(218 days)
Not Found
No
The description focuses on the physical characteristics, materials, and intended use of the electrode strip and cable for recording and stimulating electrical signals. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The device is a passive component used with separate IONM equipment.
No
The device is used for recording, monitoring, and stimulation of electrical signals on the surface of the brain to aid in IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries, not for treating any condition or disease.
Yes
The WISE Cortical Strip is intended for intraoperative use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain, and is indicated as an aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries. By recording and monitoring electrical signals to aid in neurophysiological monitoring, it is performing a diagnostic function.
No
The device description explicitly states it is composed of a strip containing electrodes and a cable, which are physical hardware components.
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: The WISE Cortical Strip is used intraoperatively (during surgery) to record, monitor, and stimulate electrical signals directly on the surface of the brain. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for intraoperative neurophysiological monitoring (IONM) during brain surgeries, which is a direct interaction with the patient's brain, not an analysis of a sample.
Therefore, the WISE Cortical Strip falls under the category of a medical device used for direct patient monitoring and intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GYC
Device Description
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.
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
Intended for intraoperative use.
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)
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 packaging integrity verification | Prove integrity of device labeling, retail box and sterile barrier system following conditioning | Pass |
| Label indelibility test | Prove that product labels preserve their integrity and readability after conditioning | Pass |
| Dielectric strength test | Prove the device cable insulation is able to withstand high voltage electrical stresses beyond what would be encountered during normal use | Pass |
| Device integrity verification | Prove that the device keeps its integrity before and after exposure to stress conditions | Pass |
| 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 cable Prove 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 conditions Prove the electrodes keep integrity following 48 hours of stimulation Prove 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 |
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°C No 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 |
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 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
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
4
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:
5
| WISE Cortical Strip
Subject Device | AD-TECH Subdural
Electrodes Predicate
Device, K191186 | AD-TECH Subdural
Electrodes Predicate
Device, K053363 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 (
30 days) use with recording,
monitoring, and stimulation
equipment for the recording,
monitoring, and stimulation
of electrical signals on the
surface of the brain. The
recording of electrical
activity supports definition of
the location of epileptogenic
foci and brain mapping. | The Ad-Tech Subdural
Electrodes (Dual-Sided
Interhemispheric, Grid,
Intraoperative, Strip,
Wyler) are intended for
temporary (