(478 days)
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.
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, Micro-contacts, Microdrive for micro-contacts, Cap, Connectors for micro and macro-contacts.
The provided 510(k) summary for the DIXI Medical Microdeep® Micro-Macro Depth Electrodes details the results of non-clinical testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (from context) | Reported Device Performance |
|---|---|---|
| Dimensional Characteristics | Verification of electrodes dimensional characteristics | Pass |
| Mechanical Characteristics | - Verification of electrode microdrive functioning- 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 | Pass |
| Electrical Characteristics | - Verification of the electrical characteristics (contacts continuity, contacts resistance, absence of short-circuit, insulating resistance)- Verification of the electrode integrity and electrical functionality after stimulation under worst case charge density | Pass |
| Device Integrity | - Verification of the absence of alteration of the packaging- Verification of the absence of alteration of the electrode | Pass |
| Comparative Testing | - Comparative test of the tensile strength of the micro-contacts between the predicate device and the subject device- Verification of the integrity and the mechanical functionality of the predicate device and the subject device after clinical simulation of use | Pass |
| Biocompatibility - Cytotoxicity | Non-cytotoxic (per ISO 10993-5) | Non-cytotoxic |
| Biocompatibility - Sensitization | Non-sensitive (per ISO 10993-10) | Non-sensitive |
| Biocompatibility - Irritation or intracutaneous reactivity | Negligible irritation (per ISO 10993-10) | Negligible irritation |
| Biocompatibility - Acute systemic toxicity | Non-toxic (per ISO 10993-11) | Non-toxic |
| Biocompatibility - Material-mediated pyrogenicity | Non-pyrogenic (per USP) | Non-pyrogenic |
| Biocompatibility - Sub-acute toxicity | Non-toxic (per ISO 10993-11) | Non-toxic |
| Biocompatibility - Genotoxicity – Mouse Lymphoma Assay | Non-genotoxic (per OECD guideline No. 490 and ISO 10993-3) | Non-genotoxic |
| Biocompatibility - Genotoxicity – Bacterial Reverse Mutation | Non-genotoxic (per OECD guideline No. 471 and ISO 10993-3) | Non-genotoxic |
| Biocompatibility - Indirect (extract) hemolysis | Non-hemolytic (per ASTM F756 and ISO 10993-4) | Non-hemolytic |
| Biocompatibility - Implantation and neurotoxicity | No or minimal reaction (per ISO 10993-6) | No or minimal reaction |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6, EO residuals per ISO 10993-7 (per ISO 11135:2014) | SAL of 10^-6 demonstrated; device meets EO residuals |
| Shelf-life | Shelf-life established based on accelerated and real-time aging | 4 years established |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test. The tests were performed in a laboratory setting by DIXI Medical. The data provenance is internal to DIXI Medical (France). All data appears to be prospective as it details performance and safety studies conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The tests performed are non-clinical, laboratory-based engineering, material, and biological evaluations. There is no "ground truth" derived from expert review in the clinical sense for these types of tests. The "ground truth" for these tests is the defined engineering specifications, material properties, and biological safety standards (e.g., ISO, USP, ASTM, OECD guidelines).
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are non-clinical laboratory tests, not clinical studies requiring adjudication of output. The results of the tests are objectively measured against pre-defined criteria in the relevant standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (electrode) and relies on non-clinical performance and safety data, as well as a comparison of technological characteristics to a predicate device, rather than a clinical effectiveness study involving human readers and AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an electrode, not an AI or algorithm-based system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests is established by:
- Engineering specifications and standards: For dimensional, mechanical, and electrical characteristics, the "ground truth" is the established design specifications and performance metrics for the device, validated against recognized engineering principles and testing methods.
- International Standards (ISO, ASTM, OECD) and Pharmacopeia (USP): For biocompatibility, sterilization, and shelf-life, the "ground truth" is defined by the requirements and acceptance criteria outlined in specific international standards and guidelines (e.g., ISO 10993 series, ISO 11135, USP).
8. The Sample Size for the Training Set
Not applicable. This device is an electrode, not an AI or algorithm-based system, so there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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
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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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
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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.
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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 MedicalMicrodeep® Micro-MacroDepth Electrodes(Subject Device) | Ad-Tech Medical InstrumentCorporationMacro Micro DepthElectrodes(Predicate device K163355) | DIXI MedicalMicrodeep 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 DepthElectrodes are intended fortemporary (<30 days) usewith recording, monitoringand stimulation equipmentfor the recording, monitoringand stimulation of electricalsignals at the subsurface levelof the brain. The recording ofelectrical activity supportsdefinition of the location ofepileptogenic foci and brainmapping. | The AD-TECH DepthElectrodes (Depth Electrodes,Foramen Ovale DepthElectrodes, Macro MicroDepth Electrodes, SpencerProbe Depth Electrodes,Wyler Sphenoidal DepthElectrodes) are intended fortemporary (< 30 days) usewith recording, monitoringand stimulation equipment forthe recording, monitoring andstimulation of electricalsignals at the subsurface levelof the brain. The recording ofelectrical activity supportsdefinition of the location of | The DIXI Medical MicrodeepDepth Electrodes are intendedfor temporary (<30 days) usewith recording, monitoringand stimulation equipment forthe recording, monitoring andstimulation of electrical signalsat the subsurface level of thebrain. |
| Attribute | DIXI MedicalMicrodeep® Micro-MacroDepth Electrodes(Subject Device) | Ad-Tech Medical InstrumentCorporationMacro Micro DepthElectrodes(Predicate device K163355) | DIXI MedicalMicrodeep Depth Electrode(Reference Device K170959) |
| Environment of Use | Intraoperative andNeurological monitoringlocations | Intraoperative andNeurological monitoringlocationsepileptogenic foci and brainmapping. | Intraoperative andNeurological monitoringlocations |
| 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 StimulationCharge 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: depthelectrode that has electricalmacro-contacts collars placedon the outside and micro-contacts cut flush at thesurface, between macro-contacts, which can bereleased | Two kinds of Macro MicroDepth Electrodes:1. BEHNKE FRIED DEPTHELECTRODES, two piecedesign:- Macro portion: depthelectrode that has electricalmacro-contacts collars placedon the outside and an innerlumen throughout the entirelength- Micro portion: wire bundle | One piece design: depthelectrode that has electricalmacro-contacts collars placedon the outside, no micro-contacts |
| Attribute | DIXI MedicalMicrodeep® Micro-MacroDepth Electrodes(Subject Device) | Ad-Tech Medical InstrumentCorporationMacro Micro DepthElectrodes(Predicate device K163355) | DIXI MedicalMicrodeep Depth Electrode(Reference Device K170959) |
| (micro-contacts) that passesthrough the inner lumen of themacro-electrode2. MACRO-MICRO DEPΤΗELECTRODES: one piecedesign: depth electrode thathas electrical macro-contactscollars placed on the outsideand micro-contacts cut flushat the surface, between macro-contacts | |||
| Removable stylet in theelectrode | 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 electrodecontacts | 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 theelectrode) | 2 mm (Macro-contact) | 1.57 mm (Macro-contact) | 2 mm (Macro-contact) |
| Attribute | DIXI MedicalMicrodeep® Micro-MacroDepth Electrodes | Ad-Tech Medical InstrumentCorporationMacro Micro DepthElectrodes | DIXI MedicalMicrodeep 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) | TitaniumSilicone (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 HoleDiameter | 2.1 mm | 2.4 mm or 2.8 mm | 2.1 mm |
| Compatible DepthElectrode Body Diameter | 0.8 mm | 0.86 mm to 1.3 mm | 0.8 mm |
| Attachment onto the skull | Threaded into a pre-drilledhole in the skull | Threaded into a pre-drilledhole in the skull | Threaded into a pre-drilledhole in the skull |
| Anchor bolt placement | Long Screwdriver | Anchor bolt placementwrench | Long Screwdriver |
| Anchor bolt removal | Wrench and ShortScrewdriver | 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 MedicalMicrodeep® Micro-MacroDepth Electrodes(Subject Device) | Ad-Tech Medical InstrumentCorporationMacro Micro DepthElectrodes(Predicate device K163355) | DIXI MedicalMicrodeep Depth Electrode(Reference Device K170959) |
| Method of sterilization | Ethylene oxide | Ethylene oxide | Ethylene oxide |
| Device Accessories | |||
| List of Accessories | Instrument guide, Bonestarter, Sliding Ruler,Coagulation Electrode andStop, Flat Screwdriver (forstop), Drill and Stop, LongScrewdriver, Anchor Bolt,Marking Rod, Cap for AnchorBolt, Depth Report device,Stylet, Stop, Sheath Holder,Extension cable, Adapter andConnection cable, and Wrenchand Short Screwdriver forAnchor Bolt. | Guide, Channeled Ruler, DrillBit with Stop and Wrench,Anchor placement/removalWrench, Anchor Bolt,Obturator and Cabrio andTech-Attach ConnectionSystems | Instrument guide, Bonestarter, Sliding Ruler,Coagulation Electrode andStop, Flat Screwdriver (forstop), Drill and Stop, LongScrewdriver, Anchor Bolt,Marking Rod, Cap for AnchorBolt, Depth Report device,Stylet, Stop, Extension cable,Adapter and Connection cable,and Wrench and ShortScrewdriver for Anchor Bolt. |
| Single-Use Accessories | Coagulation Electrode andStop, Drill and Stop, AnchorBolt, Cap for Anchor Bolt,Stylet, Sheath Holder | Drill Bit with Stop andWrench, Anchor Bolt andObturator | Coagulation Electrode andStop, Drill and Stop, AnchorBolt, Cap for Anchor Bolt,Stylet |
| Method of Sterilizationfor Single Use Accessories | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Reusable Accessories | Instrument guide, Bonestarter, Sliding Ruler, FlatScrewdriver (for stop), LongScrewdriver, Marking Rod | Guide, Channeled Ruler,Anchor placement/removalWrench, and Cabrio and Tech-Attach Connection Systems | Instrument guide, Bonestarter, Sliding Ruler, FlatScrewdriver (for stop), LongScrewdriver, Marking Rod |
| Attribute | DIXI MedicalMicrodeep® Micro-MacroDepth Electrodes(Subject Device) | Ad-Tech Medical InstrumentCorporationMacro Micro DepthElectrodes(Predicate device K163355) | DIXI MedicalMicrodeep Depth Electrode(Reference Device K170959) |
| Depth Report Device, Stop,Extension Cable, Adapter,Connection Cable, Wrenchand Short Screwdriver forAnchor Bolt | Depth Report Device, Stop,Extension Cable, Adapter,Connection Cable, Wrench andShort Screwdriver for AnchorBolt | ||
| Method of Sterilizationfor Reusable Accessories | Steam Sterilization (with theexception of the Adapter,which does not requiresterilization) | Unknown (except for Cabrioand Tech-Attach ConnectionSystems: Ethylene Oxide orSterrad) | Steam Sterilization (with theexception of the Adapter,which does not requiresterilization) |
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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 |
|---|---|---|
| DimensionalCharacteristics | Verification of electrodes dimensionalcharacteristics | Pass |
| Mechanical characteristics | - Verification of electrode microdrivefunctioning | Pass |
| - Verification of electrode water tightness | ||
| - Verification of cap maintenance on theelectrode sheath | ||
| - Verification of the antirotation function ofelectrode cap | ||
| - Verification of tensile strength of electrodemacro-contacts | ||
| Electrical characteristics | - Verification of the electrical characteristics(contacts continuity, contacts resistance,absence of short-circuit, insulating resistance) | Pass |
| - Verification of the electrode integrity and | ||
| electrical functionality after stimulation under | ||
| worst case charge density | ||
| Device integrity | - Verification of the absence of alteration of thepackaging | Pass |
| - Verification of the absence of alteration of the | ||
| electrode | ||
| Comparative Testing | - Comparative test of the tensile strength of themicro-contacts between the predicate deviceand the subject device | Pass |
| - Verification of the integrity and the mechanical | ||
| functionality of the predicate device and the | ||
| subject device after clinical simulation of use | ||
BIOCOMPATIBILITY TESTING VIII.
The contact classification for the DIXI Medical Microdeep® Micro-Macro Depth Electrode component of the subject device is an external communicating device with tissue/bone and cerebrospinal fluid contact for a prolonged duration (>24 hours to 30 days). The biocompatibility evaluation for the subject device was conducted in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and in accordance with FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff. The results of biocompatibility testing included in
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the table below demonstrate that the device meets biological safety requirements per ISO for externally communicating devices with tissue/bone and cerebrospinal fluid contact and prolonged duration (>24 hours to 30 days.).
| Test | Standard | Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitive |
| Irritation orintracutaneous reactivity | ISO 10993-10 | Negligible irritation |
| Acute systemic toxicity | ISO 10993-11 | Non-toxic |
| Material-mediatedpyrogenicity | USP | Non-pyrogenic |
| Sub-acute toxicity | ISO 10993-11 | Non-toxic |
| Genotoxicity – MouseLymphoma Assay | OECD guideline No. 490 andISO 10993-3 | Non-genotoxic |
| Genotoxicity – BacterialReverse Mutation | OECD guideline No. 471 andISO 10993-3 | Non-genotoxic |
| Indirect (extract)hemolysis | ASTM F756 and ISO 10993-4 | Non-hemolytic |
| Implantation andneurotoxicity | ISO 10993-6 | No or minimal reaction |
STERILIZATION AND SHELF-LIFE TESTING IX.
The subject device is sterilized using Ethylene Oxide. The sterilization validation has been performed in accordance with the principles of ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. A sterility assurance level (SAL) of 10 % has been demonstrated. The device meets EO residuals per ISO 10993-7.
A shelf-life of 4 years has been established based on accelerated and real-time aging.
X. CONCLUSIONS
The subject and predicate device share the same intended use – 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 differences in technological characteristics do not raise different questions of safety and effectiveness, and the nonclinical performance data submitted in the 510(k) demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.
§ 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).