Who is the manufacturer of DIXI Medical Microdeep Micro-Macro Depth Electrodes?

Dixi Medical filed the 510(k) submission for DIXI Medical Microdeep Micro-Macro Depth Electrodes (K202087).

What is the FDA product code for DIXI Medical Microdeep Micro-Macro Depth Electrodes?

GZL. It is classified under 21 CFR 882.1330 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for DIXI Medical Microdeep Micro-Macro Depth Electrodes?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DIXI Medical Microdeep Micro-Macro Depth Electrodes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DIXI Medical Microdeep Micro-Macro Depth Electrodes

K202087 · Dixi Medical · GZL · Nov 18, 2021 · Neurology

Device Facts

Record ID	K202087
Device Name	DIXI Medical Microdeep Micro-Macro Depth Electrodes
Applicant	Dixi Medical
Product Code	GZL · Neurology
Decision Date	Nov 18, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1330
Device Class	Class 2

Intended Use

The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.

Device Story

Invasive depth electrode for temporary (<30 days) intracranial use; records, monitors, and stimulates brain electrical signals. Input: neural electrical signals; Output: electrical signals transmitted to external recording/monitoring equipment. Used in intraoperative and neurological monitoring settings by physicians trained in intracranial neurophysiology. Device features macro-contacts on the exterior and micro-contacts flush at the surface; includes a microdrive for micro-contact adjustment. Output facilitates identification of epileptogenic foci and brain mapping, aiding clinical decision-making for epilepsy treatment. Benefits include precise subsurface neural signal acquisition.

Clinical Evidence

Bench testing only. Testing included dimensional verification, mechanical functionality (microdrive, water tightness, tensile strength), electrical characteristics (continuity, resistance, stimulation integrity), and biocompatibility per ISO 10993. Comparative testing against the predicate confirmed equivalent tensile strength and mechanical functionality after simulated use.

Technological Characteristics

Single-use, sterile, ethylene oxide-sterilized depth electrode. Macro-contacts: Platinum/Iridium 90/10; Micro-contacts: Tungsten. Anchor bolt: Titanium alloy Ti6Al4V (ASTM F136). One-piece design with microdrive. Dimensions: 0.8 mm macro-contact diameter, 20-micron micro-contact diameter. Connectivity: connects to external recording/stimulation equipment via connection system. No software/algorithm.

Indications for Use

Indicated for patients requiring temporary (<30 days) intracranial recording, monitoring, and stimulation of electrical signals to define epileptogenic foci and perform brain mapping. Used by physicians trained in intracranial neurophysiology.

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

Ad-Tech Medical Instrument Corporation's Macro Micro Depth Electrodes (K163355)

Reference Devices

DIXI Medical Microdeep Depth Electrode (K170959)

Related Devices

K170959 — DIXI Medical Microdeep Depth Electrode · Dixi Medical · Nov 24, 2017
K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES · Ad-Tech Medical Instrument Corp · May 25, 2006
K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes · Ad-Tech Medical Instrument Corporation · Apr 12, 2017
K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES · Ad-Tech Medical Instrument Corp · May 30, 2006
K201931 — Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) · Dixi Medical · Oct 2, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ November 18, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Steven Plymale CEO Dixi Neurolab, Inc. 145 Howland Pines Drive Oxford, MI 48371 Re: K202087 Trade/Device Name: DIXI Medical Microdeep Micro-Macro Depth Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: October 20, 2021 Received: October 22, 2021 Dear Steven Plymale: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202087 Device Name DIXI Medical Microdeep® Micro-Macro Depth Electrodes Indications for Use (Describe) The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping. Type of Use (Select one or both, as applicable) | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------------------------| | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for DIXI medical. The logo consists of a blue rectangle on the left, followed by the word "DIXI" in black, bold letters. Below "DIXI" is the word "medical" in a smaller, light gray font. The logo is simple and modern, with a focus on the company name. # 510(k) Summary #### I. SUBMITTER 510(k) Owner DIXI Medical 2A route de Pouligney 25640 Chaudefontaine, France Office: 033-3-81889890 Fax: 033-3-81889899 info@diximedical.com Official correspondent: Lucie Petegnief R&D Manager l.petegnief@diximedical.com Submission Correspondent Name: Steve Plymale CEO Dixi Neurolab Inc. 145 Howland Pines Drive Oxford, MI 48371 Email: steven.plymale@dixineurolab.com Phone: 514 882 3258 Date Prepared Oct. 20, 2021 > II. DEVICE | Name of Device: | DIXI Medical Microdeep® Micro-Macro Depth Electrode | |-----------------------|-----------------------------------------------------| | Common or Usual Name: | Depth Electrode | | Classification Name: | 21 CFR §882.1330 Depth Electrode | | Regulatory Class: | II | | Product Code: | GZL | #### III. PREDICATE DEVICE The predicate device is the Ad-Tech Medical Instrument Corporation's Macro Micro Depth Electrodes (K163355). The DIXI Medical Microdeep® Depth Electrode (K170959) was a reference device for this submission. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for DIXI medical. The logo consists of a blue rectangle on the left, followed by the word "DIXI" in black, bold letters. Below "DIXI" is the word "medical" in gray, smaller letters. The logo is simple and modern, with a focus on the company name. ### IV. DEVICE DESCRIPTION The Microdeep® Micro-Macro Depth Electrode is a single patient use, sterile and disposable device. The Microdeep® Micro-Macro Depth Electrode is invasive as it is placed in contact with nerve tissue (brain) and must only be used during an SEEG procedure with Anchor Bolts. The Microdeen® Micro-Macro Depth Electrode is intended to connect to the user's recording. monitoring and stimulation equipment using the Connection System. This product is intended to be used only by physicians in the area of biopotential recording, monitoring and stimulation / response studies who are trained in intracranial neurophysiology. The DIXI Medical Microdeep® Micro-Macro Depth Electrode is comprised of the following components: - Macro-contacts - located on the outside of the device. - . Micro-contacts - sit flush at the surface of the device between the macro electrodes. - Microdrive for micro-contacts ● - . Cap - Connectors for micro and macro-contacts ● #### V. INDICATIONS FOR USE The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for DIXI medical. The logo consists of a blue square on the left, followed by the word "DIXI" in black, bold letters. Below the word "DIXI" is the word "medical" in gray, smaller letters. The logo is simple and modern, with a focus on the company name. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI. The technological characteristics comparing to the predicate device are outlined in the Substantial Equivalent table. | Attribute | DIXI Medical Microdeep® Micro-Macro Depth Electrodes (Subject Device) | Ad-Tech Medical Instrument Corporation Macro Micro Depth Electrodes (Predicate device K163355) | DIXI Medical Microdeep Depth Electrode (Reference Device K170959) | |--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation Number | 21 CFR §882.1330 | 21 CFR §882.1330 | 21 CFR §882.1330 | | Regulation Name | Depth electrode | Depth electrode | Depth electrode | | Regulatory Class | Class II | Class II | Class II | | Product Code | GZL | GZL | GZL | | Indications for Use | The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. | The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of | The DIXI Medical Microdeep Depth Electrodes are intended for temporary (<30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. | | Attribute | DIXI Medical Microdeep® Micro-Macro Depth Electrodes (Subject Device) | Ad-Tech Medical Instrument Corporation Macro Micro Depth Electrodes (Predicate device K163355) | DIXI Medical Microdeep Depth Electrode (Reference Device K170959) | | Environment of Use | Intraoperative and Neurological monitoring locations | Intraoperative and Neurological monitoring locations epileptogenic foci and brain mapping. | Intraoperative and Neurological monitoring locations | | Provided Sterile | Yes | Yes | Yes | | Method of sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | | Single Use, disposable | Yes | Yes | Yes | | Duration of Use | < 30 days | < 30 days | < 30 days | | Maximum Stimulation Charge Density | $\leq 30 \mu C/cm^2$ | $\leq 30 \mu C/cm^2$ | $\leq 30 \mu C/cm^2$ | | Electrode Characteristics | | | | | General characteristic | One piece design: depth electrode that has electrical macro-contacts collars placed on the outside and micro- contacts cut flush at the surface, between macro- contacts, which can be released | Two kinds of Macro Micro Depth Electrodes: 1. BEHNKE FRIED DEPTH ELECTRODES, two piece design: - Macro portion: depth electrode that has electrical macro-contacts collars placed on the outside and an inner lumen throughout the entire length - Micro portion: wire bundle | One piece design: depth electrode that has electrical macro-contacts collars placed on the outside, no micro- contacts | | Attribute | DIXI Medical Microdeep® Micro-Macro Depth Electrodes (Subject Device) | Ad-Tech Medical Instrument Corporation Macro Micro Depth Electrodes (Predicate device K163355) | DIXI Medical Microdeep Depth Electrode (Reference Device K170959) | | | | (micro-contacts) that passes through the inner lumen of the macro-electrode 2. MACRO-MICRO DEPΤΗ ELECTRODES: one piece design: depth electrode that has electrical macro-contacts collars placed on the outside and micro-contacts cut flush at the surface, between macro- contacts | | | Removable stylet in the electrode | No | Yes | No | | Contacts Material | Platinum/Iridium 90/10 (Macro-contact) Tungsten (Micro-contact) | Platinum (Macro-contact) Platinum/Iridium (Micro- contact) | Platinum/Iridium 90/10 (Macro-contact) | | Electrode body diameter (brain contact) | 0.8 mm (Macro-contact) 20 microns (Micro-contact) | 1.3 mm (Macro-contact) 38 to 51 microns (Micro- contact) | 0.8 mm (Macro-contact) | | Number of electrode contacts | From 6 to 9 (Macro-contact) From 8 to 12 (Micro-contact) | From 6 to 12 (Macro-contact) From 8 to 24 (Micro-contact) | From 5 to 18 (Macro-contact) | | Electrode contact length (along body of the electrode) | 2 mm (Macro-contact) | 1.57 mm (Macro-contact) | 2 mm (Macro-contact) | | Attribute | DIXI Medical Microdeep® Micro-Macro Depth Electrodes | Ad-Tech Medical Instrument Corporation Macro Micro Depth Electrodes | DIXI Medical Microdeep Depth Electrode | | | (Subject Device) | (Predicate device K163355) | (Reference Device K170959) | | Overall length | ~ 400 mm | ≤ 660 mm | ≤ 1050 mm | | Device Accessories - Anchor Bolt | | | | | Product Code | GZL | GZL | GZL | | Regulation Number | 21 CFR §882.1330 | 21 CFR §882.1330 | 21 CFR §882.1330 | | Regulatory Class | II | II | II | | Material | Titanium alloy Ti6Al4V (ELI, ASTM F136) | Titanium Silicone (inner lumen gasket) Parylene | Titanium alloy Ti6Al4V (ELI, ASTM F136) | | Length | From 15 mm to 35 mm | From 13 mm to 26 mm | From 15 mm to 35 mm | | Required Drill Hole Diameter | 2.1 mm | 2.4 mm or 2.8 mm | 2.1 mm | | Compatible Depth Electrode Body Diameter | 0.8 mm | 0.86 mm to 1.3 mm | 0.8 mm | | Attachment onto the skull | Threaded into a pre-drilled hole in the skull | Threaded into a pre-drilled hole in the skull | Threaded into a pre-drilled hole in the skull | | Anchor bolt placement | Long Screwdriver | Anchor bolt placement wrench | Long Screwdriver | | Anchor bolt removal | Wrench and Short Screwdriver | Anchor bolt removal wrench | Wrench and Short Screwdriver | | Implantation duration | Up to 30 days | Up to 30 days | Up to 30 days | | Single use | Yes | Yes | Yes | | Attribute | DIXI Medical Microdeep® Micro-Macro Depth Electrodes (Subject Device) | Ad-Tech Medical Instrument Corporation Macro Micro Depth Electrodes (Predicate device K163355) | DIXI Medical Microdeep Depth Electrode (Reference Device K170959) | | Method of sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide | | Device Accessories | | | | | List of Accessories | Instrument guide, Bone starter, Sliding Ruler, Coagulation Electrode and Stop, Flat Screwdriver (for stop), Drill and Stop, Long Screwdriver, Anchor Bolt, Marking Rod, Cap for Anchor Bolt, Depth Report device, Stylet, Stop, Sheath Holder, Extension cable, Adapter and Connection cable, and Wrench and Short Screwdriver for Anchor Bolt. | Guide, Channeled Ruler, Drill Bit with Stop and Wrench, Anchor placement/removal Wrench, Anchor Bolt, Obturator and Cabrio and Tech-Attach Connection Systems | Instrument guide, Bone starter, Sliding Ruler, Coagulation Electrode and Stop, Flat Screwdriver (for stop), Drill and Stop, Long Screwdriver, Anchor Bolt, Marking Rod, Cap for Anchor Bolt, Depth Report device, Stylet, Stop, Extension cable, Adapter and Connection cable, and Wrench and Short Screwdriver for Anchor Bolt. | | Single-Use Accessories | Coagulation Electrode and Stop, Drill and Stop, Anchor Bolt, Cap for Anchor Bolt, Stylet, Sheath Holder | Drill Bit with Stop and Wrench, Anchor Bolt and Obturator | Coagulation Electrode and Stop, Drill and Stop, Anchor Bolt, Cap for Anchor Bolt, Stylet | | Method of Sterilization for Single Use Accessories | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | Reusable Accessories | Instrument guide, Bone starter, Sliding Ruler, Flat Screwdriver (for stop), Long Screwdriver, Marking Rod | Guide, Channeled Ruler, Anchor placement/removal Wrench, and Cabrio and Tech- Attach Connection Systems | Instrument guide, Bone starter, Sliding Ruler, Flat Screwdriver (for stop), Long Screwdriver, Marking Rod | | Attribute | DIXI Medical Microdeep® Micro-Macro Depth Electrodes (Subject Device) | Ad-Tech Medical Instrument Corporation Macro Micro Depth Electrodes (Predicate device K163355) | DIXI Medical Microdeep Depth Electrode (Reference Device K170959) | | | Depth Report Device, Stop, Extension Cable, Adapter, Connection Cable, Wrench and Short Screwdriver for Anchor Bolt | | Depth Report Device, Stop, Extension Cable, Adapter, Connection Cable, Wrench and Short Screwdriver for Anchor Bolt | | Method of Sterilization for Reusable Accessories | Steam Sterilization (with the exception of the Adapter, which does not require sterilization) | Unknown (except for Cabrio and Tech-Attach Connection Systems: Ethylene Oxide or Sterrad) | Steam Sterilization (with the exception of the Adapter, which does not require sterilization) | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for DIXI medical. The logo consists of a blue square, followed by the word "DIXI" in black, bold letters. Below "DIXI" is the word "medical" in gray, smaller letters. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for DIXI medical. The word "DIXI" is in bold, black letters, and the word "medical" is in gray letters below it. To the left of the word "DIXI" is a blue square. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for DIXI medical. The logo consists of a blue square, followed by the word "DIXI" in black, bold letters. Below "DIXI" is the word "medical" in gray, smaller letters. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for DIXI medical. The logo consists of a blue square, followed by the word "DIXI" in black, bold letters. Below "DIXI" is the word "medical" in gray, smaller letters. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for DIXI medical. The logo consists of a blue square, followed by the word "DIXI" in black, bold letters. Below "DIXI" is the word "medical" in gray, smaller letters. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for DIXI medical. The logo consists of a blue square on the left, followed by the word "DIXI" in black, bold letters. Below "DIXI" is the word "medical" in gray, smaller letters. The logo is simple and modern, with a clear emphasis on the company name. #### VII. NON-CLINICAL TESTING DIXI Medical has performed the following non-clinical laboratory testing to determine substantial equivalence. | Test | Summary of Verifications | Result | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Dimensional Characteristics | Verification of electrodes dimensional characteristics | Pass | | | | | | Mechanical characteristics | - Verification of electrode microdrive functioning | Pass | | | - Verification of electrode water tightness | | | | - Verification of cap maintenance on the electrode sheath | | | | - Verification of the antirotation function of electrode cap | | | | - Verification of tensile strength of electrode macro-contacts | | | |…