UM-212BLE blood pressure monitor is designed to measure systolic, diastolic pressure, and pulse rate of children and adults who are three (3) years and older in clinics and hospitals. The arm size is from 12 cm (4.7 inches) to 50 cm (19.7 inches). It can detect irregular heartbeats and display a symbol on its display and transmit the measurement by Bluetooth to other devices, such as PC, mobile phones, and gateways.

Device Description

UM-212BLE Blood Pressure Monitors have the same design as the predicate devices with an inflatable cuff which is wrapped around the patient's upper arm. The blood pressure measurement starts with the inflation process by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method during the deflation process. 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. UM-212BLE Blood Pressure Monitor will not inflate the cuff higher than 299 mmHg. The device will display an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressure reading with pulse rate are shown on the LCD. The values can also be transmitted by Bluetooth communication. The cuff is automatically deflated to 0 mmHg at the same time that the measurement is being displayed. If the monitor receives no further action from the user for 1 minute, it will automatically turn off.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the A&D Medical UM-212BLE Blood Pressure Monitor, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria were based on the ISO 81060-2:2013 standard for non-invasive sphygmomanometers. The study evaluated the device's accuracy in measuring systolic and diastolic blood pressure.

Standard Requirements (Acceptance Criteria)	Reported Device Performance (Adults)	Result
Criterion 1 (Adults):
Max Mean error of measurement: ± 5.0 mmHg	Mean value: SYS = +3.05 mmHg, DIA = +2.87 mmHg	Pass
Standard deviation (S.D.): 8.0 mmHg or less	Std deviation: SYS = 3.59 mmHg, DIA = 3.48 mmHg	Pass
Criterion 2 (Adults) - based on ISO 81060-2:2013 Table 1:
Permissible Standard Deviation: SYS=6.20 mmHg, DIA=6.30 mmHg	Std deviation: SYS = 3.50 mmHg, DIA = 3.11 mmHg	Pass
Criterion 1 (Children):
Max Mean error of measurement: ± 5.0 mmHg	Mean value: SYS = +3.74 mmHg, DIA = +2.88 mmHg	Pass
Standard deviation (S.D.): 8.0 mmHg or less	Std deviation: SYS = 1.15 mmHg, DIA = 1.55 mmHg	Pass
Criterion 2 (Children) - based on ISO 81060-2:2013 Table 1:
Max Permissible Standard Deviation: SYS=5.77 mmHg, DIA=6.30 mmHg	Std deviation: SYS = 1.04 mmHg, DIA = 1.37 mmHg	Pass

The device passed all specified accuracy requirements for both adult and child measurements.

2. Sample Sizes and Data Provenance

The document does not explicitly state the exact sample sizes (number of subjects) used for the clinical investigation of automated measurement type (ISO 81060-2:2013). However, the standard itself requires a minimum of 85 subjects for the primary validation.

Regarding data provenance, the document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that "A&D Medical conducted design verification and design validation activities."

3. Number of Experts and Qualifications for Ground Truth

For blood pressure measurement devices, human experts (trained observers) are typically used to establish ground truth through a reference measurement method (e.g., auscultation with a mercury sphygmomanometer). The document does not specify the number or qualifications of experts involved in the clinical investigation. However, for a study following ISO 81060-2, trained observers are a prerequisite, and their training and adherence to the standard's methodology are essential for the validity of the ground truth.

4. Adjudication Method for the Test Set

The document does not describe a specific "adjudication method" in the context of expert consensus, as this device measures a physiological parameter rather than interpreting complex medical images. The ground truth for blood pressure is established through simultaneous or closely sequential measurements by a qualified reference method, usually involving multiple valid measurements per subject. The ISO 81060-2 standard outlines the specific protocol for parallel measurements with an observer.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is not applicable here as the device is an automated blood pressure monitor measuring a physiological parameter, not an AI interpreting medical images requiring human reader comparison. Therefore, there's no comparison of human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance

The entire clinical investigation (ISO 81060-2:2013) is a standalone performance test of the algorithm (device) against a reference standard. The results provided in the table are the standalone performance of the blood pressure monitor.

7. Type of Ground Truth Used

The type of ground truth used is based on reference blood pressure measurements obtained through a validated method (typically auscultation with a mercury sphygmomanometer) by trained observers, as stipulated by ISO 81060-2:2013. This is a direct physiological measurement, not expert consensus on an interpretation, pathology, or outcomes data in the typical sense of AI diagnostics.

8. Sample Size for the Training Set

The document does not provide information on a "training set" or "test set" in the context of machine learning model development. For a device like a blood pressure monitor, the "design verification and design validation activities" are traditionally engineering and clinical studies to confirm the device's adherence to performance standards, rather than training an AI model.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and its associated ground truth establishment is not directly applicable to this type of device validation in the context of the provided 510(k) summary. The "ground truth" for the device's performance validation is the accurate simultaneous or near-simultaneous measurement of blood pressure by a validated reference method during clinical testing, as per ISO 81060-2.

Summary

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October 6, 2022

A&D Company, Ltd Chanda Melville Quality Manager 1756 Automation Parkway San Jose, California 95131

Re: K212168

Trade/Device Name: A&D Medical UM-212BLE Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 22, 2022 Received: September 6, 2022

Dear Chanda Melville:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 807); labeling (21 CFR Part 801: medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212168

Device Name

A&D Medical UM-212BLE Blood Pressure Monitor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	☐ Remediation Use (Part 21 CFR 201 Subpart D) ☑ On-The-Spot Use (21 CFR 201 Subpart C)
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__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv

This 510(k) summary provides information to demonstrate substantial equivalence and is submitted in accordance with the requirement of 21 CFR 807.92.

Date Prepared 1.

October 4, 2022

2. Submitter's Information

A&D Engineering, Inc. Ms. Chanda Melville 4622 Runway Boulevard, Ann Arbor, MI 48108 Tel: 678-230-8565 Email: cmelville@andonline.com

3. Device Information

Proprietary Name:	A&D Medical UM-212BLE Blood Pressure Monitor
Regulation Number:	21 CFR 870.1130, 21 CFR 870.1120
Regulation Name:	Noninvasive Blood Pressure Measurement System
Regulatory Class:	Class II
Product Code:	DXN, DXQ

4. Information for the 510(k) Cleared Devices (Predicate Devices)

A&D Medical UM-211 Digital Blood Pressure Monitor 510(k) number K173191 ●
A&D Medical UA-767PBT Digital Blood Pressure Monitors with 510(k) number ● K043217

5. Indications for Use

UM-212BLE blood pressure monitor is designed to measure systolic pressure, and pulse rate of children and adults who are three (3) years and older in clinics and hospitals. The arm size is from 12 cm (4.7 inches) to 50 cm (19.7 inches). It can detect irregular heartbeats and display a symbol on its display and transmit the measurement by Bluetooth to other devices, such as PC, mobile phones, and gateways.

6. Intended Use

A&D Medical UM-212BLE Blood Pressure Monitor is designed for use in clinics and hospitals. It measures systolic, diastolic, and pulse rate. UM-212BLE uses the oscillometric and auscultatory methods to determine blood pressure.

7. Device Description - Technological and Operational Characteristics Comparison

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transmitted by Bluetooth communication. The cuff is automatically deflated to 0 mmHg at the same time that the measurement is being displayed. If the monitor receives no further action from the user for 1 minute, it will automatically turn off.

UM-212BLE shares the same design and technologies with the two comparison models. Refer to the product comparison table below for the differences among these three models.

PRODUCT SPECIFICATION COMPARISON TABLE
	Predicate Device	Modified Device
	UA-767PBT	UM-211	UM-212BLE
Measurement method	Oscillometric	Oscillometric and Auscultatory	Oscillometric and Auscultatory
Blood PressureMeasurement	Automatic (One-time)	Automatic (One-time) Auscultation	AutomaticMultiple measurement (Average)Auscultation
AOBP (multiplemeasurement mode)	N/A	N/A	2 times, 3 times
First MeasurementWait Time	N/A	N/A	0 sec, 3 min, 5 min, 10 min
MeasurementInterval	N/A	N/A	30 sec, 1 min, 2 min
BP MeasurementRange	Systolic: 60 – 279 mmHgDiastolic: 40 – 200 mmHgPulse: 40 – 200 beats per minute	Systolic: 60 – 279mmHgDiastolic: 40 – 200 mmHgPulse: 40-200 beats per minute	Systolic: 60 – 279 mmHgDiastolic: 40 – 200 mmHgPulse: 40-200 beats per minute
PressureMeasurement Range	0 – 299 mmHg	0 – 299 mmHg	0 – 299 mmHg
MeasurementAccuracy	BP: ± 3 mmHgPulse: ±5%	BP: ± 3mmHgPulse: ± 5%	BP: ±3 mmHgPulse: ±5%
Deflation Method	Mechanical exhaust valve	Constant speed electrical controlled exhaust valve	Constant speed electrical controlled exhaust valve
Pressure Sensor	Capacitance type	Semiconductor type	Semiconductor type
BluetoothCommunication	Bluetooth ver2.1	N/A	Bluetooth low energy ver 4.1
Cuff Size	Small Size: 16-24 cmMedium Size: 24-36cmLarge Size: 36-45 cm	Small Size: 16-24 cmAdult Size: 22-32cmLarge Size: 31-45 cmExtra Large Size: 41-50 cm	Extra Small Size: 12 – 17cmSmall Size: 16-24 cmAdult Size: 22-32cmLarge Size: 31-45 cmExtra Large Size: 41-50 cm
Memory Size	200	99	99

8. Modifications made from the predicate devices (UM-211 & UA-767PBT):

· Modify the internal layout of the circuit and components, and ISO/IEC 80369-5 compliant cuff hose connector.

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· Include AOBP mode setting (multiple measurement mode)
· Update Bluetooth technology to Bluetooth low energy ver4.1
Add extra small cuff size

9. Discussion of standards used in the design verification and design validation

A&D Medical conducted design verification and design validation activities based on comparisons of the UM-211 and UA-767PBT predicate devices. Based on the changes, we conducted the appropriated test methodology and pass/fail criteria. After the tests were conducted, the test records were added to the UM series design history file (DHF).

A&D Medical follows FDA recognized consensus standards and guidance documents in our medical device development and manufacturing processes. The following standards were used for the design verification and evaluation of UM-212BLE blood pressure monitor. These standards include the general quality system requirements, the special requirements for CDRH (870.1130), and 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 5-40)
AAMI/ANSI/IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (FDA Recognized Number 19-4)
. AAMI/ANSI/IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests (FDA Recognized Number 19-8)
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 3-152)
AAMI/ANSI/IEC 62304:2006 Medical Device Software - Software Life Cycle Processes (FDA Recognized Number 13-79)
AAMI/ANSI/ISO 81060-2:2013 ● Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type (FDA Recognized Number 3-130)

10. Substantial Equivalence Conclusion:

Test Summary based on FDA recognized standards:

Safety & Performance IEC 60601-1:2005
Safety & EMC Tests: ● IEC 60601-1-2: 2014
Reliability Tests: ASMI/ANSI/IEC 80601-2-30:2009 & A1:2013
Risk Assessment: ISO 14971:2012
Software Assessment: IEC 62304 Software Life Cycle Process ●
Clinical BP Measurement: ISO 81060-2:2013

005 510(k) Summary rev2

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Standard Requirements		Test Result	Result
Criterion 1:Max Mean error ofmeasurement &Standard deviation	Mean : ± 5.0 mmHg	Mean value: SYS = +3.05 mmHgDIA = +2.87 mmHg	Pass
	S. D. : 8.0 mmHg orless	Std deviation: SYS = 3.59 mmHgDIA = 3.48 mmHg	Pass
Criterion 2:Max Mean error ofmeasurement &Standard deviationmeet ISO 81060-2:2013 Table 1	SYS=6.20 mmHg,DIA=6.30 mmHg	Std deviation: SYS = 3.50 mmHgDIA = 3.11 mmHg	Pass
Standard Requirements		Test Result (Test on Child)	Result
Criterion 1:Max Mean error of	Mean : ± 5.0 mmHg	Mean value: SYS = +3.74 mmHgDIA = +2.88 mmHg	Pass
measurement &Standard deviation	S. D. : 8.0 mmHg orless	Std deviation: SYS = 1.15 mmHgDIA = 1.55 mmHg	Pass
Criterion 2:Max PermissibleStandard Deviationper ISO 81060-2:2013 Table 1	SYS=5.77 mmHg,DIA=6.30 mmHg	Std deviation: SYS = 1.04 mmHgDIA = 1.37 mmHg	Pass

The summary of the test results of ISO 81061-2 is listed below. UM-212BLE passed all blood pressure measurement accuracy requirements.

UM-212BLE met all applicable requirements of the FDA recognized consensus standards and guidance documents. None of the test demonstrated that the UM-212BLE bring new issues of safety and effectiveness.

As a conclusion, UM-212BLE 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.

Regulation Number and Section

§ 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).