(206 days)
Not Found
No
The document describes a purely mechanical device (anchor bolts) and makes no mention of AI or ML technology in its intended use, device description, or performance studies.
No
The device is an accessory (anchor bolts) used to stabilize depth electrodes and minimize CSF leakage, not directly for diagnosis or treatment.
No
Explanation: The device, Ad-Tech Anchor Bolts, is described as an accessory for stabilizing Depth Electrodes and providing an access point through the skull. Its function is structural and supportive, not for collecting or analyzing data to diagnose a condition.
No
The device description clearly states it is a family of "Anchor Bolts," which are physical accessories secured in the skull. The performance studies also focus on physical properties like MR safety, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is an accessory for Depth Electrodes, used to stabilize them and minimize CSF leakage and infection during neurological procedures. This is a surgical/implantable device used in vivo (within the body).
- Device Description: The description reinforces that it's an accessory providing an access point and stabilization for Depth Electrodes, again indicating an in vivo application.
- Anatomical Site: The device is secured in the "skull," which is part of the human body.
- Intended User/Care Setting: "Intraoperative and Neurological monitoring locations" are settings where surgical and neurological procedures are performed on patients.
In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device does not fit that description.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
GZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intraoperative and Neurological monitoring locations
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Summary of Test Results (1.5T):
- Image Artifact: ASTM F2119-13, no criteria, descriptive statement, adoption from 3.0T tests since 3.0T is the worst-case.
- Magnetically Induced displacement force: ASTM F2052-15,
§ 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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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
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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)
| ☑ 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: 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
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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 | 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.
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| 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 |