(181 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: Accurate Mini Non-invasive blood pressure monitor (AMB-001)
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ISO 81060-2:2018) | Reported Device Performance (Achieved) | Pass/Fail |
|---|---|---|---|
| Blood Pressure | SBP | DBP | |
| Mean Bias (mmHg) | < 5 (± SD < 8) | -0.24 | 0.35 |
| Standard Deviation (mmHg) | < 8 (per ISO 81060-2:2018 Criterion 2) | 4.85 | 4.75 |
| Standard Deviation (SD) (mmHg) | $\le$ 6.95 / 6.95 (per ISO 81060-2:2018 Criterion 2) | 2.33 | 2.16 |
| Pulse Rate | Pulse Rate | ||
| Mean Absolute Percentage Error (MAPE) | < 5% | 1.164% | Pass |
Note on ISO 81060-2:2018 Interpretation
The provided text presents the ISO 81060-2:2018 criteria in a somewhat consolidated manner.
- Mean Error: For blood pressure, ISO 81060-2:2018 requires a mean error of $\le \pm 5$ mmHg. The reported values (-0.24 and 0.35) are well within this.
- Standard Deviation:
- Criterion 1 (mean difference $\pm$ standard deviation): This criterion requires the mean difference between the device and reference method, plus/minus its standard deviation, to be $\le 5 \pm 8$ mmHg. The text directly reports "SD (mmHg) < 8" and "4.85, 4.75", implying that the calculated SD meets this.
- Criterion 2 (standard deviation of differences): This criterion requires the standard deviation of the differences between the device and reference measurements to be $\le 6.95$ mmHg. The text explicitly states "SD ($\textit{mmHg}$) $\le$ 6.95/6.95" and reports "2.33, 2.16", which are well within this.
Additional Performance Data for Specific Confounding Factors:
| Characteristic (Confounding Factor) | Reported Device Performance (Mean Bias $\pm$ SD) | Acceptance Criteria (Implicit: ISO 81060-2:2018) | Pass/Fail (Implicit) |
|---|---|---|---|
| General Population | SBP: -0.89 $\pm$ 4.39 mmHg | $\le 5 \pm 8$ mmHg AND SD $\le 6.95$ mmHg | Pass |
| DBP: 1.19 $\pm$ 4.18 mmHg | $\le 5 \pm 8$ mmHg AND SD $\le 6.95$ mmHg | Pass | |
| Fitzpatrick Scale Type 5 & 6 | SBP: -0.57 $\pm$ 4.14 mmHg | $\le 5 \pm 8$ mmHg AND SD $\le 6.95$ mmHg | Pass |
| DBP: -0.05 $\pm$ 3.89 mmHg | $\le 5 \pm 8$ mmHg AND SD $\le 6.95$ mmHg | Pass | |
| Age 51-70 years | SBP: 1.26 $\pm$ 4.56 mmHg | $\le 5 \pm 8$ mmHg AND SD $\le 6.95$ mmHg | Pass |
| DBP: 0.21 $\pm$ 5.83 mmHg | $\le 5 \pm 8$ mmHg AND SD $\le 6.95$ mmHg | Pass | |
| BMI Grade I & II | SBP: -0.77 $\pm$ 5.03 mmHg | $\le 5 \pm 8$ mmHg AND SD $\le 6.95$ mmHg | Pass |
| DBP: -0.13 $\pm$ 4.80 mmHg | $\le 5 \pm 8$ mmHg AND SD $\le 6.95$ mmHg | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Total Subjects for Clinical Validation Study: 367 subjects.
- Subjects for General Accuracy Study: 98 subjects.
- Subjects for Confounding Factors Study: 286 subjects (independently recruited for three groups: Fitzpatrick Scale Type 5 & 6, Age 51-70 years, Body Mass Index Grade I & II).
- Data Provenance: Not explicitly stated regarding country of origin, but the study was conducted according to international standards (ISO 81060-2:2018 and IEEE 1708:2014) and likely in a clinical setting ("hospitals, clinics, long-term care" are mentioned as intended use environments). The study appears to be prospective clinical validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable: This device is a non-invasive blood pressure monitor. The ground truth (reference measurements) are established using a validated reference device ("Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer") operated by trained personnel, not through expert consensus/reading of images.
4. Adjudication Method for the Test Set
- Not Applicable: As this is a blood pressure measurement device validation, not an image interpretation task, a traditional adjudication method for multiple readers is not relevant. The ground truth is established by a reference device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No: An MRMC comparative effectiveness study is not applicable for this type of device (blood pressure monitor). The study design focuses on comparing the device's measurements against a gold standard reference device, not on assessing human reader improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes (for the device's internal algorithm): The study evaluates the "Accurate Mini BPM" itself, which is a device containing an algorithm to measure blood pressure. Its performance is assessed independently against a reference device. The blood pressure monitor is a standalone measurement device; it does not involve a human-in-the-loop for measurement, although a human operates it.
7. The Type of Ground Truth Used
- Reference Device Comparison: The ground truth for blood pressure and pulse rate measurements was established by simultaneous or closely-timed measurements from a "Welch Allyn DuraShock DS66 Trigger Aneroid Sphygmomanometer," which serves as the gold standard reference device according to the relevant ISO standards (ISO 81060-2:2018).
8. The Sample Size for the Training Set
- Not Specified / Not Applicable (for this type of submission): For a traditional 510(k) for a device like a blood pressure monitor, details about the training set for the underlying algorithms (such as the PWTT calculations) are typically considered proprietary and are not usually provided in the public 510(k) summary. The clinical trial data provided is focused on validation (test set performance) against regulatory standards. The device's underlying algorithm is based on established hemodynamic principles (Moens-Korteweg equation) and sensor data, rather than being a deep learning model trained on a large dataset in the way an AI image analysis algorithm would be.
9. How the Ground Truth for the Training Set Was Established
- Not Specified / Not Applicable (for this type of submission): As mentioned above, training set details are not typically disclosed for such devices in a 510(k) summary. The device's operation is based on physiological principles and sensor measurements, not a data-driven "ground truth" for training in the sense of expert-annotated data for machine learning.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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: +886 2 2999 1596 Fax: +886 2 2999 1196 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 DeviceAccurate Mini BPM | Predicate DeviceAccurate 24 BPM | Comparison |
|---|---|---|---|
| K number | Not Yet Assigned | K222658 | N/A |
| Indication for use | The device is a wrist-worndigital monitor intended foruse in measuring bloodpressure and pulse rate inadult patients of ages 20 -70with wrist circumferencefrom 13.5 cm to 21.5 cm andBMI<40.The Accurate Mini Non-invasive BPM is intended forspot-checking of adultpatients in hospitals, clinics,long-term care, and homeuse. The measurement resultsare stored locally in thedevice.The Accurate Mini Non-invasive BPM measuresblood pressure based onPulse Wave Transit Time(PWTT) obtained Local | The device is a wrist-worndigital monitor intended foruse in measuring bloodpressure and pulse rate inadult patient (age 20-70)population with wristcircumference ranging from13.5 cm to 21.5 cm andBMI<40.The Accurate 24 Non-invasive BPM is intended forspot-checking of adultpatients in hospitals, clinics,long-term care, and homeuse and able to obtain results.The measurement resultsstore in the device locally.The Accurate 24 Non-invasive BPM measuresblood pressure based onPulse 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)from dual Piezo Sensors andradial artery parameters fromNear InfraRed Spectroscopy(NIRS) Optic sensor. | (PWTT) obtained LocalPulse Wave Velocity (PWV)from dual Piezo Sensors andradial artery parameters fromNIRS Optic sensors. | ||||||
|---|---|---|---|---|---|---|---|
| Regulatorycompliance | ISO 81060-2 Third edition2018-11 / Amendment 1(2020)IEEE Std 1708-2014 / IEEEStd 1708a-2019 | ISO 81060-2 Third edition2018-11 / Amendment 1(2020)IEEE Std 1708-2014 / IEEEStd 1708a-2019 | Identical | ||||
| Non-ClinicalTests Submitted | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 80601-2-30ISO 10993-5ISO 10993-10ISO 10993-23IEC 62366-1 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 80601-2-30ISO 10993-5ISO 10993-10ISO 10993-23IEC 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 | ||||
| ClassificationName | Non-invasive Blood PressureMeasurement System | Non-invasive Blood PressureMeasurement System | Identical | ||||
| Use Population | Adults (age 20-70) | Adults (age 20-70) | Identical | ||||
| User Environment | Hospitals, clinics, long-termcare, and home use | Hospitals, clinics, long-termcare, and home use | Identical | ||||
| Monitoring | Spot-checking | Spot-checking | Identical | ||||
| 2 Piezo Sensors | Sensors for detecting tissuemovements (Colleting radialartery vibrations data forPWV) | Sensors for detecting tissuemovements (Colleting radialartery vibrations data forPWV) | Identical | ||||
| Optical Sensor 1 | NIRS Sensor for acquiringarterial changes | NIRS Sensor for acquiringarterial changes | Identical | ||||
| PositioningSensor | G Sensor (Position Sensor) | G Sensor (Position Sensor) | Identical | ||||
| Optical Sensor:NIRS Sensor foraligning the radialartery | NIRS Sensor for aligning theradial artery | NIRS Sensor for aligning theradial artery | Different/The Optic sensors aretechnically the samebut have been reducedfrom 2 to 1. Thischange does notchange theperformance as can beseen in the clinicalreports and as suchdoes not raise newissues of safety oreffectiveness. | ||||
| Pressure Sensors:Sensing tightnessof the wrist | Not Applicable | Sensing tightness of the wrist | Different/It was determined thatpressure sensors werenot required. Thischange does notchange the | change theperformance as can be |
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| seen in the clinicalreports and as suchdoes not raise newissues of safety oreffectiveness. | |||
|---|---|---|---|
| Principle ofOperation | Accurate Mini BPMestimates blood pressurebased on the Moens-Korteweg equation.The dual piezo sensorsobtain the pulse wave transittime by positioned in a fixedlength on radial artery forPWV and pulse rate.By utilizing arterial changescaptured by the first NIRSoptic, hemodynamic processis able to conclude the pulsepressure for SBP and DBP. | Accurate 24 BPM estimatesblood pressure based on theMoens-Korteweg equation.The dual piezo sensorsobtain the pulse wave transittime by positioned in a fixedlength on radial artery forPWV and pulse rate.By utilizing arterial changescaptured by the first NIRSoptic, hemodynamic processis able to conclude the pulsepressure for SBP and DBP. | Identical |
| Internal Powersupply | Rechargeable lithium-polymer battery | Rechargeable lithium-polymer battery | Identical |
| Measurement Site | Wrist area and skin | Wrist area and skin | Identical |
| Measurement type | Spot | Spot | Identical |
| MeasurementRange, Pulse rate | 40 to 250 bpm | 40 to 250 bpm | Identical |
| Pulse rate | $\pm$ 3%(Arms) | $\pm$ 5% | Identical |
| MeasurementRange, BP | 0 mmHg – 299 mmHg | 0 mmHg – 299 mmHg | Identical |
| Accuracy bloodPressure | $\pm$ 5 mmHg | $\pm$ 5 mmHg | Identical |
| Contact material | Wrist Skin Cushion: MedicalSiliconeWrist Holder: Nylon &Spandex, PolyurethanePlastic Parts: ABS | Wrist Skin Cushion: MedicalSiliconeWrist Holder: Nylon andFabricPlastic Parts: ABS | This change does notchange theperformance as can beseen in the clinical andbiocompatibilityreports and as suchdoes not raise newissues of safety oreffectiveness. |
| Data Display | TFT LCD on device. | PMOLED on device. | Component changedbut function remainsthe same. |
| Screen | 240(RGB)*240 Pixel | 65K Full Color | Component changedbut function remainsthe same. |
| Data Storage | Yes, Storage in the NANDflash. | Yes, Storage in the NANDflash. | Identical |
| PhysicalDimension | 38mm x 68.8mm x 14.4mm(not including the Wristholder) | 70mm x 60mm x 14mm(not including the Wristholder) | Physical dimensionchanged but does notaffect the performanceas can be seen in theclinical reports and as |
| such does not raise newissues of safety oreffectiveness. | |||
| PCB Dimension | 54mm x 32mm | 70mm x 53mm | Component changedbut function remainsthe 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)SD (mmHg) | નર્ડ | -0.24 | 0.35 |
| <8 | 4.85 | 4.75 | |
| Results | pass | pass | |
| Criterion 2 |
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| SD ( mmHg ) | $\leq$ 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.
§ 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).