Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

Q: Who is the manufacturer of Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

Ad-Tech Medical Instrument Corporation filed the 510(k) submission for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (K163355).

Q: What is the FDA product code for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

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

Q: What is the regulatory pathway for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

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

Q: What are the predicate devices for Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes?

Depth Electrode (K053358); Depth Electrode (K964644); Foramen Ovale Electrode (K990788); Macro-Micro Depth Electrode (K041604); PMT Depthalon Electrodes (K802151); PMT Depthalon Electrodes (K151790).

Q: Who can help prepare an FDA 510(k) submission like Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, 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.

K163355 · Ad-Tech Medical Instrument Corporation · GZL · Apr 12, 2017 · Neurology

Device Facts

Record ID	K163355
Device Name	Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
Applicant	Ad-Tech Medical Instrument Corporation
Product Code	GZL · Neurology
Decision Date	Apr 12, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1330
Device Class	Class 2

Indications for Use

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.

Device Story

Depth Electrodes are invasive medical devices designed for temporary (< 30 days) subsurface brain contact. They function as conductors, transmitting biopotential signals from the brain to external recording/monitoring equipment and delivering stimulation energy from external equipment to brain tissue. Used in intraoperative and neurological monitoring settings by physicians/surgeons. The device consists of electrode contacts (platinum or platinum/iridium) mounted on a probe body, often including a stylet for insertion and an optional silicone 'Stay Flange' accessory to secure the electrode tail to the skin, preventing movement. By enabling precise recording of electrical activity, the device assists clinicians in identifying epileptogenic foci and performing brain mapping, which guides surgical decision-making and potentially improves patient outcomes in epilepsy management.

Clinical Evidence

Bench testing only. Evaluations included electrical resistance measurements, dimensional verification, and stimulation testing at 30 µC/cm² to ensure electrode integrity. The optional stay flange accessory was validated for retention performance.

Technological Characteristics

Materials: Platinum or Platinum/Iridium contacts, silicone stay flange. Sensing/Actuation: Passive conductor for biopotential recording and stimulation energy delivery. Form factor: Probe-style electrodes with diameters ranging from 0.86 mm to 1.96 mm (macro) and 38-51 microns (micro). Connectivity: Wired connection to external user-supplied equipment. Sterilization: Provided sterile.

Indications for Use

Indicated for temporary (< 30 days) use in patients requiring recording, monitoring, and stimulation of subsurface brain electrical signals to define epileptogenic foci and perform brain mapping. Contraindicated for patients at risk for infection or for whom surgical recording/stimulation procedures 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 Electrode (K053358)
Depth Electrode (K964644)
Foramen Ovale Electrode (K990788)
Macro-Micro Depth Electrode (K041604)
PMT Depthalon Electrodes (K802151)
PMT Depthalon Electrodes (K151790)

Reference Devices

Cueva Cranial Nerve Electrode (K944061)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a dark color, creating a strong contrast against the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 12, 2017 Ad-tech Medical Instrument Corporation % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC. 800 Levanger Lane Stoughton, Wisconsin 53589 Re: K163355 Trade/Device Name: Depth Electrodes (Depth Electrode, Foramen Ovale Depth Eletrodes, Marco Micro Depth Electrode, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrode) Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: November 28, 2016 Received: November 30, 2016 Dear Mr. Syring: 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. 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 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 {1}------------------------------------------------ related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Carlos L. Pena -S Fr Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163355 ## Device Name Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrode, Spencer Probe Depth Electrode, Wyler Sphenoidal Depth Electrode) ## Indications for Use (Describe) 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 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) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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 Druq 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}------------------------------------------------ #### 5.0 510(k) Summary This summary is provided to support the 510(k) pre-market notification for the Depth Electrodes. | Company Name: | Ad-Tech Medical Instrument Corporation 1901 William Street Racine, WI 53404 Phone: (262) 634-1555 | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Contact: | Lisa Theama, Chief Operating Officer | | Date Summary Prepared: | January 5, 2017 | | Trade Name: | Depth Electrodes (Depth Electrode, Foramen Ovale Depth Electrode, Macro Micro Depth Electrode, Spencer Probe Depth Electrode, Wyle Sphenoidal Depth Electrode) | | Common Name: | Depth Electrode | | Classification Name: | Depth Electrode 21 CFR 882.1330 Product Code: GZL Class II | | Predicate Devices: | K053358 Depth Electrode (Primary Predicate) Ad-Tech Medical Instrument Corporation | | | K964644 Depth Electrode Ad-Tech Medical Instrument Corporation | | | K990788 Foramen Ovale Electrode Ad-Tech Medical Instrument Corporation | | | K041604 Macro-Micro Depth Electrode Ad-Tech Medical Instrument Corporation | | | K802151 and K151790 PMT Depthalon Electrodes PMT Corporation | | Reference Device: | K944061 Cueva Cranial Nerve Electrode Ad-Tech Medical Instrument Corporation | #### 5.1 Product Description The device under review is a family of Depth Electrodes. These electrodes provide sub-surface brain contact to support recording, monitoring and stimulation from user supplied equipment. {4}------------------------------------------------ #### 5.2 Intended Use of the Device 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. The intended use of the Ad-Tech Depth Electrodes is not modified by this 510(k). #### 5.3 Summary of Technological Characteristics The fundamental technical characteristics of the Depth Electrodes are not affected by this submission. Fundamentally the Depth Electrodes are a conductor of the biopotential signals from subsurface levels of the brain to the user's equipment and as applicable conductors of the stimulation energy from the user's equipment to subsurface levels of the brain. The following table provides a side-by-side comparison of the Depth Electrodes to the predicate devices applied to support this pre-market notification. | Table 5.3-1: Substantial Equivalence Technical Characteristics | | | | |----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Feature | Depth Electrodes (Under Review) | Depth Electrodes (Primary Predicate K053358) | Comment | | Indications for Use | 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. | 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 | | 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 | Intraoperative and Neurological | Intraoperative and Neurological | Same | {5}------------------------------------------------ | Table 5.3-1: Substantial Equivalence Technical Characteristics | | | | |----------------------------------------------------------------|------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------| | Feature | Depth Electrodes (Under Review) | Depth Electrodes (Primary Predicate K053358) | Comment | | Use | monitoring locations | monitoring locations | | | Duration of Use | < 30 days | < 30 days | Same | | Electrode Contact Material | Platinum/Iridium | Platinum/Iridium | Same | | Maximum Stimulation Charge Density | $ \leq 30 \mu C/cm^2 $ | Not indicated in labeling | Clarification of stimulation charge density limits for brain tissue. | The following table identifies features in comparison to predicate by Depth Electrode Commercial Name. | Table 5.3-2: Feature comparison Spencer Probe Depth Electrodes | | | | | |----------------------------------------------------------------|----------------------------------|----------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------| | Feature | Depth Electrodes Under Review | Depth Electrode (Predicate K053358 and K964644) | PMT Depthalon Electrodes (Predicate K802151, K151790) | Equivalence Comments | | Number of electrode contacts | Up to 16 | Up to 12 | Up to 16 contacts | Equivalent | | Electrode Material | Platinum | Platinum | Platinum or Stainless Steel | Same | | Electrode body diameter (brain contact) | 0.86 mm to 1.96 mm | 1 mm | 0.8 mm to 1.8 mm | Equivalent Variations of electrode body diameter are provided. | | Stylet | Yes | Yes | Yes | Same | | Neuro Navigation Stylet compatible | Yes (AD Style Only) | No | Yes (ACCUNAC® variation) | Equivalent | | Table 5.3-3: Foramen Ovale Depth Electrodes Feature Comparison | | | | |----------------------------------------------------------------|---------------------------------------------------|------------------------------------------------|--------------------------------------------------------------------------------| | Feature | Foramen Ovale Depth Electrodes Under Review | Foramen Ovale Electrode (Predicate K990788) | Equivalence Comments | | Number of electrode contacts | Up to 6 | Up to 6 | Same | | Electrode Material | Platinum | Platinum | Same | | Electrode body diameter (brain contact) | 1.1 mm | 1.0 $ ± $ 0.5 mm | Equivalent Within the tolerance of the predicate. | | Overall length | $ ≤ $ 660 mm | $ ≤ $ 383 mm | A longer electrode accommodates additional contacts and user preference. | {6}------------------------------------------------ | Table 5.3-4: Feature Comparison of Macro Micro Depth Electrodes | | | | |-----------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------| | Feature | Macro Micro Depth Electrodes Under Review | Macro-Micro Depth Electrode (Predicate K041604) | Equivalence Comments | | Number of electrode contacts | Up to 12 (Macro) Up to 24 (Micro) (Up to 32 total contacts) | Up to 12 (Macro) Up to 10 (Micro) | Additional Micro Electrode contacts are available. | | Electrode Material | Platinum (Macro Electrode) Platinum/Iridium (Micro Electrode) | Platinum (Macro Electrode) Platinum/Iridium (Micro Electrode) | Same | | Electrode body diameter (brain contact) | 1.3 mm (Macro) 38 to 51 microns (Micro) | 1.2 to 1.4 mm (Macro) 15 to 30 microns (Micro) | Equivalent | | Electrode contact length (along body of the electrode) | 1.57 mm (Macro) | 1.32 to 1.57 mm (Macro) | Same | | Overall length | ≤ 660 mm | ≤ 400 mm | A longer electrode accommodates user preference. | | Stylet | Yes | Yes | Same | | Table 5.3-5: Stay Flange Comparison to Reference Device | | | | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Depth Electrodes Under Review | Cueva Cranial Nerve Electrode (Reference Device K944061) | 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 Cueva Cranial Nerve Electrode is intended for use to monitor cranial nerves during skull base type surgeries. It is not for implantation and is to be used for surgical procedures only. The electrode and applicator are for single use only, not for reuse. The electrode and applicator are not to be resterilized. | Equivalent monitoring indication of intracranial nerves. The Cueva Electrode resides on the surface of a nerve. The Depth Electrodes are placed subsurface of a nerve (brain). | | Duration of use | < 30 days | < 10 hours | The Cueva Electrode reference device is limited to intraoperative use. | | Single patient use | Yes | Yes | Same | {7}------------------------------------------------ | Table 5.3-5: Stay Flange Comparison to Reference Device | | | | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Depth Electrodes Under Review | Cueva Cranial Nerve Electrode (Reference Device K944061) | Equivalence Comments | | disposable | | | | | 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 Molded onto electrode Tail. Suture of Stay flange for securing of connector end electrode, prevents movement of electrode. | Equivalent For both devices the Stay Flange provides a suturing surface to support stabilizing the electrode tail. | | Stay Flange patient contact material | Silicone | Silicone | Equivalent | | Compatible Depth Electrode Tail Diameter | 0.86 mm to 1.3 mm | Not Applicable Molded onto Electrode Tail. | The Stay Flange is an optional accessory to variations of Depth Electrodes. The Stay Flange is placed around the Depth Electrode tail and provides an optional method of providing Depth Electrode retention and a surface for suturing the Stay Flange to skin. | #### 5.4 Performance Tests to Demonstrate Substantial Equivalency To establish the technical equivalency of the Depth electrodes, evaluations were conducted to confirm compliance with performance requirements, including: | Test | Summary of Requirement | Result | |--------------------------------|---------------------------------------------------------------------------------|--------| | Electrical Resistance | Measure electrical resistance from the electrode contact to connector. | Pass | | Dimensional Characteristics | Dimensional requirements are met by manufacturing. | Pass | | Stimulation affect | Stimulation at 30 $\mu$ C/cm2 does not affect the electrodes. | Pass | | Optional Accessory Stay Flange | The optional accessory Stay Flange supports adequate Depth Electrode retention. | Pass | #### 5.5 Conclusion The Depth Electrodes meet performance requirements. The intended use and technology of the Depth Electrodes are the same as the predicate devices.

Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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