TM-2440 and TM-2441 blood pressure monitors are designed to monitor systolic and diastolic pressure, and pulse rate of adults who are twelve (12) years and older by using the oscillometric method.

TM-2441 has four environmental functions to measure activity monitoring (3-axis accelerometer), ambient temperature monitoring, barometric pressure monitoring, and waveform capability. These functions are not observed by patients form the device display and can only be used by the medical professionals.

Device Description

TM-2440 & TM-2441 Digital 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. TM-2440 & TM-2441 Digital Blood Pressure Monitors will not inflate the cuff higher than 299 mmHg. TM-2440 & TM-2441 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 and waiting for the next measurement timing.

AI/ML Overview

We can break down this request based on the information provided in the given text.

The device in question is the A&D Medical TM-2440 & TM-2441 Digital Blood Pressure Monitors.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The primary performance acceptance criteria for the blood pressure monitors are based on the ISO 81060-2:2013 standard.

Criterion	Acceptance Criteria (ISO 81060-2:2013)	Reported Device Performance (TM-2440 & TM-2441)	Result
Criterion 1: Mean value & Standard deviation (Comparison to reference values)	Mean value: ± 5mmHg or less Standard deviation: 8mmHg or less	Mean value: SYS = -0.80 mmHg, DIA = -0.94 mmHg Std deviation: SYS = 6.46 mmHg, DIA = 6.45 mmHg	Passed
Criterion 2: Standard deviation (Individual differences)	SYS=6.89 mmHg or less DIA=6.88 mmHg or less	Std deviation: SYS = 5.13 mmHg, DIA = 5.86 mmHg	Passed

Note: The reported device performance is for both TM-2440 and TM-2441 models, as they passed "all blood pressure measurement accuracy requirements."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: Not explicitly stated in the provided text. The text only mentions "The summary of the test results of ISO 81061-2 is listed below," implying a clinical validation study was conducted as per the ISO standard, which has specific sample size requirements. While the standard is cited, the actual number of subjects is not provided in this summary.
Data Provenance: Not explicitly stated. The study was conducted as part of the regulatory submission (510(k)) in the US, but the geographic origin of the participants or clinical sites (e.g., country of origin) is not mentioned. The study is assumed to be prospective as it's a clinical validation study for a new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated in the provided text. The ISO 81060-2:2013 standard for automated sphygmomanometers typically requires comparison of the device under test to auscultatory measurements obtained by trained observers (experts) using a mercury sphygmomanometer or validated reference device.
Qualifications of Experts: Not explicitly stated. However, given the reliance on ISO 81060-2:2013, it is implied that the ground truth (reference blood pressure values) would have been established by qualified and trained personnel according to the standard's protocol for taking reference measurements.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. For clinical validation of blood pressure monitors, the ISO 81060-2:2013 standard outlines a specific protocol for taking "reference measurements" (ground truth). This typically involves simultaneous or closely timed measurements by multiple trained observers (e.g., two observers) to minimize measurement error and observer bias, often with a predefined method for resolving discrepancies (e.g., averaging or a third observer if differences exceed a threshold). However, the specific adjudication details are not present in this summary.

5. 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

MRMC Comparative Effectiveness Study: Not applicable. The device in question is a standalone digital blood pressure monitor, not an AI-powered diagnostic imaging tool or a system designed to assist human "readers" (e.g., radiologists). Therefore, this type of study is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: Yes, indirectly. The ISO 81060-2:2013 clinical BP measurement study evaluates the performance of the device itself (the "algorithm only," in a sense, as it's an automated measurement device) against a reference standard. The results presented in the table (Criterion 1 & 2) directly reflect the device's accuracy without human intervention in the measurement process (beyond applying the cuff and initiating the measurement). The device is designed to operate as a standalone automated blood pressure monitor.

7. The Type of Ground Truth Used

Type of Ground Truth: Expert consensus applying the methodology outlined in ISO 81060-2:2013. This standard details how reference blood pressure measurements (auscultatory readings from trained observers) are obtained and averaged to form the ground truth against which the automated device's readings are compared.

8. The Sample Size for the Training Set

Sample Size for the Training Set: Not applicable / Not mentioned. This device is a measurement instrument, not typically an AI/machine learning model that undergoes a separate "training" phase with a distinct training dataset in the conventional sense. Its underlying algorithm for oscillometric blood pressure determination is based on established physiological principles and likely developed through engineering and calibration, rather than statistical machine learning training on a large dataset. The provided text does not mention any training set or machine learning components.

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

How Ground Truth for Training Set Was Established: Not applicable. As mentioned above, the concept of a "training set" and associated "ground truth" establishment in a machine learning context does not appear to apply to this device based on the provided information.

Summary

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April 24, 2019

A&D Company, Ltd Jerry Wang Director of Engineering 1756 Automation Parkwav San Jose, California 95131

Re: K173065

Trade/Device Name: A&D Medical TM-2440 & TM-2441 Digital Blood Pressure Monitors Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 22, 2019 Received: March 25, 2019

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. 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.

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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen C. Browning -S5

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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Indications for Use

510(k) Number (if known) K173065

Device Name

A&D Medical TM-2440 & TM-2441 Digital Blood Pressure Monitors

Indications for Use (Describe)

TM-2440 and TM-2441 blood pressure monitors are designed to monitor systolic and diastolic pressure, and pulse rate of adults who are twelve (12) years and older by using the oscillometric method.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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

August 13, 2018

2. Submitter's Information

A&D Engineering, Inc. Mr. Jerry Wang 1756 Automation Parkway, San Jose, CA 95131 Tel: 408-334-3326 Fax: 408-635-2313 Email: jwang@andonline.com

3. Device Information

Proprietary Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:

A&D Medical TM-2440 & TM-2441 Digital Blood Pressure Monitors 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 TM-2430 & TM-2431 Digital Blood Pressure Monitors with 510(k) . number K992808

ನ. Indications for Use

TM-2440 and TM-2441 blood pressure monitors are designed to measure systolic and diastolic pressure, and pulse rate of adults who are twelve (12) years and older by using the oscillometric method. The arm size is from 15 cm (5.9 inches) to 50 cm (19.6 inches).

6. Intended Use

A&D Medical TM-2440 & TM-2441 Digital Blood Pressure Monitors is designed for adult at home or clinic use. It measures systolic, diastolic, and pulse rate. TM-2440 & TM-2441 uses the oscillometric method to determine blood pressure. TM-2441 has a self-measurement button to enable the patient to take a measurement whenever it is needed. Both devices have an USB port

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to be connected. TM-2441 also has Bluetooth® low energy wireless (BLE) communication capability with Smart devices. TM-2440 & TM-2441 fits arm size from 15 cm to 50 cm.

7. Device Description - Technological and Operational Characteristics Comparison

8. Summary of Substantial Equivalence

Modifications made from the predicate devices:

· Modify the internal layout of the circuit and components.
· Increase the number of supported cuff size from 3 sizes to 4 sizes.
Change LCD display to OLED display.
· Change power source from 3 pcs of AA batteries to 2 pcs of AA batteries.
· Change communication method from RS-232C to USB and BLE.
· Increase the memory size from 300 to 600.
· Add non-medical function activity data by 3-axis accelometer, ambient temperature, barometric pressure, and waveform capability.

Model	Predicate Devices	Modified Device
	TM-2430 & TM-2431	TM-2440	TM-2441
MeasurementMethod	Oscillometric Method	No Change	No Change
BPMeasurementRange	Systolic: 60 – 280mmHgDiastolic: 40 – 160 mmHgPulse: 30–200 beatsper minute	Systolic: 60 – 280mmHgDiastolic: 30 – 160 mmHgPulse: 30 – 200 beats perminute	Systolic: 60 – 280mmHgDiastolic: 30 – 160 mmHgPulse: 30 – 200 beatsper minute
PressureMeasurementRange	0 – 299 mmHg	No Change	No Change
MeasurementAccuracy	BP: +/- 3mmHgPulse: +/- 5%(pulse)	No Change	No Change
MinimumDisplayResolution	1 mmHg	No Change	No Change
Pressuresensor	Semiconducting typesensor	No Change	No Change
Pressurization Source	Automatic micro pump	No Change	No Change
CuffDeflationMethod	Rapid exhaust valve	No Change	No Change
CuffAttachmentMethod	By plastic hoseconnected to monitor	No Change	No Change
Power Source	3xAlkaline battery or3xNickel-hydrogenbattery	2xAlkaline battery or2xNickel-hydrogenbattery	2xAlkaline battery or2xNickel-hydrogenbattery
Battery Life	At least 200measurements for a setof alkaline battery	No Change	No Change
Type ofprotectingagainstelectric shock	Internally poweredequipment type BF	No Change	No Change
Self / EventMeasurementMode	Enabled	Disabled	Enabled
OperatingEnvironment	50°F(10°C) to104°F(40°C)at less than 85%RH	No Change	No Change
StorageEnvironment	-4°F(-20°C) to140°F(60°C)at less than 85%RH	No Change	No Change
DataMemory Size	Last 300 measurementsof systolic, diastolic,and pulse rate	Last 600 measurementsof systolic, diastolic, andpulse rate	Last 600 measurementsof systolic, diastolic, andpulse rate
Dimensions	72 x 100 x 27(mm)	66 x 95 x 24.5(mm)	66 x 95 x 24.5(mm)
Weight	Approx. 146(g)	Approx.120(g)	Approx.135(g)
Cuff Size	Small Size: 15-22 cmAdult Size: 20-31cmLarge Size: 28-36 cm	Small Size: 15-22 cmAdult Size: 20-31cmLarge Size: 28-36 cmExtra Large Size: 36-50cm	Small Size: 15-22 cmAdult Size: 20-31cmLarge Size: 28-36 cmExtra Large Size: 36-50cm
Arm Size	15 to 36 cm	15 to 50 cm	15 to 50 cm

Product Specification Comparison Table:

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Display Typeand Size	LCD:29.5 x 8(mm)	OLED:20 x 8.5(mm)	OLED:20 x 8.5(mm)LCD:39 x 45(mm)
WaveformRecording	Disabled	Enabled	Enabled
Non-medicalDataCollection	Disabled	Disabled	Enabled (activity,ambient temperature,biometric pressure,waveform capability)
ConnectivityInterface	USB	USB	USB & BLE
Field service	Not allowed	No Change	No Change
AutomaticZero at"START"	Yes	No Change	No Change
Manual ZeroAdjustment	Not allowed	No Change	No Change
Calibration	Not allowed in the field	No Change	No Change
Sterilization	Not needed	No Change	No Change

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

A&D Medical conducted design verification and design validation activities based on the comparison of the TM-2440 and TM-2441 with the 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 collected in the TM-2440 and TM-2441 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 to for the design verification and valuation of TM-2440 and TM-2441 digital blood pressure monitors. 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)
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 ●

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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:

IEC 60601-1-2 Edition 3: 2007-03 ● Safety & EMC Tests:
Reliability Tests: ASMI/ANSI/IEC 80601-2-30:2009 & A1:2013 ●
Risk Assessment: ISO 14971:2012
Software Assessment: IEC 62304 Software Life Cycle Process ●
Bluetooth Tests: FCC Part 15 Subpart C : 2014
Clinical BP Measurement: ISO 81060-2:2013 .

The summary of the test results of ISO 81061-2 is listed below. TM-2440 and TM-2441 passed all blood pressure measurement accuracy requirements.

Standard Requirements		Test Result	Result
Criterion 1:Mean value &Standard deviation	± 5mmHg or less8mmHg or less	Mean value: SYS = -0.80 mmHgDIA = -0.94 mmHgStd deviation: SYS = 6.46 mmHgDIA = 6.45 mmHg	Passed
Criterion 2:Standard deviation	SYS=6.89,DIA=6.88 or less	Std deviation: SYS = 5.13 mmHgDIA = 5.86 mmHg	Passed

TM-2440 & TM-2441 digital blood pressure monitors have the following similarities to the predicate devices, TM-2430 & TM-2431, which previously received 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 production facility
Same Indications For Use ●

As a conclusion. TM-2440 & TM-2441 digital blood pressure monitors 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 device.

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).