The AD-TECH Depth Electrodes (Spencer Probe Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Device Description

The Depth Electrodes (Spencer Probe Depth Electrode) are intended for recording, monitoring and stimulation at sub-surface levels of the brain. These electrodes are provided sterile, disposable and single patient use. The Depth Electrodes (Spencer Probe Depth Electrodes) provide the patient contact device. The Depth Electrodes (Spencer Probe Depth Electrodes) connect to an electrode cable that is applied to the user's equipment. The electrodes are used by physicians.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Spencer Probe Depth Electrodes, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Hazard Addressed	Test Method Used	Acceptance Criterion	Reported Device Performance (Summary of Test Results)
Image Artifact	ASTM F2119-13	No Criteria, Descriptive Statement	1.5T: Adoption from 3.0T tests since 3.0T is the worst-case. 3.0T: Image distortion of 19 mm from the edge of the device.
Magnetically Induced Displacement Force	ASTM F2052-15	<45° deflection	1.5T: Adoption from 3.0T tests since 3.0T is the worst-case. 3.0T: pass (meaning deflection was less than 45°).
Magnetically Induced Torque	ASTM F2213-17, Low friction surface method	<45° rotation	1.5T: Adoption from 3.0T tests since 3.0T is the worst-case. 3.0T: pass (meaning rotation was less than 45°).
RF Induced Heating	ASTM F2182-19e2	<6°C	1.5T & 3.0T: Under the conditions defined in the labeling, the MR induced heating will be less than <6°C.
Accessory Stay Flange Conductivity	N/A (Descriptive Test)	Negligible conductivity	Results showed that conductivity was negligible, and use of the optional accessory Stay Flange would not lead to any additional safety concerns in association with MRI.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Image Artifact, Magnetically Induced Displacement Force, Magnetically Induced Torque: "The device with the maximum mass/linear length" (for image artifact) and "The device with maximum mass" (for displacement force and torque) were tested. This implies a single representative model or a limited number of "worst-case" configurations. The exact number of individual devices or instances is not specified, but it's likely a small, controlled sample to demonstrate compliance with MR safety.
- RF Induced Heating: "devices with different lengths, different electrode designs, and different insertion depths were studied." Again, the exact number isn't quantified, but it indicates a range of device configurations were tested.
Data Provenance: The studies were conducted by "Ad-Tech, in conjunction with University of Houston." The data is thus likely laboratory-generated performance data specific to the device under controlled testing conditions, not derived from patient data (retrospective or prospective). The country of origin of the data would be the USA (University of Houston).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of information is not applicable to the provided document. The studies described are engineering performance tests related to MR safety, not clinical studies requiring expert ground truth for diagnostic or therapeutic accuracy. The acceptance criteria are based on established engineering standards (ASTM and ISO).

4. Adjudication Method for the Test Set

This is not applicable as the studies are technical performance tests with objective, measurable criteria, not clinical assessments requiring adjudication of human readings or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

This is not applicable. The document describes the technical performance and safety testing of a medical device (depth electrodes) in the MR environment, not an AI-powered diagnostic or therapeutic tool that would typically undergo MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for these tests are the objective measurements against established engineering and safety standards:

Physical properties: Measured displacement, rotation, and temperature changes in a controlled MR environment.
Standard compliance: The tests aim to demonstrate compliance with ASTM and ISO standards for MR safety. The "ground truth" is therefore adherence to these physical principles and regulatory standards.

8. Sample Size for the Training Set

This is not applicable. The device is a physical electrode, not a machine learning model, so there is no training set involved.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the date May 18, 2023. The month is spelled out, followed by the day and year. The text is in a clear, legible font. The date is likely used for record-keeping or documentation purposes.

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ad-Tech Medical Instrument Corporation % Marcella Martin Senior Regulatory Consultant NAMSA 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426

Re: K223269

Trade/Device Name: Spencer Probe Depth Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth electrode Regulatory Class: Class II Product Code: GZL Dated: April 16, 2023 Received: April 18, 2023

Dear Marcella Martin:

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,

Patrick Antkowiak -S

Patrick Antkowiak Acting 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) K223269

Device Name

Depth Electrodes (Spencer Probe Depth Electrode)

Indications for Use (Describe)

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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5 510(k) Summary

Company Name, Address: a. Ad-Tech Medical Instrument Corporation 400 West Oakview Parkway Oak Creek, WI 53154

b. Contact:

Brendan McCrea Chief Technology Officer 400 West Oakview Parkway Oak Creek, WI 53154 Email: bmccrea@adtechmedical.com Phone: (262) 634-1555 x1100

c. Official Correspondent: Marcella Martin Senior Regulatory Consultant NAMSA 400 Highway 169 South, Suite 500 Minneapolis, MN 55426
d. Date prepared October 21, 2022
e. Subject Device Device Name: Device Classification Name: Regulation Number: Common Name: Device Class: Classification Product Code: Regulation Medical Specialty: 510(k) Review Panel:

Depth Electrodes (Spencer Probe Depth Electrode) Electrode, Depth 21 CFR 882.1330 Depth Electrode Class II GZL Neurology Neurology

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Predicate Device f.

The Ad-Tech Depth Electrodes is substantially equivalent to:

510(k) Number:	K163355
Device Name:	Depth Electrodes (Depth Electrodes, Foramen OvaleDepth Electrodes, Marco-Micro Depth Electrodes,Spencer Probe Depth Electrodes, Wyler SphenoidalDepth Electrodes)
Applicant:	Ad-Tech Medical Instrument Corporation
Device Classification Name:	Electrode, Depth
Regulation Number:	21 CFR 882.1330
Common Name:	Depth Electrode
Device Class:	Class II
Classification Product Code:	GZL
Regulation Medical Specialty:	Neurology
510(k) Review Panel:	Neurology

Device Description g.

The Depth Electrodes (Spencer Probe Depth Electrodes) provide the patient contact device. The Depth Electrodes (Spencer Probe Depth Electrodes) connect to an electrode cable that is applied to the user's equipment. The electrodes are used by physicians. Physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of Depth Electrodes.

Intended Use / Indications for Use h.

i. Statement of Substantial Equivalence

Table 1 and Table 2 below presents a comparison of the Depth Electrodes (Spencer Probe Depth Electrodes) to the Predicate Depth Electrodes (K163355). Table 3 is a comparison of the optional accessory Stay Flange to the Predicate.

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j. Comparison Tables

Feature	Depth Electrodes (SpencerProbe Depth Electrodes)(Under Review)	Depth Electrodes(Predicate K163355)	Comment
Indications forUse	The Ad-Tech Depth Electrodes(Spencer Probe Depth Electrodes)are intended for temporary (< 30days) use with recording,monitoring and stimulationequipment for the recording,monitoring and stimulation ofelectrical signals at the subsurfacelevel of the brain. The recordingof electrical activity supportsdefinition of the location ofepileptogenic foci and brainmapping.	The Ad-Tech Depth Electrodes(Depth Electrodes, Foramen OvaleDepth Electrodes, Macro MicroDepth Electrodes, Spencer ProbeDepth Electrodes, Wyler SphenoidalDepth Electrodes) are intended fortemporary (< 30 days) use withrecording, monitoring andstimulation equipment for therecording, monitoring andstimulation of electrical signals atthe subsurface level of the brain. Therecording of electrical activitysupports definition of the location ofepileptogenic foci and brainmapping.	Same – The Indicationsfor Use of the devicesare the same. The onlydifference is that insteadof listing the wholefamily of devices in thePredicate the device inthis submission islimited to the SpencerProbe Depth Electrodes.
ClinicalApplication	Placed in the subsurface level ofthe brain to support recording,monitoring and stimulation.	Placed in the subsurface level of thebrain to support recording,monitoring and stimulation.	Same
Contraindications	These depth electrodes should notbe used on any patient who thephysician/surgeon considers atrisk for infection or for whom thesurgical recording and stimulationprocedure cannot be performedsafely and effectively.	These depth electrodes should not beused on any patient who thephysician/surgeon considers at riskfor infection or for whom thesurgical recording and stimulationprocedure cannot be performedsafely and effectively.	Same
Single patientuse, Disposable	Yes	Yes	Same
Provided Sterile	Yes	Yes	Same
EnvironmentofUse	Intraoperative and Neurologicalmonitoring locations	Intraoperative and Neurologicalmonitoring locations	Same
Duration of Use	≤ 30 days	≤ 30 days	Same
ElectrodeContact Material	Platinum/Iridium	Platinum/Iridium	Same
MaximumStimulationCharge Density	≤ 30 µC/cm²	≤ 30 µC/cm²	Same

The following table identifies features in comparison to the predicate device specific to the Spencer Probe Depth Electrodes.

Table 2: Comparison Depth Electrodes (Spencer Probe Depth Electrode)
Feature	Spencer Probe Depth Electrodes Under Review	Spencer Probe Depth Electrodes (Predicate K163355)	Comment
Number of electrode contacts	Up to 16	Up to 16	Same
Electrode Material	Platinum	Platinum	Same
Electrode body diameter (brain contact)	0.86 mm to 1.96 mm	0.86 mm to 1.96 mm	Same

Table 2: Comparison Depth Electrodes (Spencer Probe Depth Electrode)

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Feature	Spencer Probe Depth Electrodes Under Review	Spencer Probe Depth Electrodes (Predicate K163355)	Comment
Stylet	Yes	Yes	Same
Neuro Navigation Stylet compatible	Yes(AD Style Only)	Yes(AD Style Only)	Same
MR Labeling	MR Conditional	Safety in MRI Not evaluated	Substantially Equivalent
MR Labeling does not raise any questions of the safety and effectiveness of the device because performance testing was completed to evaluate MR conditional parameters. The Depth Electrodes (Spencer Probe Depth Electrode) labeling has been updated with MR Conditional use information.

Table 3: Comparison Optional Accessory Stay Flange

Feature	Stay Flange Under Review	Stay Flange (Predicate K163355)	Equivalence Comments
Indications for Use	The AD-TECH Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrode, Macro Micro Depth Electrode, Spencer Probe Depth Electrode, Wyler Sphenoidal Depth Electrode) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.	The AD-TECH Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrode, Macro Micro Depth Electrode, Spencer Probe Depth Electrode, Wyler Sphenoidal Depth Electrode) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.	Same
Duration of use	< 30 days	< 30 days	Same
Single patient use, disposable	Yes	Yes	Same
Provided sterile	Yes	Yes	Same
Stay Flange	YesOptional accessory placed around the Depth Electrode Tail that exists the skull, providing a surface to suture to the skin, preventing movement of the electrode.	YesOptional accessory placed around the Depth Electrode Tail that exists the skull, providing a surface to suture to the skin, preventing movement of the electrode.	Same
Stay Flange patient contact material	Silicone	Silicone	Same
Compatible Depth Electrode Tail Diameter	0.86 mm to 1.3 mm	0.86 mm to 1.3 mm	Same

k. Performance Data

Ad-Tech, in conjunction with University of Houston, has conducted performance evaluations of the Depth Electrodes (Spencer Probe Depth Electrode) and optional accessory Stay Flange to address hazards in the MR environment. As per the Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, issued May 20, 2021, for passive

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devices, evaluations were conducted for image artifact, magnetically induced displacement force, magnetically induced torque and RF induced heating. Results of the testing allow the device to be labeled MR Conditional and the results summaries follow.

Hazard Addressed	Test Method Used	AcceptanceCriterion	Medical DeviceConfiguration Tested	Summary of TestResults andpass/fail ifAppropriate
Image Artifact	ASTM F2119-13	No Criteria,DescriptiveStatement	Device with themaximum mass/linearlength	Adoption from 3,0Ttests since 3.0T isthe worst-case.
Magnetically InducedDisplacement Force	ASTM F2052-15	<45° deflection	The device withmaximum mass	Adoption from 3.0Ttests since 3.0T isthe worst-case.
Magnetically InducedTorque	ASTM F2213-17,Low friction surfacemethod	<45° rotation	The device withmaximum mass	Adoption from 3.0Ttests since 3.0T isthe worst-case.
RF Induced Heating	ASTM F2182-19e2	<6°C	Based on the ISO10974methodology anddevices with differentlengths, differentelectrode designs, anddifferent insertiondepths were studied.	Under the conditiondefined in thelabeling, the MRinduced heating willbe less than <6°C

Table 4: 1.5T Test Results Summary

Table 5: 3.0T Test Results Summary

Hazard Addressed	Test Method Used	Acceptance Criterion	Medical DeviceConfiguration Tested	Summary of TestResults and pass/fail ifAppropriate
Image Artifact	ASTM F2119-13	No Criteria,DescriptiveStatement	Device with themaximum mass/linearlength	Image distortion of 19mm from the edge of thedevice
Magnetically InducedDisplacement Force	ASTM F2052-15	<45° deflection	The device withmaximum mass	pass
Magnetically InducedTorque	ASTM F2213-17,Low friction surfacemethod	<45° rotation	The device withmaximum mass	pass
RF Induced Heating	ASTM F2182-19e2	<6°C	Based on theISO10974methodology anddevices with differentlengths, differentelectrode designs, anddifferent insertiondepths were studied.	Under the conditiondefined in the labeling,the MR induced heatingwill be less than <6°C

Accessory Stay Flange Conductivity Testing

The optional accessory Stay Flange was tested for conductivity. The impedance was measured between two sample edges in air and in saline solution with conductivity of 0.47 S/m. In addition, impedance was measured between the two electrodes of multi-meter in saline without the sample.

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Results showed that conductivity was negligible and use of the optional accessory Stay Flange would not lead to any additional safety concerns in association with MRI.

l. Conclusion

The Depth Electrodes (Spencer Probe Depth Electrodes) and optional accessory Stay Flange meet performance requirements. The intended use and technology of the Depth Electrodes (Spencer Probe Depth Electrodes) are the same as the predicate device.

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).