SUBDERMAL WIRE ELECTRODE, MODEL SWE

• K Number: K062880
• Device Name: SUBDERMAL WIRE ELECTRODE, MODEL SWE
• Manufacturer: IVES EEG SOLUTIONS, INC.
• Date Cleared: 2006-12-22 ( 87 days)
• Product Code: GXZ
• Regulation Number: 882.1350
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The subdermal wire electrode (SWE) is intended for temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU). The SWE is a disposable, single use device. The SWE is intended for use in a similar manner to that of a subdermal needle electrode.

Device Description

Subdermal Wire Electrode (SWE)

AI/ML Overview

This document is an FDA 510(k) clearance letter for a Subdermal Wire Electrode (SWE). It does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter primarily:

• Confirms that the device, a Subdermal Wire Electrode (SWE), is substantially equivalent to legally marketed predicate devices.
• States its intended use: "temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU)."
• Classifies the device and outlines regulatory requirements.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or other performance-related information based on the provided text. This information would typically be found in the 510(k) submission document itself, not in the clearance letter.

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).