Who is the manufacturer of Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

Blackrock Microsystems filed the 510(k) submission for Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) (K191346).

What is the FDA product code for Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

GYC. It is classified under 21 CFR 882.1310 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

AD-TECH Subdural Cortical Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) (K053363).

Who can help prepare an FDA 510(k) submission like Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)

K191346 · Blackrock Microsystems · GYC · Feb 14, 2020 · Neurology

Device Facts

Record ID	K191346
Device Name	Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
Applicant	Blackrock Microsystems
Product Code	GYC · Neurology
Decision Date	Feb 14, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1310
Device Class	Class 2

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, 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.

Device Story

Device consists of subdural cortical electrodes (strips and grids) used for temporary (<30 days) brain surface monitoring and stimulation. Electrodes are placed by neurosurgeons in operating rooms or epilepsy monitoring facilities. Device acts as a passive electrical conductor, transmitting EEG signals from the brain to external recording/monitoring equipment or delivering stimulation currents from external stimulators. Electrodes are made of silicone with platinum:iridium or stainless steel contacts. The system includes patient cables to connect electrodes to third-party amplifiers/stimulators. By facilitating brain mapping and identifying epileptogenic foci, the device assists clinicians in surgical planning and diagnostic procedures. The device is single-patient use and disposable.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including electrical performance (continuity, impedance, dielectric strength), mechanical performance (tensile strength, bending), and comprehensive biocompatibility testing (hemolysis, cytotoxicity, implantation, irritation, sensitization, acute systemic toxicity, and pyrogenicity).

Technological Characteristics

Silicone body with platinum:iridium or stainless steel contacts. Dimensions vary by grid/strip configuration. Passive electrical conduction principle. Sterilized via Ethylene Oxide. Complies with ISO 10993, AAMI TIR12/TIR30, and ASTM standards for packaging and materials. No software or firmware.

Indications for Use

Indicated for temporary (<30 days) recording, monitoring, and stimulation of electrical signals on the brain surface to support epileptogenic foci localization and brain mapping. Contraindicated for patients at risk for infection and not intended for continuous stimulation.

Regulatory Classification

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.

Predicate Devices

AD-TECH Subdural Cortical Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) (K053363)

Related Devices

K053363 — DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES · Ad-Tech Medical Instrument Corp · May 30, 2006
K191186 — Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode · Ad-Tech Medical Instrument Corporation · Jan 25, 2020
K192764 — NeuroOne Cortical Electrode · Neuroone, Inc. · Nov 26, 2019
K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES · Ad-Tech Medical Instrument Corp · May 25, 2006
K170959 — DIXI Medical Microdeep Depth Electrode · Dixi Medical · Nov 24, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 (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 {2}------------------------------------------------ #### 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) | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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, LLC 630 Komas Drive, Suite 200 Salt Lake City, UT 84108 USA Establishment 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, LLC E-mail: rfrischknecht@blackrockmicro.com FDA 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 Neurology Class II Product Code: GYC Panel: Neurology | | 10. | Reason for Traditional 510(k): | New submission | | 11. | Predicate Device(s): | 510(k) Number: K053363 Manufacturer: Ad-Tech Medical Instrument Corporation Trade Name: AD-TECH Subdural Cortical Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) Product Code: GYC Classification: 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 {4}------------------------------------------------ - 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 {5}------------------------------------------------ #### 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 {6}------------------------------------------------ | | 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 that the Proposed Device is nearly identical in size to the predicate. The model shown (64 contact grid) for the proposed device is 78 mm x 90 mm with 400 - 450 mm pigtails; the predicate device is 80 mm x 80 mm with 375 mm pigtails. They are made with similar materials (silicone body and pigtails and platinum:iridium or stainless steel recording /stimulating pad electrodes). The differences are minor and do not affect safety or efficacy. Therefore, Substantially Equivalent | | Description | Cortical Electrode | Cortical Electrode | Identical to the predicate. Therefore, Substantially Equivalent | | Product Code | GYC (cortical electrodes) | GYC (cortical electrodes) | Identical to the predicate. Therefore, | | | | | Substantially Equivalent | | Class | II | II | Identical to the predicate. Therefore, Substantially Equivalent | | Regulation | CFR 882.1310 | CFR 882.1310 | Identical to the predicate. | | Intended Use | Subdural electrodes are single patient use, disposable, sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The 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 subdural electrodes. | Subdural electrodes are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The 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 subdural electrodes. | Nearly identical to the predicate. The proposed device is available sterile only, while the predicate device was originally available as either sterile or non-sterile. They are no longer available sterile only. Therefore. Substantially Equivalent. | | Family Members | Strips, Grids | Dual-Sided, Interhemispheric, Grid, Intraoperative, Strip, Wyler | Grids and strips are contained within the cleared electrode types of the predicate. Therefore. Substantially Equivalent. | | Indication 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 | The AD-TECH Subdural Electrodes (Dual- Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording. monitoring and stimulation of electrical | Except for branding and the more limited subset of family members, the proposed device is nearly identical to the | | | electrical activity supports definition of the location of epileptogenic foci and brain mapping. | signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. | predicate. Therefore, Substantially Equivalent. | | Contraindications | The subdural electrodes should not be used on any patient who the physician/surgeon considers at risk for infection. The subdural electrodes are not intended for continuous stimulation. Stimulation should only be applied to support the brain mapping purpose of the electrodes | The subdural electrodes should not be used on any patient who the physician/surgeon considers at risk for infection. The subdural electrodes are not intended for continuous stimulation. Stimulation should only be applied to support the brain mapping purpose of the electrodes | Identical to the predicate. | | Intended User | Neurosurgeons, Neurologists, Epileptologists, Clinical Neurophysiologists, EEG / Neurodiagnostic Technicians, OR Staff Members | Not stated formally, but clinically known to include: Neurosurgeons, Neurologists, Epileptologists, Clinical Neurophysiologists, EEG / Neurodiagnostic Technicians, OR Staff Members | Although not known to be formally stated in the predicate's submission, the intended users are assumed to be identical to the predicate. | | Intended Environment of Use | Operating rooms and epilepsy monitoring facilities | Not stated formally but clinically known to be: Operating rooms and epilepsy monitoring facilities | Although not known to be formally stated in the predicate's submission, the intended Environment of Use are assumed to be identical to the predicate. | | Targeted Patient Population | Not stated formally | Not stated formally | Neither the proposed device nor the predicate device states the targeted patient population (nor do any other similar devices cleared under the same product code). In clinical practice the use | Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission {7}------------------------------------------------ Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission {8}------------------------------------------------ Blackrock NeuroCoG Subdural Cortical Electrodes Traditional 510(k) Submission {9}------------------------------------------------ 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 to the applicable physician. Not stating a targeted patient population does not raise any new questions of safety or effectiveness. | |----------------------------------|------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | 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 Contacts ZZ | 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 {10}------------------------------------------------ | NeuroCoG Patient Cable Identification | NPC Configuration | Channels in NPC | Quick Connect Band Color/s | Bend Relief Color/s | Channels in Conductor Cable | Block Connector Size | Block Connector Qty | Number of DIN leads | NPC-XXXC-YY | | Ad-Tech did not qualify a Patient Cable as device-specific in their submission. | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------|----------------------------------|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | | | | | | | | | | NPC | Acronym for NeuroCoG Patient Cable | | | | | | | | | | | | 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 in feet (06 or 10) | | | | NPC-048D-XX | 48 | Yellow Blue | White Yellow | | | 2 | 48 | | | | | | NPC-064D-XX | 64 | White Yellow | Orange Green | | | | 64 | | | | | | NPC-096D-XX | 96 | White Yellow Green | Orange Green Grey | | | 3 | 96 | | | | | | NPC-128D-XX | 128 | White Yellow Green Blue | Orange Green Grey White | 32 | 32-channel | 4 | 128 | | | | | | NPC-032Q-XX | 32 | White Yellow Blue | Orange White Yellow | | | 1 | | | | | | | NPC-048Q-XX | 48 | White Yellow | Orange Green | | | 2 | 0 | | | | | | NPC-064Q-XX | 64 | White Yellow | Orange Green | | | 3 | | | | | | | NPC-096Q-XX | 96 | White Yellow Green | Orange Green Grey | | | | | | | | | | NPC-128Q-XX | 128 | White Yellow Green Blue | Orange Green Grey White | | | 4 | | | | | | Directions for use | A directions for use that includes a generic picture and description of the numbering and color coding scheme is included with each electrode. | | | | | A directions for use and separate "Code Chart" identifying the numbering and color coding scheme is included with each electrode. | | | | 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 style, etc. These differences do not affect the safety or effectiveness of the | | {11}------------------------------------------------ | NeuroCoG Cautionary Statements | 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 to sale by or on the order of a physician CAUTION: Reuse of this Device is prohibited as it may malfunction and cause contamination and risk to the patient CAUTION: Disconnect from monitoring equipment during cardiac defibrillation. CAUTION: Do not use NeuroCoG if packaging is damaged. CAUTION: Handle the electrode with care to prevent damage. Avoid pulling or stressing the pigtail, rings or electrodes, which could result in loss of contact recordings. CAUTION: If suturing the electrode, avoid suturing contacts, wires, and/or pigtail, as damage may result. CAUTION: Handle the electrode with care to prevent damage. Avoid pulling or stressing the pigtail, rings or electrodes, which could result in loss of contact recordings. | For Single Patient Use Only. Do not Re- Sterilize or Reuse. Not intended of Implantation (21 CFR 860.3(d): > 30 days. For Surgical Use Only. Do not use if packaging is damaged. CAUTION: Federal Law (U.S.A.) restricts this Device to sale by or on the order of a physician CAUTION: Reuse of this Device is prohibited as it may malfunction and cause contamination and risk to the patient, CAUTION: Disconnect from monitoring equipment during cardiac defibrillation. | device. Therefore, Substantially Equivalent. Additional Cautions statement for user performance issues only and do not raise any questions on safety or efficacy. Therefore, Substantially Equivalent. | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------…