Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
Device Facts
| Record ID | K211954 |
|---|---|
| Device Name | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid |
| Applicant | Spes Medica Srl |
| Product Code | GYC · Neurology |
| Decision Date | Nov 10, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1310 |
| Device Class | Class 2 |
Indications for Use
The Recording and stimulating for Central Nervous System electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for limited (≤24 hours) use with recording, monitoring, and stimulation equipment for electrical stimulation, monitoring and recording of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.
Device Story
Device consists of multipole electrode arrays (strips/grids) positioned on brain surface; inputs are electrical signals from brain surface; outputs are electrical signals transmitted to external recording/monitoring/stimulation equipment. Used in operating rooms by neurosurgeons/skilled physicians for intraoperative monitoring, brain mapping, and epileptogenic foci localization. Electrodes transform brain surface electrical activity into signals for clinical analysis; stimulation function supports brain mapping. Healthcare providers use output to guide surgical decisions. Benefits include precise localization of brain function and epileptogenic areas during surgery.
Clinical Evidence
Bench testing only. Testing included biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity, hemolysis), packaging validation (3-year shelf life, sterility, seal integrity), cable tensile strength (>30N), impedance/dielectric strength (<5kOhm), electrical safety, and environmental/shipment stress testing. All tests met pass/fail criteria.
Technological Characteristics
Platinum/iridium electrode contacts on polyurethane substrate. Lead wires: tinned copper with PVC jacket. Connectors: DIN 42802. Sterilization: Ethylene Oxide. Single-use. Dimensions: 4-5mm contact diameter, 10mm spacing. Standalone device for use with external recording/stimulation equipment.
Indications for Use
Indicated for patients requiring intraoperative monitoring, brain mapping, and localization of epileptogenic foci via surface brain electrical signal recording and stimulation. Contraindicated for patients at high 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
- 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 (K191186)
Submission Summary (Full Text)
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November 10, 2022
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Spes Medica SRL Giorgio Facco Quality Assurance & Regulatory Affairs Via Europa - Zona Industriale Battipaglia, 84091 Italy
Re: K211954
Trade/Device Name: Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC
Dated: October 3, 2022 Received: October 11, 2022
Dear Giorgio Facco:
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
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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 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,
Patrick Antkowiak -S
for
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K211954
#### Device Name
Recording and stimulating for Central Nervous System electrodes, Spes Medica Spes Medica Strip/Intraoperative Strip, Spes Medica Grid/Intraoperative Grid, Spes Medica Multi-Strip and Split Grid, Spes Medica Intraoperative Mapping Grid
#### Indications for Use (Describe)
The Recording and stimulating for Central Nervous System electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for limited ( 24 hours) use with recording, monitoring, and stimulation equipment for electrical stimulation, monitoring of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.
| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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# 510(k) Summary
| Manufacturer's Name: | Spes Medica S.r.l.<br>via Europa (Zona Ind.le), 84091 Battipaglia (SA) - Italy |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K211954 |
| Official Correspondent: | Giorgio Facco<br>Quality Assurance and Regulatory Affairs |
| Telephone Number: | 0039 0828 614191 |
| Fax Number: | 0039 0828 341788 |
| Device Trade Name: | Subdural Electrode<br>Strip/Intraoperative Strip,<br>Grid/Intraoperative Grid,<br>Multi-Strip and Split Grid,<br>Intraoperative Mapping Grid |
| Trade Names: | Recording and stimulating for Central Nervous System electrodes |
| Common or Usual Name: | Subdural Electrode |
| Classification Name: | Cortical Electrode |
| Device Class: | Class II |
| Product Code: | GYC |
| Classification Regulation: | 21 CFR 882.1310 |
| Predicate Device: | <b>Name</b> Electrode, Cortical<br><b>510(K) Number</b> K191186<br><b>Device Name</b> Subdural Strip/Intraoperative Split Electrode, Subdural<br>Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric<br>Subdural Electrode, Multi-Strip And Slit Grid Subdural Electrode,<br>Intraoperative Mapping Grid Subdural Electrode<br><b>Applicant</b> Ad-Tech Medical Instrument Corporation<br>400 West Oakview Parkway<br>Oak Creek, WI 53154 |
| Device Description: | The Recording and stimulating for Central Nervous System electrodes are used for<br>electrical stimulation, monitoring and recording of the signals on the surface of the<br>brain for intraoperative monitoring, brain mapping and location of epileptogenic foci<br><br>The electrodes are multipole arrays of electrodes that are positioned on the surface<br>of the brain.<br><br>The electrode must be designed to follow the complex anatomy and they can assume<br>different conformations in relation to the requests of clinical needs. The<br>neurosurgeon is the person recommended for electrode placement.<br><br>The electrodes have to be used under the direction of the neurosurgeon and other<br>skilled physicians to support their clinical needs |
| Intended Use: | The Recording and stimulating for Central Nervous System electrodes<br>(Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid,<br>Intraoperative Mapping Grid) are intended for limited (≤24 hours) use with<br>recording, monitoring, and stimulation equipment for electrical stimulation,<br>monitoring and recording of the signals on the surface of the brain for intraoperative<br>monitoring, brain mapping and location of epileptogenic foci. |
| Technological Comparison: | The recording and stimulation electrode area is in platinum and is on polyurethane<br>substrate body material. The cables is in PVC with touch proof 1.5 mm connector or<br>with multi connector. The lead wires terminate in a safety connector that cannot be<br>connected to an AC power outlet<br>The characteristics of Recording and stimulating for Central Nervous System<br>electrodes are substantially equivalent to the predicate devices. No new questions<br>of safety or effectiveness are raised, Recording and stimulating for Central Nervous<br>System electrodes employ the same technological characteristics as the predicate<br>device. |
| Substantial Equivalence: | Recording and stimulating for Central Nervous System electrodes is equivalent to the<br>device cleared under K191186 as is presented below in Table. |
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lt has been shown in this 510(k) submission that the differences between the Recording and stimulating for Central Nervous System electrodes and the predicate device K191186 do not raise any questions regarding its safety and effectiveness. Recording and stimulating for Central Nervous System electrodes device is substantially equivalent to the predicate device as it has the same intended use and similar technological characteristics as the previously cleared predicate devices. Recording and stimulating for Central Nervous System electrodes, as designed is determined to be substantially equivalent to the referenced predicate devices.
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| Manufacturer | Ad-Tech Medical Instrument Corporation | Spes Medica S.r.l. | Discussion Differences | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Trade Name | Subdural Strip/Intraoperative Split Electrode, Subdural<br>Grid/Intraoperative Grid Electrode, Dual-Sided<br>Interhemispheric Subdural Electrode, Multi-Strip And<br>Slit Grid Subdural Electrode, Intraoperative Mapping<br>Grid Subdural Electrode | Subdural Electrode, Strip/Intraoperative Strip,<br>Grid/Intraoperative Grid, Multi-Strip and Split<br>Grid, Intraoperative Mapping Grid | | |
| 510(k) number | K191186 | K211954 | | |
| Product Code | GYC | GYC | | |
| Intent for use | The Ad-Tech Subdural Electrodes (Strip/Intraoperative<br>Strip, Grid/Intraoperative Grid, Dual- Sided<br>Interhemispheric, Multi-Strip and Split Grid,<br>Intraoperative Mapping Grid) are intended for temporary<br>(< 30 days) use with recording, monitoring, and<br>stimulation equipment<br>for the recording, monitoring, and stimulation of<br>electrical signals on the surface of the brain. The<br>recording of electrical activity supports definition of the<br>location of epileptogenic foci and brain mapping. | The Recording and stimulating for Central Nervous<br>System electrodes (Strip/Intraoperative Strip,<br>Grid/Intraoperative Grid, Multi-Strip and Split Grid,<br>Intraoperative Mapping Grid) are intended for<br>limited (≤24 hours) use with recording, monitoring,<br>and stimulation equipment for electrical<br>stimulation, monitoring and recording of the signals<br>on the surface of the brain for intraoperative<br>monitoring, brain mapping and location of<br>epileptogenic foci. | The contact time duration of<br>Recording and stimulating for<br>Central Nervous System electrodes<br>is ≤24 hours, lower than the<br>predicate device. This range of time<br>is anyway enough long to cover the<br>clinical use described in the intent of<br>use of Recording and stimulating for<br>Central Nervous System electrodes<br>which is of intraoperative<br>monitoring, brain mapping and<br>location of epileptogenic foci. The<br>user is aware of the limited duration<br>of the use thanks to the indication in<br>the instruction for use leaflet.<br>Therefore, the predicate device can<br>be considered as the "worst case" as<br>the time contact is < 30 days.<br>Furthermore, according to the<br>biocompatibility tests, Recording<br>and stimulating for Central Nervous<br>System electrodes result to be fully<br>biocompatible so no new questions<br>of safety or effectiveness are raised. | |
| Regulation Name | Cortical Electrode | Cortical Electrode | The same of the predicate device | |
| Regulation Number | 882.1310 | 882.1310 | The same of the predicate device | |
| Device description | The device under review is a family of Subdural<br>Electrodes. These electrodes provide surface brain<br>contact to support recording, monitoring and stimulation | The Recording and stimulating for Central Nervous<br>System electrodes are used for electrical stimulation<br>and recording of the central nervous system signals | There is no significant difference<br>between the device description. The<br>electrodes have the same site of | |
| | from user supplied equipment. | for intraoperative monitoring, brain mapping and | contact in the huma body, both the | |
| Manufacturer | Ad-Tech Medical Instrument Corporation | Spes Medica S.r.l. | | |
| Trade Name | Subdural Strip/Intraoperative Split Electrode, Subdural<br>Grid/Intraoperative Grid Electrode, Dual-Sided<br>Interhemispheric Subdural Electrode, Multi-Strip And<br>Slit Grid Subdural Electrode, Intraoperative Mapping<br>Grid Subdural Electrode | Subdural Electrode, Strip/Intraoperative Strip,<br>Grid/Intraoperative Grid, Multi-Strip and Split<br>Grid, Intraoperative Mapping Grid | Discussion Differences | |
| 510(k) number | K191186 | K211954 | | |
| Product Code | GYC | GYC | | |
| | The family of Subdural Electrodes under review are used<br>under the direction of neurosurgeons and other<br>skilled physicians to support their clinical needs for<br>subdural electrodes on the brain. Based upon the<br>needs of their clinical practice and particular patients,<br>various 2-dimensional geometric shapes (length and<br>width) resulting in variations of Subdural Electrode body<br>shapes and orientation configurations are<br>necessary.<br>All variations of Subdural Electrodes under review consist<br>of the same materials and fundamental design<br>as the predicate Subdural Electrodes. Either round discs<br>or rectangular electrode contact material are<br>sandwiched between two layers of silicone substrate<br>electrode body material. The brain contacting side of<br>the silicone substrate body has material removed to<br>expose an amount of electrode contact surface area.<br>The subdural electrode wires between the electrode<br>contact and connector contacts at the most distal end<br>of the subdural electrode tail pass through a tube for<br>interface with the user's equipment. | location of epileptogenic foci. The electrodes are<br>multipole arrays of electrodes that are positioned on<br>the surface of the brain.<br>Recording and stimulating for Central Nervous<br>System electrodes are multipolar arrays of<br>electrodes the surface of the brain. The electrode<br>must be designed to follow the complex anatomy<br>and they can assume different conformations in<br>relation to the requests of clinical needs. The<br>neurosurgeon is the person recommended for<br>electrode placement.<br>The electrodes have to be used under the direction<br>of the neurosurgeon and other skilled physicians to<br>support their clinical needs | electrodes are positioned on the<br>surface of the brain during use. Both<br>the electrodes are used for<br>recording, monitoring and<br>stimulation.<br>Both the electrodes have different<br>shape in relation to the clinical<br>needs.<br>So there is no significant different<br>between the two description, just a<br>different use of the words<br>depending on the writer.<br>No new questions of safety or<br>effectiveness are raised. | |
| Recording/Stimulation<br>area Diameter | 4, 5 mm | 4, 5 mm | The same of the predicate device | |
| Electrode Body<br>surface area | < 138 cm2 | < 138 cm2 | The same of the predicate device | |
| Spacing between the<br>contacts | 10 mm | 10 mm | The same of the predicate device | |
| Connector | DIN 42802 | DIN 42802 | The same of the predicate device | |
| Leadwire Length | 200 cm | 250 cm | No significant difference.<br>The Recording and stimulating for<br>Central Nervous System electrodes | |
| Manufacturer | Ad-Tech Medical Instrument Corporation | Spes Medica S.r.l. | |…
