(133 days)
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.
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.
This document describes the Ad-Tech Medical Instrument Corporation's Depth Electrodes (K163355) and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this 510(k) summary for a traditional medical device.
However, I can extract the acceptance criteria (defined as "Summary of Requirement" in the document) and the reported performance ("Result") for the physical device testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion (Summary of Requirement) | Reported Device Performance (Result) |
|---|---|
| Measure electrical resistance from the electrode contact to connector. | Pass |
| Dimensional requirements are met by manufacturing. | Pass |
| Stimulation at 30 $\mu$ C/cm2 does not affect the electrodes. | Pass |
| The optional accessory Stay Flange supports adequate Depth Electrode retention. | Pass |
The following information is not applicable to this document as it pertains to an AI/ML software device, and this 510(k) is for a set of physical medical electrodes:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
Additional relevant information from the document:
- Intended Use: The Ad-Tech 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 the definition of epileptogenic foci and brain mapping.
- Predicate Devices: The device was deemed substantially equivalent to K053358, K964644, K990788, K041604, K802151, and K151790 (all previous Depth Electrodes from Ad-Tech Medical Instrument Corporation or PMT Corporation).
- Study Type: The submission focused on demonstrating substantial equivalence based on technical characteristics and performance testing of the physical device, rather than clinical trials or AI performance evaluations.
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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
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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
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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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 Corporation1901 William StreetRacine, WI 53404Phone: (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, WyleSphenoidal Depth Electrode) |
| Common Name: | Depth Electrode |
| Classification Name: | Depth Electrode21 CFR 882.1330Product Code: GZLClass II |
| Predicate Devices: | K053358 Depth Electrode (Primary Predicate)Ad-Tech Medical Instrument Corporation |
| K964644 Depth ElectrodeAd-Tech Medical Instrument Corporation | |
| K990788 Foramen Ovale ElectrodeAd-Tech Medical Instrument Corporation | |
| K041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corporation | |
| K802151 and K151790 PMT Depthalon ElectrodesPMT Corporation | |
| Reference Device: | K944061 Cueva Cranial Nerve ElectrodeAd-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.
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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, ForamenOvale Depth Electrodes, MacroMicro Depth Electrodes,Spencer Probe DepthElectrodes, Wyler SphenoidalDepth Electrodes) are intendedfor temporary (< 30 days) usewith recording, monitoring andstimulation equipment for therecording, monitoring andstimulation of electrical signalsat the subsurface level of thebrain. The recording ofelectrical activity supportsdefinition of the location ofepileptogenic foci and brainmapping. | The Ad-Tech Depth Electrodes(Depth Electrodes, ForamenOvale Depth Electrodes, MacroMicro Depth Electrodes,Spencer Probe DepthElectrodes, Wyler SphenoidalDepth Electrodes) are intendedfor temporary (< 30 days) usewith recording, monitoring andstimulation equipment for therecording, monitoring andstimulation of electrical signalsat the subsurface level of thebrain. The recording ofelectrical activity supportsdefinition of the location ofepileptogenic foci and brainmapping. | Same |
| ClinicalApplication | Placed in the subsurface level ofthe brain to support recording,monitoring and stimulation. | Placed in the subsurface level ofthe brain to support recording,monitoring and stimulation. | Same |
| Contraindications | These depth electrodes shouldnot be used on any patient whothe physician/surgeon considersat risk for infection or for whomthe surgical recording andstimulation procedure cannot beperformed safely andeffectively. | These depth electrodes shouldnot be used on any patient whothe physician/surgeon considersat risk for infection or for whomthe surgical recording andstimulation procedure cannot beperformed safely andeffectively. | Same |
| Single patient use,Disposable | Yes | Yes | Same |
| Provided Sterile | Yes | Yes | Same |
| Environment of | Intraoperative and Neurological | Intraoperative and Neurological | Same |
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| 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 ContactMaterial | Platinum/Iridium | Platinum/Iridium | Same |
| MaximumStimulationCharge Density | $ \leq 30 \mu C/cm^2 $ | Not indicated in labeling | Clarification ofstimulation chargedensity limits for braintissue. |
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 ElectrodesUnder Review | Depth Electrode(PredicateK053358 andK964644) | PMT DepthalonElectrodes(PredicateK802151,K151790) | EquivalenceComments |
| Number of electrodecontacts | Up to 16 | Up to 12 | Up to 16 contacts | Equivalent |
| Electrode Material | Platinum | Platinum | Platinum orStainless Steel | Same |
| Electrode bodydiameter(brain contact) | 0.86 mm to 1.96mm | 1 mm | 0.8 mm to 1.8 mm | EquivalentVariations ofelectrode bodydiameter areprovided. |
| Stylet | Yes | Yes | Yes | Same |
| Neuro NavigationStylet compatible | Yes(AD Style Only) | No | Yes(ACCUNAC®variation) | Equivalent |
| Table 5.3-3: Foramen Ovale Depth Electrodes Feature Comparison | |||
|---|---|---|---|
| Feature | Foramen OvaleDepth ElectrodesUnder Review | Foramen Ovale Electrode(Predicate K990788) | Equivalence Comments |
| Number of electrodecontacts | Up to 6 | Up to 6 | Same |
| Electrode Material | Platinum | Platinum | Same |
| Electrode bodydiameter(brain contact) | 1.1 mm | 1.0 $ ± $ 0.5 mm | EquivalentWithin the tolerance of thepredicate. |
| Overall length | $ ≤ $ 660 mm | $ ≤ $ 383 mm | A longer electrode accommodatesadditional contacts and userpreference. |
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| Table 5.3-4: Feature Comparison of Macro Micro Depth Electrodes | |||
|---|---|---|---|
| Feature | Macro Micro DepthElectrodesUnder Review | Macro-Micro DepthElectrode(Predicate K041604) | Equivalence Comments |
| Number of electrodecontacts | Up to 12 (Macro)Up to 24 (Micro)(Up to 32 total contacts) | Up to 12 (Macro)Up to 10 (Micro) | Additional Micro Electrodecontacts are available. |
| Electrode Material | Platinum (Macro Electrode)Platinum/Iridium (MicroElectrode) | Platinum (Macro Electrode)Platinum/Iridium (MicroElectrode) | Same |
| Electrode bodydiameter(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 contactlength(along body of theelectrode) | 1.57 mm (Macro) | 1.32 to 1.57 mm (Macro) | Same |
| Overall length | ≤ 660 mm | ≤ 400 mm | A longer electrodeaccommodates user preference. |
| Stylet | Yes | Yes | Same |
| Table 5.3-5: Stay Flange Comparison to Reference Device | |||
|---|---|---|---|
| Feature | Depth ElectrodesUnder Review | Cueva Cranial NerveElectrode(Reference DeviceK944061) | Equivalence Comments |
| Indications for Use | The AD-TECH DepthElectrodes (Depth Electrode,Foramen Ovale DepthElectrode, Macro MicroDepth Electrode, SpencerProbe Depth Electrode,Wyler Sphenoidal DepthElectrode) are intended fortemporary (< 30 days) usewith recording, monitoringand stimulation equipmentfor the recording, monitoringand stimulation of electricalsignals at the subsurfacelevel of the brain.The recording of electricalactivity supports definitionof the location ofepileptogenic foci and brainmapping. | The Cueva Cranial NerveElectrode is intended foruse to monitor cranialnerves during skull basetype surgeries. It is not forimplantation and is to beused for surgicalprocedures only. Theelectrode and applicatorare for single use only, notfor reuse. The electrodeand applicator are not tobe resterilized. | Equivalent monitoringindication of intracranialnerves.The Cueva Electrode resides onthe surface of a nerve. TheDepth Electrodes are placedsubsurface of a nerve (brain). |
| Duration of use | < 30 days | < 10 hours | The Cueva Electrode referencedevice is limited tointraoperative use. |
| Single patient use | Yes | Yes | Same |
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| Table 5.3-5: Stay Flange Comparison to Reference Device | |||
|---|---|---|---|
| Feature | Depth ElectrodesUnder Review | Cueva Cranial NerveElectrode(Reference DeviceK944061) | Equivalence Comments |
| disposable | |||
| Provided sterile | Yes | Yes | Same |
| Stay Flange | YesOptional accessory placedaround the Depth ElectrodeTail that exists the skull,providing a surface to sutureto the skin, preventingmovement of the electrode. | YesMolded onto electrodeTail.Suture of Stay flange forsecuring of connector endelectrode, preventsmovement of electrode. | EquivalentFor both devices the StayFlange provides a suturingsurface to support stabilizingthe electrode tail. |
| Stay Flange patientcontact material | Silicone | Silicone | Equivalent |
| Compatible DepthElectrode TailDiameter | 0.86 mm to 1.3 mm | Not ApplicableMolded onto ElectrodeTail. | The Stay Flange is an optionalaccessory to variations of DepthElectrodes. The Stay Flange isplaced around the DepthElectrode tail and provides anoptional method of providingDepth Electrode retention and asurface for suturing the StayFlange 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.
§ 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).