(90 days)
The °AirRay® 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 level of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.
The ° AirRay® Subdural Cortical Electrodes 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 physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of subdural electrodes.
The provided text is a 510(k) summary for the CorTec AirRay Subdural Cortical Electrodes. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, much of the requested information regarding acceptance criteria, a test set, ground truth establishment for a test set, expert involvement, and comparative effectiveness studies is not present in this document, as these are typically part of a different type of submission (e.g., a PMA or De Novo) or a more detailed clinical study report, which is not included here.
However, the document does contain information about biocompatibility testing, which does have acceptance criteria for physical and chemical characteristics, and the results of those tests. I will focus on that section for the table, as it is the only part that directly addresses acceptance criteria and performance against them.
Here's a breakdown of what can be extracted and what is not available:
1. Table of acceptance criteria and the reported device performance:
The document provides a "Biocompatibility Summary Table" with test methods, results, and conclusions. The acceptance criteria are implicitly "Pass" for each test, indicating that the device's performance met the required biological safety standards.
| Test (Applicable ISO 10993 Part No.) | Acceptance Criteria (Implicit) | Reported Device Performance | Conclusion (Met Acceptance Criteria) |
|---|---|---|---|
| Cytotoxicity (10993-5) | Non-cytotoxic | Pass | Non-cytotoxic |
| Sensitization (10993-10) | Non-sensitizer | Pass | Non-sensitizer |
| Irritation (ISO 10993-10) | Non-irritant | Pass | Non-irritant |
| Acute Systemic Toxicity (ISO 10993-11) | No acute systemic toxicity | Pass | No acute systemic toxicity |
| Material-mediated Pyrogenicity (ISO 10993-11) | Non-pyrogenic | Pass | Non-pyrogenic |
| Hemocompatibility (ISO 10993-4) | Non-hemolytic | Pass | Non-hemolytic |
| Subchronic Toxicity (ISO 10993-11) | No subchronic systemic toxicity and acceptable local toxicities | No systemic or local toxicities were observed, and all measured parameters (clinical observations, body weights, organ weights, hematology, clinical chemistry, necropsy, microscopic evaluation) were acceptable. | No subchronic systemic toxicity |
| Genotoxicity (ISO 10993-3) - Bacterial Mutagenicity Test (Ames Assay) | Non-mutagenic | Pass | Non-mutagenic |
| Genotoxicity (ISO 10993-3) - In Vitro Mouse Lymphoma Assay | Non-mutagenic / non-clastogenic | Pass | Non-mutagenic / clastogenic |
| Implantation (ISO 10993-6) | No adverse local effects in neural tissues, no neurotoxicity | Overall, no adverse local effects attributed to the implanted articles. All implanted animals survived with no clinical or neurological findings attributable to the test article or negative control. No evidence of CSF leakage or infection. Considered to elicit no or minimal reaction compared to negative control at 1 and 4 weeks. | No adverse local effects in neural tissues, no neurotoxicity |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document mentions that "All biocompatibility studies were conducted in compliance with Good Laboratory Practices (GLP), 21 CFR Part 58." While specific numbers for each test are not listed, the document states, for example, that the "4-week brain implantation study was conducted in rabbits" and "Both male and female animals were used." This implies a typical sample size used in GLP studies for animal testing, which adheres to specific guidelines for statistical significance (though exact numbers are often not in a 510(k) summary).
- Data Provenance: The studies were conducted on the "finished, sterilized device." The location of the studies (e.g., country) is not explicitly stated beyond the submitter's location in Germany. These are prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Biocompatibility Ground Truth: For the implantation study, it is stated that "The macroscopic and microscopic evaluations were performed by a board certified veterinary pathologist." This pathologist served as the expert for establishing the "truth" (i.e., the presence or absence of adverse tissue reactions) in that specific test. For other biocompatibility tests (cytotoxicity, sensitization, etc.), these are standardized laboratory assays with defined pass/fail criteria, so the "ground truth" is established by the assay's results per validated protocols, interpreted by qualified lab personnel.
- For human clinical performance (not applicable to this 510(k) summary): No information is provided as this is a device clearance based on substantial equivalence and non-clinical testing.
4. Adjudication method for the test set:
- For the biocompatibility studies, standard GLP practices and validated test protocols are followed. Results are typically reviewed and signed off by the study director and relevant subject matter experts (e.g., the veterinary pathologist). There's no "adjudication" in the sense of multiple human readers disagreeing on clinical image interpretation, as this is laboratory testing.
5. 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:
- No. This device is a passive implant (subdural cortical electrodes) and is not an AI-powered diagnostic device. Therefore, a MRMC study of human reader performance with or without AI assistance is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device does not have an algorithm or software component that operates in a standalone capacity. It is a physical medical device. The document explicitly states "Contains Software/Firmware: No".
7. The type of ground truth used:
- For the biocompatibility studies, the ground truth was laboratory test results and expert pathological evaluation (specifically for the implantation study). This is empirical data derived from standardized biological and chemical tests.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML device that requires a training set. The clearance is based on substantial equivalence to a predicate device and non-clinical performance testing.
9. How the ground truth for the training set was established:
- Not applicable. As a non-AI/ML device, there is no training set and therefore no ground truth established for one.
In summary, the provided document focuses on the physical and biological safety of the device through non-clinical testing, particularly biocompatibility. It is a substantial equivalence submission, comparing the new device to an existing predicate rather than demonstrating clinical efficacy through a structured clinical study with human patients and expert review of clinical outcomes/interpretations.
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March 12, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CorTec GmbH Mara Assis Regulatory Affairs & Ouality Management Neuer Messplatz 3 79108 Freiburg i. Br., Germany
Re: K183437
Trade/Device Name: AirRay Subdural Cortical Electrodes Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: November 30, 2018 Received: December 12, 2018
Dear Mara Assis:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183437
Device Name AirRay Subdural Cortical Electrodes
Indications for Use (Describe)
The °AirRay® 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 level of the brain. The recording of electrical activity supports definition 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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K183437 Traditional 510(k) Summary °AirRay® Subdural Cortical Electrodes
| Submitter | CorTec GmbHNeuer Messplatz 379108 Freiburg i. Br., GermanyTel: +49 (0)761 70 888 100Fax: +49 (0)761 70 888 399E-mail: sales@cortec-neuro.com |
|---|---|
| Contact Person | Mara AssisRegulatory Affairs & Quality ManagementE-mail: mara.assis@cortec-neuro.com |
| Date | March 12, 2019 |
| Device Name | °AirRay® Subdural Cortical Electrodes |
| Common Name | Strip and Grid Subdural Electrodes |
| Classification | Cortical Electrode21 CFR 882.1310, Class II |
| Product Code | GYC, Cortical Electrode |
| Predicate Device(s): | 510(k) Number: K053363Manufacturer: Ad-Tech Medical Instrument CorporationTrade Name: AD-TECH Subdural Cortical Electrodes (Dual-Sided InterhemisphericGrid, Intraoperative, Strip, Wyler)Product Code: GYCClassification: 21 CFR 882.1310 |
Intended Use
The ° AirRay® Subdural Cortical Electrodes 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 physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of subdural electrodes.
Indication for Use
The °AirRay® 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 level of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.
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Conformance to Special Controls / Performance Standards/ Recognized Consensus Standards
There are no special controls/performance standards associated with Product Code GYC. However, conformance to the following recognized consensus standards is declared:
| FDA # | Standard Name |
|---|---|
| ------- | --------------- |
- 5-87 IEC 62366 Consolidated Version Medical Devices - Application of Usability Engineering to Medical Devices:2014, Version 1.1
- 2-156 ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within A Risk Management Process: 2009(R)2014
- 14-452 ISO 11135-1 Sterilization of Health-Care Products - Ethylene Oxide - Requirements for The Development, Validation and Routine Control of ASterilization Process for Medical Devices: 2014
- 14-454 ISO 11607-1 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials. Sterile Barrier Systems and Packaging Systems [Including: Amendment 1 (2014)]
- 14-455 ISO 11607-2 Packaging for Terminally Sterilized Medical Devices - Part 2: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [Including: Amendment 1 (2014)]
Comparison to Predicates
The primary differences between the AirRay® Subdural Cortical Electrodes (subject device) and the predicate are:
- The proposed device offers fewer variants than the predicate. ●
- . The proposed device can accommodate 32 contacts per electrode connector instead of 16 contacts.
Biocompatibility Summary Table
The AirRay Subdural Cortical Electrodes is categorized as an implant device in prolonged (up to 30 days) contact with neural tissue/bone, cerebrospinal fluid (CSF) and blood (indirect blood contact through CSF as CSF is reabsorbed into the venous system). Based on this classification, tests relevant to the device were selected and conducted on the finished, sterilized device in accordance with ISO 10993-1 and 2016 FDA Biocompatibility Guidance. All biocompatibility studies were conducted in compliance with Good Laboratory Practices (GLP), 21 CFR Part 58. The results of the biocompatibility testing are summarized in the Table below. All prespecified acceptance criteria were met and all tests passed.
| Test (Applicable ISO10993 Part No.) | Test Method | Results | Conclusion |
|---|---|---|---|
| Cytotoxicity (10993-5) | BCA Protein Cytotoxicity Assay withTest Extract using L-929 MouseFibroblast Cells | Pass | Non-cytotoxic |
| Sensitization (10993-10) | Guinea Pig MaximizationSensitization Test | Pass | Non-sensitizer |
| Irritation (ISO 10993-10) | IntracutaneousReactivity Test | Pass | Non-irritant |
| Acute SystemicToxicity (ISO 10993-11) | Acute SystemicInjection Test | Pass | No acute systemic toxicity |
| Material- mediatedPyrogenicity (ISO10993-11) | Rabbit Pyrogen Test | Pass | Non-pyrogenic |
| Test (Applicable ISO10993 Part No.) | Test Method | Results | Conclusion |
| Hemocompatibility(ISO 10993-4) | Indirect Hemolysis Test (extract test) | Pass | Non-hemolytic |
| Subchronic Toxicity(ISO 10993-11) | 4-week Systemic Toxicity Studyfollowing Subcutaneous Implantation inRats | No systemic orlocal toxicitieswere observed inthis study.Clinicalobservations,body weights,organ weights,organ/bodyweight ratios,hematology andclinical chemistryvalues, andnecropsy resultswere acceptable.Microscopicevaluation of thecollected organsrevealed no | No subchronic systemic toxicity |
| Genotoxicity (ISO10993-3) | Bacterial Mutagenicity Test (Ames Assay) In Vitro Mouse Lymphoma Assay | PassPass | Non-mutagenicNon-mutagenic / clastogenic |
| Test (Applicable ISO10993 Part No.) | Test Method | Results | Conclusion |
| Implantation (ISO10993-6) | A 4-week brain implantation study wasconducted in rabbits. The test article andnegative control article (HDPE) wereimplanted in separate animals. Both male andfemale animals were used in the study.Throughout the study, assessments of generalhealth, neurological examinations, and bodyweight measurements were performed. Therewere two termination points in the study – 1week and 4 weeks. At each terminationtimepoint, the cranium with the brain werecollected. The implant sites and the cervicaldraining lymph nodes were macroscopicallyevaluated, collected, histologically processed,and microscopically evaluated. Followingstains were used for histopathology -hematoxylin and eosin (H&E), Iba-l formicroglia, luxol fast blue (LFB) for myelin,anti-glial fibrillary acid protein (GFAP)antibody for astroglia, and fluoro-jade B(FJB) for neuronal degeneration/necrosis.The macroscopic and microscopicevaluations were performed by a boardcertified veterinary pathologist. | Overall, there wereno adverse localeffects attributed tothe implantedarticles. Allimplanted animalssurvived the studywith no clinical orneurologicalfindings that wereattributable to thetest article or thenegative controlarticle. There wasno evidence ofcerebrospinal fluidleakage or infectionfor the test articleor the negativecontrol article. Atboth 1 and 4 weekstimepoints, the testarticle wasconsideredto elicit no orminimal reaction incomparison to thenegative controlarticle. | No adverse local effects in neuraltissues, no neurotoxicity |
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| Characteristic | Proposed Device: CorTecAirRay® Subdural Cortical ElectrodesK183437 | Predicate Device: Ad-Tech MedicalSubdural Cortical ElectrodesK053363 | Comments |
|---|---|---|---|
| Picture | Image: Proposed Device CorTec AirRay Subdural Cortical Electrodes | Image: Predicate Device Ad-Tech Medical Subdural Cortical Electrodes | The pictures show that the Proposed Device models shown (64 contact grid) for the proposed device is 80 mm x 86 mm with 370 mm electrode cables; the predicate device is 80 mm x 80 mm with 375 mm electrode cables. They are made with similar materials (silicone body and cables with platinum:iridium contacts). The manufacturing techniques of the proposed device allows for 32 contacts per cable, while the predicate only allows 16. The differences are minor and do not affect safety or effectiveness. Acceptable |
| BASIC INFORMATION AND USES | |||
| FDA Device Type | Cortical Electrode | Cortical Electrode | Acceptable |
| FDA Product Code | GYC (cortical electrodes) | GYC (cortical electrodes) | Acceptable |
| FDA Class | II | II | Acceptable |
| FDA Regulation | CFR 882.1310 | CFR 882.1310 | Acceptable |
| Intended Use | Subdural electrodes are single patient use, disposable, sterile devices. The electrodes are invasive as they are placed in contact with the brain. | 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. | Acceptable |
| The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and | The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and | ||
| Proposed Device: CorTec | Predicate Device: Ad-Tech Medical | ||
| AirRay® Subdural Cortical Electrodes | Subdural Cortical Electrodes | ||
| Characteristic | K183437 | K053363 | Comments |
| stimulation/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 | stimulation/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. | ||
| Device Family Members | Strips, Grids | Dual-Sided, Interhemispheric, Grid,Intraoperative, Strip, Wyler | Grids and strips are contained within thecleared electrode types of the predicate.Offering fewer product variants does not raiseany new questions of safety or effectiveness.Therefore, acceptable. |
| Indication for Use | The AirRay® Subdural Cortical Electrodes(Strips and Grids) are intended for temporary(<30 days) use with recording, monitoringand stimulation equipment for the recording,monitoring and stimulation of electricalsignals on the surface level of the brain. Therecording of electrical activity supportsdefinition of the location of epileptogenicfoci and brain mapping. | The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative,Strip, Wyler) are intended for temporary (< 30days) use with recording, monitoring andstimulation equipment for the recording,monitoring and stimulation of electricalsignals on the surface of the brain. Therecording of electrical activity supportsdefinition of the location of epileptogenic fociand brain mapping. | Except for branding and the more limitedsubset of family members, the proposeddevice is identical to the predicate. Brandingissues and offering fewer product variantsdoes not raise any new questions of safety oreffectiveness Therefore, acceptable. |
| Contraindications | 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 | The subdural electrodes should not be used onany 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 the predicate. Therefore,acceptable. |
| Intended User | Physicians, Surgeons, Epileptologists,Electrophysiologists, Neurosurgeons,Neurologists | Not stated formally, but clinically known inthe industry to be: Physicians, Surgeons,Epileptologists, Electrophysiologists,Neurosurgeons, Neurologists | Although not known to be formally stated inthe predicate's submission, the intended usersare assumed to be identical to the predicate.Therefore, acceptable. |
| Intended Environment ofUse | Operating rooms and epilepsy monitoringfacilities | Not stated formally but clinically known to be:Operating rooms and epilepsy monitoringfacilities | Although not known to be formally stated inthe predicate's submission, the intendedEnvironment of Use are assumed to beidentical to the predicate. Therefore,acceptable. |
| Proposed Device: CorTec | Predicate Device: Ad-Tech Medical | ||
| AirRay® Subdural Cortical Electrodes | Subdural Cortical Electrodes | ||
| Characteristic | K183437 | K053363 | Comments |
| Targeted PatientPopulation | Not stated formally | Not stated formally | Neither the proposed device nor the predicatedevice states the targeted patient population(nor do any other similar devices clearedunder the same product code). In clinicalpractice the use of the device is up to theapplicable physician. Not stating a targetedpatient population does not raise any newquestions of safety or effectiveness.Therefore, acceptable. |
| LABELING & PACKAGING INFORMATION | |||
| Product Identification | XXXX.XXXX.XX e.g. 2011.1020.01201X.XXXX.XX general product definition(group), here: 201 =ECoG electrode;XXX1.XXXX.XX product type regardingmanufacturing, here: 1 =final productXXXX.1XXX.XX product application, here:1 = clinical productXXXX.X020.XX consecutive number,here: 020XXXX.XXXX.01 product variant, here: 01= defined color coding | AANNR-YYMS-000AA = The electrode type where IS=NumberedStrip, TS=non-numbered strip orFG=GridNN= Number of contactsR = The type of contact (various options existfor small, indented, square, etc.electrodes)YY = the spacing between contactsM= Metal Type, where P=Platinum,S=Stainless SteelS = Sterility Status where X= Sterile, N=Non-Sterile000 = Uniqueness of electrode | Both companies use a formulaic catalognumbering system to encode for theapplicable variants. Minor differences existto reflect marketing preferences and fewerchoices/options for the proposed device.These issues do not affect the safety oreffectiveness of the device. Therefore,Substantially Equivalent |
| Schematic | The proposed device includes a "Code Chart"identifying the layout of the electrode as wellas the color coding identification of theelectrode cable(s) [aka tail(s)] of theelectrode. | The predicate device includes a "Code Chart"identifying the layout of the electrode as wellas the color coding identification of theelectrode cable(s) [aka tail(s)] of the electrode. | Both companies include a code chart to showthe user the layout and color-coding of theelectrode. Minor differences exist based onlayout, font sizes, marketing issues, etc.These issues do not affect the safety oreffectiveness of the device.Therefore, Substantially Equivalent |
| Cautionary Statements | Comment: See the instructions for use for afull list.MR UNSAFE | For Single Use Only. Do not Re-Sterilize orReuse. Not intended of Implantation (21 CFR860.3(d): > 30 days. For Surgical Use Only.Do not use if packaging is damaged.CAUTION: Federal Law (U.S.A.) restrictsthis Device to sale by or on the order of a | To comply with CE marking requirements,the proposed device includes additionalcaution/warning statements than thepredicate, but doing so does not raise anynew questions of safety or effectiveness.Identical to the predicate. Therefore. |
| Characteristic | Proposed Device: CorTecAirRay® Subdural Cortical ElectrodesK183437 | Predicate Device: Ad-Tech MedicalSubdural Cortical ElectrodesK053363 | Comments |
| Sterility status of theelectrodes | Sterile only | physicianCAUTION: Reuse of this Device isprohibited as it may malfunction and causecontamination and risk to the patient,CAUTION: Disconnect from monitoringequipment during cardiac defibrillation.Both sterile and non-sterile devices areoffered. | acceptable.Sterile only devices are within the boundariesof the predicate and offering only steriledevices does not raise any new questions ofsafety or effectiveness. Therefore,acceptable. |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical to the predicate. Therefore,acceptable. |
| Packaging Configuration | Individually packaged in a labeled pouch thatships in its own labeled box along withdirections for use and a code chart. | Individually packaged in a labeled pouch thatships in its own labeled box along withdirections for use and a code chart. | Identical to the predicate. Therefore,Substantially Equivalent |
| Non-Pyrogenic | not so labeled, but bacterial endotoxin testingdemonstrates that the subject device meets ≤2.15 EU/device endotoxin limit requirement;endotoxin levels on the device are less than2.15 EU/device, which is the endotoxin limitfor the CSF-contacting device. | Not so labeled | Identical to the predicate. Therefore,acceptable. |
| Single Patient Use,Disposable | Yes | Yes | Identical to the predicate. Therefore,acceptable. |
| ELECTRODE CONTACT INFORMATION | |||
| Number of ElectrodeContacts | Strips: 4 to 8, InclusiveGrids: 4 to 64, inclusive | Strips: 1 to 16, InclusiveGrids: 3 to 128, inclusive | The number of contacts for the proposeddevices is within the boundaries of thepredicate, offering a narrower range ofcontacts does not raise any new questions ofsafety or effectiveness. Therefore,acceptable. |
| Electrode Contact Spacing | 10 mmOther variations can be requested by thecustomer. | 10 mmOther variations can be requested by thecustomer. | The number of contacts for the proposeddevices is within the boundaries of thepredicate. Offering a narrower range ofcontacts does not raise any new questions of |
| Characteristic | Proposed Device: CorTecAirRay® Subdural Cortical ElectrodesK183437 | Predicate Device: Ad-Tech MedicalSubdural Cortical ElectrodesK053363 | Comments |
| Electrode ContactMaterial | 90:10 Platinum:iridium | 90:10 Platinum:iridium or Stainless Steel | safety or effectiveness Therefore, acceptable.90:10 Platinum:Iridium is within theboundaries of the predicate. Offering a fewerelectrode contact materials does not raise anynew questions of safety or effectivenessTherefore, acceptable. |
| Electrode Contact Size(exposed surface area) | 2.7 mm diameter | 1.5 mm x 1.5 mm, 1.5 mm x 3.0 mm, 2.3 mmdiameter, 4.0 mm diameter – per the K053363submission1.17, 1.8 mm, 5 mm dia. (exposed) currentlymarketed | The diameter of the contacts for the proposeddevices is within the boundaries of thepredicate. Offering a narrower range ofcontact diameters does not raise any newquestions of safety or effectiveness.Therefore, acceptable. |
| ELECTRODE CABLE (aka electrode tail) INFORMATION | |||
| Maximum contacts perelectrode cable | 32 | 16 | The proposed device offers more potentialcontacts per electrode cable than thepredicate. Doing so reduces the number ofincisions needed to tunnel the cables awayfrom the surgical site. Although this aspectof the electrodes is viewed to be a feature ofthe design process, and in theory reduces therisk of infection, it does not affect the overalldesign intent/indication for use of the deviceor its safety or effectiveness. Therefore,acceptable. |
| Diameter of the electrodecable | 1.8 mm | 1.5 to 2.1 mm | The diameter of the electrode cable for theproposed devices is within the boundaries ofthe predicate and does not raise any newquestions of safety or effectiveness.Therefore, acceptable. |
| CONNECTION CABLE (Electrode to EEG) INFORMATION | |||
| Connection Cable(510(k) Exempt) | The connection cable terminates in a safetyfemale DIN connector. It connects theelectrode cable via the connector to theamplifier / stimulator. | TECH-ATTACH and Cabrio™ ConnectionSystems which connect to a patient cable thatterminates in a safety female Din connector. Itconnects the electrode cable via the connectorto the amplifier / stimulator | Although per 21CFR890.1175, the electrode-to-EEG/Stimulator cables are exempt from510(k) submissions, their use is still vital toconnect the proposed/predicate devices to athird-party EEG. Although the specificmanufacturing methods vary, both theproposed and predicate device comply with |
| Characteristic | Proposed Device: CorTecAirRay® Subdural Cortical ElectrodesK183437 | Predicate Device: Ad-Tech MedicalSubdural Cortical ElectrodesK053363 | Comments |
| the applicable safety standards and share thesame overall design intent. Therefore,acceptable. | |||
| PRINCIPLES OF OPERATION | |||
| Interactions with ThirdParty 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.Nonetheless formal compatibility testing wasdone on commercially-available ECoGsystems and stimulators. | 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 EEGsignals produced by the CNS and/or for thecurrents produced by the stimulators. In asense, they simply serve as electrical pathways | Both devices are essentially "wires' thatsimply conduct electricity. However, theformal testing that the proposed deviceundertook does not raise any new questionsof safety or effectiveness. Therefore,acceptable. |
| Stimulation Parameters | As stated on the instructions for use, a safelevel of stimulation is below 50 µC/cm² andan acceptable stimulation is between 50µC/cm² and 108 µC/cm² This is a function ofexposed electrode contact size, pulse durationand stimulation current. | As stated on the instructions for use, a safelevel of stimulation is below 50 µC/cm² andan acceptable stimulation is between 50µC/cm² and 150 µC/cm² This is a function ofexposed electrode contact size, pulse durationand stimulation current. | Both devices claim an identical safe level ofstimulation to be less than 50 µC/cm². Theproposed device claims an acceptable rangethat is more conservative (108 µC/cm² versus150 µC/cm² than the predicate. However,being more restrictive does not raise any newquestions of safety or effectiveness.Therefore, acceptable. |
| Proposed Device: CorTecAirRay® Subdural Cortical ElectrodesK183437 | Predicate Device: Ad-Tech MedicalSubdural Cortical ElectrodesK053363 | ||
| Characteristic | Comments | ||
| ContainsSoftware/Firmware | No | No | Identical to the predicate. Acceptable. |
| STANDARDS & TESTING | |||
| Conformance to Standards | • IEC 62366 Consolidated Version MedicalDevices - Application of UsabilityEngineering to Medical Devices:2014,Version 1.1• ISO 10993-1 Biological Evaluation ofMedical Devices - Part 1: Evaluation andTesting Within A Risk ManagementProcess: 2009(R)2014• ISO 11135-1 Sterilization of Health-CareProducts - Ethylene Oxide - Requirementsfor The Development, Validation andRoutine Control of A Sterilization Processfor Medical Devices: 2014• ISO 11607-1 Packaging for TerminallySterilized Medical Devices - Part 1:Requirements for Materials, Sterile BarrierSystems and Packaging Systems[Including: Amendment 1 (2014)]• ISO 11607-2 Packaging for TerminallySterilized Medical Devices - Part 2:Requirements for Materials, Sterile BarrierSystems and Packaging Systems[Including: Amendment 1 (2014)] | None stated in the public summary for thedevice. | The proposed device declares compliance tothe current, applicable standards pertaining tohuman factors, biocompatibility, sterilizationand packaging while the predicate does not.However, doing so does not raise any newquestions of safety or effectiveness.Acceptable. |
| Electrical PerformanceTesting | As part of the manufacturing process, theelectrodes are checked for electricalcontinuity and lack of cross-talk betweenchannels.The devices were physically tested fordielectric strength, impedance and corrosionon new and aged products. | 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 underwent formalelectrical testing while the predicate did not.However, being more rigorous does not raiseany new questions of safety or effectiveness.Therefore, Substantially Equivalent |
| Electrical Safety Testing | Not Conducted - Not Applicable | Not Conducted - Not Applicable | Identical to the predicate. Therefore,Substantially Equivalent |
| Characteristic | Proposed Device: CorTecAirRay® Subdural Cortical ElectrodesK183437 | Predicate Device: Ad-Tech MedicalSubdural Cortical ElectrodesK053363 | Comments |
| EMC Testing | N/A | N/A | N/A |
| Mechanical PerformanceTesting | The devices were physically tested for tensilestrength, hardness and bending on new andaged products as well as underwent testingfor their mechanical properties. | Not Stated - it is known that the submissiondid not include formal mechanical testing | The proposed device underwent formalmechanical testing while the predicate didnot. However, being more rigorous does notraise any new questions of safety oreffectiveness. Acceptable |
| MRI Testing | MR UNSAFE; Not testingThe AirRay Subdural Cortical Electrodes isMR Unsafe | Not Stated | Labeling the device in an identical manner tothe predicate does not raise any newquestions of safety or effectiveness.Acceptable. |
| Human Factors Testing | The devices are in conformance with therequirements of IEC 62366 (UsabilityEngineering) | Not Stated – it is known that the submissiondid not include formal Human Factors testing | The proposed device underwent formalhuman factors / usability engineering testingwhile the predicate did not. However, beingmore rigorous does not raise any newquestions of safety or effectiveness.Acceptable. |
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Conclusion
The proposed AirRay® Subdural Cortical Electrodes and its predical Subdural Cortical Electrodes, are substantially equivalent based on their intended use and technological characteristics as well as their intended use environment, and indications for use. Furthermore, both systems have similar physical characterisics and stimulation parameters. The devices, namely the aspects that pertain to the number of variants, the number of contacts per electrode connector, and testing methods do not adversely impact the safety and/oreffectiveness.
§ 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).