(317 days)
The Panasonic wrist blood pressure meter, model EW280, is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.
The wrist blood pressure meter is a battery-charged non-invasive digital electronic blood pressure meter manufactured by Matsushita Electric Works, Ltd., (MEW) Osaka, Japan. The wrist blood pressure meter is intended to measure systolic and diastolic blood pressure using a pressurized cuff worn around the wrist.
Here's an analysis of the provided 510(k) summary regarding the Panasonic Wrist Blood Pressure Meter, Model EW280, focusing on acceptance criteria and the study conducted.
Acceptance Criteria and Device Performance for Panasonic Wrist Blood Pressure Meter, Model EW280
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance acceptance criteria for a novel device. The performance data presented primarily addresses verification that modifications to the new model (EW280) did not negatively impact the safety and effectiveness compared to the cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Specification | Acceptance Criteria (from Predicate Device EW273) | Reported Device Performance (EW280) |
|---|---|---|
| Main body (w) x (h) x (d) | 77 x 66 x 23 (mm) | 67 x 67 x 26 (mm) |
| Display: during measurement | "▲" lights up under "MEAS" | " |
§ 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).