(446 days)
Not Found
No
The device description and performance studies focus on the physical and electrical characteristics of the electrodes, not on any data processing or analysis capabilities that would typically involve AI/ML. There is no mention of AI, ML, or related terms in the provided text.
No
The device is used for recording and stimulation of electrical signals for brain mapping, which is a diagnostic procedure, not a therapeutic intervention.
Yes
The device is intended for "recording and stimulation of electrical signals on the surface level of the brain" and "recording of electrical activity supports brain mapping." This indicates its use in gathering data to understand or assess a medical condition (brain activity/mapping), which falls under the definition of a diagnostic device.
No
The device description clearly outlines physical components like circular contacts, silicone substrate, insulated wires, and connectors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intraoperative use... for the recording and stimulation of electrical signals on the surface level of the brain." This is a direct interaction with the patient's body (in vivo), not testing samples from the body (in vitro).
- Device Description: The device is described as an "intra-cranial electrode used intraoperatively on the surface of the brain." This further confirms its use within the body.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The purpose is to record and stimulate electrical signals for brain mapping, which is a physiological measurement, not an in vitro diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GYC
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface level of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing:
The nonclinical testing included the following tests 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).
- Dimensional Characteristics (C10-04CIOM, C10-08AIOM): Verification of electrodes dimensional characteristics. Conclusion: Pass.
- Electrical Characteristics (C10-04CIOM, C10-08AIOM): Verification of the electrodes ability to transmit a stimulation signal, resistance to a stimulation signal under worst case charge density condition, resistance to a stimulation signal under worst case current condition, dielectric strength, and electrodes stability under conditions of use (absence of corrosion). Conclusion: Pass for all.
- Mechanical Characteristics (C10-04CIOM, C10-08AIOM): Verification of the resistance to torsion of the active part and silicon sheath, electrodes resistance to bending, and electrodes resistance to traction. Conclusion: Pass for all.
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.
- Cytotoxicity (C10-08AIOM): Percent viability of test article was 93.9%, 98.6%, and 88.5% of reagent control. Result: 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. Result: 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). Result: Non-irritant.
- Pyrogenicity (C10-16CIOM): No rabbit showed an individual temperature rise higher or equal to 0.5℃ above its initial temperature. Result: Non-pyrogenic.
- Indirect (extract) hemolysis (C10-16CIOM): Mean hemolytic index for test article extract was of 0.0%. Result: Non-hemolytic.
- Acute Systemic Toxicity (C10-16AIOM): No evidence of significant systemic toxicity or mortality after test article extracts injection. Result: Non-toxic.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1310 Cortical electrode.
(a)
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.(b)
Classification. Class II (performance standards).
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)
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 201) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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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 (