(114 days)
No
The description details standard oscillometric blood pressure measurement technology and basic digital features (irregular heartbeat indicator, Bluetooth transmission, auto-off). There is no mention of AI or ML algorithms being used for measurement, analysis, or any other function. The performance studies listed are standard safety, EMC, and reliability tests, not studies typically associated with validating AI/ML performance.
No
This device is for measuring blood pressure and pulse rate, which is a diagnostic/monitoring function, not a therapeutic intervention.
Yes
The device measures blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension or arrhythmia (indicated by the irregular heartbeat indicator).
No
The device description clearly outlines hardware components like an inflatable cuff, internal pump, exhaust valve, OLED display, and Bluetooth module, indicating it is a physical device with integrated software, not a software-only device.
No, 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 UB-1100BLE UltraConnect digital blood pressure monitor measures blood pressure and pulse rate directly from the patient's wrist using a cuff and oscillometric method. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "Measure blood pressure (systolic and diastolic) and pulse rate," which is a direct physiological measurement, not an in vitro test.
Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
Measure blood pressure (systolic and diastolic) and pulse rate.
Product codes
DXN
Device Description
A&D Medical UB-1100BLE UltraConnect digital blood pressure monitor is designed for adult at home or clinic use. It measures systolic, diastolic, and pulse rate. UB-1100BLE 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. UB-1100BLE has Bluetooth® low energy wireless (BLE) communication capability with Smart devices. UB-1100BLE fits wrist size from 13.5 to 21.5 cm.
UB-1100BLE UltraConnect digital blood pressure monitor has the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's wrist. 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. UB-1100BLE UltraConnect digital blood pressure monitor will not inflate the cuff higher than 299 mmHg. UB-1100BLE 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adult
Intended User / Care Setting
adult at home or clinic use
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)
Non-clinical Test Summary:
- Safety Tests: IEC 60601-11 Edition 1.0 2010-04
- EMC Tests: IEC 60601-1-2 Edition 3: 2007-03
- ASMI/ANSI/IEC 80601-2-30:2009 & A1:2013
- Reliability Tests: Not Found
- 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
There is no modification requiring conducting clinical tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2017
A&D Company, Ltd. Jerry Wang Director Of Engineering 1756 Automation Parkwav San Jose, California 95131
Re: K170196
Trade/Device Name: A&D Medical UB-1100BLE 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: April 14, 2017 Received: April 18, 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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.
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. Willemen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
UB-1100BLE 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)
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
February 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 UB-1100BLE UltraConnect Digital Blood Pressure Monitor 21 CFR 870.1130 Noninvasive Blood Pressure Measurement System Class II DXN
4. Information for he 510(k) Cleared Devices (Predicate Devices)
- A&D Medical UB-543 Digital Blood Pressure Monitor with 510(k) number K141179 ●
- 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 Medical UB-1100BLE UltraConnect digital blood pressure monitor is designed for adult at home or clinic use. It measures systolic, diastolic, and pulse rate. UB-1100BLE 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. UB-1100BLE has Bluetooth® low energy wireless (BLE) communication capability with Smart devices. UB-1100BLE fits wrist size from 13.5 to 21.5 cm.
Device Description – Technological and Operational Characteristics Comparison 7. UB-1100BLE UltraConnect digital blood pressure monitor has the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's wrist. After the user starts the blood pressure measurement, the cuff is inflated automatically by an internal pump. The
4
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. UB-1100BLE UltraConnect digital blood pressure monitor will not inflate the cuff higher than 299 mmHg. UB-1100BLE 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.
8. Summary of Substantial Equivalence
Modifications made from the predicate devices:
- · Changed the plastic molds to have a new appearance.
- Change LCD display to OLED display.
- · Change battery type from alkaline to Li-ion.
- · Increase number of users from 2 to six users.
- · Increase the memory size to 100 per user except in the visitor mode.
- · Change pressure sensor from static electricity capacity type to semiconductor type
| Predicate Devices | Modified Device | ||
|---|---|---|---|
| Model | UA-767PBT | UB-543 | UB-1100BLE |
| Measurement Method | Oscillometric Method | Oscillometric Method | No change |
| Measurement Range | BP : 20 - 280mmHg | ||
| Pulse : 40 - 200beats per | |||
| minute | BP : 0 - 299mmHg | ||
| Pulse : 40 - 180beats | |||
| per minute | No change from UB-543 | ||
| Measurement Accuracy | BP : +/- 3mmHg or +/- | ||
| 2% of measured value, | |||
| whichever is greater | |||
| Pulse :+/- 5% (pulse) | BP : +/- 3mmHg | ||
| Pulse :+/- 5% (pulse) | No change from UB-543 | ||
| Minimum Display Resolution | 1 mmHg | 1 mmHg | No change |
| Pressure sensor | Static electricity capacity | ||
| type sensor | Static electricity | ||
| capacity type sensor | Semiconducting type | ||
| sensor | |||
| Pressurization Source | Automatic internal pump | Automatic internal | |
| pump | No change | ||
| Cuff Deflation Method | Automatic constant speed | ||
| mechanical exhaust valve | Solenoid valve for | ||
| rapid exhaust | No change from UB-543 | ||
| Display Type | LCD display | LCD display | OLED display |
| Cuff Attachment Method | By plastic hose connected | ||
| to monitor | Integrated (hoseless) | No change from UB-543 | |
| IHB | Enabled | Enabled | No change |
| %IHB | No | No | Enabled by app display. |
| Power Source | 6V DC, 4x1.5V AA | ||
| batteries or AC adaptor | |||
| as an option | 6V DC, 4x1.5V AA | ||
| batteries or AC | |||
| adaptor as an option | 3.7V Li-ion batteries | ||
| or AC adaptor as an | |||
| option | |||
| Protection | |||
| against | |||
| electrical | |||
| shock | Class I, Type B | Class I, Type B | No change |
| Battery Life | 6 months with one | ||
| measurement dairy | 6 months with one | ||
| measurement dairy | 3 months with one | ||
| measurement daily | |||
| Operating | |||
| Environment | 50°F(10°C) to | ||
| 104°F(40°C) | |||
| at less than 85%RH | 50°F(10°C) to | ||
| 104°F(40°C) | |||
| 15%RH to 85%RH | No change | ||
| Storage | |||
| Environment | -4°F(-20°C) to | ||
| 140°F(60°C) | |||
| at less than 85%RH | -4°F(-20°C) to | ||
| 140°F(60°C) | |||
| 10%RH to 95%RH | No change | ||
| Data | |||
| Memory Size | Last 40 measurements of | ||
| systolic, diastolic, and | |||
| pulse rate | Last 60 measurements | ||
| each for user 1 and | |||
| user 2. | Last 100 measurements | ||
| for each of the five user | |||
| Dimensions | 163.7(H)x111(W)x66.7( | ||
| L) mm | 56(W)x88(H)x18(D) | ||
| mm | 40(W)x126(H)x26(D) mm | ||
| Weight | 320g without batteries | 104g without batteries | 205g without batteries |
| Arm or Wrist | |||
| Size | 13 to 45 cm (Arm) | 13.5cm to 21.5cm | |
| (Wrist) | No change from UB-543 | ||
| Clock | |||
| (Time/Date) | Yes (By App) | Yes | No change from UA- |
| 767PBT | |||
| AM/PM | No | Yes | No change from UB-543 |
| Pressure | |||
| Indicator | Yes | Yes | No change |
| Wireless | |||
| Radio | |||
| Connectivity | Bluetooth wireless | No | No change from UA- |
| 767PBT | |||
| Field service | Not allowed | Not allowed | No change |
| Automatic | |||
| Zero at |
| | | |
Product Specification Comparison Table:
5
6
| Blood
Pressure
Reading
Classification
Criteria | USA JNC VII | WHO Classification
Criteria | No change from UA-
767PBT |
| ------------------------------------------------------------ | ------------- | -------------------------------- | ------------------------------ |
|---|
Key Features Comparison
| Parameter | Predicate Devices
(UB-543 & UA-767PBT) | Modified Device
(UB-1100BLE) |
|-------------------------------------------|-------------------------------------------|---------------------------------|
| 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 UB-1100BLE 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)
- . 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)
7
- 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
- ASMI/ANSI/IEC 80601-2-30:2009 & A1:2013 ● Reliability Tests:
- 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
There is no modification requiring conducting clinical tests.
UB-1100BLE UltraConnect digital blood pressure monitor has the following similarities to the predicate devices, UB-543 and UA-767PBT digital blood pressure monitors, which previously received the 510(k) clearance.
- Same intended use. ●
- Same Indications For 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 wrist size.
As a conclusion. UB-1100BLE 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.