predicate Devices(UA-651 & UA-767PBT) | Modified Device(UA-1200BLE) |
|---|---|---|
| Field service | Not allowed | No change - the same |
| Automatic zero after"START" operation | Yes | No change - the same |
| Manual zero adjustment | Not allowed | No change - the same |
| Calibration | Not allowed in the field | No change - the same |
| Sterilization | Not needed | No change - the same |
9. Discussion of standards used in the design verification and design validation
A&D Medical follows FDA recognized consensus standards and guidance documents in our medical device development and manufacturing processes. The following standards were used to for the design verification and valuation of UA-1200BLE UltraConnect Digital Blood Pressure Monitor. These standards include three major groups. First group is the general quality system requirements. Second group is the special requirements for CDRH (870.1130). The third group is related to software and app life cycle processes requirements.
- AAMI/ANSI/ISO 14971:2007/(R) 2010 (Corrected 4 October 2007) ● Medical Devices - Applications Of Risk Management To Medical Devices (FDA Recognized Number 5-70)
- IEC 60601-1-11 Edition 1.0 2010-04 Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment [Including: Technical Corrigendum 1 (2011)] (FDA Recognized Number 19-6)
- . IEC 60601-1-2 Edition 3: 2007-03 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (FDA Recognized Number 19-1)
- AAMI/ANSI/IEC 60601-1-2:2007/(R)2012 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3) (FDA Recognized Number 19-2)
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- AAMI/ANSI/ISO 81060-2 Second Edition 2013-05-01 ● Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type (FDA Recognized Number 3-117)
- . AAMI/ANSI/IEC 80601-2-30:2009 & A1:2013 Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers (FDA Recognized Number 3-130)
- . AAMI/ANSI/IEC 62304:2006 Medical Device Software - Software Life Cycle Processes (FDA Recognized Number 13-32)
10. Substantial Equivalence Conclusion: Non-clinical Test Summary:
- Safety Tests: IEC 60601-11 Edition 1.0 2010-04
- . EMC Tests: IEC 60601-1-2 Edition 3: 2007-03
- Reliability Tests: ASMI/ANSI/IEC 80601-2-30:2009 & A1:2013 ●
- Risk Assessment: ISO 14971:2012 .
- Software Assessment: IEC Medical Life Cycle Process & FDA "Guidance for the Content of Premarket Submissions for Software contained in Medical Devices", November 2005. . Bluetooth Tests: FCC Part 15 Subpart C : 2014
Clinical Test Summary based on AAMI/ANSI/ISO 81060-2 Second Edition 2013-05-01
| Item | Standard Requirements | Study Results | Pass/Fail | |
|---|---|---|---|---|
| Number of Subject | 85 or more | 85 | 100% | Pass |
| Number ofMeasurement | 3 times or more | 3 times | 100% | Pass |
| Observer | 2 | 2 | 100% | Pass |
| Observer Difference | +/-4 mmHg or less | +/- 4 mmHg less | 100% | Pass |
| Gender | Male 30% or more | 59 | 69.4% | Pass |
| Female 40% or more | 26 | 30.6% | Pass | |
| Age | Older than 12 years : 100% | 85 | 100.0% | Pass |
| Circumference ofArm | 22.0-32.0 cm : 40% or more | 49 | 57.6% | Pass |
| 32.1 - 42.0 cm : 40% or more | 36 | 42.4% | Pass | |
| 22.0-27.0cm: 20% or more | 28 | 32.9% | Pass | |
| 37.0-42.0 cm: 20% or more | 17 | 20.0% | Pass | |
| BP Range | SBP<100mmHg 5% or more | 19 | 7.5% | Pass |
| SBP>160mmHg 5% or more | 15 | 5.9% | Pass | |
| SBP<140mmHg 20% or more | 51 | 20.0% | Pass | |
| DBP<60mmHg 5% or more | 19 | 8.2% | Pass | |
| DBP>100mmHg 5% or more | 23 | 9.0% | Pass | |
| DBP >85mmHg 20% or more | 87 | 34.1% | Pass | |
| Measurement Result | Average : +/-5mmHg or less | SBP | -2.66mmHg | Pass |
| DBP | +0.90mmHg | Pass | ||
| S.D. : 8mmHg or less(Criteria 1) | SBP | 6.90mmHg | Pass | |
| DBP | 6.63mmHg | Pass |
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| S.D.: 8 mmHg or less(Criteria 2) | SBP | 5.35 mmHg | Pass |
|---|---|---|---|
| DBP | 6.12 mmHg | Pass |
UA-1200BLE of digital blood pressure monitors Digital blood pressure monitors have the following similarities to the predicate devices, UA-651 and UA-767PBT digital blood pressure monitors, which previously received the 510(k) clearance.
- Same intended use.
- Same oscillometric method to determine the blood pressure & pulse rate
- Same inflation method - automatic internal pump
- . Same fast safety deflation method - solenoid controlled exhaust valve
- Same materials, no new materials used
- Same manufacturing processes at the same facility
- . Same Indications For Use
As a conclusion. UA-1200BLE UltraConnect digital blood pressure monitor as described in its labeling and comparison analysis has not changed as a result of the modifications. The fundamental scientific technology of the modified device has not changed, either. There is no significant difference that affects the safety or effectiveness of the modified device as compared to the predicate devices.
§ 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).