DIXI Medical Microdeep Depth Electrode

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November 24, 2017 DIXI Medical % Valerie Defiesta-Ng Senior Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, California 95110 Re: K170959 Trade/Device Name: DIXI Medical Microdeep Depth Electrode Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: October 25, 2017 Received: October 26, 2017 Dear Ms. Defiesta-Ng: 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/5 description: The image shows the name "Carlos L. Pena -S" in black font. To the right of the name is the acronym "FDA" in a light blue font. The acronym is partially transparent, making it difficult to read. The image is simple and contains only text. Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170959 Device Name DIXI Medical Microdeep Depth Electrode Indications for Use (Describe) The DIXI Medical Microdeep Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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GENERAL INFORMATION [807.92(a)(1)] Applicant: DIXI Medical 2A Route de Pouligney 25640 Chaudefontaine France Phone: +33 3 81 88 98 90 +33 3 81 88 98 99 Fax: ## Contact Person: Valerie Defiesta-Ng Regulatory Consultant for DIXI Medical Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 U.S.A. Phone: 408-400-0856 Fax: 408-400-0865 Email: valerie(@experiengroup.com ## Date Prepared: October 25, 2017 #### II. DEVICE INFORMATION [807.92(a)(2)] Trade/Proprietary Name: DIXI Medical Microdeep Depth Electrode ## Generic/Common Name: Electrode, depth Classification Name: Depth electrode (21 CFR§882.1330) Regulatory Class: Class II Product Code: GZL {4}------------------------------------------------ #### PREDICATE DEVICES [807.92(a)(3)] III. - PMT® Platinum Depthalon® Depth Electrodes (K151790) . - . AD-TECH Medical Instrumentation Corporation Depth Electrodes (K053358) - Radionics Recording and Stimulating Electrode (K012850) ● #### DEVICE DESCRIPTION [807.92(a)(4)] IV. The DIXI Medical Microdeep Depth Electrode ("Microdeep Depth Electrode" or "Electrode") is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Microdeep Depth Electrodes are used under the supervision of a physician (physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes) and are intended to connect to the user's recording, monitoring and stimulation equipment. This information is then used for defining the location of epileptogenic foci and brain mapping. #### V. INDICATIONS FOR USE [807.92(a)(5)] The Indication for Use statement for the Microdeep Depth Electrodes is as follows: The DIXI Medical Microdeep Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. {5}------------------------------------------------ ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)] The Microdeep Depth Electrodes are substantially equivalent to the primary predicate device, the PMT Platinum Depthalon Depth Electrodes (K151790) as they have the same intended use in the same patient population, utilize similar performance specifications and have comparable technological features to achieve the same mechanism of action: therefore, the Microdeep Depth Electrodes do not raise any different issues of safety or effectiveness. Additional predicate devices have been selected for comparison to technological characteristics, the AD-TECH Medical Instrumentation Corporation Depth Electrodes (K053358) and the Radionics Recording and Stimulating Electrode (K012850). #### VII. PERFORMANCE DATA [807.92(b)] Performance testing was performed to assure safety and effectiveness of the Microdeep Depth Electrodes. All necessary bench testing was conducted on the Microdeep Depth Electrodes to ensure conformance to design specifications and to support a determination of substantial equivalence to the predicate devices. ## [807.92(b)(1)] The nonclinical, bench testing performed included: - Verification testing (mechanical, electrical and functional testing); ● - Biocompatibility testing; ● - . Packaging, shelf life and transit testing; and - . EO Sterilization Validation. A human cadaver study was conducted by DIXI Medical. The purpose of this human cadaver study was to demonstrate simulated use of the DIXI Medical Microdeep Depth Electrode and its implantation and tracking, when implanted according to its instructions for use (IFU). The implantation accuracy and tracking accuracy of the Microdeep Depth Electrode were compared to the implantation accuracy and tracking accuracy of a predicate device (Integra Depth Electrode, K012850). Cadaver heads were implanted with equal number of electrodes. Results are summarized herein. ## Implantation Accuracy The study compared the implantation accuracy, as measured by the final implant location, of the Microdeep Depth Electrodes to a predicate at a variety of Supratentorial targets. The mean difference in errors of the predicate and the Microdeep Depth Electrode was compared with a non-inferiority test (one side paired two-sample t-test). The data demonstrates a mean difference in errors of 2.87mm which is less than the non-inferiority margin of 3.6mm, therefore the implantation accuracy endpoint has been met. ## Tracking Accuracy The study assessed the ability of the DIXI Medical Microdeep Depth Electrode to travel within the track previously created by the DIXI Medical stylet. In summary {6}------------------------------------------------ there are three targets with a 1mm difference and 1 target with a 3mm difference, for a mean and standard deviation of 0.12mm +/- 0.47mm. The data demonstrates the ability of the DIXI Medical Microdeep Depth Electrode to travel within the track previously created by the DIXI Medical stylet. ## [807.92(b)(2)] No clinical testing was performed in support of this premarket notification. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Microdeep Depth Electrodes meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Microdeep Depth Electrodes do not raise different questions of safety or effectiveness for use as depth electrodes when compared to the predicate devices. #### CONCLUSIONS [807.92(b)(3)] VIII. The Microdeep Depth Electrodes do not raise any different questions of safety or effectiveness, as both the Microdeep Depth Electrode and the predicate devices have the same intended use, have been historically cleared for use in the same procedures, and utilize similar performance specifications and comparable technological features to achieve the same mechanism of action: therefore, the Microdeep Depth Electrode is substantially equivalent to the predicate devices. The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Microdeep Depth Electrode. As demonstrated by successful performance testing, any differences in the technological characteristics between the proposed device and the predicate devices do not raise any different questions of safety or effectiveness. Thus, the Microdeep Depth Electrode is substantially equivalent to the predicate devices. As such, the Microdeep Depth Electrode is substantially equivalent to the predicate devices, namely the PMT® Platinum Depthalon® Depth Electrode (K151790), as well as the AD-TECH Medical Instrumentation Corporation Depth Electrodes (K053358) and Radionics Recording and Stimulating Electrode (K012850).