Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and function of drill bits and accessories, with no mention of AI or ML capabilities.

Therapeutic

No.

The device is a surgical tool used to create access to the brain, not to treat a disease or condition itself.

Diagnostic

No.
The device is a cranial drill and accessories, used to create holes in the skull for neurological procedures. It does not provide any diagnostic information or assessment.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a family of cranial drill bits and accessories, which are physical instruments used for drilling holes in the skull. There is no mention of software as the primary or sole component of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "drilling holes in the skull for neurological procedures." This is a surgical procedure performed directly on a patient's body.
Device Description: The description reinforces this by detailing the physical characteristics of drill bits and accessories used to create holes in the skull.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

HBE, HBG

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: 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.

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

Not Found

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)

To establish the technical equivalency of the cranial drill bits and accessories, evaluations were conducted to confirm compliance with performance requirements, including:

Drilling efficiency: Drill through simulated skull material in

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).

Summary

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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

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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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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
1901 William Street
Racine, WI 53404
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
their accessories, Product Code: HBE, Class II
21 CFR 882.4300 Manual cranial drills, burrs, trephines, and their
accessories, Product Code: HBG, Class II |
| Predicate Devices: | K062842 Twist Drills (Bits), Primary Predicate
K122456 MRI Cranial Drill
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
Accessories
(Under Review)	Twist Drills
(Primary Predicate
K062842)	MRI Cranial Drill
(Predicate K122456,
K160129)	Comment
Intended use	The Cranial Drill Bit
and Accessories are
used with drills for
creating a hole in the
skull to provide access
or placement of
accessory components.	The Twist Drill Bit and
Accessories are used
with drills for creating a
hole in bone to provide
access or placement of
hardware.	The Cranial Drill Bit and
Accessories are used
with drills for creating a
hole in the skull to
provide access.	Same
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.	The Lorenz Twist Drills
are intended to be used
for drilling holes in large
and small bone during
orthopedic, spinal,
neurosurgical, medial
sternotomy, and oral and
maxillofacial procedures.	The MRII Cranial Drill
and accessories is
intended to provide
access through the skull
for ventriculostomy or
other neurological
procedures, such as
biopsy or catheter
placement, in or near an
MR scanner of 3T
maximum field strength.
The MRI Cranial Drill
and accessories are
intended to be used only
when the scanner is not
performing a scan. The
MRII Cranial Drill is
intended for single use
only.	The drill bits
create an
access hole in
the skull to
support
neurological
procedures.
Cranial drill
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
Bit	Yes	Yes	Yes	Equivalent
Accessories	Drill Stop
Drill Stop Wrench
Drill Sleeve Guide
Guide Block	Drill Sleeve Guide	Lancet
Depth Stop, Guard
(Drill Stop)
Ruler	The
accessories
are optional
and may be
used to
support
stereotactic
use of the
cranial drill
bit.
Provided
Sterile	Yes
(Option: Drill Bit, Drill
Stop, Drill Stop
Wrench)	No	Yes	Equivalent
Table 5.3-1: Substantial Equivalence Technical Characteristics
Feature	Cranial Drill Bits and
Accessories
(Under Review)	Twist Drills
(Primary Predicate
K062842)	MRI Cranial Drill
(Predicate K122456,
K160129)	Comment
Single patient
use,
Disposable	Yes
(Drill Bit, Drill Stop,
Drill Stop Wrench)	Yes	Yes	Equivalent
Reusable	Accessory Guide Block
and Sleeve Guide	No applicable	No applicable	Qualification
of user
applied
reusable
processes
Environment
of Use	Intraoperative	Intraoperative	Intraoperative	Same
Duration of
Use