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.

Device 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, Drill Stop Wrench, Drill Sleeve Guide, Guide Block.

AI/ML Overview

The provided document is a 510(k) summary for Ad-Tech Medical Instrument Corporation's Cranial Drill Bits and Accessories. It outlines the device's indications for use, technological characteristics, and performance tests for demonstrating substantial equivalence to predicate devices. This document does not pertain to an AI/ML powered medical device, an autonomous AI device, or other medical device software. Therefore, the questions regarding acceptance criteria and studies for AI-powered devices are not applicable.

Here's an analysis of the provided information, addressing the closest relevant aspects:

Acceptance Criteria and Device Performance for (Non-AI) Cranial Drill Bits and Accessories

The acceptance criteria are not explicitly titled as "acceptance criteria" but are embedded within the "Summary of Requirement" for the performance tests conducted. The device performance is reported as "Pass" for all listed tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Summary of Requirement)	Reported Device Performance
Drill through simulated skull material in < 1 min.	Pass
Comparison of drilled hole diameter to the desired hole size (with Guide Block, Drill Sleeve Guide and Drill Stop).	Pass
Comparison of drilled hole diameter to the desired hole size (without Guide Block, Drill Sleeve Guide and Drill Stop).	Pass
Guide Block compatible with stereotactic frame.	Pass

2. Sample size and data provenance for the test set

The document does not specify the sample size used for the tests or the provenance of any data (e.g., country of origin, retrospective/prospective). It only mentions "simulated skull material" for the drilling efficiency test.

3. Number of experts and qualifications for ground truth establishment

This information is not available in the provided document. As this device is mechanical and not an AI/ML product, expert review in this context would likely be related to design validation and usability, not establishing ground truth for algorithmic performance.

4. Adjudication method for the test set

This information is not available in the provided document. Given the nature of the device (mechanical drill bits), typical adjudication methods like 2+1 or 3+1 used for diagnostic AI are not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study results

A multi-reader multi-case (MRMC) comparative effectiveness study was not done as this is a mechanical device, not an AI-powered device intended for diagnostic or assistive interpretation by human readers. Therefore, there is no effect size of human readers improving with AI assistance to report.

6. Standalone (algorithm only without human-in-the-loop performance) study results

A standalone performance study was not done because this is a mechanical device and does not involve an algorithm.

7. Type of ground truth used

The ground truth used for these performance tests appear to be based on engineering specifications and measurable physical properties rather than clinical outcomes, expert consensus, or pathological diagnoses. For example, "drilling through simulated skull material in < 1 min" uses a timing measurement against a specified material, and "comparison of drilled hole diameter to the desired hole size" relies on a direct physical measurement against a设计 specification.

8. Sample size for the training set

This information is not applicable as this is a mechanical device and does not involve a training set for an AI/ML algorithm.

9. How the ground truth for the training set was established

This information is not applicable as this is a mechanical device and does not involve a training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three faces in profile, connected by flowing lines.

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

{1}------------------------------------------------

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

{2}------------------------------------------------

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)

☑ 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}------------------------------------------------

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 Corporation1901 William StreetRacine, WI 53404Phone: (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, andtheir accessories, Product Code: HBE, Class II21 CFR 882.4300 Manual cranial drills, burrs, trephines, and theiraccessories, Product Code: HBG, Class II
Predicate Devices:	K062842 Twist Drills (Bits), Primary PredicateK122456 MRI Cranial DrillK160129 MRII Cranial Drill and Accessories

5.1 Product Description

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.

{4}------------------------------------------------

5.2 Indications for Use

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 andAccessories(Under Review)	Twist Drills(Primary PredicateK062842)	MRI Cranial Drill(Predicate K122456,K160129)	Comment
Intended use	The Cranial Drill Bitand Accessories areused with drills forcreating a hole in theskull to provide accessor placement ofaccessory components.	The Twist Drill Bit andAccessories are usedwith drills for creating ahole in bone to provideaccess or placement ofhardware.	The Cranial Drill Bit andAccessories are usedwith drills for creating ahole in the skull toprovide access.	Same
Indicationsfor Use	The Cranial Drill Bitsand accessories areintended to be used fordrilling holes in theskull for neurologicalprocedures, such asbrain biopsy, braincontacting electrodeand electrode accessorydevice placement.	The Lorenz Twist Drillsare intended to be usedfor drilling holes in largeand small bone duringorthopedic, spinal,neurosurgical, medialsternotomy, and oral andmaxillofacial procedures.	The MRII Cranial Drilland accessories isintended to provideaccess through the skullfor ventriculostomy orother neurologicalprocedures, such asbiopsy or catheterplacement, in or near anMR scanner of 3Tmaximum field strength.The MRI Cranial Drilland accessories areintended to be used onlywhen the scanner is notperforming a scan. TheMRII Cranial Drill isintended for single useonly.	The drill bitscreate anaccess hole inthe skull tosupportneurologicalprocedures.
Cranial drillbit diameter	2.4 mm to 3.2 mm	0.7 mm to 2.4 mm	2.0 mm to 3.2 mm	Equivalent
Cranial DrillBit	Yes	Yes	Yes	Equivalent
Accessories	Drill StopDrill Stop WrenchDrill Sleeve GuideGuide Block	Drill Sleeve Guide	LancetDepth Stop, Guard(Drill Stop)Ruler	Theaccessoriesare optionaland may beused tosupportstereotacticuse of thecranial drillbit.
ProvidedSterile	Yes(Option: Drill Bit, DrillStop, Drill StopWrench)	No	Yes	Equivalent
Table 5.3-1: Substantial Equivalence Technical Characteristics
Feature	Cranial Drill Bits andAccessories(Under Review)	Twist Drills(Primary PredicateK062842)	MRI Cranial Drill(Predicate K122456,K160129)	Comment
Single patientuse,Disposable	Yes(Drill Bit, Drill Stop,Drill Stop Wrench)	Yes	Yes	Equivalent
Reusable	Accessory Guide Blockand Sleeve Guide	No applicable	No applicable	Qualificationof userappliedreusableprocesses
Environmentof Use	Intraoperative	Intraoperative	Intraoperative	Same
Duration ofUse	< 1 Minute	< 1 Minutes	< 1 Minutes	Same
Patientcontactmaterial	Stainless Steel	Stainless Steel	Stainless Steel	Same
DrillDiameters	2.4 mm to 3.2 mm	0.7 mm to 2.4 mm	2.0 mm to 3.2 mm,3.2mm to 6.0 mm	Equivalent
SterilizationMethod(whensuppliedsterile)	Ethylene Oxide process	Not applicable,Not supplied sterile	Ethylene Oxide process	Same

{5}------------------------------------------------

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")Test with Guide Block, DrillSleeve Guide and Drill Stop.	Comparison of drilled hole diameter to the desiredhole size.	Pass
Drill bit run-out ("wobble")Test with out Guide Block, DrillSleeve Guide and Drill Stop.	Comparison of drilled hole diameter to the desiredhole 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.

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
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.(b)
Classification. Class II (performance standards).