Accurate Mini Non-invasive blood pressure monitor (AMB-001)

K242352 · Accurate Meditech, Inc. · DXN · Feb 5, 2025 · Cardiovascular

Device Facts

• Record ID: K242352
• Device Name: Accurate Mini Non-invasive blood pressure monitor (AMB-001)
• Applicant: Accurate Meditech, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Feb 5, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients of ages 20 -70 with wrist circumference from 13.5 cm to 21.5 cm and BMI<40. The Accurate Mini Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics. long-term care, and home use. The measurement results are stored locally in the device. The Accurate Mini Non-invasive BPM measures blood pressure based on Pulse Wave Transit Time (PWTT) obtained Local Pulse Wave Velocity (PWV) from dual Piezo Sensors and radial artery parameters from Near InfraRed Spectroscopy (NIRS) Optic sensor.

Device Story

Wrist-worn digital monitor; measures blood pressure and pulse rate via radial artery. Inputs: tissue movement data from dual piezo sensors; arterial parameter data from NIRS optic sensor. Operation: calculates pulse wave transit time (PWTT) and pulse wave velocity (PWV) using Moens-Korteweg equation; hemodynamic processing derives systolic/diastolic pressure. Output: blood pressure and pulse rate displayed on TFT LCD; stored in local NAND flash. Used by patients or clinicians in clinical/home settings for spot-checks. Benefits: non-invasive, portable blood pressure monitoring.

Clinical Evidence

Clinical validation study (n=367) per ISO 81060-2:2018 and IEEE 1708:2014. Included confounding factor groups: Fitzpatrick Scale Types 5-6, ages 51-70, and BMI Grade I & II. Compared against Welch Allyn DuraShock DS66. Results: Mean bias for SBP -0.89 ± 4.39 mmHg and DBP 1.19 ± 4.18 mmHg (general population). Subgroup biases were within acceptance criteria. MAPE for pulse rate was 1.164%.

Technological Characteristics

Wrist-worn monitor; dual piezo sensors for tissue movement; NIRS optic sensor for arterial parameters; G-sensor for positioning. Materials: medical silicone (skin cushion), nylon/spandex/polyurethane (holder), ABS (plastic parts). Power: rechargeable lithium-polymer battery. Connectivity: local NAND flash storage. Standards: ISO 81060-2, IEEE 1708, IEC 60601-1, IEC 60601-1-2, ISO 10993.

Indications for Use

Indicated for adult patients (ages 20-70) with wrist circumference 13.5-21.5 cm and BMI <40 for spot-check blood pressure and pulse rate monitoring in hospitals, clinics, long-term care, and home settings.

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

• Accurate 24 BPM (K222658)

Reference Devices

• Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer

Submission Summary (Full Text)

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February 5, 2025

Accurate Meditech Inc. % Douglas Herrington Consultant Herrington Consulting LLC No 64, Haijing 3rd St. Sanzhi District New Taipei City, 252002 Taiwan

Re: K242352

Trade/Device Name: Accurate Mini Non-invasive blood pressure monitor (AMB-001) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 1, 2024 Received: August 8, 2024

Dear Douglas Herrington:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Aneesh S. Deoras -S

for

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

Submission Number (if known)

K242352

Device Name

Accurate Mini Non-invasive blood pressure monitor (AMB-001)

Indications for Use (Describe)

The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients of ages 20 -70 with wrist circumference from 13.5 cm to 21.5 cm and BMI<40.

The Accurate Mini Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics. long-term care, and home use. The measurement results are stored locally in the device.

The Accurate Mini Non-invasive BPM measures blood pressure based on Pulse Wave Transit Time (PWTT) obtained Local Pulse Wave Velocity (PWV) from dual Piezo Sensors and radial artery parameters from Near InfraRed Spectroscopy (NIRS) Optic sensor.

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)

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# 510(k) Summary

This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR Part 807.92

# Submitter

Accurate Meditech Inc. 8F .- 10, No. 12, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist., New Taipei City 241406, Taiwan

Phone: [phone] Fax: [phone] Contact Person: Kuan-Jen, Wang

Date Prepared: 2024/5/23

# Subject Device Information

| Trade/Device Name | Accurate Mini Non-invasive blood pressure monitor (AMB-001) |
|-------------------|-------------------------------------------------------------|
| Model | AMB-001 |
| Common Name | Non-invasive blood pressure monitor |
| Regulatory | Class II |
| Classification | 870.1130 Noninvasive blood pressure measurement system |
| Submission type | Traditional 510(k) |
| Product Code | DXN |

# Predicate Device Information

| Predicate Device | Sponsor: Accurate Meditech Inc. |
|------------------|---------------------------------|
| | Device: Accurate 24 BPM |
| | 510(K) Number: K222658 |

# Device Description:

Accurate Mini Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spotcheck of pulse rate. Measurement is performed on the wrist at the radial artery. This blood pressure monitor uses the pulse wave transit time with the hemodynamic method to measure the systolic and diastolic blood pressure and pulse rate. This device serves to measure the systolic and diastolic blood pressure and pulse rate of adults in a non-invasive manner.

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# Indications for Use:

The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patients (age 20-70) population with wrist circumference ranging from 13.5 cm to 21.5 cm and BMI<40.

The Accurate Mini Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use and is able to obtain results. The measurement results are stored in the device locally.

The Accurate Mini Non-invasive BPM measures blood pressure based on Pulse Wave Transit Time (PWTT) obtained Local Pulse Wave Velocity (PWV) from dual Piezo Sensors and radial artery parameters from NIRS Optic sensors.

# Comparison to the Predicate Device

The intended use of Accurate Mini BPM has the same intended use as predicate device Accurate 24 BPM(K222658). The technological characteristics of Accurate Mini BPM are substantially the same as the technological characteristics of the predicate device Accurate 24 BPM(K222658). The subject device and predicate device are considered Non Invasive Blood Pressure Monitors (NIBP) monitors; both the subject device and predicate device are based on obtaining pulse wave transit time for blood pressure and pulse rate calculation.

| Device | New Device<br>Accurate Mini BPM | Predicate Device<br>Accurate 24 BPM | Comparison |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| K number | Not Yet Assigned | K222658 | N/A |
| Indication for use | The device is a wrist-worn<br>digital monitor intended for<br>use in measuring blood<br>pressure and pulse rate in<br>adult patients of ages 20 -70<br>with wrist circumference<br>from 13.5 cm to 21.5 cm and<br>BMI<40.<br><br>The Accurate Mini Non-<br>invasive BPM is intended for<br>spot-checking of adult<br>patients in hospitals, clinics,<br>long-term care, and home<br>use. The measurement results<br>are stored locally in the<br>device.<br><br>The Accurate Mini Non-<br>invasive BPM measures<br>blood pressure based on<br>Pulse Wave Transit Time<br>(PWTT) obtained Local | The device is a wrist-worn<br>digital monitor intended for<br>use in measuring blood<br>pressure and pulse rate in<br>adult patient (age 20-70)<br>population with wrist<br>circumference ranging from<br>13.5 cm to 21.5 cm and<br>BMI<40.<br><br>The Accurate 24 Non-<br>invasive BPM is intended for<br>spot-checking of adult<br>patients in hospitals, clinics,<br>long-term care, and home<br>use and able to obtain results.<br>The measurement results<br>store in the device locally.<br><br>The Accurate 24 Non-<br>invasive BPM measures<br>blood pressure based on<br>Pulse Wave Transit Time | Identical |

At a high level, The subject and predicate devices are based on the following technological elements:

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| | Pulse Wave Velocity (PWV)<br>from dual Piezo Sensors and<br>radial artery parameters from<br>Near InfraRed Spectroscopy<br>(NIRS) Optic sensor. | (PWTT) obtained Local<br>Pulse Wave Velocity (PWV)<br>from dual Piezo Sensors and<br>radial artery parameters from<br>NIRS Optic sensors. | | | | | |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--|----------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Regulatory<br>compliance | ISO 81060-2 Third edition<br>2018-11 / Amendment 1<br>(2020)<br>IEEE Std 1708-2014 / IEEE<br>Std 1708a-2019 | ISO 81060-2 Third edition<br>2018-11 / Amendment 1<br>(2020)<br>IEEE Std 1708-2014 / IEEE<br>Std 1708a-2019 | Identical | | | | |
| Non-Clinical<br>Tests Submitted | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 80601-2-30<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23<br>IEC 62366-1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 80601-2-30<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-23<br>IEC 62366-1 | Identical | | | | |
| Product Codes | DXN | DXN | Identical | | | | |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Identical | | | | |
| Classification | Class II | Class II | Identical | | | | |
| Classification<br>Name | Non-invasive Blood Pressure<br>Measurement System | Non-invasive Blood Pressure<br>Measurement System | Identical | | | | |
| Use Population | Adults (age 20-70) | Adults (age 20-70) | Identical | | | | |
| User Environment | Hospitals, clinics, long-term<br>care, and home use | Hospitals, clinics, long-term<br>care, and home use | Identical | | | | |
| Monitoring | Spot-checking | Spot-checking | Identical | | | | |
| 2 Piezo Sensors | Sensors for detecting tissue<br>movements (Colleting radial<br>artery vibrations data for<br>PWV) | Sensors for detecting tissue<br>movements (Colleting radial<br>artery vibrations data for<br>PWV) | Identical | | | | |
| Optical Sensor 1 | NIRS Sensor for acquiring<br>arterial changes | NIRS Sensor for acquiring<br>arterial changes | Identical | | | | |
| Positioning<br>Sensor | G Sensor (Position Sensor) | G Sensor (Position Sensor) | Identical | | | | |
| Optical Sensor:<br>NIRS Sensor for<br>aligning the radial<br>artery | NIRS Sensor for aligning the<br>radial artery | NIRS Sensor for aligning the<br>radial artery | Different/<br>The Optic sensors are<br>technically the same<br>but have been reduced<br>from 2 to 1. This<br>change does not<br>change the<br>performance as can be<br>seen in the clinical<br>reports and as such<br>does not raise new<br>issues of safety or<br>effectiveness. | | | | |
| Pressure Sensors:<br>Sensing tightness<br>of the wrist | | Not Applicable | | Sensing tightness of the wrist | | Different/<br>It was determined that<br>pressure sensors were<br>not required. This<br>change does not<br>change the | change the<br>performance as can be |

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| | | | seen in the clinical<br>reports and as such<br>does not raise new<br>issues of safety or<br>effectiveness. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Principle of<br>Operation | Accurate Mini BPM<br>estimates blood pressure<br>based on the Moens-<br>Korteweg equation.<br><br>The dual piezo sensors<br>obtain the pulse wave transit<br>time by positioned in a fixed<br>length on radial artery for<br>PWV and pulse rate.<br><br>By utilizing arterial changes<br>captured by the first NIRS<br>optic, hemodynamic process<br>is able to conclude the pulse<br>pressure for SBP and DBP. | Accurate 24 BPM estimates<br>blood pressure based on the<br>Moens-Korteweg equation.<br><br>The dual piezo sensors<br>obtain the pulse wave transit<br>time by positioned in a fixed<br>length on radial artery for<br>PWV and pulse rate.<br><br>By utilizing arterial changes<br>captured by the first NIRS<br>optic, hemodynamic process<br>is able to conclude the pulse<br>pressure for SBP and DBP. | Identical |
| Internal Power<br>supply | Rechargeable lithium-<br>polymer battery | Rechargeable lithium-<br>polymer battery | Identical |
| Measurement Site | Wrist area and skin | Wrist area and skin | Identical |
| Measurement type | Spot | Spot | Identical |
| Measurement<br>Range, Pulse rate | 40 to 250 bpm | 40 to 250 bpm | Identical |
| Pulse rate | $\pm$ 3%(Arms) | $\pm$ 5% | Identical |
| Measurement<br>Range, BP | 0 mmHg – 299 mmHg | 0 mmHg – 299 mmHg | Identical |
| Accuracy blood<br>Pressure | $\pm$ 5 mmHg | $\pm$ 5 mmHg | Identical |
| Contact material | Wrist Skin Cushion: Medical<br>Silicone<br>Wrist Holder: Nylon &<br>Spandex, Polyurethane<br>Plastic Parts: ABS | Wrist Skin Cushion: Medical<br>Silicone<br>Wrist Holder: Nylon and<br>Fabric<br>Plastic Parts: ABS | This change does not<br>change the<br>performance as can be<br>seen in the clinical and<br>biocompatibility<br>reports and as such<br>does not raise new<br>issues of safety or<br>effectiveness. |
| Data Display | TFT LCD on device. | PMOLED on device. | Component changed<br>but function remains<br>the same. |
| Screen | 240(RGB)*240 Pixel | 65K Full Color | Component changed<br>but function remains<br>the same. |
| Data Storage | Yes, Storage in the NAND<br>flash. | Yes, Storage in the NAND<br>flash. | Identical |
| Physical<br>Dimension | 38mm x 68.8mm x 14.4mm<br>(not including the Wrist<br>holder) | 70mm x 60mm x 14mm<br>(not including the Wrist<br>holder) | Physical dimension<br>changed but does not<br>affect the performance<br>as can be seen in the<br>clinical reports and as |
| | | | such does not raise new<br>issues of safety or<br>effectiveness. |
| PCB Dimension | 54mm x 32mm | 70mm x 53mm | Component changed<br>but function remains<br>the same. |

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#### Performance Data

#### Performance Data - Bench Tests

The performance evaluation of the proposed Accurate Mini BPM included testing conducted following the FDA Guidance Documents and international standards:

- Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions." The software for this device falls under Basic Documentation, as its failure or latent flaw is unlikely to result in serious injury or death to the patient or operator.
- . Electrical safety and EMC testing were conducted on the Accurate Mini BPM device. The system complies with the IEC 60601-1 · IEC 60601-1-11 and IEC80601-2-30 standards for safety and the IEC 60601-1-2 standard for EMC.
- . Cytotoxicity, sensitization, irritation, and systemic toxicity of Accurate Mini BPM passed ISO 10993 requirements.

#### Performance Data - Clinical Tests

Our clinical study is evaluated according to ISO 81060-2:2018 and IEEE 1708:2014 [Including: Amendment 1(2019). In total, 367 subjects were included in the clinical validation study. The subjects were included according to the subject selection criteria outlined in ISO 81060-2:2018 and IEEE 1708-2014 [Including: Amendment 1(2019)]. At least 85 subjects were included for the following confounding factors: (1) Fitzpatrick Scale Type 5 and 6, (2) Subjects Ages 51-70 years, (3) Body Mass Index Grade I & II. All confounding factor groups were assessed independently.

The analysis results meet the accuracy requirements outlined in ISO 81060-2:2018. The obtained clinical results are as follows.

| Characteristic | Actual subjects | | |
|----------------------------------------|-------------------|----------|------|
| Subject, n | | | 367 |
| Overall results for all study subjects | | | |
| | Pass Requirements | Achieved | |
| | | SBP | DBP |
| Means (mmHg)<br>SD (mmHg) | નર્ડ | -0.24 | 0.35 |
| | <8 | 4.85 | 4.75 |
| Results | | pass | pass |
| Criterion 2 | | | |

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| SD ( <i>mmHg</i> ) | $\leq$ 6.95/6.95 | 2.33 | 2.16 |
|--------------------|------------------|------|------|
| Results | | pass | pass |

The Mean Absolute Percentage Error (MAPE) calculated that there is a 1.164% difference between Accurate Mini BPM and the reference device, which is less than 5% and meets the accuracy of the specification.

| Characteristic | | Actual subjects |
|----------------------------------------|-------------------|-----------------|
| Subject, n | | 40 |
| Overall results for all study subjects | | |
| | | Achieved |
| | Pass Requirements | Pulse Rate |
| MAPE | <5% | 1.164% |
| Results | | PASS |

# General study participants (The subject requirements for ISO 81060-2:2018) of accuracy study:

This was a study of 98 subjects. Participants' age ranged from 20 - 70 and 63 were male and 35 were female. The study was conducted in accordance with ISO 81060-2:2018 standard. The Accurate Mini BPM accuracy was compared to "Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer ".

# Primary endpoint

The results of the Subject Device compared to the Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer measurement in the accuracy validation data set were as follows: (1) mean bias of systolic BP: -0.89 ± 4.39 and (2) mean bias of diastolic BP: 1.19 ± 4.18 mmHg.

Those results are within the acceptance criteria for the accuracy of blood pressure monitors. The study demonstrated that the Subject Device is accurate, and the study population and results comply with the ISO standard requirements.

# Confounding factors of the study participants accuracy study:

This were three groups (Group-01: Fitzpatrick Skin Type 5 & Type 6). Group-02:Age 51-70 years and Group-03:BMI Grade I & II ) are independently recruited participants study of 286 subjects. The Accurate Mini BPM accuracy was compared to Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer.

# Primary endpoint

- . The results of the Subject Device compared to the Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer in the Fitzpatrick Scale (Type 5 & Type 6) population validation data set were as follows: (1) mean bias for systolic BP: -0.57 ± 4.14 mmHg (2) mean bias of diastolic BP: -0.05 ± 3.89 mmHg

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- The results of the Subject Device compared to the Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer in the Age (51-70 years) population validation data set were as follows: (1) mean bias for systolic BP: 1.26 ± 4.56 mmHg and (2) mean bias of diastolic BP: 0.21 ± 5.83 mmHg.
- · The results of the Subject Device compared to the Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer in the BMI (Grade I & II) population validation data set were as follows: (1) mean bias for systolic BP: -0.77 ± 5.03 mmHg and (2) mean bias of diastolic BP: -0.13 ± 4.80 mmHg.

These results are within the acceptance criteria for the accuracy of blood pressure monitors. The study demonstrated that the Subject Device is accurate, and the study population and results comply with the ISO standard requirements.

# Conclusion

The Accurate Mini BPM is as safe and effective as the predicate device. The Accurate Mini BPM has the same intended uses and indications, technological characteristics, and principles of operation. In addition, the minor technical differences between the Accurate Mini BPM and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Accurate Mini BPM is as safe and effective as the predicate. Thus, the Accurate Mini BPM is substantially equivalent.