(58 days)
Not Found
No
The 510(k) summary describes a mechanical accessory (anchor bolts) for depth electrodes and does not mention any AI or ML components or functionalities.
No
The device is described as an accessory for depth electrodes, used to stabilize the electrode and minimize CSF leakage and infection. Its primary function is structural support and sealing, not directly treating a disease or condition.
No
Explanation: The Ad-Tech Anchor Bolts are accessories used to stabilize Depth Electrodes and minimize CSF leakage. Their function is structural and supportive, not to gather information about a patient's health status or condition, which is the primary characteristic of a diagnostic device.
No
The device description and performance studies clearly indicate this is a physical medical device (Anchor Bolts) used in surgical procedures, not a software-only device.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Ad-Tech Anchor Bolts are described as accessories for Depth Electrodes. Their function is to provide an access point through the skull and stabilize the electrode. They are physically implanted into the skull.
- Lack of Biological Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. Its purpose is structural support and access, not diagnostic testing of bodily fluids or tissues.
Therefore, the Ad-Tech Anchor Bolts fall under the category of a surgical accessory or implantable device, not an in vitro diagnostic.
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. Anchor Bolts are selected and applied by a physician knowledgeable in their use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Non-clinical performance tests were conducted to demonstrate substantial equivalency. These included:
- Torque required to insert to pre-drilled skull hole: Verified the torque required to insert the Anchor Bolt into a pre-drilled hole in 40 pcf polyurethane foam (simulated skull bone) with the Placement/Removal Wrench. N=10 samples. Result: Pass, all results 48 lbf.
- Axial tension to pull Depth Electrode from the Anchor Bolt: Measured the axial tension to pull a Depth Electrode from the Anchor Bolt. N=10 samples. Result: Pass, all results > 140 grams.
- Anchor Bolt gasket resist CSF leakage: Inserted a Depth Electrode into the Anchor Bolt secured in 40 pcf polyurethane foam and applied hydrostatic pressure of 15 mmHg for 24 hours. N=22 samples. Result: Pass, no leaks observed after 24 hours.
- Sterility: Evaluated terminal ethylene oxide sterilization cycle per ANSI/AAMI/ISO 11135-1:2007 half-cycle method. Result: Pass (SAL
§ 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).
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: on the left, there is a symbol representing the Department of Health & Human Services-USA, which features a stylized depiction of human profiles. To the right of this symbol, there is the FDA logo, which includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. The text is arranged in two lines, with 'U.S. FOOD & DRUG' on the top line and 'ADMINISTRATION' on the bottom line.
August 9, 2018
Ad-Tech Medical Instrument Corporation Gary Syring Principal Consultant Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K181544
Trade/Device Name: Anchor bolt (as an accessory to Depth Electrodes) Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: June 8, 2018 Received: June 12, 2018
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. 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181544
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) |
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
5.0 510(k) Summary
This summary is provided to support the 510(k) pre-market notification for the Anchor Bolts, as accessories to Depth Electrodes.
| Company Name: | Ad-Tech Medical Instrument Corporation
400 West Oakview Parkway
Oak Creek, WI 53154
Phone: (262) 634-1555 |
|------------------------|--------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Lisa Theama, Chief Operating Officer |
| Date Summary Prepared: | June 8, 2018 |
| Trade Name: | Anchor Bolts |
| Common Name: | Anchor Bolt (Accessory to Depth Electrodes) |
| Classification Name: | Depth Electrode
21 CFR 882.1330
Product Code: GZL
Class II |
| Predicate Device: | K970418 Anchor Bolt, Accessory Depthalon® Depth Electrode
PMT Corporation |
Product Description 5.1
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.
5.2 Intended Use of the Device
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.
5.3 Summary of Technological Characteristics
The following table provides a side-by-side comparison of the Anchor Bolts to the predicate device applied to support this pre-market notification.
4
| Table 5.3-1: Substantial Equivalence Technical Characteristics | |||
|---|---|---|---|
| Feature | Anchor Bolts | ||
| (Under Review) | Anchor Bolt, Accessory | ||
| Depthalon® Depth Electrode | |||
| (Predicate K970418) | 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 PMT depth electrode anchor | ||
| bolt is an accessory used in cases | |||
| where it is necessary to minimize | |||
| concerns about potential | |||
| cerebrospinal fluid leakage and | |||
| infection of the subdural space will | |||
| stabilizing the electrode during | |||
| intraoperative electro clinical | |||
| characterization. The PMT depth | |||
| electrode anchor bolts rest on the | |||
| skull with the insertion of the | |||
| anchor bolt tapered screw threads | |||
| into a predrilled burr hole through | |||
| a skin incision. | Same. | ||
| Both Anchor Bolts | |||
| are applied to a | |||
| pre-drilled hole in | |||
| the skull. The | |||
| Anchor Bolts | |||
| support Depth | |||
| Electrode | |||
| placement. | |||
| 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 | Unknown | Given the unique |
| design of Anchor | |||
| Bolts it is very | |||
| likely that the | |||
| predicate device | |||
| requires a | |||
| placement and | |||
| removal tool. Hand | |||
| tightening an | |||
| Anchor Bolt into a | |||
| pre-drilled skull | |||
| hole is not | |||
| probable. | |||
| The length of the | |||
| Anchor Bolt is | |||
| based upon need | |||
| and user | |||
| preferences. |
5
5.4 Non-clinical Performance Tests to Demonstrate Substantial Equivalency
To establish the technical equivalency of the Anchor Bolts, evaluations were conducted to confirm compliance with performance requirements, including:
| Test | Test Method Summary | Result |
|---|---|---|
| Torque required to insert | ||
| to pre-drilled skull hole. | With a torque wrench, verify the torque required to insert | |
| the Anchor Bolt into pre-drilled hole in 40 pcf polyurethane | ||
| foam (simulated skull bone) with the Placement/Removal | ||
| Wrench is ≤ 8 in-lbs. (N=10 samples). | Pass | |
| All results ≤ | ||
| 1 in-lbs. | ||
| Axial tension to pull | ||
| Anchor Bolt out of pre- | ||
| drilled skull hole. | With a tensile tester, measure the axial tension to pull the | |
| Anchor Bolt out of a pre-drilled hole in 40 pcf polyurethane | ||
| foam is ≥ 40 lbf. (N=10 samples) | Pass | |
| All results |
48 lbf. |
| Axial tension to pull
Depth Electrode from the
Anchor Bolt. | With a tensile tester, measure the axial tension to pull a
Depth Electrode from the Anchor Bolt, ≥ 100 grams. (N=10
samples). | Pass
All results
140
grams. |
| Anchor Bolt gasket resist
CSF leakage. | Insert Depth Electrode into the Anchor Bolt secured in 40
pcf polyurethane foam. Apply a metal tube with a diameter
larger than the Depth Electrode and Anchor Bolt body,
around both. Seal the metal tube to the polyurethane foam.
Fill the metal tube with water to a hydrostatic pressure of | Pass
No leaks
observed |
| Test | Test Method Summary | Result |
| | 15 mmHg. Verify no leakage at the Depth Electrode,
Anchor Bolt after 24 hours. (N=22 samples) | after 24
hours. |
| Sterility | Anchor Bolts and Placement/Removal Wrenches are
terminally ethylene oxide sterilized devices by a validated
EtO sterilization cycle, per ANSI/AAMI/ISO 11135-1:2007
half-cycle method. The sterility assurance level (SAL) is ≤
SAL of 10-6. | Pass |
| Sterile barrier integrity | The sterile barrier package is a double Tyvek pouch. The
methods applied to evaluate the Tyvek sterile barrier
package integrity included post terminal sterilization:
simulated distribution, seal peel and bubble emission
testing. | Pass |
| Anchor Bolt silicone
gasket shelf life | The ability of real time aged Anchor Bolts with Silicone
Gaskets to meet Depth Electrode retention requirements
and minimize cerebrospinal fluid (CSF) leakage were
evaluated to the methods above for Axial tension to pull
Depth Electrode from the Anchor Bolt and Anchor Bolt
gasket resist CSF leakage. | Pass
The same
acceptance
criteria were
met. |
| Biocompatibility | The following test methods were applied to final finished
form Anchor Bolts (patient contacting materials), with
passing results:
Cytotoxicity: L929 MEM Elution Test – ISO Sensitization: Kligman Maximization Test - ISO Intracutaneous Reactivity: Intracutaneous Injection Test - ISO Acute Systemic Toxicity: 28-Day Systemic Toxicity in Rabbits via Subcutaneous Implantation Material-Mediated Pyrogenicity: Rabbit Pyrogen Test (Material Mediated) - ISO Genotoxicity: Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay - ISO and Mouse Lymphoma Mutagenesis Assay - ISO Hemocompatibility: Rabbit Blood Hemolysis Test (Indirect Contact) – ASTM Neurotoxicity by: SK-N-MC MEM Elution Test. Subacute / Subchronic Toxicity: Systemic Injection Test - ISO Implantation: Neurological (Brain) Implantation Test - ISO. | Pass |
6
5.5 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.