(231 days)
The Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-19.5 cm.
The patient population does not include adolescents aged 12 to
The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or Kpa.
The proposed electronic blood pressure monitor has eight models, including PG-800A18, PG-800A19, PG-800A28, PG-800A51, PG-800A52, PG-800A11-1, PG-800A36-1 and PG-800A37-1. All models follow the same software, measurement principle, algorithm and data storage. The main differences are product appearance.
The proposed device is intended to be used in medical facilities or at home.
The provided document is a 510(k) Summary for an Electronic Blood Pressure Monitor (K223291), seeking substantial equivalence to a predicate device (K161845). It includes information about non-clinical and clinical testing performed to demonstrate device performance and safety.
Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for the Electronic Blood Pressure Monitor are related to its accuracy in measuring blood pressure and pulse rate, and its compliance with relevant medical device standards.
Table 1: Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard) | Reported Device Performance | Remarks |
|---|---|---|---|
| Accuracy of Systolic Pressure | Mean error ≤ ±5 mmHg (ISO 81060-2:2018) | Mean error: Not explicitly stated, but meets the criteria. | "For systolic and diastolic pressures, the mean error shall be ±5mmHg or less, with a standard deviation of 8mmHg or less." |
| Accuracy of Diastolic Pressure | Mean error ≤ ±5 mmHg (ISO 81060-2:2018) | Mean error: Not explicitly stated, but meets the criteria. | "For systolic and diastolic pressures, the mean error shall be ±5mmHg or less, with a standard deviation of 8mmHg or less." |
| Accuracy Standard Deviation (BP) | Standard deviation ≤ 8 mmHg (ISO 81060-2:2018) | Standard deviation: Not explicitly stated, but meets the criteria. | "For systolic and diastolic pressures, the mean error shall be ±5mmHg or less, with a standard deviation of 8mmHg or less." |
| Pulse Rate Measurement Range | 40-199 bpm (aligns with predicate) | 40-199 bpm | Same as predicate device. |
| Blood Pressure Measurement Range | 30 ~ 280 mmHg (aligns with predicate) | 30 ~ 280 mmHg | Same as predicate device. |
| Biocompatibility | Comply with ISO 10993 series standards; no cytotoxicity, irritation, or sensitization. | Complies with ISO10993 series standards; no cytotoxicity, irritation to skin, no significant evidence of sensitization. | Confirmed through non-clinical testing. |
| Electrical Safety | Comply with IEC 60601-1 (2005, COR1:2006, COR2:2007, AMD1:2012) | Complies with IEC 60601-1 | Confirmed through non-clinical testing. |
| Electromagnetic Compatibility (EMC) | Comply with IEC 60601-1-2:2014 | Complies with IEC 60601-1-2:2014 | Updated standard version compared to predicate, but still meets requirements. |
| Particular Performance | Comply with IEC 80601-2-30 and ISO 81060-2 | Complies with IEC 80601-2-30 and ISO 81060-2 | Confirmed through non-clinical testing and clinical testing. |
Study Proving Device Meets Acceptance Criteria
The document describes both non-clinical and clinical testing.
Clinical Testing (Performance Study)
The clinical test was conducted to verify that the proposed device met the requirements of the ISO 81060-2:2018 standard.
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Sample Size used for the test set and data provenance:
- Sample Size: Not explicitly stated in the provided text. The ISO 81060-2 standard typically requires a minimum of 85 subjects with specific demographic balance (e.g., age, sex, arm circumference, and blood pressure distribution) for a full validation.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it is a clinical test for device validation, it is generally assumed to be prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for blood pressure monitor validation studies. Ground truth in such studies is typically established by simultaneous measurements using a validated reference method (e.g., auscultatory method by trained observers with a mercury sphygmomanometer) as per the ISO 81060-2 standard, not by expert consensus on images or data interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth is established by simultaneous reference measurements, not by expert interpretation requiring adjudication. ISO 81060-2 involves multiple trained observers for reference measurements.
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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:
- This is not an AI-assisted device for diagnostic interpretation; it is a direct measurement device. Therefore, an MRMC study is not relevant or applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "clinical test" is essentially the "standalone" performance of the device (algorithm and hardware combined) against a reference standard. The device operates automatically once initiated.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for blood pressure monitor validation (as per ISO 81060-2) is established by simultaneous auscultatory measurements performed by trained observers using a validated reference method (e.g., mercury sphygmomanometer with a stethoscope). This is generally considered a highly reliable and direct physiological measurement.
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The sample size for the training set:
- This device is an Electronic Blood Pressure Monitor using an oscillometric technique, not a machine learning/AI model that typically requires a separate "training set" in the conventional sense. The "algorithm" for blood pressure calculation from oscillometric pulses is built into the device. Therefore, a distinct "training set" like those used for AI models is not applicable or specified.
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How the ground truth for the training set was established:
- Not applicable for the reason stated above. The underlying oscillometric principle and algorithms are well-established.
Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. These tests covered various aspects of safety and performance.
- Testing Standards:
- ISO 10993-1:2018 (Biological evaluation - risk management)
- ISO 10993-5:2009 (Cytotoxicity)
- ISO 10993-10:2010 (Irritation and delayed-type hypersensitivity)
- IEC 60601-1:2005 + A1:2012 (Medical electrical equipment - general requirements for basic safety and essential performance)
- IEC 60601-1-11:2015 (Home healthcare environment)
- IEC 60601-1-2:2014 (EMC)
- IEC 80601-2-30:2018 (Automated non-invasive sphygmomanometers)
The document concludes that the non-clinical tests and the clinical test demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.
§ 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).