(208 days)
Not Found
No
The device description explicitly states that the device is passive, receives power from an external EEG system, and does not contain any software. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is intended for recording, monitoring, and stimulation of electrical signals on the surface of the brain, which falls under diagnostic and monitoring purposes rather than direct therapeutic intervention. While it can stimulate electrical signals, the primary stated uses do not indicate it is for treating a condition or disease.
Yes
The device's intended use explicitly states "recording, monitoring, and stimulation of electrical signals on the surface of the brain," which are functions of a diagnostic device. The device description further details its capability to interface with EEG equipment, which is used for diagnostic purposes.
No
The device description explicitly states, "It does not have any wireless capabilities and does not contain any software." It is a physical electrode array system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The Layer 7-T cortical electrodes are designed to be placed on the surface of the brain (in vivo) to record, monitor, and stimulate electrical signals. This is a direct interaction with the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states "recording, monitoring, and stimulation of electrical signals on the surface of the brain." This is a physiological measurement and intervention, not a diagnostic test on a biological sample.
Therefore, based on the definition of an IVD and the description of the Layer 7-T device, it falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Layer 7-T cortical electrodes are intended for temporary (less than 30 days) use with recording, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT).
Product codes
GYC
Device Description
The Layer 7-T is intended for temporary (less than 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 electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT).
The overall Layer 7-T consists of a sterile thin film 1024-electrode array connected to a more rigid PCB package (known as the headstage) with ribbon cables. Each ribbon cable connects to 64 channels from the electrode array. There are a total of 16 ribbon cables in the headstage, connecting 1024 electrodes on the array. The device is also provided with an intermediary yoke cable that connects the ribbon cables from the Layer 7-T headstage to standard EEG equipment via 64 standard DIN connectors. A yoke stand is also provided as an optional accessory that allows up to 16 yokes to be stacked. Surgical accessories are provided with the array and are intended to aid in deployment of the array.
The system allows the surgeon to place electrode arrays on the surface of the brain through burr holes. The inserted portion of the device can be retrieved following use by pulling the electrode array through the burr hole.
The thin film electrode array is designed to operate in a fashion identical to the currently used ECoG arrays, in that it is to be placed on the surface of the brain to interface with brain tissue through electrical recording and stimulation.
The electrode array consists of a polyimide substrate with platinum electrodes and associated electrically connecting traces and another layer of polyimide on top. A polyimide pocket is adhered via silicone to the backside of the electrode array tip. The array also contains gold radiopaque markers embedded in the silicone pocket adhesive. A rigid stainless steel radiopaque stylet is temporarily placed in the pocket during electrode array deployment.
The overall Layer 7-T system, including the yoke, is intended for single use only. The Layer 7-T is a passive device and only receives power from a connected FDA-cleared EEG system. It does not have any wireless capabilities and does not contain any software. It is not MRI-compatible. It is only intended for use in a professional healthcare environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoperative x-ray, fluoroscopy, and computerized tomography (CT)
Anatomical Site
surface of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare environment
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)
The Layer 7-T has undergone complete non-clinical testing to demonstrate that it is as safe and effective as the predicate which includes Sterilization, Packaging Validation, Shelf Life testing, Biocompatibility testing per ISO 10993-1, Electrical Safety and EMC testing, Performance testing for dimensional measurement, durability, electrochemical performance, platinum dissolution testing, Signal-to-Noise Ratio Testing, Reliability Testing, EEG system compatibility testing and human factors testing. The tests and their respective standards (if applicable) are listed below. All testing passed as expected.
Test results for:
- Dimensional Measurements: Pass
- Durability: Pass
- Electrochemical Performance: Pass
- Platinum Dissolution Testing: Pass
- Signal-to-Noise Ratio Testing: Pass
- Reliability: Pass
- EEG system compatibility: Pass
- Packaging Shelf Life: Pass
- Sterilization: Pass
Biocompatibility:
Evaluated according to FDA guidance (2023) "Use of International Standard ISO 10993-1".
Endpoints assessed: Cytoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Genotoxicity, Implantation Testing, Hemolysis (Indirect Contact), Chemical characterization and a toxicological risk assessment for subacute and subchronic toxicity.
Results support the biocompatibility of the Layer 7-T.
Electrical Safety and Electromagnetic Compatibility:
Test reports address basic safety evaluation per IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, and IEC 60601-1-6:2010, AMD1:2013, AMD2:2020. EMC testing conducted per IEC 60601-1-2:2014+A1:2020, EN 60601-1-2015+A1:2021, IEC 80601-2-49:2018, and IEC TR 60601-4-2:2024. All passed.
Human Factors:
Usability validated in accordance with "Applying Human Factors and Usability Engineering to Medical Devices" guidance and ANSI AAMI HE75:2009.
Animal Testing:
GLP animal study conducted involving 16 female Göttingen swine, divided into 1-week and 6-week implant durations. Layer 7 cortical electrode array implanted into subdural space. Compared to control animals with AD-TECH subdural strip electrodes.
Key Results: No adverse events related to Layer 7 Cortical Electrode Array. Biocompatibility confirmed. Both test article and control showed no evidence of ongoing neurotoxicity and elicited a similar cortical inflammatory response that subsided by 6 weeks.
Conclusion: Bench testing and animal studies demonstrate that the safety and performance of the Layer 7-T is similar to that of the predicate device, Ad-Tech Subdural Electrodes (K191186).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 30, 2025
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: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the seal is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a lighter blue.
Precision Neuroscience, Corp. Jayme Strauss Chief Clinical and Commercial Officer 5201 Great America Pkwy. Suite 432 Santa Clara, California 95054
Re: K242618
Trade/Device Name: Layer 7-T Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: February 27, 2025 Received: February 27, 2025
Dear Jayme Strauss:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Jay R. Gupta -S
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
3
Indications for Use
510(k) Number (if known) K242618
Device Name Layer 7-T
Indications for Use (Describe)
Layer 7-T cortical electrodes are intended for temporary (less than 30 days) use with recording, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT).
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."
4
510(k) SUMMARY
Precision Neuroscience, Corp.'s Layer 7-T
K242618
Submitter:
5201 Great America Pkwy Suite 432 Santa Clara, CA 95054 United States
Phone: (646) 771-5881
Contact Person: Jayme Strauss
Email Address: Jayme.Strauss@precisionneuro.io
Date Prepared: February 18, 2025
Name of Device: Layer 7-T
Common or Usual Name: Cortical electrode
Classification Name: Electrode, Cortical
Regulatory Class: 21 CFR 882.1310
Product Code: GYC
Predicate Device: K191186
Ad-Tech Medical Instrument Corporation
- Subdural Strip/Intraoperative Strip Electrode ●
- Subdural Grid/Intraoperative Grid Electrode ●
- Dual-Sided Interhemispheric Subdural Electrode ●
- Multi-Strip and Split Grid Subdural Electrode ●
- Intraoperative Mapping Grid Subdural Electrode ●
Device Description:
The Layer 7-T is intended for temporary (less than 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 electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT).
5
The overall Layer 7-T consists of a sterile thin film 1024-electrode array connected to a more rigid PCB package (known as the headstage) with ribbon cables. Each ribbon cable connects to 64 channels from the electrode array. There are a total of 16 ribbon cables in the headstage, connecting 1024 electrodes on the array. The device is also provided with an intermediary yoke cable that connects the ribbon cables from the Layer 7-T headstage to standard EEG equipment via 64 standard DIN connectors. A yoke stand is also provided as an optional accessory that allows up to 16 yokes to be stacked. Surgical accessories are provided with the array and are intended to aid in deployment of the array.
The system allows the surgeon to place electrode arrays on the surface of the brain through burr holes. The inserted portion of the device can be retrieved following use by pulling the electrode array through the burr hole.
The thin film electrode array is designed to operate in a fashion identical to the currently used ECoG arrays, in that it is to be placed on the surface of the brain to interface with brain tissue through electrical recording and stimulation.
The electrode array consists of a polyimide substrate with platinum electrodes and associated electrically connecting traces and another layer of polyimide on top. A polyimide pocket is adhered via silicone to the backside of the electrode array tip. The array also contains gold radiopaque markers embedded in the silicone pocket adhesive. A rigid stainless steel radiopaque stylet is temporarily placed in the pocket during electrode array deployment.
The overall Layer 7-T system, including the yoke, is intended for single use only. The Layer 7-T is a passive device and only receives power from a connected FDA-cleared EEG system. It does not have any wireless capabilities and does not contain any software. It is not MRI-compatible. It is only intended for use in a professional healthcare environment.
Intended Use / Indications for Use
Intended Use/Indications for Use:
Layer 7-T cortical electrodes are intended for temporary (less than 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 electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT).
Indications for Use Comparison to Predicate:
The proposed intended use for the Layer 7-T and the intended use for the Ad-Tech Subdural Electrodes (K191186) are identical. Both devices intended for temporarily placement on the surface of the brain for stimulating the brain or recording the brain's electrical activity.
There are minor differences in the indications for use for the Layer 7-T and the indications for use of the Ad-Tech Subdural Electrodes. Both devices are indicated for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The Layer 7-T indications state that the device may be placed in either open or burr hole procedures with the optional use of fluoroscopic imaging. This
6
additional language in the indications for use for the Layer 7-T does not alter the intended effect of the device or create a new intended use. These differences in indications are representative of the difference in technological characteristics are supported by performance testing which demonstrates that the Layer 7-T electrodes are as safe and effective as the predicate.
Summary of Technological Characteristics:
Both the Layer 7-T and the Ad-Tech Subdural Electrodes are sterile, single-use electrical conductors that are temporarily placed on the surface of the brain. Both of these devices record and/or monitor the brain's electrical activity as well as stimulate the brain. Both devices also operate in a similar manner, which is by using provided cables to connect the device to an external commercially available EEG or cortical stimulation system for recording, monitoring or stimulating.
The Layer 7-T has several minor differences as compared to the predicate including: higher electrode count, smaller contact diameter and smaller electrode body surface area. The Layer 7-T electrode array is made of polyimide and the electrode contact material is made of platinum while the Ad-Tech Subdural Electrodes are made of silicone with a platinum/iridium electrode contact material. Unlike the predicate, the Layer 7-T electrode array is also designed with an integrated pocket on the underside of the array and is provided with its own surgical tools to aid in deployment. Lastly, the Layer 7-T incorporates a printed circuit board (PCB) bonded to the electrode array. The PCB does not raise any new safety or effectiveness questions compared to the predicate, as the PCB-electrode interface is outside the body and fully enclosed in biocompatible packaging material. The PCB board has no active electronic components, and functions solely as a conduit that directs signals from the brain to connectors during recording and use. These differences do not raise new questions of safety or effectiveness and are supported by bench and animal performance data which demonstrate that the Layer 7-T is as safe and effective as the Ad-Tech Subdural Electrodes
| Feature | Layer 7-T (Subject Device) | Ad-Tech Subdural
Electrodes (K191186) | Comment |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Layer 7-T cortical electrodes
are intended for temporary
(less than 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 electrodes may
be placed in either open or
burr hole procedures with
the optional use of standard
imaging techniques such as
intraoperative x-ray,
fluoroscopy, and
computerized tomography
(CT). | The Ad-Tech Subdural
Electrodes
(Strip/Intraoperative Strip,
Grid/Intraoperative Grid, Dual-
Sided Interhemispheric,
MultiStrip and Split Grid,
Intraoperative Mapping Grid)
are intended for temporary (