Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

• K Number: K191346
• Device Name: Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
• Manufacturer: Blackrock Microsystems
• Date Cleared: 2020-02-14 ( 270 days)
• Product Code: GYC
• Regulation Number: 882.1310
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: K053363
• Predicate For: N/A

Intended Use

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Device Description

Cortical Electrode (Per FDA Classification)

AI/ML Overview

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:

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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: <6.4 µg/cm²; Carbohydrate Marker: <1.8 µg/cm² (British soil, CaviWipes and CaviCide) Disinfection: 6-log reduction in bacteria (Low-level disinfection with CaviWipes and CaviCide)
MRI Safety	Implied criteria related to potential hazards in an MR environment.	Labeled as MR Unsafe. (Indication that it was evaluated and found not safe for MR environments, hence the labeling).

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Detailed Information on Studies:

1. Sample sizes used for the test set and the data provenance:

   • Biocompatibility (Implantation Test): Performed on "Subdural Rabbit Brain". The exact number of rabbits used is not specified in this document. Data provenance is implied to be laboratory testing.
   • Cleaning/Disinfection (Patient Cable): No specific sample size for the "test set" (i.e., number of cables) is mentioned, but the methods were "British soil, CaviWipes, and CaviCide" and "Low-level disinfection with CaviWipes and CaviCide". Data provenance is laboratory testing.
   • Other tests (Hemolysis, Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, BET/LAL, Electrical, Mechanical, Packaging): The document refers to various standards (e.g., ISO, ASTM, AAMI TIR) that typically specify sample sizes for these types of tests. However, the specific sample sizes used by Blackrock Microsystems for each test are not detailed in this 510(k) summary. The studies are laboratory-based.
   • Retrospective or Prospective: All listed testing appears to be prospective laboratory testing or material characterization, rather than human clinical studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this device and submission. The "ground truth" for these types of tests (biocompatibility, electrical, mechanical, sterilization, packaging) is established by adherence to recognized scientific and engineering standards and methodologies, not by expert interpretation of clinical data or images. The "experts" would be the scientists and engineers conducting the tests and verifying compliance with the standards, whose qualifications are implied by their ability to conduct such highly specialized testing.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This is not applicable as the tests are analytical/performance-based, not interpretative (like image reading for diagnostic devices). Results are compared against predefined acceptance criteria from standards, not adjudicated by human readers.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. The Blackrock NeuroCoG Subdural Cortical Electrodes are physical medical devices (electrodes and cables) used for recording and stimulation. They are not AI-powered diagnostic devices, and no human reader interpretation or AI assistance is involved in their direct function.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is not applicable. The device is a passive electrical conductor and does not involve an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the various tests mentioned is based on established scientific and engineering principles, recognized international standards (ISO, ASTM, AAMI), and predefined acceptance limits derived from these standards. For example, for biocompatibility assays, the ground truth is the chemical and biological response of materials as measured by standardized laboratory methods (e.g., cell viability in cytotoxicity, hemolytic index in hemolysis). For electrical and mechanical tests, it's the physical properties meeting defined specifications.

7. The sample size for the training set:

   • This is not applicable. The device is a passive physical medical device and does not utilize a "training set" in the context of machine learning or AI algorithms. Its design and manufacturing are based on engineering principles and materials science.

8. How the ground truth for the training set was established:

   • This is not applicable, as there is no "training set" for this device.

Summary

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February 14, 2020

Blackrock Microsystems Rachelle Frischknecht Regulatory Affairs Specialist 630 Komas Drive, Suite 200 Salt Lake City, Utah 84108

Re: K191346

Trade/Device Name: Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: January 12, 2020 Received: January 15, 2020

Dear Rachelle Frischknecht:

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

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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 ([e-mail]) or phone [phone] 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)

K191346

Device Name

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

Indications for Use (Describe)

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Type of Use (Select one or both, as applicable)
× 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 contains the logo for Blackrock Microsystems. The logo consists of a stylized black bird-like figure to the left of the company name. The word "BLACKROCK" is printed in black, and the word "MICROSYSTEMS" is printed in blue below it.

Traditional 510(k) Summary

1.	Summary Date:	February 13, 2020
2.	Applicant Name:	Blackrock Microsystems, LLC630 Komas Drive, Suite 200Salt Lake City, UT 84108USAEstablishment Registration Number: 3007323246
3.	Correspondent:	Rachelle Frischknecht
4.	Trade Name:	Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
5.	Common Name:	Cortical Electrode, Subdural Strips and Grids
6.	Description:	Cortical Electrode (Per FDA Classification)
7.	Manufacturing Site:	Blackrock Microsystems, LLCE-mail: [e-mail] Establishment Number: 3007323246
8.	Sterilization Site:	Sterilization Site: Life Science Outsourcing, Inc.FDA Establishment Number: 2031093
9.		Classification Regulation, Class, Product Code, and Panel:21 CFR 882.1310 NeurologyClass IIProduct Code: GYCPanel: Neurology
10.	Reason for Traditional 510(k):	New submission
11.	Predicate Device(s):	510(k) Number: K053363Manufacturer: Ad-Tech Medical Instrument CorporationTrade Name: AD-TECH Subdural Cortical Electrodes (Dual-SidedInterhemispheric, Grid, Intraoperative, Strip, Wyler)Product Code: GYCClassification: 21 CFR 882.1310

12. Compliance to Special Controls / Performance Standards There are no special controls/performance standards associated with Product Code GYC. However, conformance to the following recognized consensus standards is declared:

• AAMI TIR12:2010 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health . Care Facilities: A Guide for Medical Device Manufacturers
• AAMI TIR30:2011(R)2016 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria ● for Cleaning Reusable Medical Devices
• ANSI/AAMI/ISO 10993-1:2009/(R)2013 Biological Evaluation of Medical Devices Part 1: Evaluation and ● Testing Within a Risk Management Process
• ANSI/AAMI/ISO 11737-1:2018 Sterilization of Health Care Products -Microbiological Methods Part 1: ● Determination of a Population of Microorganisms on Products

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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• ANSI/AAMI/ST72:2011/(R)2016 Bacterial Endotoxins Test Methods, Routine Monitoring, and ● Alternatives to Batch Testing
• . ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
• ASTM D4332-14 Standard Practice for Containers, Packages, or Packaging Components for Testing
• ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
• ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
• ASTM F1886-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual ● Inspection
• ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal ● Pressurization
• ASTM F2901-19 Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
• BS/EN/ISO 11607-1:2017 Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier System, and Packaging Systems
• . BS/EN/ISO 11737-2:2009 Sterilization of Medical Devices – Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation, and Maintenance of a Sterilization Process
• . IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of Usability Engineering to Medical Devices [Including CORRIGENDUM 1 (2016)]
• ISO 10993-4 Third Edition 2017-04 Biological Evaluation of Medical Devices Part 4: Selection of Test ● for Interactions with Blood
• ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices – Part 5: Tests for in Vitro Cytotoxicity
• ISO 10993-6 Third Edition 2016-12-01 Biological Evaluation of Medical Devices - Part 6: Tests for Local Effects After Implantation
• ISO 10993-7 Second Edition 2008-10-15 Biological Evaluation of Medical Devices: Ethylene Oxide ● Sterilization Residuals
• ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation of Medical Devices Part 10: Tests for ● Irritation and Skin Sensitization
• ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
• ISO 11135-1 Second Edition 2014-07-15 Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation, and Routine Control of a Sterilization for Medical Devices
• ISO 11138-1 Third Edition 2017-03 Sterilization of Health Care Products - Biological Indicators - Part 1: General Requirements
• . ISO 11138-2 Third Edition 2017-03 Sterilization of Health Care Products - Biological Indicators - Part 2: Biological Indicators for Ethylene Oxide Sterilization Processes
• 13. Indications for Use

The Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

• 14. Technological Characteristics
      Both devices are nearly identical in size and materials to the predicate and both essential serve as "electrical conductors" of either EEG signals or stimulation currents. The differences are minor and do not affect safety or efficacy.

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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15. Comparison to Predicates

The main differences between the NeuroCoG Subdural Cortical Electrodes (Strips and Grids) device under review and the predicate are as follows:

• Both companies include a means to show the user the layout and color-coding of the electrode. Differences ● exist based on layout, font sizes, marketing issues, etc. These issues do not affect the safety or effectiveness of the device.
• . The proposed device is labeled as non-pyrogenic, the predicate device is not. Labeling the devices as nonpyrogenic is not a regulatory requirement. Doing so is done for marketing purposes and does not raise any new questions of safety or effectiveness.
• . The proposed device includes additional cautions statements for user performance issues only. They do not raise any questions on safety or efficacy.
• The proposed device is available with electrode exposures of 2,3 mm diameter. The predicate device has electrode exposures of 1.5 mm, 1.5 mm x 3.0 mm, 2.3 mm diameter, 4.0 mm diameter per K053363 submission and 1.17, 1.8 mm, 5 mm dia. (exposed) currently marketed. The proposed exposure of 2.3 mm is within the boundaries of the predicate.
• The proposed device can accommodate 32 contacts per pigtail instead of 16. Doing so reduces the number of incisions needed to tunnel the pigtails away from the surgical site. Less pigtails implies fewer block connectors under the wrap leading to better patient comfort. Although this aspect of the electrodes is viewed to be a feature of the design process, and in theory reduces the potential for infection, it does not affect the overall design intent/indications for use of the device. Additionally, having more contacts per pigtail reduces the likelihood of making an electrical misconnection, but this feature does not affect the overall design intent/indication for use of the device.
• . The proposed device uses different manufacturing methods in comparison to the predicates, but the overall design intent is identical.
• . The proposed device cites numerous applicable testing and performed numerous documented tests in compliance of their requirements while the predicate device did not.
• 16. Substantial Equivalence Table

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	Proposed Device:	Predicate Device:
	Blackrock NeuroCoG Subdural Cortical Electrodes	Ad-Tech Medical Subdural Cortical
Item	(Strips and Grids)	Electrodes (K053363)	Comments
	BASIC INFORMATION AND USES
Picture	Image: Blackrock NeuroCoG Subdural Cortical Electrodes	Image: Ad-Tech Medical Subdural Cortical Electrodes	The pictures show thatthe Proposed Device isnearly identical in sizeto the predicate. Themodel shown (64contact grid) for theproposed device is 78mm x 90 mm with 400- 450 mm pigtails; thepredicate device is 80mm x 80 mm with 375mm pigtails. They aremade with similarmaterials (siliconebody and pigtails andplatinum:iridium orstainless steelrecording /stimulatingpad electrodes). Thedifferences are minorand do not affect safetyor efficacy. Therefore,SubstantiallyEquivalent
Description	Cortical Electrode	Cortical Electrode	Identical to thepredicate. Therefore,SubstantiallyEquivalent
Product Code	GYC (cortical electrodes)	GYC (cortical electrodes)	Identical to thepredicate. Therefore,
			SubstantiallyEquivalent
Class	II	II	Identical to thepredicate. Therefore,SubstantiallyEquivalent
Regulation	CFR 882.1310	CFR 882.1310	Identical to thepredicate.
Intended Use	Subdural electrodes are single patient use, disposable,sterile devices. The electrodes are invasive as they areplaced in contact with the brain.The electrodes provide the patient contact device. Theelectrodes connect to the user's recording, monitoring andstimulation/response equipment. The electrodes are usedunder the supervision of a physician. Physicians in theareas of biopotential recording, monitoring andstimulation/response studies understand the use of subduralelectrodes.	Subdural electrodes are single patient use,disposable, sterile and non-sterile devices.The electrodes are invasive as they areplaced in contact with the brain.The electrodes provide the patient contactdevice. The electrodes connect to the user'srecording, monitoring andstimulation/response equipment. Theelectrodes are used under the supervision of aphysician. Physicians in the areas ofbiopotential recording, monitoring andstimulation/response studies understand theuse of subdural electrodes.	Nearly identical to thepredicate. Theproposed device isavailable sterile only,while the predicatedevice was originallyavailable as eithersterile or non-sterile.They are no longeravailable sterile only.Therefore.SubstantiallyEquivalent.
Family Members	Strips, Grids	Dual-Sided, Interhemispheric, Grid,Intraoperative, Strip, Wyler	Grids and strips arecontained within thecleared electrode typesof the predicate.Therefore.SubstantiallyEquivalent.
Indication for Use	The Blackrock NeuroCoG Subdural Cortical Electrodes(Strips and Grids) are intended for temporary (< 30 days)use with recording, monitoring and stimulation equipmentfor the recording, monitoring and stimulation of electricalsignals on the surface of the brain. The recording of	The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative,Strip, Wyler) are intended for temporary (<30 days) use with recording, monitoring andstimulation equipment for the recording.monitoring and stimulation of electrical	Except for brandingand the more limitedsubset of familymembers, the proposeddevice is nearlyidentical to the
	electrical activity supports definition of the location ofepileptogenic foci and brain mapping.	signals on the surface of the brain. Therecording of electrical activity supportsdefinition of the location of epileptogenicfoci and brain mapping.	predicate. Therefore,SubstantiallyEquivalent.
Contraindications	The subdural electrodes should not be used on any patientwho the physician/surgeon considers at risk for infection.The subdural electrodes are not intended for continuousstimulation. Stimulation should only be applied to supportthe brain mapping purpose of the electrodes	The subdural electrodes should not be usedon any patient who the physician/surgeonconsiders at risk for infection.The subdural electrodes are not intended forcontinuous stimulation. Stimulation shouldonly be applied to support the brain mappingpurpose of the electrodes	Identical to thepredicate.
Intended User	Neurosurgeons, Neurologists, Epileptologists, ClinicalNeurophysiologists, EEG / Neurodiagnostic Technicians,OR Staff Members	Not stated formally, but clinically known toinclude: Neurosurgeons, Neurologists,Epileptologists, Clinical Neurophysiologists,EEG / Neurodiagnostic Technicians, ORStaff Members	Although not known tobe formally stated inthe predicate'ssubmission, theintended users areassumed to be identicalto the predicate.
IntendedEnvironment ofUse	Operating rooms and epilepsy monitoring facilities	Not stated formally but clinically known tobe: Operating rooms and epilepsymonitoring facilities	Although not known tobe formally stated inthe predicate'ssubmission, theintended Environmentof Use are assumed tobe identical to thepredicate.
Targeted PatientPopulation	Not stated formally	Not stated formally	Neither the proposeddevice nor thepredicate device statesthe targeted patientpopulation (nor do anyother similar devicescleared under the sameproduct code). Inclinical practice the use

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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Image /page/9/Picture/0 description: The image shows the logo for Blackrock Microsystems. The logo consists of a stylized bird-like figure on the left, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font. A registered trademark symbol is located to the right of the word "BLACKROCK".

			of the device is up tothe applicablephysician. Not statinga targeted patientpopulation does notraise any newquestions of safety oreffectiveness.
			Therefore,
			Substantially
LABELING & PACKAGING INFORMATION			Equivalent.
NeuroCoG Product	NNN-XXM- YYF-ZZC	AANNR-YYMS-000	Both companies use a
Identification	NNN = Electrode type, where	AA = The electrode type where	formulaic catalog
	STR = Strip Electrode w / 4-16 contacts	IS=Numbered Strip, TS=non-numbered	numbering system to
	GRD = Grid electrode w/ 4-99 contacts	strip or FG=Grid	encode for the
	GRC = Grid electrode w/ 100-128 contacts	NN = Number of contacts	applicable variants.
	XX = Number of Contacts	R = The type of contact (various options	Minor differences exist
	M = Metal Type, where	exist for small, indented, square, etc.	to reflect marketing
	P = Platinum	electrodes)	preferences and fewer
	S = Stainless Steele	Y Y = the spacing between contacts	choices/options. These
	YY = Uniqueness of Electrode	M= Metal Type, where P=Platinum,	issues do not affect the
	(Defined in Product Registry)	S=Stainless Steel	safety or effectiveness
	F= Feature, where	S = Sterility Status where X= Sterile,	of the device.
	N = Non-reinforced, R = Reinforced	N=Non-Sterile	Therefore,
	= Spacing of ContactsZZ	000 = Uniqueness of electrode	Substantially
	Center to Center(10mm)		Equivalent.
	C= Contact Diameter, where
	S = Standard 4mm, 2.3mm Exposed

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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NeuroCoG PatientCableIdentification	NPCConfiguration	Channelsin NPC	QuickConnectBandColor/s	BendReliefColor/s	Channels inConductorCable	BlockConnectorSize	BlockConnectorQty	Numberof DINleads	NPC-XXXC-YY		Ad-Tech did notqualify a Patient Cableas device-specific intheir submission.
									NPC	Acronym forNeuroCoG PatientCable
									XXX	Number of channels(004-128)
	NPC-004D-XX	4	Yellow	Black				4	C	Type of connector(D=DIN leads,Q=Q-Connector
	NPC-006D-XX	6	Green	Black	8	8-channel		6
	NPC-008D-XX	8	Blue	Black				8
	NPC-010D-XX	10	Black	Red				10
	NPC-012D-XX	12	White	Red	16	16-channel	1	12
	NPC-016D-XX	16	Green	Red				16
	NPC-020D-XX	20	Black	White				20
	NPC-024D-XX	24	Yellow	White				24
	NPC-032D-XX	32	White	Orange				32	YY	Length of NPC infeet (06 or 10)
	NPC-048D-XX	48	YellowBlue	WhiteYellow			2	48
	NPC-064D-XX	64	WhiteYellow	OrangeGreen				64
	NPC-096D-XX	96	WhiteYellowGreen	OrangeGreenGrey			3	96
	NPC-128D-XX	128	WhiteYellowGreenBlue	OrangeGreenGreyWhite	32	32-channel	4	128
	NPC-032Q-XX	32	WhiteYellowBlue	OrangeWhiteYellow			1
	NPC-048Q-XX	48	WhiteYellow	OrangeGreen			2	0
	NPC-064Q-XX	64	WhiteYellow	OrangeGreen			3
	NPC-096Q-XX	96	WhiteYellowGreen	OrangeGreenGrey
	NPC-128Q-XX	128	WhiteYellowGreenBlue	OrangeGreenGreyWhite			4
Directions for use	A directions for use that includes a generic picture anddescription of the numbering and color coding scheme isincluded with each electrode.					A directions for use and separate "CodeChart" identifying the numbering and colorcoding scheme is included with eachelectrode.				Both companiesinclude a means toshow the user thelayout and color-coding of the electrode.Differences exist basedon layout, font sizes,marketing style, etc.These differences donot affect the safety oreffectiveness of the

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NeuroCoGCautionaryStatements	For Single Patient Use Only. Do not Re-Sterilize or Reuse.Not intended of Implantation (21 CFR 860.3(d): > 30 days.CAUTION: Federal Law (U.S.A.) restricts this Device tosale by or on the order of a physicianCAUTION: Reuse of this Device is prohibited as it maymalfunction and cause contamination and risk to thepatientCAUTION: Disconnect from monitoring equipment duringcardiac defibrillation.CAUTION: Do not use NeuroCoG if packaging isdamaged.CAUTION: Handle the electrode with care to preventdamage. Avoid pulling or stressing the pigtail, rings orelectrodes, which could result in loss of contact recordings.CAUTION: If suturing the electrode, avoid suturingcontacts, wires, and/or pigtail, as damage may result.CAUTION: Handle the electrode with care to preventdamage. Avoid pulling or stressing the pigtail, rings orelectrodes, which could result in loss of contact recordings.	For Single Patient Use Only. Do not Re-Sterilize or Reuse. Not intended ofImplantation (21 CFR 860.3(d): > 30 days.For Surgical Use Only. Do not use ifpackaging is damaged.CAUTION: Federal Law (U.S.A.) restrictsthis Device to sale by or on the order of aphysicianCAUTION: Reuse of this Device isprohibited as it may malfunction and causecontamination and risk to the patient,CAUTION: Disconnect from monitoringequipment during cardiac defibrillation.	device.Therefore,SubstantiallyEquivalent.Additional Cautionsstatement for userperformance issuesonly and do not raiseany questions on safetyor efficacy. Therefore,SubstantiallyEquivalent.
NeuroCoGCautionaryStatements	Do not use NeuroCoG Patient Cable if pogo pins arerecessed or aggressively clean Pogo Pins such that theyrecess. Use with recessed pogo pins may result indamaging the devices or incomplete signal path.		Ad-Tech did notqualify a Patient Cableas device-specific intheir submission.

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Sterility status ofthe electrodes	Sterile only	Both sterile and non-sterile devices wereoriginally offered. Only sterile electrodes areoffered currently	Identical sterility statusof the currentlymarketed devices ofthe predicate.
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Identical to thepredicate.
Sterility status ofpatient cable	Non-Sterile	--	Ad-Tech did notqualify a Patient Cableas device-specific intheir submission.
Non-Pyrogenic	Labeled as non-pyrogenic	Not so labeled	Labeling the devices asnon-pyrogenic is not aregulatory requirement.Doing so is done formarketing purposesand does not raise anynew questions of safetyor effectiveness.Therefore,SubstantiallyEquivalent.
Single Patient Use,Disposable	Yes	Yes	Identical to thepredicate.
Shelf Life	Currently 1 year (per accelerated aging) and 1-year and 5-year real-time aging studies are ongoing)	5 years (Launched with 1 year acceleratedaging)	After 5 years, identicalto the predicate.
PackagingConfiguration	The Blackrock NeuroCoG Subdural Cortical Electrode(Strips and Grids) is double (Tyvek) pouched and placed ina chipboard box.The NeuroCoG Patient Cable is placed in a poly bag andthen cleaned and disinfected by the end-user.	The device is double (Tyvek) pouched andplaced in a chipboard box.	Identical to thepredicate.

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Image /page/13/Picture/0 description: The image shows the logo for Blackrock Microsystems. The logo consists of a stylized bird-like figure on the left, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font. The logo is clean and modern, with a focus on the company name.

ELECTRODE CONTACT INFORMATION
Number of ElectrodeContacts	Strips: 4 to 16, InclusiveGrids: 4 to 128, inclusive	1 to 128, inclusive	Within the boundaries of thepredicate.
Electrode ContactSpacing	10 mm, 5 mmOther variations can be requested by thecustomer.	10 mmOther variations can be requested by thecustomer.	Identical to the predicate.
Electrode ContactMaterial	90:10 Platinum:iridium or Stainless Steel	90:10 Platinum or Stainless Steel	Identical to the predicate.
Electrode ContactSize (exposedsurface area)	2.3 mm diameter	1.5 mm x 1.5 mm, 1.5 mm x 3.0 mm, 2.3 mmdiameter, 4.0 mm diameter - per K053363submission1.17, 1.8 mm, 5 mm dia. (exposed) currentlymarketed	Within the boundaries of thepredicate.
ELECTRODE PIGTAIL INFORMATION
Maximum contactsper pigtail	32	16	The proposed device offers morepotential contacts per pigtail thanthe predicate. Doing so reduces thenumber of incisions needed totunnel the pigtails away from thesurgical site. Less pigtails impliesfewer block connectors under thewrap leading to better patientcomfort. Although this aspect ofthe electrodes is viewed to be afeature of the design process, andin theory reduces the potential forinfection, it does not affect theoverall design intent/indication foruse of the device. Additionally,having more contacts per pigtailreduces the likelihood of making anelectrical misconnection but thisfeature does not affect the overall

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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Image /page/14/Picture/0 description: The image shows the logo for Blackrock Microsystems. The logo features a stylized penguin-like figure on the left, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font. A circled "R" trademark symbol is located to the right of the word "BLACKROCK".

Connection Cable(510(k) Exempt)	The connection cable terminates in a safetyfemale DIN leads connector or Q-Connector.It connects the electrode cable per theconnector to the amplifier / stimulator.	TECH-ATTACH and Cabrio™ ConnectionSystems which connect to a patient cable thatterminates in a safety female Din connector. Itconnects the electrode cable per the connectorto the amplifier / stimulator	design intent/indication for use ofthe device. Therefore, SubstantiallyEquivalentAlthough per 21 CFR 890.1175,the electrode-to-EEG/Stimulatorcables are 510(k) exempt, their useis still vital to connect theproposed/predicate devices to athird-party EEG. Although thespecific manufacturing methodsvary, both the proposed andpredicate device comply with theapplicable safety standards andshare the same overall designintent. Therefore, SubstantiallyEquivalent.
MANUFACTURING & PERFORMANCE CHARACTERISTICS
StimulationParameters	As stated on the instructions for use, a safelevel of stimulation is below 30 μC/cm2.This is a function of exposed electrodecontact size, pulse duration and stimulationcurrent.	As stated on the instructions for use, a safelevel of stimulation is below 30 μC/cm2. This isa function of exposed electrode contact size,pulse duration and stimulation current.	Identical to the predicate.
ElectrodeManufacturingTechnique	NeuroCoG subdural cortical electrodes arehand-made. The device consists of a siliconemat into which the pad electrodescomprising of platinum:iridium or stainlesssteel contacts are embedded. The electrodecontacts' conducting paths are electricallyconnected to their contact rings per insulatedstainless steel wires encapsulated in thepigtail.	Ad-Tech electrodes are hand-made. Theelectrodes' contacts are sandwiched in betweenlayers of liquid silicone and trimmed to size.Insulated wires extend from each electrodethrough a flexible silicone or polyurethane tubeto a connector for EEG monitoring	Manufacturing methods may varyin comparison to the predicates, butthe overall design intent andmaterials are identical.

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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Image /page/15/Picture/0 description: The image shows the logo for Blackrock Microsystems. The logo consists of a stylized black bird-like figure on the left, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font. A circled "R" trademark symbol is located to the right of the word "BLACKROCK".

Interactions withThird Party EEGs/Stimulators	Subdural electrodes themselves are non-active and serve simply as conductors for theEEG signals produced by the CNS and/or forthe currents produced by the stimulators. In asense, they simply serve as electricalpathways.	While not formally stated in the predicate's510(k) summary statement or labeling, it isknown that the predicate 510(k) submissionmaintained that the devices are non-active andserve simply as conductors for the EEG signalsproduced by the CNS and/or for the currentsproduced by the stimulators. In a sense, theysimply serve as electrical pathways.	Both devices are essentially 'wires'that simply conduct electricity.Therefore, SubstantiallyEquivalent.
Standards Cited	• AAMI TIR12:2010 Designing, Testing,and Labeling Reusable Medical Devicesfor Reprocessing in Health Care Facilities:A Guide for Medical DeviceManufacturers• AAMI TIR30:2011(R)2016 ACompendium of Processes, Materials, TestMethods, and Acceptance Criteria forCleaning Reusable Medical Devices• ANSI/AAMI/ISO 10993-1:2009/(R)2013Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing Within aRisk Management Process• ANSI/AAMI/ISO 11737-1:2018Sterilization of Health Care Products –Microbiological Methods – Part 1:Determination of a Population ofMicroorganisms on Products• ANSI/AAMI/ST72:2011/(R)2016Bacterial Endotoxins – Test Methods,Routine Monitoring, and Alternatives toBatch Testing• ASTM D4169-16 Standard Practice forPerformance Testing of ShippingContainers and Systems	STANDARDSNone cited	Citing the applicable standardsdoes not raise any new questions ofsafety or effectiveness. Therefore,Substantially Equivalent.

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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ASTM D4332-14 Standard Practice forConditioning Containers, Packages, orPackaging Components for Testing ASTM F88/F88M-15 Standard testMethod for Seal Strength of FlexibleBarrier Materials ASTM F756-17 Standard Practice forAssessment of Hemolytic Properties ofMaterials ASTM F1886-16 Standard Test Methodfor Determining Integrity of Seals forFlexible Packaging by Visual Inspection ASTM F1980-16 Standard Guide forAccelerated Aging of Sterile BarrierSystems for Medical Devices ASTM F2096-11 Standard Test Methodfor Detecting Gross Leaks in MedicalPackaging by Internal Pressurization ASTM F2901-19 Standard Guide forSelecting Tests to Evaluate PotentialNeurotoxicity of Medical Devices BS/EN/ISO 11607-1:2017 Packaging forTerminally Sterilized Medical Devices –Part 1: Requirements for Materials, SterileBarrier System and Packaging Systems BS/EN/ISO 11737-2:2009 Sterilization ofMedical Devices – MicrobiologicalMethods – Part 2: Tests of SterilityPerformed in the Definition, Validation,and Maintenance of a Sterilization Process IEC 62366-1 Edition 1.0 2015-02 MedicalDevices - Part 1: Application of UsabilityEngineering to Medical Devices[Including CORRIGENDUM 1 (2016)]

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• ISO 10993-4 Third Edition 2017-04Biological Evaluation of Medical Devices– Part 4: Selection of Test for Interactionswith Blood
• ISO 10993-5 Third Edition 2009-06-01Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity
• ISO 10993-6 Third Edition 2016-12-01Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects AfterImplantation
• ISO 10993-7 Second Edition 2008-10-15Biological Evaluation of Medical Devices:Ethylene Oxide Sterilization Residuals
• ISO 10993-10 Third Edition 2010-08-01Biological Evaluation of Medical Devices– Part 10: Tests for Irritation and SkinSensitization
• ISO 10993-11 Third Edition 2017-09Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity
• ISO 11135-1 Second Edition 2014-07-15Sterilization of Health Care Products –Ethylene Oxide – Part 1: Requirements forDevelopment, Validation, and RoutineControl of a Sterilization Validation forMedical Devices
• ISO 11138-1 Third Edition 2017-03Sterilization of Health Care Products –Biological Indicators - Part 1: GeneralRequirements
• ISO 11138-2 Third Edition 2017-03Sterilization of Health Care Products –Biological Indicators - Part 2: Biological

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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	Indicators for Ethylene Oxide SterilizationProcesses
ElectricalPerformance Testing	As part of the manufacturing process, theBlackrock NeuroCoG Subdural Electrodes(Strips and Grids) are checked for electricalcontinuity and resistance.The devices were physically tested fordielectric strength, impedance, resistanceand charge injection capacity on new andaged products.The NeuroCoG Patient Cable was tested forchannel mapping, resistance, shorts,dielectric strength, and impedance.	As part of the manufacturing process, theelectrodes are checked for electrical continuityand lack of cross-talk between channels. It isknown that the submission containedtheoretical calculations for dielectricbreakdown of the insulation and the current-carrying capacity of the internal electrodewires. No formal test results were submitted.	The proposed device underwentformal electrical testing while thepredicate did not. However, beingmore rigorous does not raise anynew questions of safety oreffectiveness. Therefore,Substantially Equivalent.
MechanicalPerformance Testing	The Blackrock NeuroCoG SubduralElectrodes (Strips and Grids) werephysically tested for tensile strength,bending, and chemical compatibility on newand aged products as well as underwentextensive verification of their mechanicalproperties.The NeuroCoG Patient Cable was tested fortensile strength, mating, bending, dropping,and chemical compatibility.	Not Stated. It is known that the submission didnot include formal mechanical testing.	The proposed device underwentformal mechanical testing while thepredicate did not. However, beingmore rigorous does not raise anynew questions of safety oreffectiveness. Therefore,Substantially Equivalent.
MRI Testing	The Blackrock NeuroCoG SubduralElectrodes and NeuroCoG Patient Cable(Strips and Grids) are MR Unsafe.	Not Stated	Labeling the device as not beingevaluated for safety andcompatibility in the MRenvironment while the predicatedevice does not raise any newquestions of safety or effectiveness.Therefore, Substantially EquivalentIdentical to the predicate.
ContainsSoftware/Firmware	No	No	Identical to the predicate

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Image /page/19/Picture/0 description: The image is a logo for Blackrock Microsystems. The logo features a stylized penguin-like figure on the left, followed by the text "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font.

Electrical SafetyTesting	Not Conducted. Not Applicable	Not Conducted. Not Applicable	Identical to the predicate.
EMC Testing	Not Conducted. Not Applicable	Not Conducted. Not Applicable	Identical to the predicate.

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) Biocompatibility Evaluation
Test	Standard	Method	Results
Hemolysis	ISO 10993-4:2017ASTM F756-17ASTM F2901:2019	Indirect Contact	Non-hemolytic
Cytotoxicity	ISO 10993-5:2009	L929 MEM Elution	Non-cytotoxic
Implantation	ISO 10993-6:2016	Subdural RabbitBrain	Non-demyelinating,Non-neurodegenerative,Non-astrocytotic, andNon-microglial-proliferative
Irritation	ISO 10993-10:2010	IntracutaneousReactivity	Non-irritant
Sensitization	ISO 10993-10:2010	KligmanMaximization	Non-sensitizer
Acute SystemicToxicity	ISO 10993-11:2017	SystemicInjection	Non-toxic

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

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Image /page/20/Picture/0 description: The image shows the logo for Blackrock Microsystems. The logo consists of a stylized penguin-like figure on the left, followed by the word "BLACKROCK" in bold, black letters. Below "BLACKROCK" is the word "MICROSYSTEMS" in a smaller, blue font. A circled "R" trademark symbol is located to the right of the word "BLACKROCK".

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) Biocompatibility Evaluation
Test	Standard	Method	Results
BET/LAL	ANSI/AAMIST72:2011/(R)2016	KineticChromogenicTechniqueThe Endotoxinlimit applied to theNeuroCoG is 2.15EU/Device (0.06EU/ml). Theselected endotoxinlimit is based onthe potentialcontact withCerebrospinalFluid.	Non-pyrogenic
Patient Cable
Test	Standard	Method	Results
Cleaning	AAMI TIR12:2010AAMITIR30:2011(R)2016	British soil,CaviWipes andCaviCide	Protein Marker:$<6.4$ µg/cm²Carbohydrate Marker:$<1.8$ µg/cm²
Disinfection	AAMI TIR12:2010	Low-leveldisinfection withCaviWipes andCaviCide	6-log reduction in bacteria

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17. Conclusions

Blackrock Microsystems believes the proposed Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) and their predicate, Ad-Tech Medical Subdural Cortical Electrodes, are substantially equivalent in their intended use, intended use environment, and indications for use. Furthermore, both systems have the same/equivalent technological characteristics, physical characteristics, and stimulation parameters. The difference that exists between the devices-namely the aspect that pertains to the number of contacts per pigtaildoes not affect the relative safety and/or effectiveness.

Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission

Regulation Number and Section

§ 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).