A&D Medical Blood Pressure Monitors

K173065 · A&D Company, Ltd. · DXN · Apr 24, 2019 · Cardiovascular

Device Facts

• Record ID: K173065
• Device Name: A&D Medical Blood Pressure Monitors
• Applicant: A&D Company, Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

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 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.

Device Story

Digital blood pressure monitors (TM-2440/TM-2441) for home or clinic use; operated by patients or clinicians. Device uses inflatable cuff wrapped around upper arm; internal pump inflates cuff; oscillometric method determines systolic/diastolic pressure and pulse rate during deflation via internal exhaust valve. Features include irregular heartbeat detection; maximum pressure safety limit (299 mmHg). TM-2441 adds 3-axis accelerometer, ambient temperature, barometric pressure, and waveform recording for professional use. Data displayed on OLED; transmitted via USB or Bluetooth (TM-2441) to connected apps. Healthcare providers use output to monitor patient BP trends and pulse rate; aids in hypertension management and cardiovascular assessment.

Clinical Evidence

Bench testing only. Clinical accuracy validated per ISO 81060-2:2013. Results: Mean error (SYS -0.80 mmHg, DIA -0.94 mmHg) and standard deviation (SYS 5.13 mmHg, DIA 5.86 mmHg) met all pass criteria for blood pressure measurement accuracy.

Technological Characteristics

Noninvasive oscillometric sphygmomanometer. Materials: same as predicate. Sensing: semiconducting pressure sensor. Energy: 2x AA batteries. Connectivity: USB (both), BLE (TM-2441). Display: OLED. Dimensions: 66 x 95 x 24.5 mm. Software: IEC 62304 compliant. Sterilization: not required.

Indications for Use

Indicated for monitoring systolic and diastolic blood pressure and pulse rate in adults 12 years and older using the oscillometric method. TM-2441 includes non-patient-facing environmental monitoring (3-axis accelerometer, ambient temperature, barometric pressure) and waveform capability for use by medical professionals.

Regulatory Classification

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.

Predicate Devices

• A&D Medical TM-2430 & TM-2431 Digital Blood Pressure Monitors (K992808)

Submission Summary (Full Text)

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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<br>Method | Oscillometric Method | No Change | No Change |
| BP<br>Measurement<br>Range | Systolic: 60 – 280mmHg<br>Diastolic: 40 – 160 mmHg<br>Pulse: 30–200 beats<br>per minute | Systolic: 60 – 280mmHg<br>Diastolic: 30 – 160 mmHg<br>Pulse: 30 – 200 beats per<br>minute | Systolic: 60 – 280mmHg<br>Diastolic: 30 – 160 mmHg<br>Pulse: 30 – 200 beats<br>per minute |
| Pressure<br>Measurement<br>Range | 0 – 299 mmHg | No Change | No Change |
| Measurement<br>Accuracy | BP: +/- 3mmHg<br>Pulse: +/- 5%(pulse) | No Change | No Change |
| Minimum<br>Display<br>Resolution | 1 mmHg | No Change | No Change |
| Pressure<br>sensor | Semiconducting type<br>sensor | No Change | No Change |
| Pressurizatio<br>n Source | Automatic micro pump | No Change | No Change |
| Cuff<br>Deflation<br>Method | Rapid exhaust valve | No Change | No Change |
| Cuff<br>Attachment<br>Method | By plastic hose<br>connected to monitor | No Change | No Change |
| Power Source | 3xAlkaline battery or<br>3xNickel-hydrogen<br>battery | 2xAlkaline battery or<br>2xNickel-hydrogen<br>battery | 2xAlkaline battery or<br>2xNickel-hydrogen<br>battery |
| Battery Life | At least 200<br>measurements for a set<br>of alkaline battery | No Change | No Change |
| Type of<br>protecting<br>against<br>electric shock | Internally powered<br>equipment type BF | No Change | No Change |
| Self / Event<br>Measurement<br>Mode | Enabled | Disabled | Enabled |
| Operating<br>Environment | 50°F(10°C) to<br>104°F(40°C)<br>at less than 85%RH | No Change | No Change |
| Storage<br>Environment | -4°F(-20°C) to<br>140°F(60°C)<br>at less than 85%RH | No Change | No Change |
| Data<br>Memory Size | Last 300 measurements<br>of systolic, diastolic,<br>and pulse rate | Last 600 measurements<br>of systolic, diastolic, and<br>pulse rate | Last 600 measurements<br>of systolic, diastolic, and<br>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<br>Adult Size: 20-31cm<br>Large Size: 28-36 cm | Small Size: 15-22 cm<br>Adult Size: 20-31cm<br>Large Size: 28-36 cm<br>Extra Large Size: 36-50<br>cm | Small Size: 15-22 cm<br>Adult Size: 20-31cm<br>Large Size: 28-36 cm<br>Extra Large Size: 36-50<br>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<br>and Size | LCD:29.5 x 8(mm) | OLED:20 x 8.5(mm) | OLED:20 x 8.5(mm)<br>LCD:39 x 45(mm) |
|-----------------------------------|--------------------------|-------------------|-------------------------------------------------------------------------------------------|
| Waveform<br>Recording | Disabled | Enabled | Enabled |
| Non-medical<br>Data<br>Collection | Disabled | Disabled | Enabled (activity,<br>ambient temperature,<br>biometric pressure,<br>waveform capability) |
| Connectivity<br>Interface | USB | USB | USB & BLE |
| Field service | Not allowed | No Change | No Change |
| Automatic<br>Zero at<br>"START" | Yes | No Change | No Change |
| Manual Zero<br>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:<br>Mean value &<br>Standard deviation | ± 5mmHg or less<br>8mmHg or less | Mean value: SYS = -0.80 mmHg<br>DIA = -0.94 mmHg<br>Std deviation: SYS = 6.46 mmHg<br>DIA = 6.45 mmHg | Passed |
| Criterion 2:<br>Standard deviation | SYS=6.89,<br>DIA=6.88 or less | Std deviation: SYS = 5.13 mmHg<br>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.