PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)

K970418 · Pmt Corp. · GZL · Apr 29, 1997 · Neurology

Device Facts

• Record ID: K970418
• Device Name: PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
• Applicant: Pmt Corp.
• Product Code: GZL · Neurology
• Decision Date: Apr 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

The PMT Depth Electrode Anchor Bolt is an accessory used in cases where it’s necessary to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode during intraoperative electroclincal characterization.

Device Story

Device is a titanium alloy anchor bolt used to stabilize depth electrodes during neurosurgical procedures. Surgeon inserts bolt into pre-drilled skull burr hole; depth electrode is passed through a silicone gasket in the bolt's screw cap port. Once electrode reaches target foci, screw cap is tightened to fixture the electrode, preventing movement and minimizing CSF leakage or infection risk. Device accommodates electrodes with 0.050 ± 0.005 inch diameter; available in 25-40mm lengths. Designed to withstand 100g longitudinal force. Used in clinical/surgical settings by neurosurgeons/neurophysiologists.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on silicone gasket (Cytotoxicity, Sensitization, Irritation, Acute Systemic toxicity) and Titanium alloy (Intracutaneous, Acute Systemic Toxicity, Sensitization). Sterilization validated via 100% Ethylene Oxide overkill method (10^-6 SAL). Pyrogen testing conducted via Limulus Amebocyte Lysate Test per USP Endotoxin Reference Standard (limit 2.4 Eu/device). Mechanical testing confirmed ability to withstand 100 gram longitudinal force.

Technological Characteristics

Materials: Titanium alloy (Ti 6Al 4V) and silicone gasket. Dimensions: 25mm, 30mm, 35mm, 40mm lengths; port accommodates 0.050 ± 0.005 inch diameter electrodes. Principle: Mechanical screw-thread fixation with silicone gasket seal. Sterilization: 100% Ethylene Oxide (overkill method).

Indications for Use

Indicated for use as an accessory to stabilize depth electrodes during intraoperative electroclinical characterization in patients undergoing neurosurgical procedures requiring intracranial electrode placement.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• Smith Skull Anchor bolt (Ad-tech Medical Instrument Corporation)

Reference Devices

• PMT Depthalon Depth Electrode (K802151)
• PMT Depthalon Depth Electrode (K802152)

Submission Summary (Full Text)

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K970418
510(k) Notification Summary
Anchor Bolt, Depthalon Electrode Accessory
January 27, 1997

# Premarket Notification [510(k)] Summary

**Submitters name:** PMT CORPORATION
**APR 29 1997**

**Submitters Address:** PMT Corporation
1500 Park Road
Chanhassen, MN 55317

**Phone:** [phone]
**Fax:** [phone]
**Contact name:** Edward F. Valdez
**Date:** 1/27/97

**Trade name:** PMT® Anchor Bolt, Accessory Depthalon® Depth Electrode
**Common name:** Anchor Bolt
**Classification name:** No known classification name.

## Equivalent device(s):

The PMT Depth Electrode Anchor Bolt is equivalent to the Smith Skull Anchor bolt manufactured by Ad-tech Medical Instrument Corporation.

## Device Description

### Basic Design

The PMT Depth Electrode Anchor Bolt is an accessory used in cases where it’s necessary to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode during intraoperative electroclincal characterization.

The PMT Depth Electrode Anchor Bolt is attached onto the skulls with the insertion of the Anchor Bolt Tapered Screw Threads into a pre-drilled burr hole, through a skin incision.

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PMT® Corporation
510(k) Notification Summary
Anchor Bolt, Depthalon Electrode Accessory
January 27, 1997

Once installed on to the skull a PMT Depthalon® Depth Electrode (510(k) number K802151 and K802152) can be inserted into the Anchor Bolt Screw Cap Port Hole through the Silicone Gasket and into the cranium. The PMT Depth Electrode Anchor Bolt is made of Titanium alloy (Ti 6Al 4V) with a silicone gasket. The gasket is designed to accept the PMT Depthalon® Depth Electrode.

The port hole of the PMT Depth Electrode Anchor Bolt is designed to accommodate depth electrodes with a diameter of $0.050 \pm .005$ inches. Additional designs will be made available to accommodate different manufactures and models of Depth Electrodes with various diameters.

Once the Depth Electrode is at the intended foci, the Port Hole Screw Cap can be tightened to fixture the PMT Depthalon® Depth Electrode. The Device is designed to withstand a longitudinal (push/pull) 100 gram force.

The PMT Depth Electrode Anchor Bolt is available in 25mm, 30mm, 35mm and 40mm lengths to accommodate neurophysiologist preference.

The PMT Depth Electrode Anchor Bolt is provided in a primary and secondary pouch. The pouch is a Tyvek and cellophane configuration. The Tyvek pouch with the chevron design feature provides a 1-3 lb. pull apart strength.

The PMT Depth Electrode Anchor Bolt is provided sterile or non-sterile. The type of sterilization used is 100% Ethylene Oxide. The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a non-sterile unit of $10^{-6}$.

The PMT Depth Electrode Anchor Bolt is provided pyrogen free. The method of determination is the Limulus Amebocyte Lysate Test. The Bacterial Endotoxin test is conducted as described in the USP Endotoxin Reference Standard. The pyrogen limit for the PMT Depth Electrode Anchor Bolt is 2.4 Eu/device.

The PMT Depthalon® Electrode Anchor Bolt is tested for biocompatibility. The silicone gasket material has been tested per the General Program Memo # G95-1, the device is classified as an implant device, contacting tissue/bone with an "A" class duration of contact (< 24 hours). The silicone materials used passed the tests for Cytotoxicity, Sensitization, Irritation and Acute Systemic toxicity. The Titanium alloy has passed the Intracutaneous, Acute Systemic Toxicity and Sensitization test (Implant).

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