(89 days)
No
The device description and performance studies focus on mechanical properties and traditional surgical instrument function, with no mention of AI or ML.
No
Explanation: This device is described as a nonpowered hand-held instrument used for cutting or drilling bone during surgical procedures, not for treating or mitigating a disease or condition. Its function is purely mechanical, a surgical tool.
No
The device is described as "nonpowered hand-held for trauma, reconstruction, or orthognathic procedures to drill or cut into the upper or lower jaw", and is used to create features in bone for the insertion of screws. Its function is to modify tissue (cutting, drilling, tapping), not to analyze or interpret biological signals or images for diagnosis.
No
The device description explicitly states the device is a physical instrument (taps and countersinks) made of stainless steel, and the performance studies focus on mechanical testing.
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 "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." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details the physical characteristics and function of taps and countersinks used for preparing bone. These are surgical instruments.
- 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, 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 surgery.
N/A
Intended Use / Indications for Use
The 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.
Product codes
DZJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
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
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known)
Device Name Dental Bone Cutting Instruments
Indications for Use (Describe)
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.
| 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, LLC |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| United States of America | |
| Contact: | Susan Lewandowski |
| Lewandowskis@synthes.com | |
| Telephone 610-719-5852 | |
| Facsimile 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
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.
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.
4
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 .
5
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 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. | An orthopedic manual | |||
| surgical instrument is a | ||||
| nonpowered hand-held device | ||||
| intended for medical purposes | ||||
| to manipulate tissue or for use | ||||
| with other devices in | ||||
| orthopedic surgery. | The Synthes 90° Screwdriver | |||
| is indicated for the manual | ||||
| and powered pre-drilling and | ||||
| insertion of bone fixation | ||||
| screws in oral/maxillofacial | ||||
| surgery. | The IPC System is indicated | |||
| for the incision/cutting, | ||||
| removal, drilling and sawing | ||||
| of soft and hard tissue and | ||||
| bone, and biomaterials in | ||||
| Neurosurgical (Cranial, | ||||
| Craniofacial), Orthopedic, | ||||
| Arthroscopic, Spinal, | ||||
| Sternotomy, and General | ||||
| surgical procedures. | ||||
| The IPC POWEREASE | ||||
| System is indicated for | ||||
| drilling, tapping and driving | ||||
| screws and working end | ||||
| attachments during spinal | ||||
| surgery, including open and | ||||
| minimally invasive | ||||
| procedures. It is also used in | ||||
| the placement or cutting of | ||||
| screws, posts and rods. | ||||
| FDA Product Code | DZJ | LXH | DZI, DZJ | HBE, HWE, GWF |
| 21 CFR | 872.4120 | 888.4540 | 872.4120 | 882.4310 |
| Regulation | ||||
| Description | Bone cutting instrument and | |||
| accessories | Orthopedic manual surgical | |||
| instruments | Bone cutting instrument and | |||
| accessories | Powered simple cranial drills, | |||
| burrs, trephines, and their | ||||
| accessories | ||||
| 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 Bone
Cutting Instruments, e.g.
Taps and Countersinks
(subject devices) | DePuy Synthes Bone
Cutting Instruments (Class I
equivalents – Product Code
LXH) | Synthes 90° Screwdriver
K082649
(primary predicate) | Medtronic Sofamor Danek
POWEREASE System
K123270
(reference device) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | Countersinks are intended to
create a countersink feature in
bone to provide a contact
surface for screw heads and to
reduce palpability of the bone
screw.
Taps are intended to create
threads in a pre-drilled hole in
order to accomodate a bone
screw. | Countersinks are intended to
create a countersink feature in
bone to provide a contact
surface for screw heads and to
reduce palpability of the
screw.
Taps are intended to create
threads in a pre-drilled hole in
order to accomodate a bone
screw. | The Synthes 90° Screwdriver
consists of a screwdriver
handle, shaft, screw holder,
screw holder insert and a
variety of attachments such as
drill bits and screwdriver
blades for manual and
powered right angled pre-
drilling and insertion of
screws.
The screw holder can be
turned at an angle behind the
screwdriver head for
improved visibility. | The POWEREASETM
System Working Ends
consists of instruments such as
taps, drill bits, screwdrivers,
post cutter, set screw break-
off tool, reduction nut driver
and sleeves. The working ends
have a manual alternative. The
working ends, listed above,
are compatible with the CD
HORIZON SOLERA and the
TSRH 3Dx Spinal System
implants. Of the working
ends, only the taps,
screwdrivers, drill bits, and
sleeves are also compatible
with Medtronic's NIM-
ECLIPSE Spinal System. |
| Device material(s) | Stainless steel 440A | Stainless steel | Stainless Steel,
Aluminum | Stainless Steel |
| Principles of
function/technology | Countersinks feature cutting
flutes at the working end of
the instrument that continue a
distance up the shaft of the
instrument and a centering pin
at the working end of the
instrument. The user will
insert the centering pin into a
drilled pilot hole, ensuring | Countersinks feature cutting
flutes at the working end of
the instrument that continue a
distance up the shaft of the
instrument and a centering pin
at the working end of the
instrument. The user will
insert the centering pin into a
drilled pilot hole, ensuring | The 90° Screwdriver is
designed to transmit the
torque required for screw
insertion.
The low profile head provide
minimal overall height for
minimally invasive pre-
drilling and insertion of | The instrument modifications
detailed in this submission
have no impact on the
technological characteristic of
the existing instruments. The
working end Taps are
intended for tapping during
spinal surgery, including both
open and minimally invasive |
| DePuy Synthes Dental Bone
Cutting Instruments, e.g.
Taps and Countersinks
(subject devices) | DePuy Synthes Bone
Cutting Instruments (Class I
equivalents - Product Code
LXH) | Synthes 90° Screwdriver
K082649
(primary predicate) | Medtronic Sofamor Danek
POWEREASE System
K123270
(reference device) | |
| that the countersink feature is
concentric with the drilled
hole.
Taps are designed to be
compatible with
corresponding Synthes screws
and/or drill bits
Taps have cutting threads that
run along the length of the
instrument. The diameter and
thread profile of the tap is
designed to match to the
diameter and thread profile of
an associated screw | that the countersink feature is
concentric with the drilled
hole.
Taps are designed to be
compatible with
corresponding Synthes screws
and/or drill bits
Taps have cutting threads that
run along the length of the
instrument. The diameter and
thread profile of the tap is
designed to match to the
diameter and thread profile of
an associated screw | screws in the mandible.
The instrument can be
attached to a power source for
drilling; maximum input
speed in 15,000 rpm.
The screw holder can be
turned at an angle behind the
screwdriver head for
improved visibility, simple
handling and minimally
invasive use at the surgical
site.
The instrument is suitable for
right-angled pre-drilling of
holes for screw insertion. | procedures. The working ends
are used to facilitate the
placement of the rods. Like
the predicate POWEREASE
System instruments, the
subject instruments are
manufactured from stainless
steel. | |
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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.