(505 days)
Not Found
No
The summary describes a passive electrode device for recording and stimulating brain signals. There is no mention of AI/ML in the device description, intended use, or performance studies. The performance studies focus on material and electrical safety, not algorithmic performance.
No
Explanation: A therapeutic device is used for treating or curing a disease. This device is used for recording, monitoring, and stimulating for diagnostic purposes (e.g., brain mapping, locating epileptogenic foci) and not for treatment.
Yes
The device is intended for recording and monitoring signals on the surface of the brain for intraoperative monitoring, brain mapping, and location of epileptogenic foci. These activities are performed to identify and characterize medical conditions, which aligns with the definition of a diagnostic device.
No
The device description clearly states it is a physical electrode array placed on the surface of the brain, which is a hardware component. The performance studies also include tests related to the physical properties and safety of the hardware.
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, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: This device is a set of electrodes designed to be placed directly on the surface of the brain. Its purpose is to record and stimulate electrical signals in vivo (within the living body) for monitoring, mapping, and locating epileptogenic foci.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of specimens taken from the body. It interacts directly with the brain tissue.
Therefore, this device falls under the category of a medical device used for direct physiological monitoring and stimulation, not an in vitro diagnostic.
N/A
Intended Use / 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 of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.
Product codes
GYC
Device Description
The Recording and stimulating for Central Nervous System electrodes are used 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.
The electrodes are multipole arrays of electrodes that are positioned on the surface of the brain.
The electrode must be designed to follow the complex anatomy and they can assume different conformations in relation to the requests of clinical needs. The neurosurgeon is the person recommended for electrode placement.
The electrodes have to be used under the direction of the neurosurgeon and other skilled physicians to support their clinical needs
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surface of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgeon and other skilled physicians / Operating rooms and temporary
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cytotoxicity
- Description: These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.
- Result: Test sample results to have a reactivity grade of 0 (=none reactivity)
- Conclusion: NON-CYTOTOXIC. No test extract does not show any reactivity.
Skin Irritation
- Description: This method describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
- Result: The requirements of the test are met if the final test sample score is 1.0 or less. The final test sample score is 1.0. Very slight erythema (barely perceptible).
- Conclusion: NON-IRRITATING. The test item satisfied the requirements of the test which require a final score.
Skin sensitization
- Description: This method describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
- Result: The results show a % sensitising treated guinea pigs equal to 0% (=no visible change).
- Conclusion: NON-SENSITIZING. On the basis of the results the tested item must be considered not sensitizing.
Systemic toxicity
- Description: This method is a biological evaluation to evaluate the systemic toxicity.
- Result: Weight increase: no weight loss was recorded in any treated and control animals. Mortality: in none of the treated and control animals mortality was observed. Clinical symptoms: in none of the treated and control animals toxic signs or symptoms were observed.
- Conclusion: DO NOT CAUSE TOXIC SYMPTOMS. On the basis of the results the tested item doesn't cause toxic symptoms and satisfies the requirements of the test.
Pyrogenicity test
- Description: The aim of the present report is to describe procedure and results obtained for Pyrogen Test.
- Result: Two of the eight rabbits showed individual rise of temperature ≥ 0.5°C and the sum of the eight individual rises is 2.0°C (
§ 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
November 10, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized caduceus symbol. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Manufacturer's Name: | Spes Medica S.r.l.
via Europa (Zona Ind.le), 84091 Battipaglia (SA) - Italy |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K211954 |
| Official Correspondent: | Giorgio Facco
Quality Assurance and Regulatory Affairs |
| Telephone Number: | 0039 0828 614191 |
| Fax Number: | 0039 0828 341788 |
| Device Trade Name: | Subdural Electrode
Strip/Intraoperative Strip,
Grid/Intraoperative Grid,
Multi-Strip and Split Grid,
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: | Name Electrode, Cortical
510(K) Number K191186
Device Name 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
Applicant Ad-Tech Medical Instrument Corporation
400 West Oakview Parkway
Oak Creek, WI 53154 |
| Device Description: | The Recording and stimulating for Central Nervous System electrodes are used 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
The electrodes are multipole arrays of electrodes that are positioned on the surface
of the brain.
The electrode must be designed to follow the complex anatomy and they can assume
different conformations in relation to the requests of clinical needs. The
neurosurgeon is the person recommended for electrode placement.
The electrodes have to be used under the direction of the neurosurgeon and other
skilled physicians to support their clinical needs |
| Intended 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. |
| Technological Comparison: | The recording and stimulation electrode area is in platinum and is on polyurethane
substrate body material. The cables is in PVC with touch proof 1.5 mm connector or
with multi connector. The lead wires terminate in a safety connector that cannot be
connected to an AC power outlet
The characteristics of Recording and stimulating for Central Nervous System
electrodes are substantially equivalent to the predicate devices. No new questions
of safety or effectiveness are raised, Recording and stimulating for Central Nervous
System electrodes employ the same technological characteristics as the predicate
device. |
| Substantial Equivalence: | Recording and stimulating for Central Nervous System electrodes is equivalent to the
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 | |||
| Grid/Intraoperative Grid Electrode, Dual-Sided | ||||
| Interhemispheric Subdural Electrode, Multi-Strip And | ||||
| Slit Grid Subdural Electrode, Intraoperative Mapping | ||||
| Grid Subdural Electrode | Subdural Electrode, Strip/Intraoperative Strip, | |||
| Grid/Intraoperative Grid, Multi-Strip and Split | ||||
| Grid, Intraoperative Mapping Grid | ||||
| 510(k) number | K191186 | K211954 | ||
| Product Code | GYC | GYC | ||
| Intent for use | The Ad-Tech Subdural Electrodes (Strip/Intraoperative | |||
| Strip, Grid/Intraoperative Grid, Dual- Sided | ||||
| Interhemispheric, Multi-Strip and Split Grid, | ||||
| Intraoperative Mapping Grid) are intended for temporary | ||||
| ( |