(458 days)
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models:
Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
Here's an analysis of the provided text regarding the acceptance criteria and study for the Med-link Wrist Digital Blood Pressure Monitor Model: ESM101 and Med-link Upper Arm Digital Blood Pressure Monitor Model: ESM201.
1. Table of Acceptance Criteria & Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Pressure Accuracy | ±3 mmHg (AAMI SP10) | ±3 mmHg (ISO 80601-2-30 and ISO 81060-2) |
| Pulse Accuracy | ±5% (AAMI SP10) | ±5% (ISO 80601-2-30 and ISO 81060-2) |
| Measurement Range (Pressure) | 0~280 mmHg | 0~280 mmHg |
| Measurement Range (Pulse) | 40~199 beats/minute | 40~199 beats/minute |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-1-11 | Comply with IEC 60601-1 |
| EMC (Electromagnetic Compatibility) | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Biocompatibility | All patient contacting materials evaluated by ISO 10993-1, -5, -10 | All patient contacting materials evaluated by ISO 10993-1, -5, -10 |
Study That Proves the Device Meets Acceptance Criteria:
The document states that a series of tests were performed in accordance with several standards to assess the safety and effectiveness of the Med-link Digital Blood Pressure Monitor. Specifically for performance, the standard cited is ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. This standard outlines the requirements for clinical validation of automated non-invasive sphygmomanometers.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the clinical validation described by ISO 81060-2. However, the ISO 81060-2 standard itself mandates a minimum number of subjects for clinical validation. This information would typically be found in the full clinical study report, which is not included in this 510(k) summary.
The document does not explicitly state the country of origin of the data nor whether the study was retrospective or prospective. It just mentions "a series of safety, essential performance and biocompatibility tests were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications for establishing the ground truth during the clinical validation tests (ISO 81060-2). Clinical validation per ISO 81060-2 typically involves simultaneous auscultatory measurements by trained observers (experts) that serve as the reference standard against which the automated device's measurements are compared.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method used. In the context of ISO 81060-2, the reference standard for blood pressure measurements is typically established by two trained observers performing auscultatory measurements. Discrepancies between these observers would then usually be handled by a predefined adjudication process (e.g., a third observer). However, this specific detail is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the standalone performance of the device against a reference standard.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document states that "a series of safety, essential performance and biocompatibility tests were performed" and explicitly mentions ISO 81060-2, Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers and ISO 81060-2 Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type. These standards are used to establish the standalone performance of the device (algorithm only, as applied in an automated device like this blood pressure monitor).
7. Type of Ground Truth Used
Based on the reference to ISO 81060-2, the ground truth for the test set would be expert auscultatory measurements (the "reference sphygmomanometer"). This involves trained human observers using mercury or aneroid sphygmomanometers to manually measure blood pressure, which is then compared to the automated device's readings.
8. Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This type of device (a deterministic blood pressure monitor based on oscillometry) typically does not involve machine learning models that require a separate "training set" in the same way an AI/ML-based diagnostic device would. The internal algorithms are typically calibrated and validated, but not "trained" on a large dataset in the sense of deep learning.
9. How the Ground Truth for the Training Set Was Established
As no training set is indicated for this type of device, this question is not applicable based on the provided information.
§ 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).