(68 days)
KD-3917 and KD-3909 Semi 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-3917 and KD-3909 Semi 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 sphygmanometers. The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module; the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-3909 is 2×60 times, the memory capability of KD-3917 is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-3909 also has the function of averaging the last three measurements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitors:
Based on the provided 510(k) summary, the device's performance is not reported against specific acceptance criteria in a detailed table as requested. However, it states that the device "conforms to the following standards," which define the performance expectations for such devices. The primary standard for blood pressure monitors is AAMI SP10.
Here's a breakdown of the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The direct acceptance criteria in a quantitative table with corresponding reported performance for this specific device are not explicitly provided in the executive summary. Instead, the document states conformity to relevant standards.
Implicit Acceptance Criteria (based on AAMI SP10:2002)
| Criteria Category | General Performance Acceptance (AAMI SP10) | Reported Device Performance (from K091739 summary) |
|---|---|---|
| Accuracy (Blood Pressure) | Mean difference between device and reference standard ± 5 mmHg, with standard deviation ≤ 8 mmHg (for both systolic and diastolic pressure). This is a common requirement in AAMI SP10. The sum of the absolute differences between the device and reference for any 5 mmHg interval should not exceed 25% for 30 or more subjects. | Not explicitly stated with specific numerical results (mean difference, standard deviation) for blood pressure accuracy. The document states that the device "conforms to the following standards," including AAMI SP10:2002, AAMI/ANSI SP10:2002/A1:2003, and AAMI/ANSI SP10:2002/A2:2006. This implies that the device met the accuracy requirements outlined in these standards. |
| Accuracy (Pulse Rate) | Typically, within ± 5% or ± 5 beats/min (whichever is greater) of a reference standard. | Not explicitly stated with specific numerical results. The document notes that the "pulse rate range is changed from 30-180 times/min to 40-180 times/min" for the new devices compared to the predicate, but this is a range change, not an accuracy claim. The conformity to AAMI SP10 would imply meeting its pulse rate accuracy requirements. |
| Cuff Pressure Range | Typically specified pressure range. | "The performance parameter of cuff pressure range... are different from the predicted device KD-391." Actual range for KD-3917/KD-3909 not explicitly stated, but conformity to AAMI SP10 indicates it meets the standard's requirements for the stated use. |
| Overpressure Limit | Device should not exceed a safe overpressure limit (e.g., typically 300 mmHg for adult blood pressure monitors). | "The performance parameter of... overpressure limit are different from the predicted device KD-391." Actual limit for KD-3917/KD-3909 not explicitly stated, but conformity to AAMI SP10 indicates it meets the standard's requirements for safety. |
| Environmental Parameters | Operational range for temperature and humidity. | The operational range for humidity is " |
§ 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).