(90 days)
Not Found
No
The summary describes a passive electrode device for recording and stimulating brain signals. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used for recording, monitoring, and stimulation of electrical signals for diagnostic purposes (defining epileptogenic foci and brain mapping), not for treating a condition.
Yes
The device is intended for "recording, monitoring, and stimulation of electrical signals on the surface level of the brain" and "The recording of electrical activity supports definition of epileptogenic foci and brain mapping," which are diagnostic purposes.
No
The device description explicitly states that the device is a "single patient use, disposable, sterile device" and "invasive as they are placed in contact with the brain." It also describes physical and electrical performance testing, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The °AirRay® Subdural Cortical Electrodes are designed to be placed directly on the surface of the brain to record, monitor, and stimulate electrical signals. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) procedure.
- Intended Use: The intended use is for recording, monitoring, and stimulation of electrical signals on the brain's surface to support the definition of epileptogenic foci and brain mapping. This is a direct interaction with the patient's living tissue, not the analysis of a specimen taken from the patient.
Therefore, the °AirRay® Subdural Cortical Electrodes fall under the category of implantable or invasive medical devices used for neurological monitoring and stimulation, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The °AirRay® Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (
§ 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).
0
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
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/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 ( 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
K183437 Traditional 510(k) Summary °AirRay® Subdural Cortical Electrodes
| Submitter | CorTec GmbH
Neuer Messplatz 3
79108 Freiburg i. Br., Germany
Tel: +49 (0)761 70 888 100
Fax: +49 (0)761 70 888 399
E-mail: sales@cortec-neuro.com |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mara Assis
Regulatory Affairs & Quality Management
E-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 Electrode
21 CFR 882.1310, Class II |
| Product Code | GYC, Cortical Electrode |
| 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 |
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. 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 | To comply with CE marking requirements,
the proposed device includes additional
caution/warning statements than the
predicate, but doing so does not raise any
new questions of safety or effectiveness.
Identical to the predicate. Therefore. |
| Characteristic | Proposed Device: CorTec
AirRay® Subdural Cortical Electrodes
K183437 | Predicate Device: Ad-Tech Medical
Subdural Cortical Electrodes
K053363 | Comments |
| Sterility status of the
electrodes | Sterile only | 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.
Both sterile and non-sterile devices are
offered. | acceptable.
Sterile only devices are within the boundaries
of the predicate and offering only sterile
devices does not raise any new questions of
safety or effectiveness. Therefore,
acceptable. |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical to the predicate. Therefore,
acceptable. |
| Packaging Configuration | Individually packaged in a labeled pouch that
ships in its own labeled box along with
directions for use and a code chart. | Individually packaged in a labeled pouch that
ships in its own labeled box along with
directions for use and a code chart. | Identical to the predicate. Therefore,
Substantially Equivalent |
| Non-Pyrogenic | not so labeled, but bacterial endotoxin testing
demonstrates that the subject device meets ≤
2.15 EU/device endotoxin limit requirement;
endotoxin levels on the device are less than
2.15 EU/device, which is the endotoxin limit
for 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 Electrode
Contacts | Strips: 4 to 8, Inclusive
Grids: 4 to 64, inclusive | Strips: 1 to 16, Inclusive
Grids: 3 to 128, inclusive | The number of contacts for the proposed
devices is within the boundaries of the
predicate, offering a narrower range of
contacts does not raise any new questions of
safety or effectiveness. Therefore,
acceptable. |
| Electrode Contact Spacing | 10 mm
Other variations can be requested by the
customer. | 10 mm
Other variations can be requested by the
customer. | The number of contacts for the proposed
devices is within the boundaries of the
predicate. Offering a narrower range of
contacts does not raise any new questions of |
| Characteristic | Proposed Device: CorTec
AirRay® Subdural Cortical Electrodes
K183437 | Predicate Device: Ad-Tech Medical
Subdural Cortical Electrodes
K053363 | Comments |
| Electrode Contact
Material | 90:10 Platinum:iridium | 90:10 Platinum:iridium or Stainless Steel | safety or effectiveness Therefore, acceptable.
90:10 Platinum:Iridium is within the
boundaries of the predicate. Offering a fewer
electrode contact materials does not raise any
new questions of safety or effectiveness
Therefore, 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 mm
diameter, 4.0 mm diameter – per the K053363
submission
1.17, 1.8 mm, 5 mm dia. (exposed) currently
marketed | The diameter of the contacts for the proposed
devices is within the boundaries of the
predicate. Offering a narrower range of
contact diameters does not raise any new
questions of safety or effectiveness.
Therefore, acceptable. |
| ELECTRODE CABLE (aka electrode tail) INFORMATION | | | |
| Maximum contacts per
electrode cable | 32 | 16 | The proposed device offers more potential
contacts per electrode cable than the
predicate. Doing so reduces the number of
incisions needed to tunnel the cables away
from the surgical site. Although this aspect
of the electrodes is viewed to be a feature of
the design process, and in theory reduces the
risk of infection, it does not affect the overall
design intent/indication for use of the device
or its safety or effectiveness. Therefore,
acceptable. |
| Diameter of the electrode
cable | 1.8 mm | 1.5 to 2.1 mm | The diameter of the electrode cable for the
proposed devices is within the boundaries of
the predicate and does not raise any new
questions of safety or effectiveness.
Therefore, acceptable. |
| CONNECTION CABLE (Electrode to EEG) INFORMATION | | | |
| Connection Cable
(510(k) Exempt) | The connection cable terminates in a safety
female DIN connector. It connects the
electrode cable via the connector to the
amplifier / stimulator. | TECH-ATTACH and Cabrio™ Connection
Systems which connect to a patient cable that
terminates in a safety female Din connector. It
connects the electrode cable via the connector
to the amplifier / stimulator | Although per 21CFR890.1175, the electrode-
to-EEG/Stimulator cables are exempt from
510(k) submissions, their use is still vital to
connect the proposed/predicate devices to a
third-party EEG. Although the specific
manufacturing methods vary, both the
proposed and predicate device comply with |
| Characteristic | Proposed Device: CorTec
AirRay® Subdural Cortical Electrodes
K183437 | Predicate Device: Ad-Tech Medical
Subdural Cortical Electrodes
K053363 | Comments |
| | | | the applicable safety standards and share the
same overall design intent. Therefore,
acceptable. |
| | PRINCIPLES OF OPERATION | | |
| Interactions with Third
Party EEGs/ Stimulators | Subdural electrodes themselves are non-
active and serve simply as conductors for the
EEG signals produced by the CNS and/or for
the currents produced by the stimulators. In a
sense, they simply serve as electrical
pathways.
Nonetheless formal compatibility testing was
done on commercially-available ECoG
systems and stimulators. | While not formally stated in the predicate's
510(k) summary statement or labeling, it is
known that the predicate 510(k) submission
maintained that the devices are non-active and
serve simply as conductors for the EEG
signals produced by the CNS and/or for the
currents produced by the stimulators. In a
sense, they simply serve as electrical pathways | Both devices are essentially "wires' that
simply conduct electricity. However, the
formal testing that the proposed device
undertook does not raise any new questions
of safety or effectiveness. Therefore,
acceptable. |
| Stimulation Parameters | As stated on the instructions for use, a safe
level of stimulation is below 50 µC/cm² and
an acceptable stimulation is between 50
µC/cm² and 108 µC/cm² This is a function of
exposed electrode contact size, pulse duration
and stimulation current. | As stated on the instructions for use, a safe
level of stimulation is below 50 µC/cm² and
an acceptable stimulation is between 50
µC/cm² and 150 µC/cm² This is a function of
exposed electrode contact size, pulse duration
and stimulation current. | Both devices claim an identical safe level of
stimulation to be less than 50 µC/cm². The
proposed device claims an acceptable range
that is more conservative (108 µC/cm² versus
150 µC/cm² than the predicate. However,
being more restrictive does not raise any new
questions of safety or effectiveness.
Therefore, acceptable. |
| | Proposed Device: CorTec
AirRay® Subdural Cortical Electrodes
K183437 | Predicate Device: Ad-Tech Medical
Subdural Cortical Electrodes
K053363 | |
| Characteristic | | | Comments |
| Contains
Software/Firmware | No | No | Identical to the predicate. Acceptable. |
| STANDARDS & TESTING | | | |
| Conformance to Standards | • IEC 62366 Consolidated Version Medical
Devices - Application of Usability
Engineering to Medical Devices:2014,
Version 1.1
• ISO 10993-1 Biological Evaluation of
Medical Devices - Part 1: Evaluation and
Testing Within A Risk Management
Process: 2009(R)2014
• ISO 11135-1 Sterilization of Health-Care
Products - Ethylene Oxide - Requirements
for The Development, Validation and
Routine Control of A Sterilization Process
for Medical Devices: 2014
• ISO 11607-1 Packaging for Terminally
Sterilized Medical Devices - Part 1:
Requirements for Materials, Sterile Barrier
Systems and Packaging Systems
[Including: Amendment 1 (2014)]
• ISO 11607-2 Packaging for Terminally
Sterilized Medical Devices - Part 2:
Requirements for Materials, Sterile Barrier
Systems and Packaging Systems
[Including: Amendment 1 (2014)] | None stated in the public summary for the
device. | The proposed device declares compliance to
the current, applicable standards pertaining to
human factors, biocompatibility, sterilization
and packaging while the predicate does not.
However, doing so does not raise any new
questions of safety or effectiveness.
Acceptable. |
| Electrical Performance
Testing | As part of the manufacturing process, the
electrodes are checked for electrical
continuity and lack of cross-talk between
channels.
The devices were physically tested for
dielectric strength, impedance and corrosion
on new and aged products. | As part of the manufacturing process, the
electrodes are checked for electrical continuity
and lack of cross-talk between channels. It is
known that the submission contained
theoretical calculations for dielectric
breakdown of the insulation and the current-
carrying capacity of the internal electrode
wires. No formal test results were submitted. | The proposed device underwent formal
electrical testing while the predicate did not.
However, being more rigorous does not raise
any 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: CorTec
AirRay® Subdural Cortical Electrodes
K183437 | Predicate Device: Ad-Tech Medical
Subdural Cortical Electrodes
K053363 | Comments |
| EMC Testing | N/A | N/A | N/A |
| Mechanical Performance
Testing | The devices were physically tested for tensile
strength, hardness and bending on new and
aged products as well as underwent testing
for their mechanical properties. | Not Stated - it is known that the submission
did not include formal mechanical testing | The proposed device underwent formal
mechanical testing while the predicate did
not. However, being more rigorous does not
raise any new questions of safety or
effectiveness. Acceptable |
| MRI Testing | MR UNSAFE; Not testing
The AirRay Subdural Cortical Electrodes is
MR Unsafe | Not Stated | Labeling the device in an identical manner to
the predicate does not raise any new
questions of safety or effectiveness.
Acceptable. |
| Human Factors Testing | The devices are in conformance with the
requirements of IEC 62366 (Usability
Engineering) | Not Stated – it is known that the submission
did not include formal Human Factors testing | The proposed device underwent formal
human factors / usability engineering testing
while the predicate did not. However, being
more rigorous does not raise any new
questions 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.