(28 days)
KD-972 Fully Automatic Wireless Blood Pressure Wrist 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 13.5cm-22cm.
KD-972 Wireless 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 13.5cm-22cm. The operational principle is based on oscillometric and silicon integrates pressure sensor technology. it can calculate the systolic and diastolic blood pressure, the measurement results can also be classified by the function of blood pressure classification indicator. If any irregular heartbeat is detected, it can be shown to the user. More over, it also obtains the function of averaging the measurement results. KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor achieves its function by integrate the device with an iPhone, iPod touch or iPad. For it does not contain an LCD or other display components, so It's necessary for the new device to connect to an iPhone, iPod touch or iPad containing a support software to constitute a complete blood pressure measurement system. And the new device connect iPhone, iPod or iPad through bluetooth.
This is a 510(k) summary for a blood pressure monitor, which primarily focuses on regulatory compliance and substantial equivalence to a predicate device. It doesn't detail a clinical study with an acceptance criteria table in the way one might expect for a diagnostic AI device.
However, based on the provided text, I can infer and extract information relevant to the device's acceptable performance criteria and how it's assessed against international standards for blood pressure monitors.
1. Table of Acceptance Criteria and Reported Device Performance
The device is designed and manufactured according to IEC 80601-2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. This standard defines the accuracy requirements for blood pressure devices. While the exact numerical criteria from IEC 80601-2-30 aren't explicitly listed in the document, adherence to this standard implies meeting its specified accuracy thresholds.
Since no specific performance metrics like sensitivity, specificity, or AUC are provided in the document for a "device performance" section, the reported performance is simply its conformity to the mentioned standards.
| Acceptance Criteria (Implied by Standard Adherence) | Reported Device Performance |
|---|---|
| Conformance to IEC 80601-2-30 (Basic safety and essential performance of automated non-invasive sphygmomanometers) | "KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor conforms to the following standards: ... IEC 80601-2-30, Medical electrical equipment-Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanmeters,2009." |
| Conformance to IEC 60601-1 (General requirements for safety) | "KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor conforms to the following standards: ... IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995." |
| Conformance to EN 60601-1-2 (Electromagnetic Compatibility) | "KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor conforms to the following standards: ... EN 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests, 2007." |
| Substantial Equivalence to Predicate Device (KD-7964) | "Our device KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor is substantially equivalent to the Fully Automatic Electronic Blood Pressure Monitor KD-7964 whose 510(k) number is K102906." |
2. Sample Size for the Test Set and Data Provenance
The provided text does not explicitly state a sample size for a clinical test set related to the blood pressure measurement accuracy. It mentions "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies that some testing was done to support the claim of substantial equivalence despite changes from the predicate device (e.g., measurement during inflation vs. deflation, Bluetooth connectivity). However, the details of such a test (sample size, methodology, data provenance) are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not mention the use of experts or the establishment of ground truth in the context of a clinical test set for accuracy. Blood pressure device validation typically involves comparison to a reference standard, often taken by trained clinicians, but these details are absent from the summary.
4. Adjudication Method for the Test Set
Since no specific clinical study with a test set involving human interpretation is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not mentioned in this document. This type of study is typically associated with diagnostic imaging AI devices where human readers interpret cases with and without AI assistance. This document describes a blood pressure monitor, which is a measurement device, not a diagnostic imaging AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This document describes a standalone device in the sense that it measures blood pressure automatically. The "standalone" performance, in this context, would be its adherence to the accuracy requirements of the specified standards (IEC 80601-2-30). The statement "KD-972 Fully Automatic Wireless Blood Pressure Wrist Monitor conforms to the following standards" serves as the proof that the device, in its intended operational mode (without continuous human intervention during the measurement process itself, though human interaction is needed to initiate and view results via an iPhone/iPad), meets these performance criteria. No explicit study titled "standalone performance study" is detailed, but conformance to the standard implies this.
7. Type of Ground Truth Used
The ground truth for a blood pressure monitor's accuracy is typically established by comparing its readings to a validated reference method, such as invasive arterial pressure measurement or auscultatory measurement by trained observers using a mercury sphygmomanometer. However, the document does not explicitly state the type of ground truth used for any specific performance testing. Conformity to IEC 80601-2-30 implies that the appropriate ground truth measurement methods were used during the validation testing required by that standard.
8. Sample Size for the Training Set
This device is a traditional medical device (a blood pressure monitor) and not an AI/ML-based device that would typically involve a "training set" for model development. Therefore, a training set and its sample size are not applicable or mentioned in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, there is no training set and thus no ground truth establishment for a training set.
§ 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).