(206 days)
Not Found
No
The summary describes a physical electrode device for recording and stimulating brain signals, with no mention of AI or ML in its function or processing.
No
The device is used for recording, monitoring, and stimulation of electrical signals to locate epileptogenic foci, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used for "recording, monitoring and stimulation of electrical signals at the subsurface level of the brain," and "The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping." This indicates its use in diagnosing the location of epileptogenic foci.
No
The device description explicitly states that the device is a physical electrode intended for insertion into the brain and connects to external equipment via a cable. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The AD-TECH Depth Electrodes are used to record, monitor, and stimulate electrical signals directly within the brain. They are implanted into the patient's body.
- Intended Use: The intended use is to support the definition of the location of epileptogenic foci and brain mapping by recording electrical activity in vivo (within the living organism).
The device interacts directly with the patient's brain, not with specimens taken from the patient. Therefore, it falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AD-TECH Depth Electrodes (Spencer Probe 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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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
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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
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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 ( Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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 (