(267 days)
No
The 510(k) summary describes passive electrodes for recording and stimulating electrical signals. There is no mention of any computational processing, algorithms, or learning capabilities.
No.
The device is intended for recording, monitoring, and stimulation of electrical signals on the surface of the brain to define epileptogenic foci and for brain mapping, which are diagnostic and procedural support functions, not therapeutic interventions.
Yes
Explanation: The device is intended for "recording, monitoring, and stimulation of electrical signals on the surface of the brain" and expressly states that "The recording of electrical activity supports definition of epileptogenic foci and brain mapping." This indicates its use in identifying and characterizing medical conditions, which is diagnostic.
No
The device description clearly details physical components like electrodes, silicone substrate, wires, and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Ad-Tech Subdural Electrodes are designed to be placed directly on the surface of the brain to record, monitor, and stimulate electrical signals. This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Intended Use: The intended use clearly states recording, monitoring, and stimulation of electrical signals on the surface of the brain to support definition of epileptogenic foci and brain mapping. This is a direct interaction with the patient's brain, not an analysis of a sample taken from the patient.
Therefore, the Ad-Tech Subdural Electrodes fall under the category of a medical device used for direct physiological monitoring and stimulation, not an IVD.
N/A
Intended Use / Indications for Use
The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemissheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary (
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
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January 25, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Ad-Tech Medical Instrument Corporation Gary Syring Compliance Manager/Regulatory Specialist 400 West Oakview Parkway Oak Creek, Wisconsin 53154
Re: K191186
Trade/Device Name: 1) Subdural Strip/Intraoperative Strip Electrode, 2) Subdural Grid/Intraoperative Grid Electrode, 3) Dual-Sided Interhemispheric Subdural Electrode, 4) Multi-Strip and Split Grid Subdural Electrode, 5) Intraoperative Mapping Grid Subdural Electrode Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical Electrode Regulatory Class: Class II Product Code: GYC Dated: December 23, 2019 Received: December 27, 2019
Dear Gary 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. 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.
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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 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 medical devices and radiation-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.
for Jay Gupta 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) K191186
Device Name
Subdural Strip/Intraoperative Strip Electrode, Subdural Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Split Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
Indications for Use (Describe)
The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemissheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary ( 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."
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Image /page/3/Picture/0 description: The image shows the logo for AD-TECH Medical Instrument Corporation. The logo features the text "AD-TECH" in a bold, sans-serif font, followed by the words "MEDICAL INSTRUMENT CORPORATION" in a smaller, lighter font. To the left of the text is a stylized graphic of three curved lines, resembling sound waves or a stylized tree.
Traditional 510(k) Summary - K191186
This 510(k) summary was prepared to provide an understanding of the basis for the determination of substantial equivalence in accordance with the requirements 21 CFR 807.92.
| Submitter's Name: | Ad-Tech Medical Instrument Corporation
400 West Oakview Parkway
Oak Creek, WI 53154
Phone: (262) 634-1555 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Contact Telephone: | Suzie Towers, Director, Quality Assurance, Regulatory Affairs
262-634-1555 |
| Date Summary Prepared: | January 24, 2020 |
| Device Trade Name: | Subdural Electrode
-Strip/Intraoperative Strip,
-Grid/Intraoperative Grid,
-Dual-Sided Interhemispheric,
-Multi-Strip and Split Grid, and
-Intraoperative Mapping Grid |
| Common Name: | Subdural Electrode |
| Classification Name: | Cortical Electrode
21 CFR 882.1310
Product Code: GYC Class II |
| Predicate Devices: | K053363 Subdural Electrode
-Dual-Sided Interhemispheric,
-Grid,
-Intraoperative,
-Strip, and
Wyler |
Purpose of Submission
Both the predicate Subdural Electrodes and the Subdural Electrodes under review are characterized by physical features that describe the characteristics of the variations. Modification of available Subdural Electrode Product Family features addressed by this 510(k) submission are summarized in the table below.
Image /page/3/Picture/6 description: The image shows the logo and contact information for AD-TECH MEDICAL INSTRUMENT CORPORATION. The address is 400 WEST OAKVIEW PARKWAY, OAK CREEK, WI 53154 U.S.A. The phone number is 262-634-1555, the fax number is 262-634-5668, and the toll-free number is 800-776-1555. The email address is sales@adtechmedical.com, and the website is www.adtechmedical.com.
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| Modification | Substantial Equivalence Discussion | Scientific Methods for
Evaluating New/Different
Characteristics |
|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
commercial
name changes | From: Strip Subdural Electrodes, To: Subdural Strip
From: Intraoperative Subdural Electrodes,
To: Intraoperative Strip Electrodes
From: Grid Subdural Electrodes (Wyler Electrodes),
To: Grid Electrode
From: Intraoperative Subdural Electrodes
To: Intraoperative Grid Electrode
From: Grid Subdural Electrodes, Intraoperative Subdural
Electrodes
To: Intraoperative Mapping Grid Electrodes | The naming convention
modifications clarify Subdural
Strip Electrodes can be used
intraoperatively. This change is
consistent with the predicate's
intended use. The predicate 510(k)
indicated Strip Subdural and Grid
Subdural electrodes could be used
intraoperatively.
This change is a renaming of the
Grid subdural electrodes,
Intraoperative Subdural Electrodes.
"Mapping" is a clinical term
applied to the use of subdural
electrodes for stimulation and
recording of locations on the brain
surface. This change is consistent
with the indications for use of
Subdural Electrodes, which is not
modified by the submission. |
| Addition of
Multi-Strip and
Split Grid
subdural
electrode
variations | The Multi-Strip and Split Grid Electrode variations
embody individual Strip and Grid Subdural Electrodes
into one assembly, combining the Tails to support ease of
subcutaneous tunneling, see Figure 1. The same materials
and manufacturing processes are applied to create these
electrodes as were applied in the predicate submission.
As a convenience to the user, the multiple tails from each
electrode are placed together into one tube of electrode
tails. | Confirmation of the electrical
pathway from the connector on the
distal end of electrode to the
electrode contact is verified for
proper resistance and no cross
connect to another electrode
contact or connector contact. |
| Intraoperative
Mapping Grid
Subdural
Electrode
contacts
increased from
5 to 6 contacts. | The Intraoperative Mapping Grid Subdural Electrode
variations embodies 1 to 6 single electrode contacts into
one assembly, see Figure 2. The electrode tail terminates
in a 1.5 mm, recessed female connector for interface to
the user's equipment. The same materials and
manufacturing processes are applied to create these
electrodes as those materials and manufacturing
processes that were used for the predicate device. | Confirmation of the electrical
pathway from the connector on the
distal end of electrode to each
electrode contact is verified for
proper resistance and no cross
connect to another electrode
contact or connector contact. |
| The maximum
number of
Subdural
Electrode
Contacts is
increased from
128 to 256
contacts. | The same electrode contact material and manufacturing
processes are applied to fabricate the 256 contact
electrode. The silicone substrate body surface area of the
electrode is not modified, the higher electrode contact
count is accomplished with the same surface area of
Subdural Electrode body. | Confirmation of the electrical
pathway from the connector on the
distal end of electrode to the
electrode contact is verified for
proper resistance and no cross
connect to another electrode
contact. |
| Subdural
Electrode
contact spacing | The center to center spacing between electrode contacts is
modified from: 1 to 10 mm, to: 1 to 20 mm. It is user | The same manufacturing processes
applied with application of the
electrodes to a build template that |
| Subdural Electrode Product Family Feature Modifications | | |
| Modification | Substantial Equivalence Discussion | Scientific Methods for
Evaluating New/Different
Characteristics |
| (center to
center) | preference and choice with regard to what subdural
electrode contact spacing is preferred. | identifies the mechanical
dimensions of center to center
contact spacing. |
| The range of
round (Disc)
Electrode
Contact
diameters. | The range of Subdural Electrode contact diameters for
round contacts, the dimension of the electrode disc placed
between the silicone materials of the electrode body, is
modified from: 4 to 6 mm, to: 1.96 to 6.35 mm. The
same materials and manufacturing processes are applied
to create these electrodes.
The Electrode contact diameter is comparable to the
predicate cylindrical (rectangular) minimum of 1.5 mm
diameter with the Subdural Strip and Intraoperative Strip
Electrodes. | The electrode contact to tail
contact electrical resistance is
confirmed as meeting applicable
specification. |
| Range of round
(Disc)
Electrode
Contact
exposure
diameter | The Electrode Contact is the exposed metal surface,
contacting the brain. Based on user preference the range
of electrode contact exposure diameter is modified from:
1.8 to 4 mm (2.54 to 12.5 mm² surface are), to: 1.17 to
5.00 mm (1.08 to 19.6 mm² surface area). | The potential impact to safety and
effectiveness could be the charge
the density when stimulation is
applied and the applied stimulation
affecting subdural electrode
resistance.
Charge density limits of