Who is the manufacturer of Anchor Bolts as Accessories to Depth Electrodes?

Ad-Tech Medical Instrument Corporation filed the 510(k) submission for Anchor Bolts as Accessories to Depth Electrodes (K223276).

What is the FDA product code for Anchor Bolts as Accessories to Depth Electrodes?

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

What is the regulatory pathway for Anchor Bolts as Accessories to Depth Electrodes?

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

Who can help prepare an FDA 510(k) submission like Anchor Bolts as Accessories to 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.

Anchor Bolts as Accessories to Depth Electrodes

K223276 · Ad-Tech Medical Instrument Corporation · GZL · May 18, 2023 · Neurology

Device Facts

Record ID	K223276
Device Name	Anchor Bolts as Accessories to Depth Electrodes
Applicant	Ad-Tech Medical Instrument Corporation
Product Code	GZL · Neurology
Decision Date	May 18, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1330
Device Class	Class 2

Intended Use

The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

Device Story

Anchor Bolts serve as skull-mounted access points and stabilization supports for depth electrodes; used during intraoperative and neurological monitoring procedures. Device threaded into pre-drilled skull hole; provides mechanical retention (>100g force) for depth electrodes; minimizes CSF leakage and subdural space infection risk. Operated by physicians/surgeons in clinical settings. Device is passive; no electronic or algorithmic components. Benefits include secure electrode placement and reduced risk of complications during monitoring. MR Conditional status allows use in MRI environments under specified conditions.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluations conducted to address MR environment hazards, including image artifact, magnetically induced displacement force, torque, and RF-induced heating, following FDA guidance and ASTM standards.

Technological Characteristics

Passive mechanical device. Materials: Titanium, Silicone (inner lumen gasket), Parylene. Dimensions: 13-26 mm length; compatible with 0.86-1.3 mm diameter depth electrodes. Retention force >100g. MR Conditional. Sterilization: Provided sterile; placement/removal wrench is user-sterilizable.

Indications for Use

Indicated for use as an accessory to depth electrodes to provide an access point through the skull and stabilize the electrode. Contraindicated for patients at risk for infection, patients where the procedure cannot be performed safely, or patients with softening of the skull or low skull bone density.

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

Anchor Bolt (K181544)

Related Devices

K181544 — Anchor Bolt (as an accessory to Depth Electrodes) · Ad-Tech Medical Instrument Corporation · Aug 9, 2018
K970418 — PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) · Pmt Corp. · Apr 29, 1997
K032337 — HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 · Hemedex Incorporated · Oct 21, 2003
K992591 — CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS · Codman & Shurtleff, Inc. · Oct 15, 1999
K233703 — Bone Anchor (NGS-BA-01) · ClearPoint Neuro, Inc. · Apr 26, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is the Department of Health & Human Services logo. The FDA acronym is in a blue square, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text to the right of the square. May 18, 2023 Ad-Tech Medical Instrument Corporation % Linford Leitch Regulatory Consultant NAMSA Medical Research Organization 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426 Re: K223276 Trade/Device Name: Anchor Bolts as Accessories to Depth Electrodes Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: April 17, 2023 Received: April 18, 2023 Dear Linford Leitch: 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 {1}------------------------------------------------ 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 (QS) 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, # 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223276 Device Name Anchor Bolts as Accessories to Depth Electrodes Indications for Use (Describe) The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 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." {3}------------------------------------------------ #### 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: Linford Leitch 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: GZL Regulation Medical Specialty: 510(k) Review Panel: Anchor Bolts Electrode, Depth 21 CFR Anchor Bolt (Accessory to Depth Electrode) Class II Neurology Neurology {4}------------------------------------------------ #### Predicate Device f. The Anchor Bolt is substantially equivalent to: | 510(k) Number: | K181544 | |-------------------------------|--------------------------------------------| | Device Name: | Anchor Bolt | | Applicant: | Ad-Tech Medical Instrument Corporation | | Device Classification Name: | Electrode, Depth | | Regulation Number: | 21 CFR 882.1330 | | Common Name: | Anchor Bolt (Accessory to Depth Electrode) | | Device Class: | Class II | | Classification Product Code: | GZL | | Regulation Medical Specialty: | Neurology | | 510(k) Review Panel: | Neurology | ## g. Device Description The device under review is a family of Anchor Bolts. Anchor Bolts are optional accessories to Depth Electrodes. These Anchor Bolts provide an optional access point through the skull and stabilization support for Depth Electrodes. - h. Intended Use / Indications for Use The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes. - i. Statement of Substantial Equivalence Table 1: Comparison Anchor Bolts - Features of the Anchor Bolts are detailed below: - j. Comparison Table Table 1: Comparison Anchor Bolts | Feature | Anchor Bolts (Under Review) | Anchor Bolts K181544 | Comment | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Indications for Use | The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes. | The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes. | Same | | Clinical Application | Threaded into a pre-drilled hole in the skull. | Threaded into a pre-drilled hole in the skull. | Same | | Duration of use | < 30 days | < 30 days | | {5}------------------------------------------------ | Feature | Anchor Bolts (Under Review) | Anchor Bolts K181544 | Comment | |------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Contraindications | Anchor Bolts should not be used on any patient whom the physician/ surgeon considers at risk for infection or on whom the use cannot be performed safely. The Anchor Bolt should not be used with patients that have softening of the skull or low skull bone density. | Anchor Bolts should not be used on any patient whom the physician/ surgeon considers at risk for infection or on whom the use cannot be performed safely. The Anchor Bolt should not be used with patients that have softening of the skull or low skull bone density. | Same | | Anchor Bolt Single patient use, Disposable Provided Sterile | Yes (Anchor Bolts provided sterile, optional for Placement/Removal Wrench ) | Yes (Anchor Bolts provided sterile, optional for Placement/Removal Wrench) | Same | | User Sterilizable | Yes (Placement/Removal Wrench only) | Yes (Placement/Removal Wrench only) | Same | | Environment of Use | Intraoperative and Neurological monitoring locations | Intraoperative and Neurological monitoring locations | Same | | Duration of Use | < 30 days | < 30 days | Same | | Patient contact material | TitaniumSilicone (inner lumen gasket) Parylene | TitaniumSilicone (inner lumen gasket) Parylene | Same | | Length | 13 mm to 26 mm | 13 mm to 26 mm | Same | | Compatible Depth Electrode Body Diameter | 0.86 mm to 1.3 mm | 0.86 mm to 1.3 mm | Same | | Depth Electrode Retention Force | > 100 grams | > 100 grams | Same | | Placement / Removal Wrench | Yes | Yes | Same | | MR Labeling | MR Conditional | Safety in MRI Not Evaluated | Substantially Equivalent | | MR Labeling does not raise any questions of the safety and effectiveness of the device because performance | | | | testing was completed to evaluate MR conditional parameters. The Anchor Bolts labeling has been updated with MR Conditional use information. ## k. Performance Data Ad-Tech, in conjunction with University of Houston, has conducted performance evaluations of the Anchor Bolts to address hazards in the MR environment. As per the Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, issued May 20, 2021, for passive devices, evaluations were conducted for image artifact, magnetically induced displacement force, magnetically induced torque and RF induced heating. Results of the testing allow the device to be labeled MR Conditional and the results summaries follow. {6}------------------------------------------------ | Hazard Addressed | Test Method Used | Acceptance Criterion | Medical Device Configuration Tested | Summary of Test Results and pass/fail if Appropriate | |--------------------------------------------|--------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | Image Artifact | ASTM F2119-13 | No Criteria, Descriptive Statement | Device with the maximum mass/linear length | Adoption from 3.0T tests since 3.0T is the worst-case. | | Magnetically Induced displacement force | ASTM F2052-15 | <45° deflection | The device with maximum mass | Adoption from 3.0T tests since 3.0T is the worst-case. | | Magnetically Induced Torque | ASTM F2213-17, Low friction surface method | <45° rotation | The device with maximum mass | Adoption from 3.0T tests since 3.0T is the worst-case. | | RF Induced Heating | ASTM F2182-19e2 | <6°C | Based on the ISO10974 methodology and devices with different lengths, different electrode designs, and different insertion depths were studied. | Under the condition defined in the labeling, the MR induced heating will be less than <6°C | Table 2: 1.5T Test Result Summary ## Table 3: 3.0T Test Result Summary | Hazard Addressed | Test Method Used | Acceptance Criterion | Medical Device Configuration Tested | Summary of Test Results and pass/fail if Appropriate | |--------------------------------------------|--------------------------------------------------|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Image artifact | ASTM F2119-13 | No Criteria, Descriptive Statement | Device with the maximum mass/linear length | Image distortion of 19 mm from the edge of the device | | Magnetically Induced Displacement Force | ASTM F2052-15 | <45° deflection | The device with maximum mass | pass | | Magnetically Induced Torque | ASTM F2213-17, Low friction surface method | <45° rotation | The device with maximum mass | pass | | RF Induced Heating | ASTM F2182-19e2 | <6°C | Based on the ISO10974 methodology and devices with different lengths, different electrode designs, and different insertion depths were studied | Under the condition defined in the labeling, the MR induced heating will be less than <6°C | #### l. Conclusion The Anchor Bolts meet performance requirements equivalent to the predicate device. The intended use and technology of the Anchor Bolts are the same as the predicate device.