Cranial Drill Bits and Accessories
Device Facts
| Record ID | K170442 |
|---|---|
| Device Name | Cranial Drill Bits and Accessories |
| Applicant | Ad-Tech Medical Instrument Corporation |
| Product Code | HBE · Neurology |
| Decision Date | Sep 7, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4310 |
| Device Class | Class 2 |
Indications for Use
The Cranial Drill Bits and accessories are intended to be used for the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement.
Device Story
Cranial drill bits and accessories create access holes in the skull for neurological procedures; used for brain biopsy, electrode placement, and accessory device placement. System includes twist drill bits (16-30 cm length, 2.4-3.2 mm diameter), drill stops, drill stop wrenches, drill sleeve guides, and guide blocks. Used intraoperatively by surgeons; drill sleeve guides and guide blocks interface with stereotactic frames to minimize bit wobble and ensure precise placement. Device provides mechanical access; does not involve electronic processing or AI. Benefits include precise, controlled skull penetration for neurosurgical access.
Clinical Evidence
Bench testing only. Evaluations confirmed drilling efficiency (drilling through simulated skull in < 1 minute), drill bit run-out (wobble) performance with and without guide accessories, and mechanical compatibility with stereotactic frames. All tests passed.
Technological Characteristics
Materials: Stainless steel. Principle: Mechanical drilling. Dimensions: 16-30 cm length, 2.4-3.2 mm diameter. Connectivity: None (mechanical). Sterilization: Ethylene Oxide (for sterile-supplied components). Components: Drill bits, drill stops, wrenches, sleeve guides, guide blocks.
Indications for Use
Indicated for patients undergoing neurological procedures requiring skull access, including brain biopsy, brain contacting electrode placement, and electrode accessory device placement.
Regulatory Classification
Identification
Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
Predicate Devices
Submission Summary (Full Text)
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2017
Ad-tech Medical Instrument Corporation % Gary Syring Principal Consultant Ouality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K170442
Trade/Device Name: Cranial Drill Bits and Accessories Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories Regulatory Class: Class II Product Code: HBE, HBG Dated: August 7, 2017 Received: August 10, 2017
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
# Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K170442
Device Name Cranial Drill Bits and Accessories
Indications for Use (Describe)
The Cranial Drill Bits and accessories are intended to be used for the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement.
Type of Use (Select one or both, as applicable)
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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#### 510(k) Summary - K170442 5.0
This summary is provided to support the 510(k) pre-market notification for the Cranial Drill Bits and accessories.
| Company Name: | Ad-Tech Medical Instrument Corporation<br>1901 William Street<br>Racine, WI 53404<br>Phone: (262) 634-1555 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Lisa Theama, Chief Operating Officer |
| Date Summary Prepared: | August 3, 2017 |
| Trade Name: | Cranial Drill Bits and Accessories |
| Common Name: | Cranial Drill Bits |
| Classification Name: | 21 CFR 882.4310 Powered simple cranial drills, burrs, trephines, and<br>their accessories, Product Code: HBE, Class II<br>21 CFR 882.4300 Manual cranial drills, burrs, trephines, and their<br>accessories, Product Code: HBG, Class II |
| Predicate Devices: | K062842 Twist Drills (Bits), Primary Predicate<br>K122456 MRI Cranial Drill<br>K160129 MRII Cranial Drill and Accessories |
#### 5.1 Product Description
The device under review is a family of cranial drill bits and accessories. These cranial drill bits and accessories are applied to create a hole through the skull in support of neurological procedures.
Cranial drill bits are twist drill bits used for drilling holes in the skull, supporting access to the brain for brain biopsy, brain contacting electrode placement, electrode accessory placement such as Anchor Bolts or other needs as determined by the user. The cranial drill bit variations are 16 cm to 30 cm length and 2.4 mm to 3.2 mm outer diameter.
Accessories to the cranial drill bits include:
- Drill Stop: A collar placed on the outer diameter of the drill bit to provide a depth placement ● indicator.
- Drill Stop Wrench: The Drill Stop Wrench attaches the Drill Stop to the cranial drill bit.
- . Drill Sleeve Guide: The Drill Sleeve Guide is an optional accessory, consisting of a hollow tube of stainless steel that the cranial drill bit passes through to minimize the wobble of the drill bit as it is passed to the skull. The Drill Sleeve Guide is placed within a stereotactic frame.
- . Guide Block: A Guide Block is an optional accessory that adapts to a stereotactic frame to hold the Drill Sleeve Guide.
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#### 5.2 Indications for Use
The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement.
#### 5.3 Summary of Technological Characteristics
The following table provides a side-by-side comparison the Cranial Drill Bits and accessories to the predicate devices applied to support this pre-market notification.
| Table 5.3-1: Substantial Equivalence Technical Characteristics | | | | |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Feature | Cranial Drill Bits and<br>Accessories<br>(Under Review) | Twist Drills<br>(Primary Predicate<br>K062842) | MRI Cranial Drill<br>(Predicate K122456,<br>K160129) | Comment |
| Intended use | The Cranial Drill Bit<br>and Accessories are<br>used with drills for<br>creating a hole in the<br>skull to provide access<br>or placement of<br>accessory components. | The Twist Drill Bit and<br>Accessories are used<br>with drills for creating a<br>hole in bone to provide<br>access or placement of<br>hardware. | The Cranial Drill Bit and<br>Accessories are used<br>with drills for creating a<br>hole in the skull to<br>provide access. | Same |
| Indications<br>for Use | The Cranial Drill Bits<br>and accessories are<br>intended to be used for<br>drilling holes in the<br>skull for neurological<br>procedures, such as<br>brain biopsy, brain<br>contacting electrode<br>and electrode accessory<br>device placement. | The Lorenz Twist Drills<br>are intended to be used<br>for drilling holes in large<br>and small bone during<br>orthopedic, spinal,<br>neurosurgical, medial<br>sternotomy, and oral and<br>maxillofacial procedures. | The MRII Cranial Drill<br>and accessories is<br>intended to provide<br>access through the skull<br>for ventriculostomy or<br>other neurological<br>procedures, such as<br>biopsy or catheter<br>placement, in or near an<br>MR scanner of 3T<br>maximum field strength.<br>The MRI Cranial Drill<br>and accessories are<br>intended to be used only<br>when the scanner is not<br>performing a scan. The<br>MRII Cranial Drill is<br>intended for single use<br>only. | The drill bits<br>create an<br>access hole in<br>the skull to<br>support<br>neurological<br>procedures. |
| Cranial drill<br>bit diameter | 2.4 mm to 3.2 mm | 0.7 mm to 2.4 mm | 2.0 mm to 3.2 mm | Equivalent |
| Cranial Drill<br>Bit | Yes | Yes | Yes | Equivalent |
| Accessories | Drill Stop<br>Drill Stop Wrench<br>Drill Sleeve Guide<br>Guide Block | Drill Sleeve Guide | Lancet<br>Depth Stop, Guard<br>(Drill Stop)<br>Ruler | The<br>accessories<br>are optional<br>and may be<br>used to<br>support<br>stereotactic<br>use of the<br>cranial drill<br>bit. |
| Provided<br>Sterile | Yes<br>(Option: Drill Bit, Drill<br>Stop, Drill Stop<br>Wrench) | No | Yes | Equivalent |
| Table 5.3-1: Substantial Equivalence Technical Characteristics | | | | |
| Feature | Cranial Drill Bits and<br>Accessories<br>(Under Review) | Twist Drills<br>(Primary Predicate<br>K062842) | MRI Cranial Drill<br>(Predicate K122456,<br>K160129) | Comment |
| Single patient<br>use,<br>Disposable | Yes<br>(Drill Bit, Drill Stop,<br>Drill Stop Wrench) | Yes | Yes | Equivalent |
| Reusable | Accessory Guide Block<br>and Sleeve Guide | No applicable | No applicable | Qualification<br>of user<br>applied<br>reusable<br>processes |
| Environment<br>of Use | Intraoperative | Intraoperative | Intraoperative | Same |
| Duration of<br>Use | < 1 Minute | < 1 Minutes | < 1 Minutes | Same |
| Patient<br>contact<br>material | Stainless Steel | Stainless Steel | Stainless Steel | Same |
| Drill<br>Diameters | 2.4 mm to 3.2 mm | 0.7 mm to 2.4 mm | 2.0 mm to 3.2 mm,<br>3.2mm to 6.0 mm | Equivalent |
| Sterilization<br>Method<br>(when<br>supplied<br>sterile) | Ethylene Oxide process | Not applicable,<br>Not supplied sterile | Ethylene Oxide process | Same |
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#### 5.4 Performance Tests to Demonstrate Substantial Equivalency
To establish the technical equivalency of the cranial drill bits and accessories, evaluations were conducted to confirm compliance with performance requirements, including:
| Test | Summary of Requirement | Result |
|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------|
| Drilling efficiency | Drill through simulated skull material in < 1 min. | Pass |
| Drill bit run-out ("wobble")<br>Test with Guide Block, Drill<br>Sleeve Guide and Drill Stop. | Comparison of drilled hole diameter to the desired<br>hole size. | Pass |
| Drill bit run-out ("wobble")<br>Test with out Guide Block, Drill<br>Sleeve Guide and Drill Stop. | Comparison of drilled hole diameter to the desired<br>hole size. | Pass |
| Mechanical compatibility | Guide Block compatible with stereotactic frame | Pass |
#### ર્ રંડ Conclusion
The cranial drill bits and accessories meet performance requirements equivalent to the predicates. The intended use and technology of the cranial drill bits and accessories are the same as the predicate devices.
