A&D Medical Blood Pressure Monitors

• K Number: K173065
• Device Name: A&D Medical Blood Pressure Monitors
• Manufacturer: A&D Company, Ltd
• Date Cleared: 2019-04-24 ( 572 days)
• Product Code: DXN
• Regulation Number: 870.1130

Intended Use

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.

Predicate Devices

K992808

Reference Devices

K992808

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard oscillometric blood pressure measurement and basic environmental sensors, with no mention of AI or ML algorithms for data analysis or interpretation.

Therapeutic

No.
The device is for monitoring purposes, not for treating or rehabilitating a disease or condition. While it can detect an irregular heartbeat, it does not provide therapy for it.

Diagnostic

Yes.
The device measures systolic and diastolic pressure, and pulse rate, and also includes an irregular heartbeat indicator. These measurements provide clinical information intended for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as an inflatable cuff, internal pump, internal exhaust valve, and OLED display, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The TM-2440 and TM-2441 are blood pressure monitors. They measure physiological parameters (blood pressure and pulse rate) directly from the patient's body using a cuff and the oscillometric method. They do not analyze samples taken from the body.
• Intended Use: The intended use is to monitor blood pressure and pulse rate, which is a direct physiological measurement, not an in vitro test.
• Device Description: The description details the mechanical and electronic processes of measuring blood pressure through cuff inflation and deflation, not the analysis of biological samples.

Therefore, the TM-2440 and TM-2441 fall under the category of non-invasive physiological monitoring devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DXN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper arm

Indicated Patient Age Range

adults who are twelve (12) years and older

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)

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.

Criterion 1:
Mean value &
Standard deviation
± 5mmHg or less
8mmHg or less
Mean value: SYS = -0.80 mmHg
DIA = -0.94 mmHg
Std deviation: SYS = 6.46 mmHg
DIA = 6.45 mmHg
Result: Passed

Criterion 2:
Standard deviation
SYS=6.89,
DIA=6.88 or less
Std deviation: SYS = 5.13 mmHg
DIA = 5.86 mmHg
Result: Passed

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K992808

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 ([e-mail]) or phone [phone] 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.

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.

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: [phone] Fax: [phone] Email: [e-mail]

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).

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.

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

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.

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
Measurement
Method	Oscillometric Method	No Change	No Change
BP
Measurement
Range	Systolic: 60 – 280mmHg
Diastolic: 40 – 160 mmHg
Pulse: 30–200 beats
per minute	Systolic: 60 – 280mmHg
Diastolic: 30 – 160 mmHg
Pulse: 30 – 200 beats per
minute	Systolic: 60 – 280mmHg
Diastolic: 30 – 160 mmHg
Pulse: 30 – 200 beats
per minute
Pressure
Measurement
Range	0 – 299 mmHg	No Change	No Change
Measurement
Accuracy	BP: +/- 3mmHg
Pulse: +/- 5%(pulse)	No Change	No Change
Minimum
Display
Resolution	1 mmHg	No Change	No Change
Pressure
sensor	Semiconducting type
sensor	No Change	No Change
Pressurizatio
n Source	Automatic micro pump	No Change	No Change
Cuff
Deflation
Method	Rapid exhaust valve	No Change	No Change
Cuff
Attachment
Method	By plastic hose
connected to monitor	No Change	No Change
Power Source	3xAlkaline battery or
3xNickel-hydrogen
battery	2xAlkaline battery or
2xNickel-hydrogen
battery	2xAlkaline battery or
2xNickel-hydrogen
battery
Battery Life	At least 200
measurements for a set
of alkaline battery	No Change	No Change
Type of
protecting
against
electric shock	Internally powered
equipment type BF	No Change	No Change
Self / Event
Measurement
Mode	Enabled	Disabled	Enabled
Operating
Environment	50°F(10°C) to
104°F(40°C)
at less than 85%RH	No Change	No Change
Storage
Environment	-4°F(-20°C) to
140°F(60°C)
at less than 85%RH	No Change	No Change
Data
Memory Size	Last 300 measurements
of systolic, diastolic,
and pulse rate	Last 600 measurements
of systolic, diastolic, and
pulse rate	Last 600 measurements
of systolic, diastolic, and
pulse 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 cm
Adult Size: 20-31cm
Large Size: 28-36 cm	Small Size: 15-22 cm
Adult Size: 20-31cm
Large Size: 28-36 cm
Extra Large Size: 36-50
cm	Small Size: 15-22 cm
Adult Size: 20-31cm
Large Size: 28-36 cm
Extra Large Size: 36-50
cm
Arm Size	15 to 36 cm	15 to 50 cm	15 to 50 cm

Product Specification Comparison Table:

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| Display Type
and Size | LCD:29.5 x 8(mm) | OLED:20 x 8.5(mm) | OLED:20 x 8.5(mm)
LCD:39 x 45(mm) |
|-----------------------------------|--------------------------|-------------------|-------------------------------------------------------------------------------------------|
| Waveform
Recording | Disabled | Enabled | Enabled |
| Non-medical
Data
Collection | Disabled | Disabled | Enabled (activity,
ambient temperature,
biometric pressure,
waveform capability) |
| Connectivity
Interface | USB | USB | USB & BLE |
| Field service | Not allowed | No Change | No Change |
| Automatic
Zero at
"START" | Yes | No Change | No Change |
| Manual Zero
Adjustment | 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 less
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	SYS=6.89,
DIA=6.88 or less	Std deviation: SYS = 5.13 mmHg
DIA = 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.