(391 days)
The Electronic Blood Pressure Monitor is intended to measure the systolic 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 adult 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-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A36 and PG-800A37. 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 text describes the 510(k) summary for the "Electronic Blood Pressure Monitor" (multiple models: PG-800A25, PG-800A27, PG-800A31, PG-800A32, PG-800A33, PG-800A35, PG-800A36, PG-800A37) by Shenzhen Pango Electronic Co., Ltd. The document aims to demonstrate substantial equivalence to a predicate device (PG-800A Series Electronic Blood Pressure Monitor, Models PG-800A5, PG-800A5D, K131569).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is primarily assessed against recognized standards for non-invasive sphygmomanometers. The document states compliance rather than providing specific numerical results for each criterion explicitly in a performance table. However, it specifically references ISO 81060-2:2013 for clinical validation.
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance/Result) |
|---|---|
| Safety and Essential Performance | |
| IEC 60601-1:2005+A1:2002 (General Requirements for basic safety and essential performance) | Complies |
| IEC 60601-1-11:2010 (Home Healthcare Environment) | Complies |
| Electromagnetic Compatibility (EMC) | |
| IEC 60601-1-2:2007 (EMC) | Complies |
| Particular Requirements for Automated Non-Invasive Sphygmomanometers | |
| IEC 80601-2-30:2009 | Complies |
| Clinical Validation of Automated Measurement Type | |
| ISO 81060-2:2013 | Complies |
| Biocompatibility | |
| ISO 10993 series standards | No cytotoxicity; No irritation to skin; No significant evidence of sensitization |
It's important to note that while the document states "Complies," the specific numerical acceptance criteria (e.g., mean difference and standard deviation from reference measurements for blood pressure, as specified in ISO 81060-2) are not provided in this excerpt. The "Complies" statement indicates the device met these criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states compliance with ISO 81060-2:2013, which outlines requirements for clinical validation. While the exact sample size for the test set is not explicitly stated in this summary, ISO 81060-2:2013 typically requires a minimum of 85 subjects for clinical validation studies for automated non-invasive sphygmomanometers.
The data provenance (country of origin, retrospective/prospective) is not specified in this summary. It only indicates that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For clinical validation as per ISO 81060-2, blood pressure measurements are typically taken by trained observers using a mercury sphygmomanometer or auscultatory method simultaneously or sequentially with the device under test. The standard specifies requirements for these observers, including training and demonstration of accuracy.
The number of experts/observers and their specific qualifications are not explicitly stated in this excerpt. However, it can be inferred that trained personnel, likely medical professionals, would have been involved to establish the reference measurements as per the ISO standard requirements.
4. Adjudication Method for the Test Set
The document does not explicitly mention an adjudication method for the test set. In clinical validation studies for blood pressure monitors, the "ground truth" measurements from trained observers are generally considered the reference, and the device's readings are compared against these. There isn't typically an adjudication process in the same way as, for example, for image-based diagnostic systems.
5. 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. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This is a blood pressure monitor, not an AI-assisted diagnostic tool that relies on human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an "Electronic Blood Pressure Monitor" and measures blood pressure via an "oscillometric technique." This is inherently a standalone algorithm-only (without human-in-the-loop performance for the measurement itself) device. The algorithm processes the oscillometric signals to determine blood pressure. User interaction is for initiating the measurement and reading the displayed results. The clinical validation in ISO 81060-2 is precisely this – comparing the automated device's output against reference measurements.
7. The Type of Ground Truth Used
The ground truth used for relevant performance criteria (specifically, clinical validation) would be reference blood pressure measurements obtained by trained observers using a validated method (e.g., auscultatory method with a mercury sphygmomanometer or other validated reference device) in accordance with the ISO 81060-2:2013 standard.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. For oscillometric blood pressure monitors, the core algorithm for blood pressure determination is typically developed and refined using internal data and engineering principles during the R&D phase. The information provided focuses on the validation against standards.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for any training set was established. This information is usually proprietary to the manufacturer's R&D process for algorithm development and is not typically included in FDA 510(k) summaries, which focus on compliance with recognized standards for safety and effectiveness.
§ 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).