(68 days)
KD-388BD 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-388BD 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 memory capability of KD-388BD is 2×60 times.
The provided text describes a 510(k) summary for the KD-388BD Semi Automatic Electronic Blood Pressure Monitor. While it mentions adherence to standards like AAMI SP10, it does not contain detailed information about specific acceptance criteria for blood pressure accuracy performance or a study proving the device meets those criteria, as typically found in clinical validation reports.
Here's a breakdown of the information that is available in the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Missing. The document states that the device "conforms to the following standards," including AAMI SP10:2002. AAMI SP10 is the key standard for non-invasive sphygmomanometers, and it outlines specific accuracy requirements for systolic and diastolic blood pressure measurements (e.g., mean difference ≤ ±5 mmHg with a standard deviation ≤ 8 mmHg). However, the document does not provide a table comparing these AAMI SP10 acceptance criteria with the actual performance data (mean difference, standard deviation) obtained from a study.
2. Sample Size Used for the Test Set and Data Provenance
Missing. The document only generally states, "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." It does not specify any sample size for a test set or the provenance of any data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Missing. There is no mention of experts or ground truth establishment for a test set. For blood pressure monitors, ground truth is typically established by trained observers using auscultation with a reference sphygmomanometer, following a defined protocol (e.g., AAMI SP10).
4. Adjudication Method
Missing. No adjudication method is mentioned as there is no description of a separate test set requiring such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not relevant for a blood pressure monitor, which measures a quantifiable physiological parameter rather than interpreting complex medical images or cases. Therefore, there is no mention of such a study or effect size.
6. Standalone (Algorithm Only) Performance
Partially Addressed, but without specific data. The device itself is a "Semi Automatic Electronic Blood Pressure Monitor," implying it's an automated device that provides a reading. Its performance, as per the AAMI SP10 standard it claims to conform to, would be a standalone assessment of its accuracy against a reference method. However, specific standalone performance data (e.g., mean difference and standard deviation of blood pressure readings against a reference) is not provided.
7. Type of Ground Truth Used
Implicitly, but not explicitly stated or detailed. For a blood pressure monitor, the "ground truth" used for validation against AAMI SP10 typically involves simultaneous or closely timed measurements by trained observers using a mercury or an equivalently validated reference sphygmomanometer (auscultatory method). The document states conformance to AAMI SP10, which implies this method would have been used, but it does not explicitly state it or provide details of the ground truth method or its establishment.
8. Sample Size for the Training Set
Missing. Training sets are generally relevant for machine learning algorithms. While an oscillometric device uses an algorithm, the document doesn't discuss a "training set" in the context of a machine learning model. It describes testing against a standard rather than training an AI model.
9. How the Ground Truth for the Training Set Was Established
Missing. As no training set is discussed, this information is also absent.
Summary of what is present:
- Conformance to standards: The device claims to conform to AAMI SP10, IEC 60601-1, and IEC 60601-1-2. AAMI SP10 sets the performance criteria for non-invasive blood pressure monitors.
- Predicate Device: KD-322 (K083395) is identified as the predicate device, with the new device (KD-388BD) being "substantially equivalent."
- Minor differences from predicate: The document notes minor differences like appearance, additional memory, and a slight change in pulse rate range (30-180 to 40-180 times/min). It states that "[t]he test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies some level of testing was performed, likely to re-verify compliance with AAMI SP10 for the modified device, but the details are not provided.
*In conclusion, while the device claims conformance to AAMI SP10 (which defines the acceptance criteria for blood pressure monitors), the provided 510(k) summary does not contain the specific acceptance criteria in a table, nor does it present the detailed results of a study (sample size, performance metrics, ground truth methodology, etc.) that demonstrate the device explicitly meets those criteria. This level of detail is typically found in the full testing report, which is not part of this summary.
§ 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).