(68 days)
The E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord. The electrode adheres to the patient over its entire surface. Its purpose is to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
Indications for use are general monopolar electrosurgery on newborn or prematurely born patients of between approximately 1 and 6 lbs.
The E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode is a single use, non-sterile dispersive electrode with a preattached cord, the purpose of which is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. It is specifically designed for use on newborn and prematurely born patients whose small size creates a limited area for pad placement and makes placement of other, larger-size pads difficult.
The provided document is a 510(k) summary for a medical device (E7512 Neonatal REM PolyHesive™ II Neonatal Patient Return Electrode). It describes the device, its intended use, and its technological characteristics compared to predicate devices. It states that performance testing has been done to verify function and meet design specifications and standards. However, this document is a regulatory submission intended to demonstrate substantial equivalence, not a detailed study report that proves a device meets specific acceptance criteria with reported numerical performance values.
Therefore, I cannot extract the level of detail regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study specifics (like MRMC studies or human-in-the-loop performance) that your request entails from this document.
The document primarily focuses on:
- Device Identification: Proprietary and common names, classification, and submitter information.
- Predicate Devices: Listing previously cleared devices for comparison.
- Device Description: Physical characteristics and function.
- Intended Use: The patient population and surgical context for the device.
- Technological Characteristics: How the device compares to predicates, noting differences in size, REM system inclusion, and adhesive border.
- Performance Data (General Statement): A general statement that "Performance testing has been performed to verify that the device functions as intended and that design specifications and applicable consensus standards have been met." It does not provide the specific acceptance criteria or the actual performance results.
In summary, the detailed information requested regarding the acceptance criteria and study particulars is not present in this 510(k) summary. This document confirms that performance testing was done, but not what the acceptance criteria were, how the device performed against them, or the specific methodology of those tests in detail.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.