Search Results

KD-7941 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 wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

KD-7941 Fully Automatic Electronic Blood Pressure Monitor is Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around the wrist, which cuff circumference is limited to 6.1023 inches to 9.8425 inches, the device can analyze the signals promptly and display the results. It has some other functions, such as 120 memory recall / 2 users, calculating average of last 3 readings and color changing area with LED lighting on outer case to indicate blood pressure classification level.

The provided text describes a 510(k) summary for the KD-7941 Fully Automatic Electronic Blood Pressure Monitor. However, it does not contain the detailed information about a study proving the device meets acceptance criteria as requested in the prompt.

Here's a breakdown of what is available and what is missing:

Information Present in the Document:

• Device Name: KD-7941 Fully Automatic Electronic Blood Pressure Monitor
• Intended Use: To monitor and display diastolic, systolic blood pressure, and pulse rate of adults using a wrist cuff, for use by medical professionals or at home.
• Predicate Device: KD-795 Andon Health Co., Ltd (K070826)
• Standards Met: ANSI/AAMI SP-10 standard, IEC 60601-1, IEC 60601-1-2.
• Regulatory Clearance: 510(k) clearance by FDA (K083319) based on substantial equivalence.

Information NOT Present in the Document (and therefore cannot be provided in response to the prompt's specific questions):

• A table of acceptance criteria and reported device performance: While it states the device "meet the following standards," it doesn't provide specific quantitative acceptance criteria (e.g., accuracy ranges for blood pressure measurements) or the device's measured performance against those criteria.
• Sample size used for the test set and data provenance: No information on the number of subjects or the source of the data used for performance testing.
• Number of experts used to establish ground truth and their qualifications: Not mentioned.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned, and generally not applicable for a standalone blood pressure monitor.
• Standalone (algorithm only) performance: This device is a measurement device, so its performance is standalone algorithm performance in essence, but no detailed breakdown of the algorithm's performance metrics is provided beyond meeting general standards.
• Type of ground truth used: Not explicitly stated, though for blood pressure monitors, this would typically involve comparison to a validated reference method (e.g., auscultatory readings by trained observers).
• Sample size for the training set: Not applicable for a device cleared via 510(k) without a machine learning component requiring a distinct training set. The "training" here would be the development and calibration against reference methods.
• How ground truth for the training set was established: Not mentioned.

Conclusion:

The provided 510(k) summary indicates that the KD-7941 Fully Automatic Electronic Blood Pressure Monitor meets the ANSI/AAMI SP-10 standard for blood pressure monitors, along with general electrical safety and EMC standards. However, it does not include the detailed study results, specific acceptance criteria values, or methodology (like sample size, ground truth establishment, expert qualifications, or MRMC studies) that your prompt requests. For devices like blood pressure monitors approved via 510(k) pathways, the FDA often relies on adherence to recognized performance standards (like AAMI SP10) rather than requiring extensive clinical trials with detailed statistical reporting of performance beyond what's needed to show substantial equivalence.

To answer your prompt with the requested level of detail, additional documentation (such as the full test report submitted to the FDA for ANSI/AAMI SP-10 compliance) would be necessary.

Ask a specific question about this device