(71 days)
KD-556 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-556 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 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 is 2×60 times. If any irregular-heartbeat is detected, it can be shown on the LCD. It 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-556 Fully Automatic Electronic Blood Pressure Monitor:
Based on the provided 510(k) summary, the device is being cleared based on substantial equivalence to a predicate device, the KD-556 Fully Automatic Electronic Blood Pressure Monitor (K090963). The documentation indicates that the two devices are identical in performance, and the new submission primarily addresses the addition of a new cuff size. Therefore, the "study that proves the device meets the acceptance criteria" largely relies on the predicate device's performance and the demonstration that the minor difference (new cuff) does not raise new safety or effectiveness concerns.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with AAMI SP10:2002 Standard (manual, electronic or automated sphygmanometers) | Device "conforms to" and "is designed and manufactured according to" AAMI SP10:2002, and its amendments A1:2003 and A2:2006. |
| Compliance with IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety) | Device "conforms to" IEC 60601-1:1988, Amendment 1, 1991-11, Amendment 2, 1995. |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests) | Device "conforms to" IEC 60601-1-2 (Edition 2:2001 with Amendment 1:2004, Edition 2.1). |
| Performance (Accuracy of BP and Pulse Rate Measurement) | "Performance" is stated as "Identical" to the predicate device (K090963). No specific performance metrics (e.g., mean difference, standard deviation) are provided in this summary. The assumption is that the predicate device met the accuracy requirements of AAMI SP10. |
| Cuff Circumference | The device supports a cuff circumference of 22cm-48cm, an expansion from the predicate device's offering (which likely covered 22cm-30cm, as the new submission adds 22cm-30cm). |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details about a specific clinical test set for the KD-556 device in this submission. The basis for clearance is:
- Substantial Equivalence: The primary assertion is that this device is "identical" in performance to the predicate device K090963.
- Engineering/Bench Testing: The submission states, "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This "test" likely refers to bench testing to validate the new cuff size's performance in adherence to AAMI SP10, rather than a separate clinical trial with a defined patient sample size. No sample size or data provenance (country, retrospective/prospective) is mentioned for any new testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Since the submission relies on substantial equivalence and compliance with engineering standards (AAMI SP10, IEC 60601-1, IEC 60601-1-2), there is no mention of a human-read test set requiring experts to establish ground truth. Compliance with AAMI SP10 typically involves comparison against a reference standard (e.g., a mercury sphygmomanometer) by trained observers, but the details of such a study are not provided in this summary.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with human readers requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device for measuring blood pressure, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to this type of device and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in essence. The device itself is "standalone" in that it performs the measurement and displays results without human interpretation of raw data (other than reading the displayed numbers). The performance evaluation, as indicated by conformity to AAMI SP10, would be a standalone evaluation of the device's accuracy against a reference standard. However, the details of this standalone performance test (e.g., specific accuracy metrics, sample size) are not provided in this summary, as it largely defers to the predicate device's performance.
7. The Type of Ground Truth Used
For non-invasive blood pressure monitors assessed against AAMI SP10, the "ground truth" (or reference standard) is typically established by:
- Auscultation (or sometimes intra-arterial measurement): Using a mercury sphygmomanometer with a trained observer (or two observers for consensus) listening to Korotkoff sounds, potentially against a simultaneously recorded invasive arterial pressure for stricter validation.
- The AAMI SP10 standard itself specifies the methodology for clinical validation, including the use of reference measurements.
However, this submission does not explicitly state the ground truth used, as it relies on the predicate device's compliance.
8. The Sample Size for the Training Set
Not applicable. This device is an electronic blood pressure monitor based on oscillometric technology, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its operational principle is based on pre-programmed algorithms for oscillometric measurement, not on a dataset used for model training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for a machine learning model.
§ 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).