AirRay Subdural Cortical Electrodes

K183437 · Cortec GmbH · GYC · Mar 12, 2019 · Neurology

Device Facts

• Record ID: K183437
• Device Name: AirRay Subdural Cortical Electrodes
• Applicant: Cortec GmbH
• Product Code: GYC · Neurology
• Decision Date: Mar 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1310
• Device Class: Class 2

Intended 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.

Device Story

AirRay Subdural Cortical Electrodes are sterile, single-patient-use, invasive devices placed in contact with the brain surface. They function as passive electrical pathways, connecting to third-party recording, monitoring, and stimulation equipment. Used in operating rooms and epilepsy monitoring facilities by physicians (neurosurgeons, neurologists, epileptologists, electrophysiologists). The device transmits EEG signals from the CNS or delivers stimulation currents. By enabling brain mapping and identification of epileptogenic foci, the device assists clinicians in surgical planning and epilepsy management. The device is MR Unsafe.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993-1, -3, -4, -5, -6, -10, -11), electrical performance (continuity, cross-talk, dielectric strength, impedance, corrosion), and mechanical performance (tensile strength, hardness, bending). Biocompatibility testing included a 4-week brain implantation study in rabbits, which showed no adverse local effects or neurotoxicity.

Technological Characteristics

Materials: Silicone body/cables, 90:10 Platinum:Iridium contacts. Form factor: Strips (4-8 contacts) and Grids (4-64 contacts). Connectivity: Passive electrical conductor to third-party EEG/stimulator via safety female DIN connector. Sterilization: Ethylene Oxide. Standards: IEC 62366, ISO 10993-1, ISO 11135-1, ISO 11607-1/2.

Indications for Use

Indicated for temporary (<30 days) recording, monitoring, and stimulation of electrical signals on the brain surface to support definition of epileptogenic foci and brain mapping. No specific patient population (age/gender) defined.

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)

Submission Summary (Full Text)

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March 12, 2019

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### K183437 Traditional 510(k) Summary °AirRay® Subdural Cortical Electrodes

| Submitter | CorTec GmbH<br>Neuer Messplatz 3<br>79108 Freiburg i. Br., Germany<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mara Assis<br>Regulatory Affairs & Quality Management<br>E-mail: [e-mail] |
| Date | March 12, 2019 |
| Device Name | °AirRay® Subdural Cortical Electrodes |
| Common Name | Strip and Grid Subdural Electrodes |
| Classification | Cortical Electrode<br>21 CFR 882.1310, Class II |
| Product Code | GYC, Cortical Electrode |
| Predicate Device(s): | 510(k) Number: K053363<br>Manufacturer: Ad-Tech Medical Instrument Corporation<br>Trade Name: AD-TECH Subdural Cortical Electrodes (Dual-Sided Interhemispheric<br>Grid, Intraoperative, Strip, Wyler)<br>Product Code: GYC<br>Classification: 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 ISO<br>10993 Part No.) | Test Method | Results | Conclusion |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Cytotoxicity (10993-5) | BCA Protein Cytotoxicity Assay with<br>Test Extract using L-929 Mouse<br>Fibroblast Cells | Pass | Non-cytotoxic |
| Sensitization (10993-10) | Guinea Pig Maximization<br>Sensitization Test | Pass | Non-sensitizer |
| Irritation (ISO 10993-<br>10) | Intracutaneous<br>Reactivity Test | Pass | Non-irritant |
| Acute Systemic<br>Toxicity (ISO 10993-<br>11) | Acute Systemic<br>Injection Test | Pass | No acute systemic toxicity |
| Material- mediated<br>Pyrogenicity (ISO<br>10993-11) | Rabbit Pyrogen Test | Pass | Non-pyrogenic |
| Test (Applicable ISO<br>10993 Part No.) | Test Method | Results | Conclusion |
| Hemocompatibility<br>(ISO 10993-4) | Indirect Hemolysis Test (extract test) | Pass | Non-hemolytic |
| Subchronic Toxicity<br>(ISO 10993-11) | 4-week Systemic Toxicity Study<br>following Subcutaneous Implantation in<br>Rats | No systemic or<br>local toxicities<br>were observed in<br>this study.<br>Clinical<br>observations,<br>body weights,<br>organ weights,<br>organ/body<br>weight ratios,<br>hematology and<br>clinical chemistry<br>values, and<br>necropsy results<br>were acceptable.<br>Microscopic<br>evaluation of the<br>collected organs<br>revealed no<br> | No subchronic systemic toxicity |
| Genotoxicity (ISO<br>10993-3) | Bacterial Mutagenicity Test (Ames Assay) In Vitro Mouse Lymphoma Assay | Pass<br>Pass | Non-mutagenic<br>Non-mutagenic / clastogenic |
| Test (Applicable ISO<br>10993 Part No.) | Test Method | Results | Conclusion |
| Implantation (ISO<br>10993-6) | A 4-week brain implantation study was<br>conducted in rabbits. The test article and<br>negative control article (HDPE) were<br>implanted in separate animals. Both male and<br>female animals were used in the study.<br>Throughout the study, assessments of general<br>health, neurological examinations, and body<br>weight measurements were performed. There<br>were two termination points in the study – 1<br>week and 4 weeks. At each termination<br>timepoint, the cranium with the brain were<br>collected. The implant sites and the cervical<br>draining lymph nodes were macroscopically<br>evaluated, collected, histologically processed,<br>and microscopically evaluated. Following<br>stains were used for histopathology -<br>hematoxylin and eosin (H&E), Iba-l for<br>microglia, luxol fast blue (LFB) for myelin,<br>anti-glial fibrillary acid protein (GFAP)<br>antibody for astroglia, and fluoro-jade B<br>(FJB) for neuronal degeneration/necrosis.<br>The macroscopic and microscopic<br>evaluations were performed by a board<br>certified veterinary pathologist. | Overall, there were<br>no adverse local<br>effects attributed to<br>the implanted<br>articles. All<br>implanted animals<br>survived the study<br>with no clinical or<br>neurological<br>findings that were<br>attributable to the<br>test article or the<br>negative control<br>article. There was<br>no evidence of<br>cerebrospinal fluid<br>leakage or infection<br>for the test article<br>or the negative<br>control article. At<br>both 1 and 4 weeks<br>timepoints, the test<br>article was<br>considered<br>to elicit no or<br>minimal reaction in<br>comparison to the<br>negative control<br>article. | No adverse local effects in neural<br>tissues, no neurotoxicity |

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| Characteristic | Proposed Device: CorTec<br>AirRay® Subdural Cortical Electrodes<br>K183437 | Predicate Device: Ad-Tech Medical<br>Subdural Cortical Electrodes<br>K053363 | 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. The<br>electrodes are used under the supervision of a<br>physician. Physicians in the areas of<br>biopotential recording, monitoring and<br>stimulation/response studies understand the<br>use of subdural electrodes | stimulation/response equipment. The<br>electrodes are used under the supervision of a<br>physician. Physicians in the areas of<br>biopotential recording, monitoring and<br>stimulation/response studies understand the<br>use of subdural electrodes. | |
| Device Family Members | Strips, Grids | Dual-Sided, Interhemispheric, Grid,<br>Intraoperative, Strip, Wyler | Grids and strips are contained within the<br>cleared electrode types of the predicate.<br>Offering fewer product variants does not raise<br>any new questions of safety or effectiveness.<br>Therefore, acceptable. |
| Indication for Use | The AirRay® Subdural Cortical Electrodes<br>(Strips and Grids) are intended for temporary<br>(<30 days) use with recording, monitoring<br>and stimulation equipment for the recording,<br>monitoring and stimulation of electrical<br>signals on the surface level of the brain. The<br>recording of electrical activity supports<br>definition of the location of epileptogenic<br>foci and brain mapping. | The AD-TECH Subdural Electrodes (Dual-<br>Sided Interhemispheric, Grid, Intraoperative,<br>Strip, Wyler) are intended for temporary (< 30<br>days) use with recording, monitoring and<br>stimulation equipment for the recording,<br>monitoring and stimulation of electrical<br>signals on the surface of the brain. The<br>recording of electrical activity supports<br>definition of the location of epileptogenic foci<br>and brain mapping. | Except for branding and the more limited<br>subset of family members, the proposed<br>device is identical to the predicate. Branding<br>issues and offering fewer product variants<br>does not raise any new questions of safety or<br>effectiveness Therefore, acceptable. |
| Contraindications | The subdural electrodes should not be used<br>on any patient who the physician/surgeon<br>considers at risk for infection.<br>The subdural electrodes are not intended for<br>continuous stimulation. Stimulation should<br>only be applied to support the brain mapping<br>purpose of the electrodes | The subdural electrodes should not be used on<br>any patient who the physician/surgeon<br>considers at risk for infection.<br>The subdural electrodes are not intended for<br>continuous stimulation. Stimulation should<br>only be applied to support the brain mapping<br>purpose of the electrodes | Identical to the predicate. Therefore,<br>acceptable. |
| Intended User | Physicians, Surgeons, Epileptologists,<br>Electrophysiologists, Neurosurgeons,<br>Neurologists | Not stated formally, but clinically known in<br>the industry to be: Physicians, Surgeons,<br>Epileptologists, Electrophysiologists,<br>Neurosurgeons, Neurologists | Although not known to be formally stated in<br>the predicate's submission, the intended users<br>are assumed to be identical to the predicate.<br>Therefore, acceptable. |
| Intended Environment of<br>Use | Operating rooms and epilepsy monitoring<br>facilities | Not stated formally but clinically known to be:<br>Operating rooms and epilepsy monitoring<br>facilities | Although not known to be formally stated in<br>the predicate's submission, the intended<br>Environment of Use are assumed to be<br>identical to the predicate. Therefore,<br>acceptable. |
| | Proposed Device: CorTec | Predicate Device: Ad-Tech Medical | |
| | AirRay® Subdural Cortical Electrodes | Subdural Cortical Electrodes | |
| Characteristic | K183437 | K053363 | Comments |
| Targeted Patient<br>Population | Not stated formally | Not stated formally | Neither the proposed device nor the predicate<br>device states the targeted patient population<br>(nor do any other similar devices cleared<br>under the same product code). In clinical<br>practice the use of the device is up to the<br>applicable physician. Not stating a targeted<br>patient population does not raise any new<br>questions of safety or effectiveness.<br>Therefore, acceptable. |
| |…