(63 days)
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No
The document describes a surgical drill with a new coating and provides performance data related to the coating's durability. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device, surgical drills, taps, and burs, are instruments used for preparing bone for implants or for removing devices. They are tools used in a surgical procedure, but they do not directly treat a disease or condition themselves.
No
Explanation: The device, surgical drills, taps, and burs, are described as tools for preparing bone (osteotomy) and harvesting bone material. Their function is purely interventional (surgical/procedural) and does not involve diagnosing a condition or disease.
No
The device description clearly states it is a physical surgical drill with an applied coating, not a software product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical drills, taps, and burs are used in dental and oral/maxillofacial surgery for preparing bone, harvesting bone material, and removing devices from bone. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as surgical instruments (drills, taps, and burs) with a coating. These are physical tools used in surgery.
- Lack of In Vitro Activity: An IVD is a device intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not examine specimens from the body. It is used to modify the body itself.
- Performance Studies: The performance studies focus on the durability and wear resistance of the coating on the surgical instruments, which are relevant to their function as surgical tools, not as diagnostic devices.
In summary, this device is a surgical instrument used for physical manipulation of bone during surgery, not for testing or analyzing specimens from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Surgical drills, taps and burs are used in dental, oral/maxillofacial surgery for preparing the bone (osteotomy), to receive an implant(s) or other device for bone fracture repair for restorative reconstruction. Trephine burs are used harvest bone material for autologous bone grafting procedures and to remove fractured surgical and implantable devices from the bone.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The purpose of this submission is to request marketing clearance for all drills, taps and burs (hereinafter referred to simply as "drills") manufactured and/or distributed by 3i, with an Amorphous Carbon (AC) coating applied to the cutting surfaces of the devices. This submission is for clearance of AC as a coating for current and future drill designs.
3i currently manufactures and distributes a wide range of reusable and disposable machine, electro-polished and titanium nitride (TiN) surface finished drills for the oral/maxillofacial surgical market. Current drill designs are essentially the same as others constructed of Stainless Steel with machined, electro-polished or applied TiN finishes. Applied TiN coatings seem to extend useful life of the drills, helps prevent corrosion and due to its bright yellow color, provides an excellent means for depth marking on the drill itself. It is the benefits of the TiN coatings that has prompted a extensive search of other similar biocompatable coatings.
The AC coating is black in color, provides excellent capabilities for "masking" or machining depth markings, will not corrode and is sterilizable by autoclaye or chemclave, or any of the other normal manufacturing sterilization means (Ie: ETO, Co60 Irradiation, Plasma, etc.).
AC is a molecular bond of titanium, nitrogen, carbon and hydrogen, applied to the metal surfaces of the drills using a proprietary gas (vacuum) deposition process. The process produces a very hard, dense, amorphous, thin film (as opposed to the crystalline structure of natural diamond). These carbon based coatings are extremely hard and lubricous, very desirable qualities for "ware parts" and devices subjected to abrasive ware environments, such as drills and cutting tools.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone, jaw bone, lower lip, chin region, lower jaw, tissue beside the nose, upper jaw, maxillar sinus, labial and lingual plates, mandibular canal
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Testing of the AC coating.
Sample Size: Not specified.
Key Results:
- ROLLING CONTACT FATIGUE TEST: Uncoated - 8.0 hrs, TiN/Ti Coated - 102 hrs, AC Coated - 120 hrs.
- SLIDING WARE TEST: No detectable ware after 5 hours for AC coated. TiN/Ti Coated showed Coefficient of Friction: 0.110 and 0.124. AC coated showed Coefficient of Friction: 0.090 and 0.080.
- SCRATCH TEST: Critical load (in/lbs) to coating failure - 33.7 lbs.
- MICRO-BLAST TEST: Time (seconds) to full coating removal: 78.1 seconds.
These tests and the results obtained demonstrate the AC coating to be superior in durability to uncoated and TiN coated steel, under conditions much more sever than will be encountered in 3i's indicated surgical applications. "Scratch" and "Blast" test results confirm the gas deposition process applies the coating such that it will not flake or chip off under normal handling and surgical use conditions. While there are some indications of clinical benefits with AC coated surgical cutting devices and 3i's initial testing has confirmed improvements in durability, there are no new specific clinical, sharpness or durability claims at this time regarding AC coated drills.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
4 1997
Image /page/0/Picture/1 description: The image is a logo for Implant Innovations. The logo features a stylized "3i" in bold, black font. The "i" is slanted to the right and is partially enclosed in a white box. Below the "3i" is the text "IMPLANT INNOVATIONS" in a smaller, bold font. There is a horizontal line above the text.
4555 Riverside Drive Palm Beach Gardens, FL 33410 1-800-443-8166 (561) 776-6700
510(k) SUMMARY
IMPLANT INNOVATION'S, INC. (3i) SURGICAL DRILLS, TAPS BURS w/ AMORPHOUS CARBON COATING
To the Requestor:
This information is taken directly from the original Pre-Market Notification [510(k)], submission, provided to the United States Food and Drug Administration. No information regarding safety or efficacy has been deleted from that submission, for this summary.
510(k) SUBMISSION: AMORPHOUS CARBON COATING -SURGICAL DRILLS AND BURS
1. CLASSIFICATION NAME:
Amorphous Carbon coating (AC) in and by itself has no classification name. Devices it will be incorporated with are Dental/Surgical drills, burs and taps use in osteotomy preparation for placement of dental, oral/maxillofacial implants or other oral and maxillofacial osteo-surgical procedures.
COMMON/USUAL NAMES: 2.
Dental/Surgical pilot drills, twist drills, round drills, taps, burs, counterbores, countersinks, tri-flute cylinder burs, tri-spade drills and trephine burs.
3. PROPRIETARY NAME:
3i Dental/Surgical Drills, Burs and Taps. NOTE: There is no proprietary marketing
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names under consideration at this time for the AC drills, burs, taps. All such devices with AC coating will be appropriately identified within a proprietary name and/or description.
ESTABLISHMENT REGISTRATION NUMBER: 1038806 4.
CLASSIFICATION: ડ.
Bone cutting instruments and accessories, per Section 872.4120 are classified as Class II devices.
Dental Hand instruments, per Section 872.4565 are classified as Class I devices and have been exempted from Pre-Market Notification requirements, if materials used in construction are the same as used prior to 05/28/76.
Intraoral dental drills, per Section 872.4130 are classified as Class I devices, exempt from Pre-Market Notification.
3i received marketing clearance on drills taps and burs with and without a Titanium Nitride Coating that was classified by FDA as Class I.
Dental drills used in surgical procedures to create the osteotomy for placement of dental implants may be considered "accessory devices" to the dental implant and therefore also considered Class III.
PERFORMANCE STANDARDS: Unknown 6.
7. FORM:
The purpose of this submission is to request marketing clearance for all drills, taps and burs (hereinafter referred to simply as "drills") manufactured and/or distributed by 3i, with an Amorphous Carbon (AC) coating applied to the cutting surfaces of the devices. This submission is for clearance of AC as a coating for current and future drill designs.
3i currently manufactures and distributes a wide range of reusable and disposable machine, electro-polished and titanium nitride (TiN) surface finished drills for the oral/maxillofacial surgical market. Current drill designs are essentially the same as others constructed of Stainless Steel with machined, electro-polished or applied
2
TiN finishes. Applied TiN coatings seem to extend useful life of the drills, helps prevent corrosion and due to its bright yellow color, provides an excellent means for depth marking on the drill itself. It is the benefits of the TiN coatings that has prompted a extensive search of other similar biocompatable coatings.
Research has shown superior performance under extremely harsh conditions over machine finished, electro-polished and even TiN coatings, with use of "diamond like carbon", "amorphous diamond", "amorphous carbon" (AC) or any of a number of other similar carbon based coatings, exhibiting extreme hardness and low friction characteristics, not unlike that of natural diamond. NOTE: For purposes of this submission the term "amorphous carbon" (AC) will be used to identify the coating to be incorporated with 3i drills.
AC coatings provide excellent biocompatability, chemical inertness and a hermetic barrier to a wide range of products. It may be applied to metals, ceramics and some plastics, depending upon application processes used. In medical device use, due to excellent ware resistance and biocompatability, AC is applied to scalpels and other cutting devices, replacement-joint (Orthopedics) ware surfaces and other implantable parts. The very desirable aspects of AC coatings currently realized by other medical/surgical applications will also benefit dental surgical applications by helping to reduce surgical trauma and enhanced tissue release through very low coefficient of friction, that may also increase drilling efficiency, decrease drilling (chair) time and perhaps promote enhanced post-operative healing. Based on initial testing, AC coating will extend useful life of drills, increase visibility and ware resistance of depth marks and reduce possibility of corrosion.
The AC coating is black in color, provides excellent capabilities for "masking" or machining depth markings, will not corrode and is sterilizable by autoclaye or chemclave, or any of the other normal manufacturing sterilization means (Ie: ETO, Co60 Irradiation, Plasma, etc.).
AC is a molecular bond of titanium, nitrogen, carbon and hydrogen, applied to the metal surfaces of the drills using a proprietary gas (vacuum) deposition process. The process produces a very hard, dense, amorphous, thin film (as opposed to the crystalline structure of natural diamond). These carbon based coatings are extremely hard and lubricous, very desirable qualities for "ware parts" and devices subjected to abrasive ware environments, such as drills and cutting tools. Extensive testing has been accomplished on AC coated cutting tools and drills, used in much harsher applications than surgical drilling. On parts and components subjected
3
to prolonged frictional applications under extreme conditions, the AC coating greatly improves ware characteristics compared to uncoated and TiN coated parts and components.
Specific testing has been undertaken with the AC coating to be used on 3i drills, results of which are not inconsistent with results published by several other related suppliers and applications.
ROLLING CONTACT FATIGUE TEST:
| Uncoated | - 8.0 hrs |
|---|---|
| TiN/Ti Coated | - 102 hrs |
| AC Coated | - 120 hrs |
SLIDING WARE TEST:
Results: No detectable ware after 5 hours.
| TiN/Ti Coated | Coefficient of Friction: 0.110 |
|---|---|
| TiN/Ti Coated | Coefficient of Friction: 0.124 |
| AC coated | Coefficient of Friction: 0.090 |
| AC coated | Coefficient of Friction: 0.080 |
SCRATCH TEST:
Critical load (in/lbs) to coating failure - 33.7 lbs
MICRO-BLAST TEST:
Time (seconds) to full coating removal: 78.1 seconds.
These tests and the results obtained demonstrate the AC coating to be superior in durability to uncoated and TiN coated steel, under conditions much more sever than will be encountered in 3i's indicated surgical applications. "Scratch" and "Blast" test results confirm the gas deposition process applies the coating such that it will not flake or chip off under normal handling and surgical use conditions.
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INDICATIONS FOR USE: 8.
Surgical drills, taps and burs are used in dental, oral/maxillofacial surgery for preparing the bone (osteotomy), to receive an implant(s) or other device for bone fracture repair for restorative reconstruction.
CONTRAINDICATIONS: 9.
Surgical drilling for implant placement should not be undertaken in any case where remaining jaw bone is too diminished to support implants.
10. WARNINGS:
For safe and effective use of any surgical device or equipment including drills, it is strongly recommended that specialized training be undertaken since surgical techniques are highly specialized and complex procedures.
PRECAUTIONS: 11.
Thorough screening of prospective surgical candidates must be performed. Visual inspection as well as panoramic and pariapical radiographs are essential to determine anatomical landmarks, occlusal conditions, pariodontal status, and adequacy of bone. Lateral cephalometric radiographs. CT Scans, and tomograms may also be beneficial.
ADVERSE EFFECTS: 12.
In dental implant surgery, improper drilling techniques or use of incorrect drills can result in loss of implant anchorage (failure to osseointegrate) or loss of the prosthesis after surgery. Lack of quantity or quality of remaining bone, infection, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are other potential causes for loss of fixture anchorage.
SURGICAL COMPLICATIONS: 13.
The surgical procedure has risks, including localized swelling, dehiscence, tenderness of short duration, edema, hematoma, or bleeding. Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Though
5
it would most probably be of a temporary nature, in very rare cases numbness has been permanent. Gingival/ Mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but generally responds to local care.
LABEL/LABELING MATERIALS: 14.
Labeling will not change from previous labeling except that the label will state "Amorphous Carbon Coated Drills (Taps) (Burs). All other required label information will be consistent with current labeling. There are no current proposed marketing materials planned for the AC coating on 3i drills.
SUBSTANTIAL EQUIVALENCE: 15.
The proposed drills burs and taps with the AC coating are substantially equivalent to currently market 3i drills, taps and burs with either a polished or TiN coating, in that the basic design and all indications for use have not changed. Though the material used to coat the drills , burs and taps is different in composition from the original coating (TiN), it is a recognized surface treatment for Orthopedic implant appliances as well as other medical/surgical devices. The safety and efficacy of AC coatings is well documented in literature and marketing materials by others in the industry. While there are some indications of clinical benefits with AC coated surgical cutting devices and 3i's initial testing has confirmed improvements in durability, there are no new specific clinical, sharpness or durability claims at this time regarding AC coated drills.
The only difference between the proposed AC drills and previous drills is the inclusion of the AC surface coating.
16. 510(k) CERTIFICATION AND SUMMARY FOR SUBMISSION:
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for Endosseous Dental Implant systems, including surgical use of all associated drills, taps and burs.
Endosseous Implants (including drills, taps and burs):
Failure of the implant to osseointegrate or loss of osseointegration can be caused by improper patient selection (patients with systemic diseases which affect bone
6
physiology, patients with habits such as bruxing or clenching, patients who are physically or psychologically unable to carry out proper implant hygiene, heavy smoking or alcohol use), by improper surgical technique, over- heating of bone by improper technique or use of dull drills, taps or burs, or improper case planning or restorative technique (over-loading of implants through improper placement, use of an insufficient number of implants or excessive cantilever). Improper implant processing by the manufacturer or improper handling by the customer, resulting in contamination, can also effect osseointegration.
Fracture of implants can occur, particularly in implants with apical cross-holes. Fracture occurs either on insertion of screw-type implants due to excessive torque (improper surgical technique such as an error in drill selection) or in service due to loss of bone. Fracture of abutments and abutment screws occurs in implant systems and is usually attributed to factors within the control of the implant team, such as lack of passive fit of the restoration or excessive cantilever, or within the control of the patient, such as bruxing.
Other types of safety and efficacy problems which have been observed for endosseous dental implant systems are local soft tissue degeneration and bone resorption, paresthesia, perforation of the maxillar sinus, perforation of labial and lingual plates, local and systemic infection, prosthetic framework fracture, nerve injury, bone fracture, injury to adjacent teeth and their supporting bone, oroantral or oronasal fistula, gingival hyperplasia, soft tissue overgrowth, perforation of the gingiva by the healing screw, mucosal abscess, displacement of the implant into the mandibular canal, hemorrhage of the floor of the mouth due to transection of the sublingualyattery and breakage of drill tip, requiring surgical removal.
William G. Conety Regulatory Affairs
... END SUMMARY ...................
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing right, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 1997
Mr. William G. Conety ·Regulatory Affairs Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
K973771 Re: Dental/Surgical Drills, Burs, Taps Trade Name: Regulatory Class: III Product Code: DZE September 30, 1997 Dated: Received: October 2, 1997
Dear Mr. Conety:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Conety
through 542 of the Act for devices under the Electronic chrough 312 or the notrol provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinding of babbeanelar oquresults in a classification for your markeess production permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on compriation and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regulation chercica) Missianalig by other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timoth Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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510(k) Number: K
Page 1 of 1
Device Name: Surgical drills, burs and taps w/Amorphous Carbon Coating.
INDICATIONS FOR USE:
Surgical drills, taps and burs are used in dental, oral/maxillofacial surgery for preparing the bone (osteotomy), to receive an implant(s) or other device for bone fracture repair for restorative reconstruction. Trephine burs are used harvest bone material for autologous bone grafting procedures and to remove fractured surgical and implantable devices from the bone.
DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sk and Gene 510(k) Numb
Prescription Use:_ L__________________________________________________________________________________________________________________________________________________________ Per 21 CFR 801.109)