The Dental Bone Cutting Instruments are nonpowered hand-held for trauma, reconstruction, or orthognathic procedures to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw.

Device Description

Dental bone cutting instruments are taps and countersinks. Countersinks are used to create a countersink feature in bone to provide a contact surface for screw heads and to reduce the palpability of the screw head. Taps are used to create threads in a pre-drilled hole in order to accommodate a bone screw. The taps and countersinks are manufactured from Stainless Steel 440A in accordance with ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments as well as ASTM A276 Specification for Stainless Steel Bars and Shapes.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dental Bone Cutting Instruments:

This document is a 510(k) premarket notification for a medical device (Dental Bone Cutting Instruments). A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "device performance" in the context of this 510(k) submission is primarily focused on demonstrating substantial equivalence to a predicate device. The performance data provided is mechanical testing, indicating that the new device performs comparably to the predicate.

Acceptance Criteria Category	Specific Criteria (Inferred from testing)	Reported Device Performance and Evidence
Mechanical Performance	`Tolerance Analysis` (Comparability to predicate)	`Tolerance Analysis` conducted. Performance deemed `comparable to that of the primary predicate device`.
	`Torque and Torsional Testing` (Comparability to predicate)	`Torque and Torsional Testing` conducted. Performance deemed `comparable to that of the primary predicate device`.
	`Reliability Analysis` (Comparability to predicate)	`Reliability Analysis` conducted. Performance deemed `comparable to that of the primary predicate device`.
Safety and Effectiveness	No new questions of safety and effectiveness compared to predicate.	Mechanical testing demonstrates `any differences in technological characteristics... do not raise any new questions of safety and effectiveness`.
	At least as safe and effective as the primary predicate.	`The proposed devices are at least as safe and effective as the primary predicate.`

Study Details:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified in the document. The testing performed was "Mechanical Testing" (Tolerance Analysis, Torque and Torsional Testing, Reliability Analysis) which likely involved specific device samples for these tests, but the exact number isn't mentioned.
- Data Provenance: The testing was conducted by or for Synthes (USA) Products, LLC. The location of the testing laboratories or the origin of the materials used in the testing is not specified. It is an internal company study for regulatory submission.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This type of information is not applicable to this submission. The "ground truth" for mechanical testing is typically established through engineering specifications, material standards (e.g., ASTM F899, ASTM A276), and comparison to the predicate device's known performance, rather than expert consensus on interpretive data like images.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies where multiple experts interpret data (e.g., medical images) to establish a consensus ground truth. This submission relies on objective mechanical engineering tests.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual bone cutting instrument, not an AI algorithm. Therefore, "standalone algorithm" performance is irrelevant.
The Type of Ground Truth Used:
- For the mechanical testing, the "ground truth" would be the engineering specifications, material properties (e.g., as defined by ASTM standards), and the performance characteristics of the legally marketed primary predicate device (Synthes 90° Screwdriver K082649). The goal was to demonstrate that the subject device's mechanical performance was comparable within acceptable engineering tolerances.
Sample Size for the Training Set:
- Not applicable. This device is a physical instrument, not a learning algorithm or AI. There is no concept of a "training set" in this context.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the reason stated above.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2015

Synthes (USA) Products, LLC Ms. Susan Lewandowski Project Leader, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K150796

Trade/Device Name: Dental Bone Cutting Instruments Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZJ Dated: March 25, 2015 Received: March 26, 2015

Dear Ms. Lewandowski:

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.

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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 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 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 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 yours,

Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K150796

Device Name Dental Bone Cutting Instruments

Indications for Use (Describe)

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

Date Prepared:	June 23, 2015
Submitter:	Synthes USA Products, LLC1301 Goshen ParkwayWest Chester, PA 19380United States of America
Contact:	Susan LewandowskiLewandowskis@synthes.comTelephone 610-719-5852Facsimile 484-356-9682
DEVICE

Device Name:	Dental Bone Cutting Instruments
Classification Name:	Bone cutting instruments and accessories
Regulatory Class:	II
Product code:	DZJ (Driver, Wire, and Bone Drill Manual)21 CFR 872.4120

PREDICATE DEVICE

Synthes 90° Screwdriver K082649 is the primary predicate.

Medtronic Sofamor Danek POWEREASE System K123270 is used as a reference device in support of this submission.

DEVICE DESCRIPTION

INDICATIONS FOR USE

Dental Bone Cutting Instruments

Dental bone cutting instruments are nonpowered hand-held devices intended for trauma, reconstruction, or orthognathic procedures to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw.

Synthes 90° Screwdriver

The Synthes 90° Screwdriver is indicated for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery.

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Both the dental bone cutting instruments and the primary predicate Synthes 90° Screwdriver K082649 are indicated for use in oral/maxillofacial surgery to drill or cut into the upper or lower jaw; both have product code DZJ. Additionally, the dental bone cutting instruments defined herein as Class II product code DZJ are the same instruments currently marketed by Synthes as Class I product code LXH (Orthopedic manual surgical instruments). The same instruments have two intended uses.

The reference device Medtronic Sofamor Danek POWEREASE System K123270 does not have the same intended use as the dental bone cutting instruments as the POWEREASE system is used during spinal surgery. The reference system is intended for "drilling, tapping and driving screws" and includes instruments such as taps, drill bits, screwdrivers, etc. The product code is HBE (Drills, Burrs, Trephines and Accessories simple, powered). The reference device is included to show that taps have been cleared within premarket notification submissions.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

Primary Predicate

Both the dental bone cutting instruments and the primary predicate Synthes 90° Screwdriver K082649 are indicated for use in oral/maxillofacial surgery to drill or cut into the upper or lower jaw. Additionally, the dental bone cutting instruments defined herein as Class II product code DZJ are the same instruments currently marketed by Synthes as Class I product code LXH. The same instruments have two intended uses.

Technological Similarities of Dental Bone Cutting Instruments to Primary Predicate

Both instruments are intended to be used for predrilling a hole in preparation for a . bone screw to be placed in the upper or lower jaw
Both can be operated manually ●
Both are manufactured from stainless steel

Technological Differences of Dental Bone Cutting Instruments to Primary Predicate

The 90° Screwdriver is used to drive or insert screws as well as to cut bone; the ● tap is only used to cut threads into bone to receive a bone screw and the countersink is only used to create a countersink feature in bone to reduce palpability of the screw head
The 90° Screwdriver can be operated manually or with power; the dental bone ● cutting instruments are manual instruments only

Reference Device

Both the dental bone cutting instruments and the reference device Medtronic Sofamor Danek POWEREASE System K123270 are generally intended to be used during surgery for the cutting into bone. The reference device is included to show that taps have been cleared within premarket notification submissions.

Technological Similarities of Dental Bone Cutting Instruments to Reference Device

Both devices are intended to be used to prepare bone for placement of a screw .

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Image /page/5/Picture/0 description: The image shows the word "SYNTHES" in bold, black font. To the left of the word is a circular logo with a design inside. To the right of the word is a small, circled "R", indicating that the word is a registered trademark.

Taps from the POWEREASE system can be operated manually like the dental bone cutting instruments
Both are manufactured from stainless steel ●

Technological Differences of Dental Bone Cutting Instruments to Reference Device

. The POWEREASE System instruments are intended for drilling, tapping and driving screws; the dental bone cutting instruments have a more limited intended use - the tap is only used to cut threads into bone to receive a bone screw and the countersink is only used to create a countersink feature in bone to reduce palpability of the screw head
The POWEREASE System instruments can be operated manually or with power; the dental bone cutting instruments are manual use only
The POWEREASE System is intended for spinal surgery (Neurology), the Dental ● Bone Cutting instruments are intended for oral/maxillofacial surgery (Dental)

SE Summary

There are technological differences between the subject device and both the predicate and reference devices. However, the technological differences do not raise different questions of safety and effectiveness, and are related to the more limited intended use and simpler operating principle of the subject device as compared to the two previously cleared devices.

PERFORMANCE DATA

Mechanical Testing

The performance data provided in support of substantial equivalence of the proposed devices are as follows:

Tolerance Analysis ●
. Torque and Torsional Testing
. Reliability Analysis

Clinical Studies

Clinical testing was not necessary for the determination of substantial equivalence.

The performance data demonstrate that the mechanical performance of the proposed dental bone cutting instruments e.g. taps and countersinks is comparable to that of the primary predicate device and supports substantial equivalence to the primary predicate device for safe and effective bone cutting in the upper and lower jaw.

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Image /page/6/Picture/0 description: The image shows the logo for SYNTHES, a medical device company. The logo consists of a stylized symbol to the left of the word "SYNTHES" in bold, uppercase letters. Below the word "SYNTHES" is the word "CONCLUSIONS" in a smaller font size.

The proposed devices have the same intended use as the primary predicate device. The mechanical testing included in this submission demonstrates that:

. Any differences in technological characteristics of the primary predicate and/or reference device do not raise any new questions of safety and effectiveness.
. The proposed devices are at least as safe and effective as the primary predicate.

It is concluded that the information included in this submission supports substantial equivalence.

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Image /page/7/Picture/0 description: The image shows the logo for Synthes, a medical device company. The logo consists of a stylized symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. A registration mark is present to the right of the word. A horizontal line is present underneath the logo.

Device Comparison Table

	DePuy Synthes Dental Bone	DePuy Synthes Bone	Synthes 90° Screwdriver	Medtronic Sofamor Danek
	Cutting Instruments, e.g.	Cutting Instruments (Class I	K082649	POWEREASE System
	Taps and Countersinks	equivalents – Product Code	(primary predicate)	K123270
	(subject devices)	LXH)		(reference device)
Indications for use	The Dental Bone CuttingInstruments are nonpoweredhand-held devices intendedfor trauma, reconstruction, ororthognathic procedures todrill or cut into the upper orlower jaw and may be used toprepare bone to insert a wire,pin, or screw.	An orthopedic manualsurgical instrument is anonpowered hand-held deviceintended for medical purposesto manipulate tissue or for usewith other devices inorthopedic surgery.	The Synthes 90° Screwdriveris indicated for the manualand powered pre-drilling andinsertion of bone fixationscrews in oral/maxillofacialsurgery.	The IPC System is indicatedfor the incision/cutting,removal, drilling and sawingof soft and hard tissue andbone, and biomaterials inNeurosurgical (Cranial,Craniofacial), Orthopedic,Arthroscopic, Spinal,Sternotomy, and Generalsurgical procedures.The IPC POWEREASESystem is indicated fordrilling, tapping and drivingscrews and working endattachments during spinalsurgery, including open andminimally invasiveprocedures. It is also used inthe placement or cutting ofscrews, posts and rods.
FDA Product Code	DZJ	LXH	DZI, DZJ	HBE, HWE, GWF
21 CFR	872.4120	888.4540	872.4120	882.4310
RegulationDescription	Bone cutting instrument andaccessories	Orthopedic manual surgicalinstruments	Bone cutting instrument andaccessories	Powered simple cranial drills,burrs, trephines, and theiraccessories
Review Panel	Dental	Orthopedic	Dental	Neurology
Device Class	2	1	2	2

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Image /page/8/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is located underneath the word. A registered trademark symbol is located to the right of the word.

	DePuy Synthes Dental BoneCutting Instruments, e.g.Taps and Countersinks(subject devices)	DePuy Synthes BoneCutting Instruments (Class Iequivalents – Product CodeLXH)	Synthes 90° ScrewdriverK082649(primary predicate)	Medtronic Sofamor DanekPOWEREASE SystemK123270(reference device)
Device Description	Countersinks are intended tocreate a countersink feature inbone to provide a contactsurface for screw heads and toreduce palpability of the bonescrew.Taps are intended to createthreads in a pre-drilled hole inorder to accomodate a bonescrew.	Countersinks are intended tocreate a countersink feature inbone to provide a contactsurface for screw heads and toreduce palpability of thescrew.Taps are intended to createthreads in a pre-drilled hole inorder to accomodate a bonescrew.	The Synthes 90° Screwdriverconsists of a screwdriverhandle, shaft, screw holder,screw holder insert and avariety of attachments such asdrill bits and screwdriverblades for manual andpowered right angled pre-drilling and insertion ofscrews.The screw holder can beturned at an angle behind thescrewdriver head forimproved visibility.	The POWEREASETMSystem Working Endsconsists of instruments such astaps, drill bits, screwdrivers,post cutter, set screw break-off tool, reduction nut driverand sleeves. The working endshave a manual alternative. Theworking ends, listed above,are compatible with the CDHORIZON SOLERA and theTSRH 3Dx Spinal Systemimplants. Of the workingends, only the taps,screwdrivers, drill bits, andsleeves are also compatiblewith Medtronic's NIM-ECLIPSE Spinal System.
Device material(s)	Stainless steel 440A	Stainless steel	Stainless Steel,Aluminum	Stainless Steel
Principles offunction/technology	Countersinks feature cuttingflutes at the working end ofthe instrument that continue adistance up the shaft of theinstrument and a centering pinat the working end of theinstrument. The user willinsert the centering pin into adrilled pilot hole, ensuring	Countersinks feature cuttingflutes at the working end ofthe instrument that continue adistance up the shaft of theinstrument and a centering pinat the working end of theinstrument. The user willinsert the centering pin into adrilled pilot hole, ensuring	The 90° Screwdriver isdesigned to transmit thetorque required for screwinsertion.The low profile head provideminimal overall height forminimally invasive pre-drilling and insertion of	The instrument modificationsdetailed in this submissionhave no impact on thetechnological characteristic ofthe existing instruments. Theworking end Taps areintended for tapping duringspinal surgery, including bothopen and minimally invasive
DePuy Synthes Dental BoneCutting Instruments, e.g.Taps and Countersinks(subject devices)	DePuy Synthes BoneCutting Instruments (Class Iequivalents - Product CodeLXH)	Synthes 90° ScrewdriverK082649(primary predicate)	Medtronic Sofamor DanekPOWEREASE SystemK123270(reference device)
that the countersink feature isconcentric with the drilledhole.Taps are designed to becompatible withcorresponding Synthes screwsand/or drill bitsTaps have cutting threads thatrun along the length of theinstrument. The diameter andthread profile of the tap isdesigned to match to thediameter and thread profile ofan associated screw	that the countersink feature isconcentric with the drilledhole.Taps are designed to becompatible withcorresponding Synthes screwsand/or drill bitsTaps have cutting threads thatrun along the length of theinstrument. The diameter andthread profile of the tap isdesigned to match to thediameter and thread profile ofan associated screw	screws in the mandible.The instrument can beattached to a power source fordrilling; maximum inputspeed in 15,000 rpm.The screw holder can beturned at an angle behind thescrewdriver head forimproved visibility, simplehandling and minimallyinvasive use at the surgicalsite.The instrument is suitable forright-angled pre-drilling ofholes for screw insertion.	procedures. The working endsare used to facilitate theplacement of the rods. Likethe predicate POWEREASESystem instruments, thesubject instruments aremanufactured from stainlesssteel.

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Image /page/9/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design. A horizontal line is present below the word. A circled R symbol is present to the right of the word.

(End of summary)

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Image /page/10/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized depiction of a bone. A registered trademark symbol is located to the right of the word. A horizontal line is located underneath the word.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.