(505 days)
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.
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.
The provided text describes the acceptance criteria and the results of various performance tests for the Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid (hereinafter referred to as "the device").
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Cytotoxicity | Reactivity grade of 0 (none reactivity) | Test sample results to have a reactivity grade of 0 (=none reactivity) | NON-CYTOTOXIC. No test extract does not show any reactivity. |
| Skin Irritation | Final test sample score of 1.0 or less | The final test sample score is 1.0. Very slight erythema (barely perceptible). | NON-IRRITATING. The test item satisfied the requirements of the test. |
| Skin Sensitization | % sensitising treated guinea pigs equal to 0% (no visible change) | The results show a % sensitising treated guinea pigs equal to 0% (=no visible change). | NON-SENSITIZING. The tested item is considered not sensitizing. |
| Systemic Toxicity | No weight loss, mortality, or toxic signs/symptoms in treated and control animals | 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. | DO NOT CAUSE TOXIC SYMPTOMS. The tested item doesn't cause toxic symptoms and satisfies the requirements of the test. |
| Pyrogenicity Test | Sum of individual temperature rises < 3.3°C, with no more than two rabbits showing individual rise of temperature ≥ 0.5°C. | 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 (<3.3°C). | ABSENCE OF PYROGENS. The tested item meets the requirement for absence of pyrogens. |
| Hemolysis Test (indirect contact) | Final hemolytic index between 0-2 (non-hemolytic grade) | The final hemolytic index for all three experimental replicates result to be between the range 0-2, which means: non hemolytic grade. | NOT HEMOLYTIC for indirect contact. The tested item is not hemolytic for indirect contact. |
| Packaging Validation (3 years shelf-life) | Sterility, sterile barrier characteristics, seals integrity and strength, visual inspection, peeling, seals width, absence of pinholes, impermeability to microorganisms must be compliant after accelerated aging. | - Visual inspection: compliant- Seals integrity: compliant- Peeling: compliant- Seals width: compliant- Pinholes absence: compliant- Microorganisms impermeability: compliant- Seals strength: compliant. Average strength internal pouch at T0: 2,22 N/1,5mm. Average strength outer pouch at T0: 2,32 N/1,5mm. Average strength internal pouch at T3: 2,15 N/1,5mm. Average strength outer pouch at T0: 2,42 N/1,5mm.- Sterility tests: compliant, Sterile. | The sterile barrier system maintains integrity (efficacy) for the foreseen 3-year shelf-life, with no damage or alterations to pouches, and products remaining morphologically and visually intact and sterile after accelerated aging. |
| Cable Tensile Testing | Tensile strength during pull-out > 30N | All the tensile strength evaluates results to be greater than 30N (average 41.35 N). | The device demonstrates very high strength during pull-out tests, ensuring manufacturing process safety and strength of use. |
| Impedance Test and Dielectric Strength | Impedance < 5kOhm both pre and post stimulation | All the impedance evaluates results to be less than 5kOhm both pre and post simulation. | Stimulation doesn't affect or worsen the electrode performance. |
| Electrical Safety - Insulation | All different parts of the electrode (connector, case, dielectric) must be insulated at 250V, 500V, and 1000V. | All the different parts of the electrode (connector, case, dielectric) results to be insulated. | The electrodes are isolated and comply with electrical safety requirements. |
| Climatic Tests | No damage to the product due to changes in temperature and relative humidity. | Refrigerated storage test, extreme cold test, and tropical test showed positive results. The test samples were then subjected to vibration tests. | No damage to the product has been observed. |
| Shipment Tests | No impact/damage on packaging and materials from handling, stacking, vibration, and impact tests. | The results of handling test, vehicle stacking test, loose load vibration test, vehicle vibration test, and concentrated impact test are found to be in compliance with the pass/fail criteria of the tests. | No damage to the product has been observed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each test in terms of the number of devices or specific units. However, it does refer to "test sample results," "test item," and "test articles" for various tests. For the pyrogenicity test, it explicitly mentions "eight rabbits." The packaging validation for shelf-life refers to "pouches samples" and "medical devices sterile barrier system samples."
The data provenance is from Spes Medica S.r.l., Italy, and the studies are prospective performance tests conducted to demonstrate the device's safety and effectiveness.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided in the document. The studies described are performance and biological evaluations, not clinical studies involving expert interpretation for ground truth.
4. Adjudication Method:
This information is not applicable as the studies are technical performance and biocompatibility tests, not studies requiring adjudication of disagreements among human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not done. The document focuses on the technical and biological performance of the device itself, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
This information is not applicable. The device is an electrode for recording and stimulating the central nervous system, and not an algorithm or AI-powered diagnostic tool.
7. Type of Ground Truth Used:
The ground truth for these studies is based on established scientific and regulatory standards for biocompatibility, electrical safety, mechanical durability, and packaging integrity. The results are compared against predefined acceptance criteria for these tests. For instance:
- Biocompatibility (Cytotoxicity, Skin Irritation, Sensitization, Systemic Toxicity, Hemolysis): Based on the biological response of cells/animals to the device materials according to standardized test methods (e.g., ASTM F 756-17 mentioned for Hemolysis).
- Pyrogenicity: Based on the temperature response of rabbits.
- Packaging and Shelf Life: Based on the physical properties and sterility of the packaging after accelerated aging.
- Electrical and Mechanical Performance: Based on measured values against engineering specifications.
8. Sample Size for the Training Set:
This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The studies are for product performance and safety validation.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for an AI/ML algorithm.
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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
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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) |
|---|
| ☑ 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 FaccoQuality Assurance and Regulatory Affairs |
| Telephone Number: | 0039 0828 614191 |
| Fax Number: | 0039 0828 341788 |
| Device Trade Name: | Subdural ElectrodeStrip/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, Cortical510(K) Number K191186Device Name Subdural Strip/Intraoperative Split Electrode, SubduralGrid/Intraoperative Grid Electrode, Dual-Sided InterhemisphericSubdural Electrode, Multi-Strip And Slit Grid Subdural Electrode,Intraoperative Mapping Grid Subdural ElectrodeApplicant Ad-Tech Medical Instrument Corporation400 West Oakview ParkwayOak Creek, WI 53154 |
| Device Description: | The Recording and stimulating for Central Nervous System electrodes are used forelectrical stimulation, monitoring and recording of the signals on the surface of thebrain for intraoperative monitoring, brain mapping and location of epileptogenic fociThe electrodes are multipole arrays of electrodes that are positioned on the surfaceof the brain.The electrode must be designed to follow the complex anatomy and they can assumedifferent conformations in relation to the requests of clinical needs. Theneurosurgeon is the person recommended for electrode placement.The electrodes have to be used under the direction of the neurosurgeon and otherskilled 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 withrecording, monitoring, and stimulation equipment for electrical stimulation,monitoring and recording of the signals on the surface of the brain for intraoperativemonitoring, brain mapping and location of epileptogenic foci. |
| Technological Comparison: | The recording and stimulation electrode area is in platinum and is on polyurethanesubstrate body material. The cables is in PVC with touch proof 1.5 mm connector orwith multi connector. The lead wires terminate in a safety connector that cannot beconnected to an AC power outletThe characteristics of Recording and stimulating for Central Nervous Systemelectrodes are substantially equivalent to the predicate devices. No new questionsof safety or effectiveness are raised, Recording and stimulating for Central NervousSystem electrodes employ the same technological characteristics as the predicatedevice. |
| Substantial Equivalence: | Recording and stimulating for Central Nervous System electrodes is equivalent to thedevice 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, SubduralGrid/Intraoperative Grid Electrode, Dual-SidedInterhemispheric Subdural Electrode, Multi-Strip AndSlit Grid Subdural Electrode, Intraoperative MappingGrid Subdural Electrode | Subdural Electrode, Strip/Intraoperative Strip,Grid/Intraoperative Grid, Multi-Strip and SplitGrid, Intraoperative Mapping Grid | ||
| 510(k) number | K191186 | K211954 | ||
| Product Code | GYC | GYC | ||
| Intent for use | The Ad-Tech Subdural Electrodes (Strip/IntraoperativeStrip, Grid/Intraoperative Grid, Dual- SidedInterhemispheric, Multi-Strip and Split Grid,Intraoperative Mapping Grid) are intended for temporary(< 30 days) use with recording, monitoring, andstimulation equipmentfor the recording, monitoring, and stimulation ofelectrical signals on the surface of the brain. Therecording of electrical activity supports definition of thelocation of epileptogenic foci and brain mapping. | The Recording and stimulating for Central NervousSystem electrodes (Strip/Intraoperative Strip,Grid/Intraoperative Grid, Multi-Strip and Split Grid,Intraoperative Mapping Grid) are intended forlimited (≤24 hours) use with recording, monitoring,and stimulation equipment for electricalstimulation, monitoring and recording of the signalson the surface of the brain for intraoperativemonitoring, brain mapping and location ofepileptogenic foci. | The contact time duration ofRecording and stimulating forCentral Nervous System electrodesis ≤24 hours, lower than thepredicate device. This range of timeis anyway enough long to cover theclinical use described in the intent ofuse of Recording and stimulating forCentral Nervous System electrodeswhich is of intraoperativemonitoring, brain mapping andlocation of epileptogenic foci. Theuser is aware of the limited durationof the use thanks to the indication inthe instruction for use leaflet.Therefore, the predicate device canbe considered as the "worst case" asthe time contact is < 30 days.Furthermore, according to thebiocompatibility tests, Recordingand stimulating for Central NervousSystem electrodes result to be fullybiocompatible so no new questionsof 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 SubduralElectrodes. These electrodes provide surface braincontact to support recording, monitoring and stimulation | The Recording and stimulating for Central NervousSystem electrodes are used for electrical stimulationand recording of the central nervous system signals | There is no significant differencebetween the device description. Theelectrodes 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, SubduralGrid/Intraoperative Grid Electrode, Dual-SidedInterhemispheric Subdural Electrode, Multi-Strip AndSlit Grid Subdural Electrode, Intraoperative MappingGrid Subdural Electrode | Subdural Electrode, Strip/Intraoperative Strip,Grid/Intraoperative Grid, Multi-Strip and SplitGrid, Intraoperative Mapping Grid | Discussion Differences | |
| 510(k) number | K191186 | K211954 | ||
| Product Code | GYC | GYC | ||
| The family of Subdural Electrodes under review are usedunder the direction of neurosurgeons and otherskilled physicians to support their clinical needs forsubdural electrodes on the brain. Based upon theneeds of their clinical practice and particular patients,various 2-dimensional geometric shapes (length andwidth) resulting in variations of Subdural Electrode bodyshapes and orientation configurations arenecessary.All variations of Subdural Electrodes under review consistof the same materials and fundamental designas the predicate Subdural Electrodes. Either round discsor rectangular electrode contact material aresandwiched between two layers of silicone substrateelectrode body material. The brain contacting side ofthe silicone substrate body has material removed toexpose an amount of electrode contact surface area.The subdural electrode wires between the electrodecontact and connector contacts at the most distal endof the subdural electrode tail pass through a tube forinterface with the user's equipment. | location of epileptogenic foci. The electrodes aremultipole arrays of electrodes that are positioned onthe surface of the brain.Recording and stimulating for Central NervousSystem electrodes are multipolar arrays ofelectrodes the surface of the brain. The electrodemust be designed to follow the complex anatomyand they can assume different conformations inrelation to the requests of clinical needs. Theneurosurgeon is the person recommended forelectrode placement.The electrodes have to be used under the directionof the neurosurgeon and other skilled physicians tosupport their clinical needs | electrodes are positioned on thesurface of the brain during use. Boththe electrodes are used forrecording, monitoring andstimulation.Both the electrodes have differentshape in relation to the clinicalneeds.So there is no significant differentbetween the two description, just adifferent use of the wordsdepending on the writer.No new questions of safety oreffectiveness are raised. | ||
| Recording/Stimulationarea Diameter | 4, 5 mm | 4, 5 mm | The same of the predicate device | |
| Electrode Bodysurface area | < 138 cm2 | < 138 cm2 | The same of the predicate device | |
| Spacing between thecontacts | 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.The Recording and stimulating forCentral Nervous System electrodes | |
| Manufacturer | Ad-Tech Medical Instrument Corporation | Spes Medica S.r.l. | ||
| Trade Name | Subdural Strip/Intraoperative Split Electrode, SubduralGrid/Intraoperative Grid Electrode, Dual-SidedInterhemispheric Subdural Electrode, Multi-Strip AndSlit Grid Subdural Electrode, Intraoperative MappingGrid Subdural Electrode | Subdural Electrode, Strip/Intraoperative Strip,Grid/Intraoperative Grid, Multi-Strip and SplitGrid, Intraoperative Mapping Grid | Discussion Differences | |
| 510(k) number | K191186 | K211954 | ||
| Product Code | GYC | GYC | ||
| is 50 cm longer than the predicatedevice but this is a no relevantdifferent considering that thepredicate device cable is 2 meterlong as well.No new questions of safety oreffectiveness are raised consideringalso that the LAL and bioburdentests performed on Recording andstimulating for Central NervousSystem electrodes had results incompliance with the standard | ||||
| Recording/Stimulationarea material | Platinum/Iridium orStainless Steel | Platinum/Iridium | The same of the predicate device forplatinum/Iridium. Spes Medica donot supply the Stainless steel version | |
| Substrate material | Silicone | Polyurethane | No significant difference.Both the materials have a large usein medical devices field.Furthermore, the Recording andstimulating for Central NervousSystem electrodes result to be fullybiocompatible so no new questionsof safety or effectiveness are raised | |
| Leadwire | Tinned Copper with PVC Jacket Connector | Tinned Copper with PVC Jacket Connector | The same of the predicate device | |
| Single Use | Yes | Yes | The same of the predicate device | |
| Provided to the usersterile | Yes | Yes | The same of the predicate device | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | The same of the predicate device | |
| Shelf life | 2 years | 3 years | Spes Medica electrodes have a shelf-life longer than the predicate device | |
| Manufacturer | Ad-Tech Medical Instrument Corporation | Spes Medica S.r.l. | ||
| Trade Name | Subdural Strip/Intraoperative Split Electrode, SubduralGrid/Intraoperative Grid Electrode, Dual-SidedInterhemispheric Subdural Electrode, Multi-Strip AndSlit Grid Subdural Electrode, Intraoperative MappingGrid Subdural Electrode | Subdural Electrode, Strip/Intraoperative Strip,Grid/Intraoperative Grid, Multi-Strip and SplitGrid, Intraoperative Mapping Grid | Discussion Differences | |
| 510(k) number | K191186 | K211954 | ||
| Product Code | GYC | GYC | ||
| however the tests about shelf-life | ||||
| validation have been performed by | ||||
| Spes Medica and the results were | ||||
| compliant. So no new questions of | ||||
| safety or effectiveness are raised. | ||||
| Single Use | Yes | Yes | The same of the predicate device | |
| The contact time duration ofRecording and stimulating for | ||||
| Central Nervous System electrodes | ||||
| is ≤24 hours, lower than the | ||||
| predicate device. | ||||
| This range of time is anyway enough | ||||
| long to cover the clinical use | ||||
| described in the intent of use of | ||||
| Recording and stimulating for | ||||
| Central Nervous System electrodes | ||||
| which is of intraoperative | ||||
| monitoring, brain mapping and | ||||
| Duration of Use | < 30 days | ≤24 hours | location of epileptogenic foci. The | |
| user is aware of the limited duration | ||||
| of the use thanks to the indication in | ||||
| the instruction for use leaflet. | ||||
| Therefore, the predicate device can | ||||
| be considered as the "worst case" as | ||||
| the time contact is < 30 days. | ||||
| Furthermore, according to the | ||||
| biocompatibility tests, Recording | ||||
| and stimulating for Central Nervous | ||||
| System electrodes result to be fully | ||||
| biocompatible so no new questions | ||||
| of safety or effectiveness are raised. | ||||
| Manufacturer | Ad-Tech Medical Instrument Corporation | Spes Medica S.r.l. | ||
| Trade Name | Subdural Strip/Intraoperative Split Electrode, SubduralGrid/Intraoperative Grid Electrode, Dual-SidedInterhemispheric Subdural Electrode, Multi-Strip AndSlit Grid Subdural Electrode, Intraoperative MappingGrid Subdural Electrode | Subdural Electrode, Strip/Intraoperative Strip,Grid/Intraoperative Grid, Multi-Strip and SplitGrid, Intraoperative Mapping Grid | Discussion Differences | |
| 510(k) number | K191186 | K211954 | ||
| Product Code | GYC | GYC | ||
| Maximum StimulationCharge Density | $ \u2264 30 \u03bcC/cm2 $ | $ \u2264 30 \u03bcC/cm2 $ | The same of the predicate device | |
| Environment of Use | Operating rooms and temporary | Operating rooms and temporary | The same of the predicate device | |
| Contraindications | The subdural electrodes should not be used on anypatient whom the physician/surgeon considers at riskfor infection.The subdural electrodes are not intended for continuousstimulation.Stimulation should only be applied to support the brainmapping purpose of the electrodes | The electrode is not recommended for continuousstimulation.Stimulation should be only applied to supportbrain mapping.The electrodes should not be used on patientswith high risk of infection | The same of the predicate device.Spes medica has inserted all thesepoints in the warnings in theinstruction for use |
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| Performance Testing Summary | |||
|---|---|---|---|
| Test | Description | Result | Conclusion |
| Cytotoxicity(performed on IEP0020) | These methods are designed todetermine the biological response ofmammalian cells in vitro usingappropriate biological parameters. | Test sample results to have a reactivitygrade of 0 (=none reactivity) | NON-CYTOTOXICNo test extract does not show any reactivity |
| Skin Irritation(performed on IEP0020) | This method describes the procedure forthe assessment of medical devices andtheir constituent materials with regard totheir potential to produce irritation andskin sensitization. | The requirements of the test are met if thefinal test sample score is 1.0 or less.The final test sample score is 1.0. Veryslight erythema (barely perceptible). | NON-IRRITATINGThe test item satisfied the requirements of the testwhich require a final score |
| Performance Testing Summary | |||
| Test | Description | Result | Conclusion |
| Skin sensitization(performed on IEP0020) | This method describes the procedure forthe assessment of medical devices andtheir constituent materials with regard totheir potential to produce irritation andskin sensitization. | The results show a % sensitisingtreated guinea pigs equal to 0% (=novisible change) | NON-SENSITIZINGOn the basis of the results the tested item must beconsidered not sensitizing. |
| Systemic toxicity(performed on IEP0008) | This method is a biological evaluation toevaluate the systemic toxicity . | Weight increase: no weight loss wasrecorded in any treated and controlanimals.Mortality: in none of the treated andcontrol animals mortality wasobserved.Clinical symptoms: in none of thetreated and control animals toxic signsor symptoms were observed. | DO NOT CAUSE TOXIC SYMPTOMSOn the basis of the results the tested item doesn'tcause toxic symptoms and satisfies the requirementsof the test. |
| Pyrogenicity test(performed on IEP0008) | The aim of the present report is todescribe procedure and results obtainedfor Pyrogen Test. | Two of the eight rabbits showedindividual rise of temperature 2 0.5°Cand the sum of the eight individualrises is 2.0°C (<3.3° C). | ABSENCE OF PYROGENSOn the basis of the results the tested item meets therequirement for the absence of pyrogens |
| Hemolysis test(performed on IEP0020) | The aim of the present report is toevaluate if the test item causes materialinduced hemolysis for indirect contact,according to ASTM F 756-17 | The final hemolytic index for all thethree experimental replicates result tobe between the range 0-2 whichmeans: non hemolytic grade. | NOT HEMOLYTIC for indirect contactOn the basis of the results the tested item is nothemolytic for indirect contact. |
| Packaging ValidationProtocol(3 years of shelflife) | The accelerated aging process describesa procedures for developing acceleratedaging protocols to rapidly determine theeffects, if any, due to the passage of timeon sterile integrity of the sterile barriersystem. | The results of the tests on medicaldevices sterile barrier system samplesin object not aged [referred as T0] andaged in accelerated conditions for theperiod corresponding to foreseen shelflife [referred as T3] are as follow: | For the samples in object, the obtained resultsconduct to the following conclusions:– Sterile barrier characteristics: the pouchessamples have no damage or alteration due toaging process and are coherent with the not agedones. |
| Packaging validationtest(Sterility test) | The test is performed in order todetermine the charge (expressed inNewton/cm2) necessary to separate thetwo sides of the seal. This test isperformed on both dry and wet material. | – Visual inspection: compliant– Seals integrity: compliant– Peeling: compliant– Seals width: compliant– Pinholes absence: compliant | – Products characteristics: the medical devices werenot morphologically and visually damaged whencompared to not aged samples.– Sterile barrier system verification: after anaccelerated aging process simulating 3 years ofshelf - life, the verification data for sterile barrier |
| Performance Testing Summary | |||
| Test | Description | Result | Conclusion |
| - Microorganisms impermeability: compliant- Seals strength: compliant. Average strength internal pouch at T0: 2,22 N/1,5mm. Average strength outerpouch at T0: 2,32 N/1,5mm. Average strength internal pouch atT3: 2,15 N/1,5mm. Average strength outer pouch at T0: 2,42 N/1,5mm.- Sterility tests: compliant, Sterile. | systems result in compliance with requirementsand the medical devices samples are sterile; it isalso noted that no discrepancies have been foundwith respect to the results obtained in the testsconducted on the non-ageing referenced samples.So, it can be concluded that the sterile barriersystem (double flat pouch in coupled material),used for Spes Medica recording and stimulating forCentral nervous system electrodes maintains theintegrity, i.e. its efficacy, for the foreseen shelf -life period corresponding to 3 years. | ||
| Cable tensile testing | Spes Medica have been tested to get afeedback on the tensile strength ofsubdural electrodes and to understandthe limit value during pull out the cable. | All the results are found to be incompliance with the pass/fail criteriaset at the beginning of the test.All the tensile strength evaluatesresults to be greater than 30N. | The results obtained show that for Recording andstimulating for Central Nervous System electrodeshave a very high strength force during the pull-outtest. The average is 41.35 N and this value doesn'taffect the electrode or the connection part but it isthe limit of the cables. The results give to Recordingand stimulating for Central Nervous Systemelectrodes the safety of manufacturing process andthe strength of the use. |
| Impedance test anddielectric strength | Spes Medica have been tested to get afeedback on the subdural electrodes usenot only for recording but also forstimulation. The aim is to confirm thatthe devices do not lose their features orworsentheirperformancesafterstimulation. | All the results are found to be incompliance with the pass/fail criteriaset at the beginning of the test.All the impedance evaluates results tobe less than 5kOhm both pre and postsimulation. | The results obtained show that for Recording andstimulating for Central Nervous System electrodesstimulation doesn't affect or get worse the electrodeperformance. |
| Electrically Safety -Insulation | Evaluate the isolation of the product inthe different part at different voltage250V, 500V and 1000V. | All the different parts of the electrode(connector, case, dielectric) results tobe insulated. | The results obtained show that for Recording andstimulating for Central Nervous System electrodesare isolated and are in compliance withrequirements for electrical safety. |
| Climatic Tests | Understand if changing temperature andrelative humidity (RH) have effects on | The test samples have been subjectedto the following test: | No damage of the product has been observed |
| Performance Testing Summary | |||
| Test | Description | Result | Conclusion |
| packaging and materials which may berelated to their field performance. | • Refrigerated storage test• Extreme cold test• Tropical testwith positive results. The test sampleafter that have been subjected tovibration tests | ||
| Shipment Tests | Understand if:• HANDLING TEST,• VEHICLE STACKING TEST,• LOOSE LOAD VIBRATION TEST,• VEHICLE VIBRATION TEST,• CONCENTRATED IMPACT TESThave a impact on packaging andmaterials. | The result of the following tests• HANDLING TEST,• VEHICLE STACKING TEST,• LOOSE LOAD VIBRATION TEST,• VEHICLE VIBRATION TEST,• CONCENTRATED IMPACT TESTare found to be in compliance withthe pass/fail criteria of the tests | No damage of the product has been observed |
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We specify that the test articles used in the Performonce Testing Summary table are identical to the finished, sterilized proposed in the 510() submission per formulation, suppliers, processing, sterilization (including dose and duration), and geometry and no chemicals have been added (e.g., plasticiens, fillers, clor additives, cleaning agents, mold release agents).
Conclusion
All performance testing conducted as outlined above demonstrate that the performance and design specifications. Based on the results obtained, Spes Medica s.r.l. believous System electrodes is substantially equivalent and performs as well as the the predicate devices (K191186).
§ 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).