(84 days)
No
The device description focuses on the mechanical aspects of an anchor bolt for stabilizing electrodes and does not mention any computational or analytical functions that would involve AI/ML.
No
The device is an accessory (anchor bolt) used to stabilize depth electrodes during electroclinical characterization and is not itself providing therapy.
Yes
The device is an accessory that stabilizes a depth electrode, which is used for "intraoperative electroclinical characterization." This characterization is a diagnostic process to understand brain activity.
No
The device description clearly describes a physical hardware component (an anchor bolt made of Titanium alloy and silicone) intended for surgical implantation. It does not mention any software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the PMT Depth Electrode Anchor Bolt is an accessory used to stabilize an electrode inserted into the cranium through a pre-drilled burr hole in the skull. It is an implantable device that interacts directly with tissue and bone.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples outside of the body. Its function is entirely related to the physical placement and stabilization of an electrode within the patient's skull.
Therefore, the device's intended use and mechanism of action do not align with the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
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. 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 ± .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°. 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 (
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).
0
PMT® Corporation
510(k) Notification Sur Anchor Bolt, Depthalon Electrode Accesso January 27, 1997
Premarket Notification [510(k)] Summary
APR 2 9 1997
Submitters name: PMT CORPORATION
Submitters Address: PMT Corporation 1500 Park Road Chanhassen, MN 55317
Phone: (612) 470-0866
Fax: (612) 470-0865
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.
1
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 ± .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°.
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 (