(270 days)
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (
Cortical Electrode (Per FDA Classification)
This document is a Traditional 510(k) Summary for the Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids). It asserts substantial equivalence to a predicate device (AD-TECH Subdural Cortical Electrodes) rather than claiming specific performance criteria and a study to meet them. Therefore, the requested information on acceptance criteria and a study proving the device meets them cannot be directly extracted as it would for a claim of new performance.
However, I can interpret the document's content to provide related information about the device's safety and effectiveness testing where it implicitly establishes "acceptance criteria" through conformance to recognized standards and successful test results.
Here's a breakdown of the available information, structured to align as closely as possible with your request:
Acceptance Criteria and Device Performance (Indirectly Derived from Safety and Performance Testing)
The document focuses on demonstrating substantial equivalence to a predicate device, which means proving the new device is as safe and effective as the legally marketed predicate. The "acceptance criteria" are generally implied to be compliance with relevant standards and successful completion of various tests, demonstrating that the device performs as intended and does not raise new questions of safety or efficacy.
| Category | Acceptance Criteria (Implicit/Standard-based) | Reported Device Performance (Results) |
|---|---|---|
| Biocompatibility | ISO 10993 Series (parts 1, 4, 5, 6, 10, 11) and ASTM F756-17, ASTM F2901:2019 standards for biological compatibility (e.g., non-hemolytic, non-cytotoxic, non-irritant, non-sensitizer, non-toxic, non-demyelinating, non-neurodegenerative, non-astrocytotic, non-microglial-proliferative with subdural rabbit brain implantation) | Hemolysis: Non-hemolytic (Indirect Contact) |
| Cytotoxicity: Non-cytotoxic (L929 MEM Elution) | ||
| Implantation: Non-demyelinating, Non-neurodegenerative, Non-astrocytotic, and Non-microglial-proliferative (Subdural Rabbit Brain) | ||
| Irritation: Non-irritant (Intracutaneous Reactivity) | ||
| Sensitization: Non-sensitizer (Kligman Maximization) | ||
| Acute Systemic Toxicity: Non-toxic (Systemic Injection) | ||
| Pyrogenicity | ANSI/AAMI ST72:2011/(R)2016 for bacterial endotoxins; Endotoxin limit of 2.15 EU/Device (0.06 EU/ml) based on potential contact with Cerebrospinal Fluid. | BET/LAL: Non-pyrogenic (Kinetic Chromogenic Technique) |
| Sterilization | Conformance to ISO 11135-1, ISO 11138-1, ISO 11138-2 standards for Ethylene Oxide sterilization (implied to achieve sterility assurance level). | Ethylene Oxide sterilization method, "Sterile only" status. (Specific sterility assurance level not quantified here, but compliance to standards indicates successful sterilization). |
| Packaging Integrity | Conformance to ASTM F88/F88M-15, ASTM F1886-16, ASTM F1980-16, ASTM F2096-11, BS/EN/ISO 11607-1:2017 for seal strength, visual inspection, accelerated aging, and gross leak detection. | Studies are ongoing, but "Currently 1 year (per accelerated aging) and 1-year and 5-year real-time aging studies are ongoing)" leading to an initial 1-year shelf life. Packaging configuration is double (Tyvek) pouched and placed in a chipboard box. |
| Electrical Performance | Electrical continuity, resistance, dielectric strength, impedance, and charge injection capacity (on new and aged products). For patient cable: channel mapping, resistance, shorts, dielectric strength, and impedance. | The devices were physically tested for dielectric strength, impedance, resistance and charge injection capacity on new and aged products. The NeuroCoG Patient Cable was tested for channel mapping, resistance, shorts, dielectric strength, and impedance. Results are stated as successful but not quantified with specific values in this summary. |
| Mechanical Performance | Tensile strength, bending, and chemical compatibility on new and aged products. For patient cable: tensile strength, mating, bending, dropping, and chemical compatibility. | The Blackrock NeuroCoG Subdural Electrodes were physically tested for tensile strength, bending, and chemical compatibility on new and aged products, as well as underwent extensive verification of their mechanical properties. The NeuroCoG Patient Cable was tested for tensile strength, mating, bending, dropping, and chemical compatibility. Results are stated as successful but not quantified with specific values in this summary. |
| Cleaning & Disinfection (Patient Cable) | AAMI TIR12:2010, AAMI TIR30:2011(R)2016 for cleaning (protein and carbohydrate markers) and low-level disinfection (6-log reduction in bacteria). | Cleaning: Protein Marker: |
§ 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).