(218 days)
The WISE Cortical Strip is intended for intraoperative (≤24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.
The WCS is indicated as an aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries.
The WISE Cortical Strip is medical device composed of:
- A strip containing 4 electrodes that is positioned during surgery on the exposed surface of the brain
- A cable composed of 4 conductive channels intended to transfer electrical signals to and from a commercial connecting cable.
The device is intended to be used only for intraoperative monitoring during brain surgery and is not implanted.
The WCS is a sterile, single-use device, individually packaged with a shelf life of 18 months.
Manufacture of the device uses a WISE proprietary patented technology called "Supersonic Cluster Beam Implantation" (SCBI). This technology produces flexible conductors by enabling thin conducting metal layers to be deposited on a silicone substrate. This enables the strip to be flexible and conform to the brain's surface.
The WCS is intended to be used with FDA-cleared IONM equipment and a reusable connecting cable. The device does not include (as an accessory or component) these separate devices.
The provided text describes a 510(k) premarket notification for the WISE Cortical Strip (WCS). However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.
The document details:
- Device Description: The WISE Cortical Strip is a medical device composed of a strip with 4 electrodes and a cable for transferring electrical signals. It's intended for intraoperative use (≤24 hours) with recording, monitoring, and stimulation equipment.
- Intended Use: Aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries for recording, monitoring, and stimulation of electrical signals on the brain surface.
- Technological Characteristics Comparison: Compares the WCS to predicate devices (Ad-Tech Intraoperative Strip Electrode and Ad-Tech Intraoperative Subdural Electrode). Key similarities include intraoperative use, sterilization method, electrode configuration, and stimulation charge density. Differences include contact materials (Platinum only for WCS vs. Platinum:Iridium or stainless steel for predicate), non-pyrogenic labeling for WCS, and the unique Supersonic Cluster Beam Implantation (SCBI) manufacturing process for WCS.
- Non-Clinical Performance Data: A table of bench testing performed, including:
- Labeling and packaging integrity verification
- Label indelibility test
- Dielectric strength test
- Device integrity verification
- AC impedance test (with a specific acceptance criterion of ≤ 10 kΩ @ 10 Hz)
- Insulation test
- Compatibility with recorders test
- Compatibility with stimulators test
- Stimulation and metal release test
- Bias current tolerance test
All tests passed.
- Biocompatibility Testing: Performed according to ISO 10993-1 for an externally communicating device with tissue and cerebrospinal contact (limited duration ≤ 24 hours). Tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Pyrogenicity, Acute Systemic Toxicity, and Indirect Hemolysis. All results indicated the device materials are safe.
- Sterilization and Shelf-Life Testing: Validated Ethylene Oxide sterilization (SAL of 10-6) and established an 18-month shelf-life via accelerated aging.
What is missing for the requested information regarding AI/ML device acceptance criteria and studies:
The provided text describes a hardware medical device (cortical strip electrode), not an AI/ML software device. Therefore, the concepts of "test set," "training set," "ground truth establishment," "number of experts," "adjudication methods," and "MRMC studies" as they apply to AI/ML performance evaluation are not applicable and are not present in this document.
The "acceptance criteria" presented are for the physical and electrical performance of the electrode itself (e.g., AC impedance ≤ 10 kΩ), mechanical integrity, biocompatibility, and sterility, which are standard for such devices.
Therefore, it is impossible to complete the requested table and answer the specific questions about AI/ML device performance from the provided document.
If the intent was to find information on a software component that uses AI/ML with the data from this cortical strip, that information is not in this FDA submission summary. This document focuses solely on the WISE Cortical Strip hardware.
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November 22, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
WISE S.r.l. % Terri Bogucki Regulatory Consultant Decus Biomedical 2342 Shattuck Ave #333 Berkeley, California 94704
Re: K221123
Trade/Device Name: WISE Cortical Strip (WCS) Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: October 24, 2022 Received: October 26, 2022
Dear Terri Bogucki:
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
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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
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
Patrick Antkowiak -
Enclosure
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Indications for Use
510(k) Number (if known) K221123
Device Name WISE Cortical Strip
Indications for Use (Describe)
The WISE Cortical Strip is intended for intraoperative (≤24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.
The WCS is indicated as an aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries.
| 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
| Submitter's Name: | WISE S.r.l. |
|---|---|
| Address: | Via Michelangelo Buonarroti, 38 |
| 20093 Cologno Monzese (MI) - Italy | |
| Contact Person: | Terese Bogucki |
| Title: | Regulatory Consultant |
| Telephone Number: | 650-488-7799 |
| Fax Number: | 650-227-2264 |
| Email: | terri@decusbiomedical.com |
| Date Summary Prepared: | 10 November 2022 |
| Device Proprietary Name: | WISE Cortical Strip |
| Model Number: | WCS04S10A-00-001 |
| Common Name: | Cortical electrode |
| Regulation Number: | 21 CFR 882.1310 |
| Product Code: | GYC |
| Device Class: | II |
| Predicate Devices | Manufacturer: Ad-Tech Medical Instrument |
| Corporation | |
| Address: 400 West Oakview Parkway | |
| Oak Creek, Wisconsin 53154 | |
| Regulation Number: 21 CFR 882.1310 | |
| Regulation Name: Cortical electrode | |
| Device Class: Class II | |
| Product Code: GYC | |
| Primary Predicate | |
| Trade name: Ad-Tech Intraoperative Strip Electrode | |
| 510(k) Number: K191186 | |
| 510(k) Clearance Date: 15 January 2020 | |
| Secondary Predicate | |
| Trade name: Ad-Tech Intraoperative Subdural Electrode | |
| 510(k) Number: K053363 |
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l Description of the Device
The WISE Cortical Strip is medical device composed of:
- A strip containing 4 electrodes that is positioned during surgery on the . exposed surface of the brain
- . A cable composed of 4 conductive channels intended to transfer electrical signals to and from a commercial connecting cable.
The device is intended to be used only for intraoperative monitoring during brain surgery and is not implanted.
The WCS is a sterile, single-use device, individually packaged with a shelf life of 18 months.
Manufacture of the device uses a WISE proprietary patented technology called "Supersonic Cluster Beam Implantation" (SCBI). This technology produces flexible conductors by enabling thin conducting metal layers to be deposited on a silicone substrate. This enables the strip to be flexible and conform to the brain's surface.
The WCS is intended to be used with FDA-cleared IONM equipment and a reusable connecting cable. The device does not include (as an accessory or component) these separate devices.
2 Indications for Use
Both the WISE Cortical Strip (subject device) and Ad-Tech Intraoperative Strip Electrode (predicate device) are designed to be used intraoperatively for the recording, monitoring and stimulation of electrical signals on the surface of the brain. The Indications for Use for the subject and predicate devices are:
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| WISE Cortical StripSubject Device | AD-TECH SubduralElectrodes PredicateDevice, K191186 | AD-TECH SubduralElectrodes PredicateDevice, K053363 |
|---|---|---|
| The WISE Cortical Stripis intended forintraoperative (≤ 24 hours)use with recording,monitoring andstimulation equipment forthe recording, monitoring,and stimulation ofelectrical signals on thesurface of the brain.The WCS is indicated asan aid to IntraOperativeNeurophysiologicalMonitoring (IONM)during brain surgeries. | The Ad-Tech SubduralElectrodes(Strip/Intraoperative Strip,Grid/Intraoperative Grid,Dual-Sided Interhemispheric,Multi-Strip and Split Grid,Intraoperative Mapping Grid)are intended for temporary (30 days) use with recording,monitoring, and stimulationequipment for the recording,monitoring, and stimulationof electrical signals on thesurface of the brain. Therecording of electricalactivity supports definition ofthe location of epileptogenicfoci and brain mapping. | The Ad-Tech SubduralElectrodes (Dual-SidedInterhemispheric, Grid,Intraoperative, Strip,Wyler) are intended fortemporary (< 30 days) usewith recording, monitoring,and stimulation equipmentfor the recording,monitoring, and stimulationof electrical signals on thesurface of the brain. Therecording of electricalactivity supports definitionof the location ofepileptogenic foci and brainmapping. |
3 Summary of Technological Characteristics Comparison
The primary and secondary predicate devices have regulatory clearance as part of a family of electrodes provided in multiple shapes and configurations that support a range of intraoperative and subdural (implanted <30 day) use. Specifically, the Ad-Tech Intraoperative Strip Electrode is claimed as the primary predicate device.
The technologic characteristics of the subject and predicate devices are similar in the following ways:
- . They are subdural cortical electrodes used intraoperatively to transfer electrical signals to and from the brain for the same duration of use, in the same environment of use, by the same users.
- They are sterilized using EO and provided sterile, for single-use . onlv.
- . They come in configurations that have four numbered 2.3 mm diameter electrodes spaced 10 mm apart in a silicone substrate ending in a.
- The strips end in a 1.5 mm diameter electrode cable that attaches to a ● separate connecting cable for use.
- Consistent with the clinical practice safety limit, they support a ● maximum stimulation charge density of < 30 µC/cm².
The main technological differences between the subject and predicate devices are:
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- The contact materials are similar but not identical; the subject ● device electrodes are Platinum only, whereas the predicate device electrodes are made of 90:10 Platinum:Iridium or stainless steel.
- The subject device is labeled "non-pyrogenic" while the predicate is . not.
- . The subject device is manufactured using a unique Supersonic Cluster Beam Implantation process which produces a very flexible electrode strip that conforms with the cortex surface.
4 Non-Clinical Performance Data
Testing was performed with the WCS to support substantial equivalence to the predicate device. Testing included performance testing, biocompatibility, and shelf-life testing.
Bench testing was conducted on WCS devices that were exposed to 2x sterilization, 18 months of accelerated aging, environmental conditioning and transport simulation prior to testing. In addition to ensure their integrity even under conditions of misuse, many of the tests were conducted after the devices were exposed to soaking, linear elongation, and bending conditioning.
The following standards were utilized in the evaluation:
- ASTM D1980-16, Standard Guide for Accelerated Aging of Sterile Barrier . Systems for Medical Devices
- ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or . Packaging Components for Testing
- ASTM D4169-16, Standard Practice for Performance Testing of Shipping ● Containers and Systems
| Test Case Name | Purpose | Conclusion |
|---|---|---|
| Labelling and packagingintegrity verification | Prove integrity of device labeling, retail boxand sterile barrier system followingconditioning | Pass |
| Label indelibility test | Prove that product labels preserve theirintegrity and readability after conditioning | Pass |
| Dielectric strength test | Prove the device cable insulation is able towithstand high voltage electrical stressesbeyond what would be encountered duringnormal use | Pass |
| Device integrityverification | Prove that the device keeps its integritybefore and after exposure to stressconditions | Pass |
| Test Case Name | Purpose | Conclusion |
| AC impedance test | Prove the device is able to conduct signals between the electrodes on the strip and the corresponding electrodes on the cable with a total impedance ≤ 10 kΩ @ 10 Hz*Prove the device is compatible with the Cabrio L-SRL-4DIN connecting cableProve the performance of the device with the Cabrio L-SRL-4DIN and WCS Link connecting cables is equivalent | Pass |
| Insulation test | Prove that the device insulation resistance meets requirements following 1 hour immersion in saline solution | Pass |
| Compatibility with recorders test | Prove the device is compatible with EEG/ECOG recorders measuring the values of offset voltage and combined offset instability and internal noise | Pass |
| Compatibility with stimulators test | Prove the device is compatible with commercially available neurostimulators (compliant with IEC60601-1 and IEC60601-2-40) by demonstrating the electrode's ability to deliver worst-case condition stimulating pulses | Pass |
| Stimulation and metal release test | Prove the device is able to deliver stimulation pulses for 48 hours in simulated conditionsProve the electrodes keep integrity following 48 hours of stimulationProve that the platinum released from the electrodes during 48 hours stimulation is within safe limits | Pass |
| Bias current tolerance test | Prove the device is compatible with EEG/ECOG recorders measuring the values of the DC offset voltage does not exceed the limits of the input voltage when a DC bias current is applied to a pair of electrodes for 24 hours | Pass |
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Direct comparison testing of the subject device and the secondary predicate demonstrates that both devices meet the ≤ 10 kΩ acceptance criteria at 10 Hz. In addition, the subject device maintains this performance level even after exposure to worst-case stimulation conditions.
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Biocompatibility Testing 5
Biocompatibility testing was performed based on the nature and duration of patient contact outlined in ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the FDA guidance document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 2020). The device was tested per the ISO 10993-1 requirements for an externally communicating device with tissue contact and cerebrospinal contact for a limited duration (≤ 24 hours).
| Test | Result | Conclusion |
|---|---|---|
| Cytotoxicity | The full strength EMEM10 test article extract showed no cytotoxic potential to L-929 mouse fibroblast cells | Non-cytotoxic |
| Sensitization | Topical application of the 0.9% NaCl extract and the sesame extract did not induce delayed sensitization in the guinea pig | Non-sensitizer |
| Intracutaneous reactivity | The 0.9% NaCl extract of the test article and the sesame extract did not induce any erythema or edema reactions after injection by intracutaneous route in the rabbit | Non-irritant |
| Pyrogenicity | Sum of temperature rises = 0.69°CNo rabbit showed an individual temperature rise higher or equal to 0.5°C above its initial temperature | Non-pyrogenic |
| Acute Systemic Toxicity | There was no evidence of significant systemic toxicity or mortality after test article extracts injection | Non-toxic |
| Indirect Hemolysis | Based on the hemolytic index of the assay sample above the negative control, the WCS is demonstrated to be non-hemolytic for indirect contact | Non-hemolytic |
Results of testing demonstrate that the materials used in the construction of the WCS are safe for their intended use.
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Sterilization and Shelf-Life Testing 6
Sterilization of the subject device using Ethylene Oxide was validated following ANSI/AAMI/ISO 11135:2014 and demonstrated a SAL of 10-6. A shelf-life of 18 months has been established based on accelerated aging.
7 Substantial Equivalence Conclusion
The WCS is substantially equivalent to the Ad-Tech Intraoperative Strip Electrode based on the intended use and technological characteristics as well as the intended users and intended use environment. Both devices have similar physical characteristics and stimulation parameters. The manufacturing differences are demonstrated through the testing to not adversely impact the subject device's safety or effectiveness. Therefore, one can conclude that the WISE Cortical Strip is substantially equivalent to the Ad-Tech Intraoperative Strip Electrode predicate device and is safe for its intended use.
§ 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).