(87 days)
KD-7906 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-7906 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 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 test results. Besides, It can store and show 2*60 times measuring result with the day and time. And it has the function of blood pressure level classification and calculating the average of the last 3 readings.
Here's an analysis of the KD-7906 Fully Automatic Electronic Blood Pressure Monitor based on the provided 510(k) submission, specifically addressing acceptance criteria and supporting studies where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to meeting specific standards as the primary acceptance criteria for the KD-7906. The performance itself is largely claimed to be "Identical" to a predicate device, K070826.
| Acceptance Criteria (Standard Met) | Reported Device Performance (Claimed based on the provided document) |
|---|---|
| ANSI/AAMI SP-10 standard | Met standard; Performance "Identical" to predicate (K070826) |
| IEC 60601-1 (Safety) | Met standard |
| IEC 60601-1-2 (EMC) | Met standard |
Note: The document does not provide specific numerical performance metrics (e.g., mean difference, standard deviation between device readings and a reference method) from a dedicated clinical study for the KD-7906 itself. Instead, it relies on the claim of "Identical" performance to its predicate device, K070826, which would have had to meet these standards in its own submission.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a sample size for a test set used to evaluate the KD-7906's performance directly. The claim is that its performance is "Identical" to the predicate device (K070826). Therefore, any test set data would refer to the studies conducted for the predicate.
The document does not mention the country of origin of any data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As the submission relies on demonstrating substantial equivalence to a predicate device and meeting general standards, specific details about expert-established ground truth for a new clinical study are absent.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) submission for the KD-7906. This type of study is more common for diagnostic imaging devices where human interpretation is involved. For an automatic blood pressure monitor, the performance is typically evaluated against direct physiological measurements.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a "Fully Automatic Electronic Blood Pressure Monitor," implying it operates in a standalone manner without human intervention for the measurement process itself. While a "standalone" study in the AI sense might not be explicitly stated, the nature of the device means its performance evaluation inherently reflects its standalone capability in generating blood pressure readings. The document does not describe specific "algorithm only" performance separate from the device.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the KD-7906's verification. However, for a device claiming to meet the ANSI/AAMI SP-10 standard, the ground truth for blood pressure measurement studies typically involves:
- Auscultatory reference method: Measurements taken by trained observers using a mercury sphygmomanometer or highly accurate aneroid sphygmomanometer, often with dual observers for consensus.
8. The Sample Size for the Training Set
The provided document does not specify a sample size for a training set. This 510(k) submission describes an electronic blood pressure monitor, not an AI/ML algorithm that typically undergoes a distinct training phase with a dedicated dataset. The device operates based on oscillometric principles, which are well-established.
9. How the Ground Truth for the Training Set Was Established
Since this is not an AI/ML device with a distinct "training set" in the modern sense, the concept of establishing ground truth for a training set is not applicable here. The oscillometric algorithm's development and calibration would have been based on extensive physiological data and established principles, likely incorporating a form of "ground truth" through direct arterial pressure measurements or expert auscultation during its initial design and validation. However, this is not detailed in the 510(k) for the KD-7906.
§ 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).