Who is the manufacturer of Spencer Probe Depth Electrodes?

Ad-Tech Medical Instrument Corporation filed the 510(k) submission for Spencer Probe Depth Electrodes (K223269).

What is the FDA product code for Spencer Probe Depth Electrodes?

GZL. It is classified under 21 CFR 882.1330 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Spencer Probe Depth Electrodes?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Spencer Probe Depth Electrodes?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Spencer Probe Depth Electrodes

K223269 · Ad-Tech Medical Instrument Corporation · GZL · May 18, 2023 · Neurology

Device Facts

Record ID	K223269
Device Name	Spencer Probe Depth Electrodes
Applicant	Ad-Tech Medical Instrument Corporation
Product Code	GZL · Neurology
Decision Date	May 18, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1330
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Spencer Probe Depth Electrodes are sterile, single-patient-use devices for subsurface brain recording, monitoring, and stimulation. Electrodes consist of platinum/iridium contacts (up to 16) on a body (0.86–1.96 mm diameter). Used by physicians in intraoperative or neurological monitoring settings; device connects to external recording/stimulation equipment via electrode cable. Optional silicone stay flange secures electrode to skin to prevent movement. Device provides electrical signal input to external equipment; physician interprets signals to map brain activity and locate epileptogenic foci. Benefits include precise localization of seizure-generating tissue for surgical planning. Updated labeling designates device as MR Conditional based on testing for image artifact, displacement force, torque, and RF-induced heating.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluations conducted for MR environment safety, including image artifact, magnetically induced displacement force, magnetically induced torque, and RF-induced heating at 1.5T and 3.0T. All tests met acceptance criteria (e.g., RF heating <6°C, displacement/torque <45°).

Technological Characteristics

Platinum/Iridium electrode contacts; silicone stay flange. Dimensions: 0.86–1.96 mm diameter. Passive device; no internal energy source. Sterile, single-use. MR Conditional. Standards: ASTM F2119-13 (image artifact), ASTM F2052-15 (displacement), ASTM F2213-17 (torque), ASTM F2182-19e2 (RF heating).

Indications for Use

Indicated for temporary (< 30 days) recording, monitoring, and stimulation of electrical signals at subsurface brain levels to define epileptogenic foci and perform brain mapping. Contraindicated for patients at risk for infection or where surgical recording/stimulation cannot be performed safely.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

Depth Electrodes (K163355)

Related Devices

K170959 — DIXI Medical Microdeep Depth Electrode · Dixi Medical · Nov 24, 2017
K213170 — SENSOSEEG Depth Electrodes · Sensomedical Labs, Ltd. · Apr 18, 2023
K163355 — Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes · Ad-Tech Medical Instrument Corporation · Apr 12, 2017
K151790 — PMT Platinum Depthalon Depth Electrode · Pmt Corporation · Jul 14, 2016
K202087 — DIXI Medical Microdeep Micro-Macro Depth Electrodes · Dixi Medical · Nov 18, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {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, # 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 {2}------------------------------------------------ # Indications for Use 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) | |----------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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}------------------------------------------------ #### 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 {4}------------------------------------------------ #### Predicate Device f. 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 | #### Device Description g. 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. #### Intended Use / Indications for Use h. 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. {5}------------------------------------------------ #### j. Comparison Tables | Feature | Depth Electrodes (Spencer Probe Depth Electrodes) (Under Review) | Depth Electrodes (Predicate K163355) | Comment | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. | The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal 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. | Same – The Indications for Use of the devices are the same. The only difference is that instead of listing the whole family of devices in the Predicate the device in this submission is limited to the Spencer Probe Depth Electrodes. | | Clinical Application | Placed in the subsurface level of the brain to support recording, monitoring and stimulation. | Placed in the subsurface level of the brain to support recording, monitoring and stimulation. | Same | | Contraindications | These depth electrodes should not be used on any patient who the physician/surgeon considers at risk for infection or for whom the surgical recording and stimulation procedure cannot be performed safely and effectively. | These depth electrodes should not be used on any patient who the physician/surgeon considers at risk for infection or for whom the surgical recording and stimulation procedure cannot be performed safely and effectively. | Same | | Single patient use, Disposable | Yes | Yes | Same | | Provided Sterile | Yes | Yes | Same | | Environment of Use | Intraoperative and Neurological monitoring locations | Intraoperative and Neurological monitoring locations | Same | | Duration of Use | ≤ 30 days | ≤ 30 days | Same | | Electrode Contact Material | Platinum/Iridium | Platinum/Iridium | Same | | Maximum Stimulation Charge 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) {6}------------------------------------------------ | 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 | Yes Optional accessory placed around the Depth Electrode Tail that exists the skull, providing a surface to suture to the skin, preventing movement of the electrode. | Yes Optional 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 {7}------------------------------------------------ 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 | Acceptance Criterion | Medical Device Configuration Tested | Summary of Test Results and pass/fail if Appropriate | |--------------------------------------------|--------------------------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | Image Artifact | ASTM F2119-13 | No Criteria, Descriptive Statement | Device with the maximum mass/linear length | Adoption from 3,0T tests since 3.0T is the worst-case. | | Magnetically Induced Displacement Force | ASTM F2052-15 | <45° deflection | The device with maximum mass | Adoption from 3.0T tests since 3.0T is the worst-case. | | Magnetically Induced Torque | ASTM F2213-17, Low friction surface method | <45° rotation | The device with maximum mass | Adoption from 3.0T tests since 3.0T is the worst-case. | | RF Induced Heating | ASTM F2182-19e2 | <6°C | Based on the ISO10974 methodology and devices with different lengths, different electrode designs, and different insertion depths were studied. | Under the condition defined in the labeling, the MR induced heating will be 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 Device Configuration Tested | Summary of Test Results and pass/fail if Appropriate | |--------------------------------------------|--------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Image Artifact | ASTM F2119-13 | No Criteria, Descriptive Statement | Device with the maximum mass/linear length | Image distortion of 19 mm from the edge of the device | | Magnetically Induced Displacement Force | ASTM F2052-15 | <45° deflection | The device with maximum mass | pass | | Magnetically Induced Torque | ASTM F2213-17, Low friction surface method | <45° rotation | The device with maximum mass | pass | | RF Induced Heating | ASTM F2182-19e2 | <6°C | Based on the ISO10974 methodology and devices with different lengths, different electrode designs, and different insertion depths were studied. | Under the condition defined in the labeling, the MR induced heating will 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. {8}------------------------------------------------ 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.