(24 days)
KD-738 and KD-739 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-738 and KD-739 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. 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 60 times. If any irregular heartbeat is detected, it can be shown on the LCD.
The provided text describes a 510(k) summary for the KD-738 and KD-739 Fully Automatic Electronic Blood Pressure Monitors. However, it does not contain specific details about acceptance criteria or a dedicated study proving the device meets those criteria.
The document focuses on demonstrating substantial equivalence to a predicate device (KD-7909) and conformity to recognized standards. It states: "However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness." This implies that the testing was primarily to confirm similar performance to the predicate and compliance with standards rather than a detailed study against specific acceptance criteria for a novel device.
Given the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Acceptance Criteria implied by Standard) | Reported Device Performance (Implied by Conformity to Standards) |
|---|---|
| Accuracy of Diastolic Blood Pressure measurement | Conforms to AAMI SP10:2002 and its amendments |
| Accuracy of Systolic Blood Pressure measurement | Conforms to AAMI SP10:2002 and its amendments |
| Accuracy of Pulse Rate measurement | Conforms to AAMI SP10:2002 and its amendments |
| Cuff Pressure Range | Different from predicate KD-7909 (Specific range not provided in this document) |
| Overpressure Limit | Different from predicate KD-7909 (Specific limit not provided in this document) |
| Electrical Safety | Conforms to IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 |
| Mechanical Safety | Identical to predicate device (Implies conformity to relevant standards) |
| Biocompatibility | Identical to predicate device (Implies conformity to relevant standards) |
Note: The document explicitly states that the device conforms to "AAMI SP10:2002, Manual, electronic or automated sphygmanometers," and its amendments. This standard outlines accuracy requirements for blood pressure devices. For example, AAMI SP10 typically requires mean differences between the device and a reference method (e.g., auscultation) to be within ±5 mmHg with a standard deviation of no more than 8 mmHg. The document implies the device meets these types of criteria by stating conformity to the standard, but does not provide the specific numerical results from their testing against these criteria.
Missing Information:
The document primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards (IEC 60601-1, IEC 60601-1-2, and AAMI SP10). It does not detail a specific performance study with clearly defined acceptance criteria and corresponding results in the manner requested.
Therefore, the following information cannot be extracted from the provided text:
- 2. Sample Size Used for the Test Set and Data Provenance: Not specified.
- 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not specified, as a direct comparative study against expert ground truth is not detailed.
- 4. Adjudication Method: Not applicable/specified for this type of submission.
- 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed or described. This type of study is usually for image-based diagnostic aids, not blood pressure monitors.
- 6. Standalone Performance (Algorithm Only): Not applicable for this device type, which is a physical measurement device.
- 7. Type of Ground Truth Used: Implied to be reference measurements as per AAMI SP10 (e.g., simultaneous auscultation by trained observers), but not explicitly detailed in the document.
- 8. Sample Size for the Training Set: Not applicable, as this is a traditional measurement device, not an AI/ML algorithm requiring a training set.
- 9. How the Ground Truth for the Training Set was Established: Not applicable.
§ 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).