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K Number
K960885
Device Name
MODEL 1240, SMALL E NET
Manufacturer
PHYSIOMETRIX, INC.
Date Cleared
1996-04-26

(53 days)

Product Code
GXY
Regulation Number
882.1320
Type
Traditional
Panel
NE
Reference & Predicate Devices
K930080
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment.
Headpiece (42-48 cm) for EEG Monitoring

Device Description

The small e-Net is designed to fit patients with a head size in the range of 42 - 48 cm in circumference. It is constructed using the same materials and manufacturing processes as the larger sized net 54 - 62 cm) which is described in K930080. The e-Net serves two functions as a part of the Hydro Dot NeuroMonitoring System. First, it locates the EEG electrodes according the 10-20 International System. Secondly, it conducts the electrical signal sensed by the electrodes from the skin to the EEG equipment. The small e-Net is fabricated from the same materials as the larger version. Only the size of the components was reduced to achieve the proportional fir on the intended head sizes.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (Physiometrix, Inc.'s Small e-Net Model 1240). However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

  • Device Description: What the small e-Net is, its intended use (EEG monitoring for head sizes 42-48 cm), and its construction.
  • Regulatory Classification: Identifying it as a Class II cutaneous electrode and its predicate device.
  • FDA Substantially Equivalent Letter: This letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It also outlines general control provisions and regulatory responsibilities.

Therefore, I cannot provide the requested table and study details based on the given input. The document is a regulatory approval notice, not a performance study report.

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).