May 18, 2023

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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.02
Silver Spring, MD 20993
www.fda.gov
K223269 - Marcella Martin Page 2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (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-reporting-
combination-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-devices/medical-device-safety/medical-device-reporting-
mdr-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/medical-
devices/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-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) 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
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

510(k) Number (if known)

K223269

Device Name
Depth Electrodes (Spencer Probe Depth Electrode)

Indications for Use (Describe)

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.

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
[email protected]
“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.”

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
5 510(k) Summary
a. Company Name, Address:
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: [email protected]
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: Depth Electrodes (Spencer Probe Depth Electrode)
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

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f. Predicate Device
The Ad-Tech Depth Electrodes is substantially equivalent to:
510(k) Number: K163355
Device Name: Depth Electrodes (Depth Electrodes, Foramen Ovale
Depth Electrodes, Marco-Micro Depth Electrodes,
Spencer Probe Depth Electrodes, Wyler Sphenoidal
Depth 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
g. 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.
Physicians in the areas of biopotential recording, monitoring and stimulation/response
studies understand the use of Depth Electrodes.

h. Intended Use / Indications for Use

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.

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
Table 1: Comparison Depth Electrodes
Depth Electrodes (Spencer Depth Electrodes
Feature Probe Depth Electrodes) (Predicate K163355) Comment
(Under Review)
Indications for The Ad-Tech Depth Electrodes The Ad-Tech Depth Electrodes Same – The Indications
Use (Spencer Probe Depth Electrodes) (Depth Electrodes, Foramen Ovale for Use of the devices
are intended for temporary (< 30 Depth Electrodes, Macro Micro are the same. The only
days) use with recording, Depth Electrodes, Spencer Probe difference is that instead
monitoring and stimulation Depth Electrodes, Wyler Sphenoidal of listing the whole
equipment for the recording, Depth Electrodes) are intended for family of devices in the
monitoring and stimulation of temporary (< 30 days) use with Predicate the device in
electrical signals at the subsurface recording, monitoring and this submission is
level of the brain. The recording stimulation equipment for the limited to the Spencer
of electrical activity supports recording, monitoring and Probe Depth Electrodes.
definition of the location of stimulation of electrical signals at
epileptogenic foci and brain the subsurface level of the brain. The
mapping. recording of electrical activity
supports definition of the location of
epileptogenic foci and brain
mapping.
Clinical Placed in the subsurface level of Placed in the subsurface level of the Same
Application the brain to support recording, brain to support recording,
monitoring and stimulation. monitoring and stimulation.
Contraindications These depth electrodes should not These depth electrodes should not be Same
be used on any patient who the used on any patient who the
physician/surgeon considers at physician/surgeon considers at risk
risk for infection or for whom the for infection or for whom the
surgical recording and stimulation surgical recording and stimulation
procedure cannot be performed procedure cannot be performed
safely and effectively. safely and effectively.
Single patient Yes Yes Same
use, Disposable
Provided Sterile Yes Yes Same
Environment of Intraoperative and Neurological Intraoperative and Neurological Same
Use monitoring locations monitoring locations
Duration of Use < 30 days < 30 days Same
Electrode Platinum/Iridium Platinum/Iridium Same
Contact Material
Maximum < 30 µC/cm2 < 30 µC/cm2 Same
Stimulation
Charge Density

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 Spencer Probe Depth Comment
Depth Electrodes Electrodes (Predicate
Under Review K163355)
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

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Feature Spencer Probe
Spencer Probe Depth Comment
Depth Electrodes
Electrodes (Predicate
Under Review K163355)
Stylet Yes Yes Same
Neuro Navigation Stylet compatible Yes Yes Same
(AD Style Only) (AD Style Only)
MR Labeling MR ConditionalSafety in MRI Not Substantially
evaluated 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 The AD-TECH Depth Electrodes (Depth Same
Electrode, Foramen Ovale Depth Electrode, Foramen Ovale Depth
Electrode, Macro Micro Depth Electrode, Electrode, Macro Micro Depth Electrode,
Spencer Probe Depth Electrode, Wyler Spencer Probe Depth Electrode, Wyler
Sphenoidal Depth Electrode) are intended Sphenoidal Depth Electrode) are intended
for temporary (< 30 days) use with for temporary (< 30 days) use with
recording, monitoring and stimulation recording, monitoring and stimulation
equipment for the recording, monitoring equipment for the recording, monitoring
and stimulation of electrical signals at the and stimulation of electrical signals at the
subsurface level of the brain. subsurface level of the brain.
The recording of electrical activity The recording of electrical activity
supports definition of the location of supports definition of the location of
epileptogenic foci and brain mapping. epileptogenic foci and brain mapping.
Duration of use < 30 days < 30 days Same

Single patient use, Yes Yes

disposable Same

Provided sterile Yes Yes

Same

Stay Flange Yes Yes

Optional accessory placed around the Depth Optional accessory placed around the Depth Same
Electrode Tail that exists the skull, providing a Electrode Tail that exists the skull, providing
surface to suture to the skin, preventing a surface to suture to the skin, preventing
movement of the electrode. movement of the electrode.
Stay Flange patient Silicone Silicone Same
contact material
Compatible Depth 0.86 mm to 1.3 mm 0.86 mm to 1.3 mm Same
Electrode Tail
Diameter

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.
Table 4: 1.5T Test Results Summary
Hazard Addressed Test Method Used Acceptance Medical Device Summary of Test
Criterion Configuration Tested Results and
pass/fail if
Appropriate
Image Artifact ASTM F2119-13 No Criteria, Device with the Adoption from 3,0T
Descriptive maximum mass/linear tests since 3.0T is
Statement length the worst-case.
Magnetically Induced ASTM F2052-15 <45° deflection The device with Adoption from 3.0T
Displacement Force maximum mass tests since 3.0T is
the worst-case.
Magnetically Induced ASTM F2213-17, <45° rotation The device with Adoption from 3.0T
Torque Low friction surface maximum mass tests since 3.0T is
method the worst-case.
RF Induced Heating ASTM F2182-19e2 <6°C Based on the ISO10974 Under the condition
methodology and defined in the
devices with different labeling, the MR
lengths, different induced heating will
electrode designs, and be less than <6°C
different insertion
depths were studied.

Table 5: 3.0T Test Results Summary

Hazard Addressed Test Method Used Acceptance Medical Device Summary of Test
Criterion Configuration Tested Results and pass/fail if
Appropriate
Image Artifact ASTM F2119-13 No Criteria, Device with the Image distortion of 19
Descriptive maximum mass/linear mm from the edge of the
Statement length device
Magnetically Induced ASTM F2052-15 <45° deflection The device with pass
Displacement Force maximum mass
Magnetically Induced ASTM F2213-17, <45° rotation The device with pass
Torque Low friction surface maximum mass
method
RF Induced Heating ASTM F2182-19e2 <6°C Based on the Under the condition
ISO10974 defined in the labeling,
methodology and the MR induced heating
devices with different will be less than <6°C
lengths, different
electrode designs, and
different insertion
depths were studied.

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.

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