Who is the manufacturer of Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

Dixi Medical filed the 510(k) submission for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) (K201931).

What is the FDA product code for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

GYC. It is classified under 21 CFR 882.1310 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

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

Who can help prepare an FDA 510(k) submission like Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)?

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 Intraoperative Subdural Electrodes (Strips and Grids)

K201931 · Dixi Medical · GYC · Oct 2, 2021 · Neurology

Device Facts

Record ID	K201931
Device Name	Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
Applicant	Dixi Medical
Product Code	GYC · Neurology
Decision Date	Oct 2, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1310
Device Class	Class 2

Intended Use

The DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) are intended for intraoperative use for less than or equal to 24 hours with recording and stimulation equipment for the recording and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports brain mapping.

Device Story

Intra-cranial electrodes used intraoperatively on brain surface; designed for EEG recording and brief stimulation for brain mapping. Device consists of circular stainless steel contacts sandwiched between two layers of silicone substrate; insulated wires extend from contacts through flexible tube to connectors for equipment interface. Used in OR by neurosurgeons/clinicians. Output is electrical signal data transmitted to external recording/stimulation equipment; clinicians interpret signals to map brain function. Benefits include localized brain activity monitoring during surgery.

Clinical Evidence

Bench testing only. Included dimensional verification, electrical characteristics (stimulation signal transmission, resistance, dielectric strength, corrosion stability), and mechanical testing (torsion, bending, traction). Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, intracutaneous reactivity, pyrogenicity, hemolysis, and acute systemic toxicity. All tests passed.

Technological Characteristics

Subdural cortical electrodes; stainless steel contacts; silicone substrate. 6.0mm diameter contacts. 1.5mm female socket connectors. Sterile, single-use. Ethylene Oxide sterilization (SAL 10^-6). 5-year shelf life. Standards: ASTM F1980 (aging), ASTM D4332 (climatic), ASTM D4169 (transport). Max stimulation charge density < 30 µC/cm².

Indications for Use

Indicated for intraoperative use (≤24 hours) in patients requiring recording and stimulation of electrical signals on the brain surface to support brain mapping.

Regulatory Classification

Identification

A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.

Predicate Devices

Ad-Tech Medical Instrument Corporation's Subdural Cortical Electrodes (K191186)

Related Devices

K211954 — Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid · Spes Medica Srl · Nov 10, 2022
K202087 — DIXI Medical Microdeep Micro-Macro Depth Electrodes · Dixi Medical · Nov 18, 2021
K082250 — AURAGEN CORTICAL SURFACE ELECTRODES · Integra Neurosciences · Oct 10, 2008
K191346 — Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) · Blackrock Microsystems · Feb 14, 2020
K992194 — CORTICAL MAPPING UNIT, MODEL CMU · Ad-Tech Medical Instrument Corp · Sep 13, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 2, 2021 DIXI Medical % Cindy Domecus Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough. California 94010 Re: K201931 Trade/Device Name: DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: September 1, 2021 Received: September 2, 2021 ## Dear Cindy Domecus: 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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, 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) K201931 ### Device Name DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) Indications for Use (Describe) The DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) are intended for intraoperative use for less than or equal to 24 hours with recording and stimulation equipment for the recording and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports brain mapping. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 201 Subpart D) </div> | |------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 201) </div> | | X Prescription Use (Part 21 CFR 801 Subpart D) __ Over-The-Counter Use (21 CFR 801 Subpart C) ## 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}------------------------------------------------ ## 510(k) Summary #### I. SUBMITTER 510(k) Owner DIXI Medical 2A route de Poulignev 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 Cindy Domecus, R.A.C. (US & EU) Domecus Consulting Services LLC Phone: (650) 343-4813 Fax: (650) 343-7822 Email: Cindy@DomecusConsulting.com Date Prepared September 24, 2021 II. DEVICE Name of Device: DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) Common or Usual Name: Intraoperative Subdural Electrode Classification Name: 21 CFR §882.1310 Cortical Electrode Regulatory Class: II Product Code: GYC III. PREDICATE DEVICE The predicate device is the Ad-Tech Medical Instrument Corporation's Subdural Cortical Electrodes (K191186). There have been no recalls for the predicate device. DEVICE DESCRIPTION IV. The DIXI Medical Intraoperative Subdural Electrode (Strips and Grids) is an intra-cranial electrode used intraoperatively on the surface of the brain. The device is designed for {4}------------------------------------------------ electroencephalography (EEG) recording and brief stimulation for brain mapping purposes. The DIXI Medical Intraoperative Subdural Electrode consists of circular contacts sandwiched between two layers of silicone substrate. The brain contacting side of the silicone substrate body has material removed to expose an amount of contact surface area. Insulated wires extend from each contact through a flexible tube which terminates in connectors for direct connection to user's equipment. | Product Reference | Configuration | Schematic drawing | |----------------------|-----------------------------------------------------------------|----------------------------------------------------------------------| | C10-08AIOM | 1 strip x 8 contacts Contacts numbered from 1 to 8 | Image: Schematic drawing of a connector with 1 strip of 8 contacts. | | C10-16AIOM | 2 strip x 8 contacts Contacts numbered from 1 to 16 | Image: Schematic drawing of a connector with 2 strips of 8 contacts. | | C10-06BIOM | 1 strip x 6 contacts Contacts numbered from 1 to 6 | Image: Schematic drawing of a connector with 1 strip of 6 contacts. | | C10-12BIOM | 2 strip x 6 contacts Contacts numbered from 1 to 12 | Image: Schematic drawing of a connector with 2 strips of 6 contacts. | | C10-04CIOM | 1 strip x 4 contacts Contacts numbered from 1 to 4 | Image: Schematic drawing of a connector with 1 strip of 4 contacts. | A summary of the subject device configurations is provided below. {5}------------------------------------------------ | Product Reference | Configuration | Schematic drawing | |----------------------|-----------------------------------------------------------------|----------------------------------------| | C10-08CIOM | 2 strip x 4 contacts Contacts numbered from 1 to 8 | Image: Schematic drawing of C10-08CIOM | | C10-16CIOM | 4 strip x 4 contacts Contacts numbered from 1 to 16 | Image: Schematic drawing of C10-16CIOM | #### INDICATIONS FOR USE V. The Indications for Use for the subject and predicate devices are noted below. | DIXI Medical Intraoperative Subdural Electrodes SUBJECT DEVICE | AD-TECH Subdural Cortical Electrodes PREDICATE DEVICE, K191186 | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) are intended for intraoperative use for less than or equal to 24 hours with recording and stimulation equipment for the recording and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports brain mapping. | The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemispheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. | ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The predicate device clearance is for a family of electrodes, whereas the subject device is for a single electrode type. As such, the below comparisons are between the subject device and the corresponding electrode type within the predicate device family of electrodes (i.e., the Intraoperative Strip and Intraoperative Grid). {6}------------------------------------------------ Both the subject and predicate devices are intended for use with recording and stimulation equipment for the recording and stimulation of electrical signals at the surface level of the brain. At a high level, the subject and predicate devices are based on the following same technological elements: - Both the subject and predicate device are subdural cortical electrodes for the same . duration of use in the same environment of use. - . Both the subject and predicate device are provided sterile and for single-use only and use the same method of sterilization. - . Both the subject and predicate device have a maximum stimulation charge density of < 30 µC/cm². - . The subject and predicate device have the same contact spacing, maximum number of contacts per electrode cable and diameter of electrode cable. The following technological differences exist between the subject and the Intraoperative Strip and Intraoperative Grid predicate devices: - The number of contacts per electrode is similar. The number of contacts for strips is . the same. The maximum number of contacts for predicate Intraoperative Grid is unknown but, in any case, the number of contacts for the subject device is within the range of the number of contacts for the predicate device. - . The contact materials are similar but not identical; the subject device is stainless steel only, whereas the predicate device includes 90:10 Platimum:Iridium not present in the subject device. - . The contact external diameter is similar but not identical; the subject device is 6.0mm-diameter only. The contact exposure diameter is similar but not identical. The subject device exposure diameter is within the range of exposure diameter for the predicate device. - . Both the subject and predicate device cabling terminate in a 1.5mm female socket, but there is the option with the predicate device to connect to a patient cable. #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Nonclinical Testing The nonclinical testing included in the table below was conducted on subject devices, on baseline and aged devices. Aged devices underwent three sterilization cycles, accelerated aging equivalent to real-time ageing of 5 years (ASTM F1980), extreme climatic conditions (ASTM D4332) and tests of transport (ASTM D4169). | Test Performed | Tested Device Reference | Objective | Conclusion | |--------------------------------|-------------------------------|-----------------------------------------------------------|------------| | Dimensional Characteristics | C10-04CIOM C10-08AIOM | Verification of electrodes dimensional characteristics | Pass | {7}------------------------------------------------ | Test Performed | Tested Device Reference | Objective | Conclusion | |-------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------|------------| | Electrical Characteristics | C10-04CIOM C10-08AIOM | Verification of the electrodes ability to transmit a stimulation signal | Pass | | | | Verification of the electrodes resistance to a stimulation signal under worst case charge density condition | Pass | | | | Verification of the electrodes resistance to a stimulation signal under worst case current condition | Pass | | | | Verification of the electrodes dielectric strength | Pass | | | | Verification of electrodes stability under conditions of use (absence of corrosion) | Pass | | Mechanical Characteristics | C10-04CIOM C10-08AIOM | Verification of the resistance to torsion of the active part and silicon sheath | Pass | | | | Verification of electrodes resistance to bending | Pass | | | | Verification of electrodes resistance to traction | Pass | # Biocompatibility Testing The biocompatibility evaluation for the subject device was conducted in accordance with the FDA's September 2020 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 biocompatibility evaluation included the following tests and results: {8}------------------------------------------------ | Test | Tested Device Reference | Result | Conclusion | |------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | Cytotoxicity | C10-08AIOM | Test 1: Percent viability of test article was 93.9% of reagent control. Test 1: Percent viability of test article was 98.6% of reagent control. Test 3: Percent viability of test article was 88.5% of reagent control. | Non-cytotoxic | | Sensitization | C10-16CIOM | Topical application of the 0.9% sodium chloride extract and the sesame oil extract did not induce delayed sensitization in the guinea pig. | Non-sensitizer | | Intracutaneous reactivity | C10-16CIOM | Difference between each test extract overall mean score and corresponding control blank overall mean score was lower than 1.0 (0.0 for the 0.9% sodium chloride extract and sesame oil test extracts). | Non-irritant | | Pyrogenicity | C10-16CIOM | No rabbit showed an individual temperature rise higher or equal to 0.5℃ above its initial temperature. | Non- pyrogenic | | Indirect (extract) hemolysis | C10-16CIOM | Mean hemolytic index for test article extract was of 0.0%. | Non- hemolytic | | Acute Systemic Toxicity | C10-16AIOM | No evidence of significant systemic toxicity or mortality after test article extracts injection. | Non-toxic | The contact classification for the subject device is an external communicating device with tissue/bone contact and cerebrospinal fluid (CSF) contact for a limited (≤24 hours) duration. # Sterilization and Shelf-Life Testing The subject device is sterilized using Ethylene Oxide to a SAL = 10-6. A shelf-life of 5 years has been established based on accelerated and real-time aging. #### CONCLUSIONS VIII. The Indications for Use for the subject device is a subset of the Indications for Use for the predicate device, and the differences in technological characteristics do not raise new or different questions of safety and effectiveness, with the non-clinical and biocompatibility testing performed demonstrating the continued effectiveness of the subject device as compared to the predicate device.