(133 days)
No
The summary describes a physical electrode device for recording and stimulating brain signals, with no mention of AI or ML for data analysis or processing.
No
The device is described as electrodes used for recording, monitoring, and stimulation of electrical signals in the brain for diagnostic purposes (defining epileptogenic foci and brain mapping), not for treating a condition.
Yes
The device is described as supporting "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain" and "The recording of electrical activity supports definition of epileptogenic foci and brain mapping," which are diagnostic activities.
No
The device description explicitly states it is a "family of Depth Electrodes," which are physical hardware components intended for insertion into the brain. The performance studies also focus on physical characteristics like electrical resistance and dimensional characteristics.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain." This involves interacting directly with the patient's body to measure electrical activity.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not operate on samples taken from the body.
- Device Description: The description confirms that the electrodes provide "sub-surface brain contact," reinforcing that it's an in-vivo device.
Therefore, the Ad-Tech Depth Electrodes are an in-vivo medical device, not an in-vitro diagnostic device.
N/A
Intended Use / 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 (
§ 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).
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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
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
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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 ( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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 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.
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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 (