(478 days)
No
The summary describes a physical medical device (electrodes) for recording and stimulating brain signals. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is intended for recording, monitoring, and stimulation of electrical signals for diagnostic purposes (defining epileptogenic foci and brain mapping), not for treating a condition.
Yes
The device is intended for "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain" and "The recording of electrical activity supports definition of epileptogenic foci and brain mapping," which are diagnostic activities.
No
The device description clearly states it is a physical, invasive electrode comprised of hardware components (Macro-contacts, Micro-contacts, Microdrive, Cap, Connectors).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are designed for direct insertion into the brain to record, monitor, and stimulate electrical signals within the body (in vivo).
- Intended Use: The intended use clearly states it's for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain to support definition of epileptogenic foci and brain mapping. This is an in-vivo procedure.
- Device Description: The description emphasizes its invasive nature and placement in contact with nerve tissue (brain).
The device is a medical device, but its function and intended use fall under the category of devices used within the body for diagnosis and treatment, not for testing samples taken from the body.
N/A
Intended Use / Indications for Use
The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (
§ 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).
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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
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
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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 ( 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 (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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Image /page/12/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.
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 or | ||
| intracutaneous reactivity | ISO 10993-10 | Negligible irritation |
| Acute systemic toxicity | ISO 10993-11 | Non-toxic |
| Material-mediated | ||
| pyrogenicity | USP | Non-pyrogenic |
| Sub-acute toxicity | ISO 10993-11 | Non-toxic |
| Genotoxicity – Mouse | ||
| Lymphoma Assay | OECD guideline No. 490 and | |
| ISO 10993-3 | Non-genotoxic | |
| Genotoxicity – Bacterial | ||
| Reverse Mutation | OECD guideline No. 471 and | |
| ISO 10993-3 | Non-genotoxic | |
| Indirect (extract) | ||
| hemolysis | ASTM F756 and ISO 10993-4 | Non-hemolytic |
| Implantation and | ||
| neurotoxicity | 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 (