(50 days)
KD-930 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
KD-930 Fully Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm. It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmomanometers. The operational principle is based on oscillometric method and silicon integration pressure sensor technology. It can calculate the systolic and diastolic blood pressure, the measurements results can also be classified and displayed by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown on to the user. More over, it can also calculate the average of the last three measurements.
The provided text describes the KD-930 Fully Automatic Electronic Blood Pressure Monitor. However, it does not contain details about a specific study proving the device meets acceptance criteria in the format requested. While it references standards the device conforms to, it does not explicitly outline a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically seen in a detailed performance study summary.
The document mainly focuses on:
- Device information: Trade name, common name, classification, and predicate device.
- Device description: How it works (oscillometric method), what it measures (systolic, diastolic, pulse rate), and features (irregular heartbeat detection, average of last three measurements).
- Intended use: Measuring blood pressure and pulse rate in adults with an upper arm cuff.
- Comparison to predicate device: Stating similarities and differences with the KD-556 and a general statement that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies tests were done but provides no specifics.
- Standards conformance: A list of relevant IEC, UL, and AAMI standards.
Given the absence of the specific study details you requested, I can only extract information that is present. Below is a structured response reflecting the available data and explicitly stating what aspects are not provided in the text.
Acceptance Criteria and Device Performance Study for KD-930 Fully Automatic Electronic Blood Pressure Monitor
The provided 510(k) summary for the KD-930 Fully Automatic Electronic Blood Pressure Monitor states conformance to several standards, including AAMI SP10:2002. Compliance with AAMI SP10 typically defines the acceptance criteria for blood pressure monitors. However, the document does not explicitly present a table of acceptance criteria and reported device performance from a specific study within the summary itself. Instead, it indicates that the device "conforms to" these standards.
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document states the device "conforms to" AAMI SP10:2002 (and its amendments). For non-invasive blood pressure monitors, AAMI SP10 specifies accuracy requirements, typically:
- Mean difference: ≤ 5 mmHg
- Standard deviation: ≤ 8 mmHg
- These apply to both systolic and diastolic blood pressure measurements when compared to a reference method (e.g., auscultation by trained observers).
- Reported Device Performance: The provided text does not include a table or specific data showing the KD-930's measured mean difference and standard deviation against these AAMI SP10 criteria. It generally states that "the test in this submission provides demonstration that these small differences [from the predicate] do not raise any new questions of safety and effectiveness," implying a study was conducted but not detailing its results in this summary.
| Acceptance Criteria (based on AAMI SP10:2002) | Reported Device Performance (Not explicitly stated in summary) |
|---|---|
| Mean difference ≤ 5 mmHg (Systolic BP) | Details not provided in the summary. |
| Standard deviation ≤ 8 mmHg (Systolic BP) | Details not provided in the summary. |
| Mean difference ≤ 5 mmHg (Diastolic BP) | Details not provided in the summary. |
| Standard deviation ≤ 8 mmHg (Diastolic BP) | Details not provided in the summary. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified in the provided summary.
- Qualifications of Experts: Not specified in the provided summary.
4. Adjudication Method for Test Set
- Not specified in the provided summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No information about an MRMC study is provided. This device is an automated blood pressure monitor, not an imaging interpretation device typically assessed with MRMC studies.
6. Standalone Performance (Algorithm Only)
- The device itself is a standalone algorithm/device for blood pressure measurement, as it is an "Automatic Electronic Blood Pressure Monitor." It measures and displays readings without human interpretation being part of the core measurement process. The conformance to AAMI SP10, if demonstrated, would be for its standalone performance. However, specific standalone performance metric values are not provided.
7. Type of Ground Truth Used
- The ground truth for blood pressure monitor validation per AAMI SP10 is typically established by simultaneous measurements by trained human observers using a mercury sphygmomanometer (auscultation method), often with a double-blind protocol. While not explicitly stated for this specific study summary, conformance to AAMI SP10 implies this method of ground truth establishment.
8. Sample Size for Training Set
- This device is based on the oscillometric method and silicon integration pressure sensor technology, and likely uses established algorithms rather than a "training set" in the machine learning sense. Therefore, information about a training set sample size is not applicable in the context of this traditional medical device validation. If there were any internal calibration data or look-up tables based on population data, it is not mentioned.
9. How Ground Truth for Training Set Was Established
- As above, the concept of a "training set" and associated ground truth establishment is not applicable for this type of traditional blood pressure monitoring device based on physical principles, rather than a machine learning model that requires a labeled dataset for training.
§ 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).