(57 days)
Arm Blood Pressure Monitor is intended to measure the blood pressure and pulse rate of person older than twelve (12) years in household or medical facilities.
Arm Blood Pressure Monitor, model: BPM-A7VL is a Noninvasive Blood Pressure Measurement System that is intended for measuring blood pressure through oscillation mensuration. The subject device will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; The record maybe revisited. lt measures blood pressure and pulse rate through inflating cuff which rounding the upper arm of patients. The BPM-A7VL is small, portable and used in home or medical facilities environment. The Arm Blood Pressure Monitor consists of two parts: main unit and cuffs. The BPM-A7VL is composed of PCBA, crystal oscillator, pump, valve, enclose, and LCD. Cuffs including cuff of size 23cm33cm and cuff of size 33cm47cm.
The provided text describes a 510(k) submission for an Arm Blood Pressure Monitor (model: BPM-A7VL). This is a non-invasive blood pressure measurement system. The acceptance criteria and the study proving the device meets these criteria are primarily focused on its clinical accuracy, electrical safety, electromagnetic compatibility (EMC), biocompatibility, and software performance.
Here's a breakdown based on the provided information:
Acceptance Criteria and Reported Device Performance
The core performance acceptance criteria for blood pressure monitors are typically defined by recognized standards such as ISO 81060-2 and IEC 80601-2-30. The text explicitly states that the device's performance complies with these standards.
Table of Acceptance Criteria and Reported Device Performance:
| Criteria Category | Standard/Parameter | Acceptance Criteria (from standard) | Reported Device Performance/Compliance |
|---|---|---|---|
| Clinical Accuracy | ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01 (Clinical Investigation) | Clinical Accuracy Requirements: (The document does not explicitly state the numerical acceptance criteria of ISO 81060-2, but it implies adherence to its statistical requirements for device vs. reference measurements.) Generally, for a device to be compliant, the mean difference between the device and reference measurements should be within ±5 mmHg with a standard deviation of 8 mmHg or less, for both systolic and diastolic pressure, when compared to the reference standard across a range of subjects. More stringent criteria often apply, such as the AAMI criteria which demands at least 85 subjects, specific distributions of age, arm circumference, and blood pressure ranges to ensure robust validation. | "The test data showed the clinical accuracy of the subject device complied with the requirements of ISO 81060-2 Third edition 2018-11 Amendment 1 2020-01." |
| Blood Pressure Measurement Accuracy | Inherent Specification (often derived from standards) | ±3 mmHg | ±3 mmHg (Stated as "Same" as predicate device) |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, FDA Guidance | Negative for Cytotoxicity, Sensitization, and Irritation for patient-contacting components. | "The Material of Patient contact components of subject device has been validated for Cytotoxicity though testing against ISO 10993- 5, for Sensitization though testing against ISO 10993-10 and ISO 10993-23 tested and all test results are positive, the difference of subject device with predicate device A02-SE4 (K241129) do not raise new questions of safety and effectiveness." (Note: "all test results are positive" here means positive for the test procedure results indicating that the material passed the biocompatibility requirements, not that it tested positive for toxicity/sensitization/irritation). |
| Electrical Safety | ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], IEC 60601-1-11:2015/2020 (Home Healthcare Environment) | Device must meet general requirements for basic safety and essential performance, especially for devices used in home healthcare. | "The system complies with the AAMI ANSI ES60601-1, IEC 60601-1-11 for electrical safety..." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: 2014+AMD1:2020 | Device must perform as intended in its electromagnetic environment without introducing unacceptable electromagnetic disturbances to other devices or being unduly affected by such disturbances. | "...the IEC 60601-1-2 standard for EMC..." (system complies). |
| Software Performance | IEC 62304 Edition 1.1 2015-06, FDA Guidance for software in medical devices (May 2005) | Software must be verified and validated to ensure it performs as intended and does not pose unacceptable risks (especially given its "moderate" level of concern). | "Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005. The software for this device was considered as a "moderate" level of concern... The system complies with IEC 62304 Edition 1.1 2015-06 for software verification." |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: 85 subjects were used for the clinical accuracy test.
- Data Provenance: The document does not explicitly state the country of origin. It indicates a "clinical accuracy test report and data analysis followed the requirements of the ISO 81060-2," implying a formal clinical study. The submission is from Shenzhen IMDK Medical Technology Co., Ltd. (China), so it's highly probable the study was conducted retrospectively or prospectively in China, but this is not definitively stated. The study type is prospective clinical accuracy testing, as it involves a concurrent comparison with a reference standard.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The clinical accuracy testing for blood pressure monitors, as per ISO 81060-2, typically involves a comparison against a reference method (usually auscultatory measurements using a mercury or aneroid sphygmomanometer by trained observers). The document mentions "Aneroid sphygmomanometer" and "Measuring Method: Aneroid/auscultation method" as the reference equipment.
- ISO 81060-2 requires at least two trained observers (experts) to simultaneously and independently measure blood pressure using the reference method, usually blinded to each other's readings and the device's readings. The document does not explicitly state the number or qualifications of these observers, but their involvement is a fundamental requirement for ISO 81060-2 compliance. They would be healthcare professionals (e.g., physicians, nurses, technicians) specially trained and certified for accurate auscultatory blood pressure measurement.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- For ISO 81060-2, the standard adjudication method typically involves the simultaneous independent measurements by two trained observers. If their readings differ by a certain threshold (e.g., > 4 mmHg), a third observer or a consensus reading might be involved for specific cases, or those readings might be discarded. The document does not detail the exact adjudication criteria but implies adherence to the ISO standard.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This document is for a non-invasive blood pressure monitor, which is a physical measurement device, not an AI-assisted diagnostic imaging tool where MRMC studies are typically performed. The "AI" component mentioned refers to the automated measurement algorithm within the device, not a separate AI for interpretation assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone performance was evaluated. The clinical accuracy study evaluates the device's (algorithm's) ability to accurately measure blood pressure independently of direct human interpretation, comparing its output directly against a highly accurate reference standard. The device itself is "standalone" in its measurement function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the clinical accuracy study was established using expert auscultatory measurements (performed by trained observers) from a validated reference device (Aneroid sphygmomanometer, Model: CM-BPM-D, K211084), following the methodology prescribed by ISO 81060-2.
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The sample size for the training set:
- Not applicable / Not specified. This submission is for a medical device that uses an oscillometric measurement principle and internal algorithms. It is not an AI/ML device that typically undergoes explicit "training" on a separate dataset in the same way as, for example, an image classification model. The software component mentioned underwent "verification and validation," which implies testing against requirements and design specifications, not training on a dataset. The algorithms are likely fixed based on established oscillometric principles.
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How the ground truth for the training set was established:
- Not applicable. As explained above, there isn't a "training set" in the context of an AI/ML model for this type of device. The ground truth for the performance verification (clinical accuracy testing) was established via expert auscultatory measurements against a reference device, as detailed above.
§ 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).