Search Results

The DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (

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

• 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.

Ask a specific question about this device