(292 days)
The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patient (age 20-70) population with wrist circumference ranging from 13.5 cm to 21.5 cm and BMI<40.
The Accurate 24 Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use and able to obtain results. The measurement results store in the device locally.
The Accurate 24 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.
Accurate 24 Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spot-check of pulse rate. Measurement is performed on the wrist of 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.
The Accurate 24 Non-invasive blood pressure monitor was evaluated according to ISO 81060-2:2018 and IEEE 1708:2014 [Including: Amendment 1(2019)].
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ISO 81060-2:2018) | Achieved SBP (mmHg) | Achieved DBP (mmHg) | Results SBP | Results DBP |
|---|---|---|---|---|---|
| Means (Bias) | ±5 mmHg | 1.67 | 1.01 | Pass | Pass |
| Standard Deviation (Criterion 1) | ≤ 8 mmHg | 4.04 | 5.32 | Pass | Pass |
| Standard Deviation (Criterion 2) | ≤ 6.76/6.87 mmHg | 2.73 | 3.55 | Pass | Pass |
2. Sample size used for the test set and data provenance:
- Total Subjects: 376 subjects were included in the clinical validation study.
- General Accuracy Study: 114 subjects (73 male, 41 female, aged 20-70 years) for the primary endpoint.
- Confounding Factors Study: 286 subjects were independently recruited across three groups:
- Fitzpatrick Scale Type 5 & Type 6
- Ages 51-70 years
- BMI Grade I & II
- Data Provenance: Not explicitly stated, but the study was conducted to meet international standards (ISO 81060-2:2018 and IEEE 1708:2014), suggesting a clinical trial setting. It is likely a prospective study as subjects were "included" and "recruited" for the validation.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
The ground truth was established by comparing the Accurate 24 BPM to a reference device, the "Welch Allyn DuraShock DS66 Trigger Aneroid." This is a commercially available and clinically accepted manual blood pressure device. The study design implies that trained medical professionals or technicians measured blood pressure using this reference device. The number of such "experts" is not specified, but standard clinical practice for such studies would involve multiple trained personnel. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed beyond their ability to accurately use the reference device.
4. Adjudication method:
The document does not explicitly describe an adjudication method for the test set, such as 2+1 or 3+1. The ground truth appears to be based on direct comparison to the Welch Allyn DuraShock DS66 Trigger Aneroid, which serves as the reference measurement. Discrepancies, if any, would likely be handled by repeated measurements or adherence to strict protocol for the reference device, rather than a separate expert adjudication panel.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone accuracy of the device against a reference standard, not its impact on human readers' performance with and without AI assistance.
6. Standalone performance (algorithm only without human-in-the-loop performance):
Yes, a standalone performance study was done. The entire clinical evaluation described focuses on the accuracy of the Accurate 24 BPM device itself, comparing its measurements to those obtained by a reference blood pressure monitor. There is no mention of human-in-the-loop assessment or AI assistance for human readers in this context.
7. Type of ground truth used:
The ground truth used was comparison to a clinically accepted reference device, specifically the "Welch Allyn DuraShock DS66 Trigger Aneroid." This is a form of clinical reference standard comparison for blood pressure measurements.
8. Sample size for the training set:
The document does not specify a separate training set or its sample size. The description of clinical performance data is related to the validation/test set. It is common for such devices to be developed and internally validated using proprietary datasets, but this information is not provided in a regulatory submission summary.
9. How the ground truth for the training set was established:
As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is not provided in this document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure embracing a sphere. The FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font and "ADMINISTRATION" in a smaller font.
August 7, 2023
Accurate Meditech Inc. % Douglas Herrington Official Correspondent Herrington Consulting LLC No 64, Haijing 3rd St Sanzhi District New Taipei City, 252 Taiwan
Re: K222658
Trade/Device Name: Accurate 24 Non-invasive blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN
Dear Douglas Herrington:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 21, 2023. Specifically, FDA is updating this SE Letter to correct the official contact name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Stephen Browning OHT2: Office of Cardiovascular Devices, 240-402-5241, Stephen.Browning@fda.hhs.gov.
Sincerely,
Stephen C. Browning -S
Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 21, 2023
Accurate Meditech Inc. Wang Kuan-Jen General Manager 8F-10, No. 12, Lane 609, Sec. 5, Chongxin Rd., Sanchong Dist., New Taipei City, 241406 Taiwan
Re: K222658
Trade/Device Name: Accurate 24 Non-invasive blood pressure monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: May 15, 2023 Received: May 15, 2023
Dear Wang Kuan-Jen:
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/ofdocs/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.
{2}------------------------------------------------
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 devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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-regulatoryassistance/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.
Robert T. Kazmierski -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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K222658
Device Name
Accurate 24 Non-invasive blood pressure monitor
Indications for Use (Describe)
The device is a wrist-worn digital monitor intended for use in measuring blood pressure and pulse rate in adult patient (age 20-70) population with wrist circumference ranging from 13.5 cm to 21.5 cm and BMI<40.
The Accurate 24 Non-invasive BPM is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use and able to obtain results. The measurement results store in the device locally.
The Accurate 24 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
5. 510(k) Summary
This summary of 510(k) information is submitted as required by requirements of SMDA and 21 CFR Part 807.92
5.1 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: 2023/6/17
5.2 Subject Device Information
| Trade/Device Name | Accurate 24 Non-invasive blood pressure monitor |
|---|---|
| Model | Accurate 24 BPM |
| 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 |
5.3 Predicate Device Information
| Predicate Device | Sponsor: Biobeat Technologies Ltd |
|---|---|
| Device: BB-613 WP | |
| 510(K) Number: K190792 |
5.4 Device Description:
Accurate 24 Non-Invasive blood pressure monitor device is a small, lightweight, handheld device intended to measure and display blood pressure trending (Systolic and Diastolic) and spot-check of pulse rate. Measurement is performed on the wrist of 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.
{5}------------------------------------------------
5.5 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 24 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 store in the device locally.
The Accurate 24 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.
5.6 Comparison to the Predicate Device
The intended use of Accurate 24 BPM has the same intended use as predicate device BB-613 WP(K190792). The technological characteristics of Accurate 24 BPM are substantially similar to the technological characteristics of the predicate device BB-613 WP(K190792). The subject device and predicate device are considered NIBP monitors; both the subject device and predicate device are based on obtaining pulse wave transit time for blood pressure and pulse rate calculation. At a high level, the subject and predicate devices are based on the following same technological elements:
| Functionality | New DeviceAccurate 24 BPM | Predicate DeviceBB-613WP |
|---|---|---|
| Indications for use | The device is a wrist-worn digitalmonitor intended for use inmeasuring blood pressure and pulserate in adult patient (age 20-70)population with wrist circumferenceranging from 13.5 cm to 21.5 cm andBMI<40. | The BB-613 WP is a wrist-worn orskin attached device indicated for usein measuring and displayingfunctional oxygen saturation ofarterial hemoglobin (%SpO2) andpulse rate. |
| The Accurate 24 Non-invasive BPMis intended for spot-checking of adultpatients in hospitals, clinics, long-term care, and home use and able toobtain results. The measurementresults store in the device locally. | The BB-613WP can also trackchanges in blood pressure based onPulse Wave Transit Time (PWTT)which is obtained utilizing pulsemeasurements from the integratedSpO2 sensor, following a calibrationprocess using oscillometricblood pressure monitor. | |
| The Accurate 24 Non-invasive BPMmeasures blood pressure based onPulse Wave Transit Time (PWTT)obtained Local Pulse Wave Velocity(PWV) from dual Piezo Sensors andradial artery parameters from NIRSOptic sensors. | The BB-613WP is intended for spot-checking of adult patients in hospitals,clinics, long-term care, and home use. | |
| Product Codes | DXN | DXN, DQA, DRG |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 |
| Classification | Class II | Class II |
| Classification Name | Noninvasive Blood Pressure | Noninvasive Blood Pressure |
{6}------------------------------------------------
| Measurement System | Measurement System | |
|---|---|---|
| Use Population | Adults (age 20-70) | Adults |
| User Environment | Hospitals, clinics, long-term care, and home use | Hospitals, clinics, long-term care, and home use |
| Monitoring | Spot-checking | Spot-checking |
| Principle of Operation | Accurate 24 BPM estimates blood pressure based on the Moens-Korteweg equation.The dual piezo sensors obtain the pulse wave transit time by positioned in a fixed length on radial artery for PWV and pulse rate.By utilizing arterial changes captured by the first NIRS optic, hemodynamic process is able to conclude the pulse pressure for SBP and DBP. | Pulse reflectance technology, Four LED (red + IR) and photo diode absorbs reflected light. Tracking changes of blood pressure is done by pulse wave transit time which is obtained utilizing pulse measurements from the integrated skin attached SpO2 sensor |
| Internal Power supply | Rechargeable lithium-polymer battery | Rechargeable lithium-polymer battery |
| Measurement Site | Wrist area and skin | Wrist area and skin |
| Measurement type | Spot | Spot |
| Measurement Range, Pulse rate | 40 to 250 bpm | 40 to 250 bpm |
| Pulse rate | ±5% | ±3%(Arms) |
| Measurement Range, BP | 0 mmHg - 299 mmHg | 0 mmHg - 299 mmHg |
| Accuracy blood Pressure | ±5 mmHg | ±5 mmHg |
| Contact material | Wrist Skin Cushion: Medical SiliconeWrist Holder: Nylon and FabricPlastic Parts: ABS | Polycarbonate, photodiode window, silicone, adhesive patch |
| Data Display | PMOLED on device. | LCD on device or handheld display unit (e.g., mobile phone) |
| Screen | 65K Full Color | Black and White |
| Data Storage | Yes, Storage in the NAND flash. | No, but can transmit the data to handheld device |
5.7 Performance Data
Performance Data - Bench Tests
The performance evaluation of the proposed Accurate 24 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 Software Contained in Medical Devices." The software for this device was considered a "major" concern since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
- Electrical safety and EMC testing were conducted on the Accurate 24 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.
{7}------------------------------------------------
- Cytotoxicity, sensitization, irritation, and systemic toxicity of Accurate24 BPM passed ISO 10993 standard.
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, 376 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. All analysis met the accuracy requirements outlined in ISO 81060-2:2018. The obtained clinical results are as follows.
| Characteristic | Actual subjects | ||
|---|---|---|---|
| Subject, n | 376 | ||
| overall results for all study subjects | |||
| Pass requirements | Achieved | ||
| SBP | DBP | ||
| Means (mmHg) | $\u00b1 5$ | 1.67 | 1.01 |
| SD (mmHg) | $\u2264 8$ | 4.04 | 5.32 |
| Results | pass | Pass | |
| Criterion 2 | |||
| SD (mmHg) | $\u2264 6.76/6.87$ | 2.73 | 3.55 |
| Results | pass | pass |
General study participants (The subject requirements for ISO 81060-2:2018) of accuracy study:
This was a study of 114 subjects. Participants' age ranged from 20 - 70 and 73 were male and 41 were female. The study was conducted in accordance with ISO 81060-2:2018 standard. The Accurate 24 BPM accuracy was compared to "Welch Allyn DuraShock DS66 Trigger Aneroid".
Primary endpoint
The results of the Subject Device compared to the Welch Allyn DuraShock DS66 Trigger Aneroid measurement in the accuracy validation data set were as follows: (1) mean bias of systolic BP: 2.00±2.97 and (2) mean diastolic bias: 1.33 ±4.17 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.
{8}------------------------------------------------
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 24 BPM accuracy was compared to Welch Allyn DuraShock DS66 Trigger Aneroid.
Primary endpoint
- . The results of the Subject Device compared to the Welch Allyn DuraShock DS66 Trigger Aneroid in the Fitzpatrick Scale (Type 5 & Type 6) population validation data set were as follows: (1) mean bias for systolic BP: 1.81 ± 4.44 mmHg (2) mean bias of diastolic BP: -0.90 ± 5.13 mmHg (3) PR accuracy: 0.175 beats/min.
- . The results of the Subject Device compared to the Welch Allyn DuraShock DS66 Trigger Aneroid in the Age (51-70 years) population validation data set were as follows: (1) mean bias for systolic BP: 1.53 ± 4.04 mmHg and (2) mean bias of diastolic BP: 2.13 ± 6.50 mmHg.
- . The results of the Subject Device compared to the Welch Allyn DuraShock DS66 Trigger Aneroid in the BMI (Grade I & II) population validation data set were as follows: (1) mean bias for systolic BP: 1.11 ± 4.55 mmHg and (2) mean bias of diastolic BP: 1.36 ± 4.87 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.
5.9 Conclusion
The Accurate 24 BPM is as safe and effective as the predicate devices. The Accurate 24 BPM has the same intended uses and similar indications, technological characteristics, and principles of operation. In addition, the minor technical differences between the Accurate 24 BPM and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Accurate 24 BPM is as safe and as effective as the predicate. Thus, the Accurate 24 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).