(114 days)
No
The document describes a system of dental implants, surgical tools, and prosthetic components for restoring chewing function. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is a dental implant system used to restore chewing function and aesthetics, which falls under restorative dentistry rather than therapeutic treatment for a disease or condition.
No
The provided text describes the Trefoil system as a method for placing dental implants and a pre-designed prosthetic bar to restore chewing function. It is a treatment device, not a diagnostic one.
No
The device description explicitly details physical components such as dental implants, surgical components, and prosthetic components made of titanium, stainless steel, and titanium vanadium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "restore chewing function in fully edentulous mandibles" by placing dental implants and a prosthetic bar. This is a surgical and prosthetic procedure, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of dental implants, surgical components, and prosthetic components. These are all physical devices used for implantation and restoration, not reagents, instruments, or systems intended for the examination of specimens derived from the human body.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status. The device's function is purely mechanical and restorative.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Trefoil system is used to restore chewing function in fully edentulous mandibles.
The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol.
The following prerequisites must be fulfilled:
- Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for 11.5 mm implant and 14.5mm for 13.0 mm implant).
- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- Implant-supported prosthetics seated directly on dedicated implants.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA, DZI
Device Description
The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.
The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.
The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal connection. The implant is available in three diameters 4.3, 5.0, and 5.5 mm. All three diameters are available in lengths of 11.5 and 13mm and have a 4.5 mm tissue collar that has a smooth machined surface without threads. The apex of the implants has cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandible (fully edentulous mandibles)
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)
Fatigue testing was performed to establish that the TREFOIL System will withstand foreseeable mastication forces. Fatigue testing was done by using a test scenario developed for splinted implant applications. Fatigue testing was conducted and results analyzed in accordance with ISO 14801. The results demonstrate significantly higher fatigue strength than the predicate TREFOIL System (K152836).
Biocompatibility testing for the TREFOIL framework assembly and Stabilizing Screw V-Template was performed in accordance with CEN EN ISO 10993-5, CEN EN ISO 10993-12, and CEN EN ISO 10993-18.
No clinical data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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).
Not Found
§ 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
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K170135
Trade/Device Name: TREFOIL System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA, DZI Dated: April 5, 2017 Received: April 6, 2017
Dear Charlemagne Chua:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K170135 |
|---|---|
| Device Name | TREFOIL System |
| Indications for Use (Describe) | |
| The Trefoil system is used to restore chewing function in fully edentulous mandibles. | |
| The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol. | |
| The following prerequisites must be fulfilled: | |
| - Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for 11.5 mm implant and 14.5mm for 13.0 mm implant). | |
| - Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. | |
| - Implant-supported prosthetics seated directly on dedicated implants. | |
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (1/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
K170135-S001: Al Response (13 MAR 2017)
Page 8 of 32
PSC Publishing Services (301) 443-6740
EF
3
I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Date Prepared: April 5, 2017
II. DEVICE
Name of Device: TREFOIL System Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Primary Product Code: DZE Other Product Code(s): NHA, DZI
III. PREDICATE DEVICE
Primary predicate: Nobel Biocare - TREFOIL System (K152836) This predicate has not been subject to a design-related recall.
Reference predicate: Nobel Biocare - NobelSpeedy Implants (K050406) This predicate has not been subject to a design-related recall
IV. DEVICE DESCRIPTION
The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.
The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.
The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal connection. The implant is available in three
Nobel Biocare Traditional 510(k) Notification TREFOIL System April 2017
A.4.
4
diameters 4.3, 5.0, and 5.5 mm. All three diameters are available in lengths of 11.5 and 13mm and have a 4.5 mm tissue collar that has a smooth machined surface without threads. The apex of the implants has cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.
V. INDICATIONS FOR USE
The Trefoil system is used to restore chewing function in fully edentulous mandibles.
The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surqical technique combined with an immediate function loading provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol.
The following prerequisites must be fulfilled:
- Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for -11.5 mm implant and 14.5mm for 13.0 mm implant).
- -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- -Implant-supported prosthetics seated directly on dedicated implants.
5
VI. Comparison of Technological Characteristics
Comparison of intended use and indication for use statement
| Technological
| characteristics | Subject Device | Primary Predicate |
|---|---|---|
| Intended use | TREFOIL System | TREFOIL System (K152836) |
| The TREFOIL System is intended for the intraoral treatment of totally | ||
| edentulous mandibles by providing anchorage of the framework in | ||
| order to restore chewing function and esthetics. By the aid of the | ||
| surgical components (guides and templates etc.) three implants are | ||
| placed in predetermined positions, corresponding to the pre- | ||
| fabricated prosthetic Framework that is used. | The TREFOIL System is intended for the intraoral treatment of totally | |
| edentulous mandibles by providing anchorage of the framework in | ||
| order to restore chewing function and esthetics. By the aid of the | ||
| surgical components (guides and templates etc.) three implants are | ||
| placed in predetermined positions, corresponding to the pre- | ||
| fabricated prosthetic Framework that is used. | ||
| Indication for | ||
| use statement | The Trefoil system is used to restore chewing function in fully | |
| edentulous mandibles. | The TREFOIL System is used to restore chewing function in | |
| fully edentulous mandibles. | ||
| The three implants of the Trefoil system are placed between | ||
| the mental foramina in fully edentulous mandibles in a 1-stage | ||
| surgical technique combined with an immediate function | ||
| loading protocol, provided sufficient primary stability for the | ||
| selected technique is achieved. In cases where sufficient | ||
| primary stability of one or more implants is not reached, the | ||
| implants along with the bar may also be used with an early or | ||
| delayed loading protocol. | The three implants of the TREFOIL System are placed | |
| between the mental foramina in fully edentulous mandibles in | ||
| a 1-stage surgical technique combined with an immediate | ||
| function loading protocol, provided sufficient primary stability | ||
| for the selected technique is achieved. In cases where | ||
| sufficient primary stability for two implants or more is not | ||
| reached, the implants along with the Framework may also be | ||
| used with an early or delayed loading protocol. | ||
| The following prerequisites must be fulfilled: |
- Adequate quantity of bone (minimum width of 7mm; and
minimum heights of 13mm for 11.5 mm implant and
14.5mm [for 13.0 mm implant). Adequate mouth opening
(minimum 40 mm) to accommodate the guided surgery
instruments.
Implant-supported prosthetics seated directly on dedicated
implants. | The following prerequisites must be fulfilled: - Adequate quantity of bone (minimum height of 13mm and
minimum width of 6- 7mm).
Adequate mouth opening (minimum 40 mm) to
accommodate the guided surgery instruments.
Implant-supported prosthetics seated directly on dedicated
implants |
| Comparison of Intended use/Indications for Use: The intended use of the updated TREFOIL System is the same as the predicate TREFOIL System. The first
bullet in the prerequisite list of the Indications for use statement has been modified to reflect the change in implant body design. This change is within the
dimensions listed on the predicate indication for use. Additionally, a change in the indications for use was added to ensure 1.5mm of structural support below the
implants for the 13.0 mm implants. The indication for use has also been changed to increase the amount of implants reaching primary stability needed for
immediate function from 2 to 3. This change is also within the current predicate range and reduces the possibility of implant mobility. | | |
6
Comparison of Implant Technological Characteristics
| Technological
| characteristics | Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Implant Design Features | TREFOIL System | TREFOIL System (K152836) | NobelSpeedy Implants (K050406) | |
| Implant | ||||
| Body Design | Parallel walled | Parallel walled | Parallel walled | |
| Implant Tip | ||||
| Design | Tapered self cutting | Tapered self cutting | Tapered self cutting | |
| Implant | ||||
| Length | 16.0 mm overall (11.5 mm body w/ 4.5 mm collar) | |||
| 17.5 mm overall (13.0 mm body w/ 4.5 mm collar) | 16.0 mm overall (11.5 mm body w/ 4.5 mm collar) | |||
| 17.5 mm overall (11.5 mm body w/ 6.0 mm collar) | 7, 8.5, 10, 11.5, 13.0, 15.0, 18.0 mm | |||
| Implant | ||||
| Diameter | 4.3, 5.0, 5.5 mm | 4.93 mm | 4.0, 5.0, 6.0 mm | |
| Collar | ||||
| Diameter | 4.5 mm | 4.5 mm | 4.1, 5.1, 5.8 mm | |
| Collar Height | 4.5 mm | 4.5, 6.0 mm | N/A | |
| Connection | ||||
| Type | Morse taper with Internal Hex | Morse taper with Internal Hex | External hex | |
| Internal Tri-Lobe | ||||
| Device | ||||
| Material | CP titanium | CP titanium | CP titanium | |
| Surface | ||||
| modification | TiUnite (anodic oxidation) | TiUnite (anodic oxidation) | TiUnite (anodic oxidation) |
7
Comparison of Framework Bar Technological Characteristics
| Technological
| characteristics | Subject Device | Primary Predicate | |
|---|---|---|---|
| TREFOIL System | TREFOIL System (K152836) | ||
| Bar Design Features | Bar Design | Preshaped single piece design screw retained to implant. | Preshaped single piece design screw retained to implant. |
| Intended platform | TREFOIL implant (intenal conical connection) | TREFOIL implant (intenal conical connection with snap fit) | |
| Materials | Titanium vanadium alloy | Titanium vanadium alloy | |
| Surface modification | Machined titanium | Machined titanium | |
| Compensation mechanism | Round abutment and corresponding framework and screw disks | Round abutment and corresponding framework and screw disks | |
| Prosthetic media | Acrylic | Acrylic | |
| Fixed cantilever length | 18.8 mm | 18.8 mm |
8
| Technological
| characteristics | Subject Device | Primary Predicate | ||
|---|---|---|---|---|
| TREFOIL System | TREFOIL System (K152836) | |||
| Surgical tooling type | Drill | Diameter | 2.0, 2.4/2.8, 3.2/3.6, 3.8/4.2, 4.2/4.6, 4.2/5.0 mm | 2.0, 3.0, 3.8, 4.0, 4.2, 4.4 mm |
| Material | Stainless Steel | |||
| DLC coated | Stainless Steel | |||
| DLC coated | ||||
| Connection | ISO 1797 Type 1 | ISO 1797 Type 1 | ||
| Markings | All drills marked for 11.5 mm and 13.5 mm length implants | All drills marked for 11.5 mm and 13.5 mm length implants | ||
| Intended use | The drills are used together with corresponding Templates for | |||
| drills for the preparation of the implant sites | The drills are used together with corresponding Templates for | |||
| drills for the preparation of the implant sites. | ||||
| Diameter | 4.3, 5.0, 5.5 mm | 5.0 mm | ||
| Materials | Stainless Steel | |||
| DLC coated | Stainless Steel | |||
| DLC coated | ||||
| Connection | ISO 1797 Type 1 | ISO 1797 Type 1 | ||
| Intended use | The screw tap is used when dense bone is present to | |||
| prepare for the threaded implant | The screw tap is used when dense bone is present to prepare for | |||
| the threaded implant | ||||
| Length | 14.0 mm (to stop) | |||
| 19.7 mm (overall) | 14.0 mm (to stop) | |||
| 19.3 mm (overall) | ||||
| Materials | Stainless Steel | Stainless Steel | ||
| Intended use | The stabilizing screw is used to temporarily connect the V- | |||
| template to the alveolar ridge | The stabilizing screw is used to temporarily connect the V- | |||
| template to the alveolar ridge |
Comparison of Surgical Tooling Technological Characteristics
9
Analysis of Differences Between Subject Device and Predicate
Indications for use
The first bullet in the prerequisite list has been modified to reflect the change in implant body design. This change is within the dimensions listed on the predicate indication for use. Additionally, a change in the indications for use was added to ensure 1.5mm of structural support below the implants for the 13.0 mm implants. The indication has also been changed to increase the amount of implants reaching primary stability needed for immediate function from 2 to 3. This change is also within the current predicate range and reduces the possibility of implant mobility.
Implant technological characteristics
The subject Trefoil implant is a hybrid between the existing Trefoil implant (K152836) and the NobelSpeedy implant (K050406). The subject Trefoil implant has the basic collar and abutment connection as the existing Trefoil implant (K152836) and body design characteristics of the NobelSpeedy implant (K050406). The subject Trefoil implant now has one collar length and two implant body lengths. This maintains the same overall implant lengths as the predicate Trefoil implant (K152836). The available subject Trefoil implant body diameters are different from but within the range of the NobelSpeedy implant (K050406). The subject Trefoil implant was tested using a modified ISO 14801 test protocol and the results favorably compared to the Trefoil implant (K152836).
Framework technological characteristics
The subject TREFOIL System uses the same framework components as the TREFOIL System (K152836) with one exception. The framework no longer has a snap fit. This was done by modifying the round abutment. The subject Trefoil implant and Framework was tested using a modified ISO 14801 test protocol and the results favorably compared to the Trefoil implant (K152836).
Surgical Tooling
The drill for the subject TREFOIL System uses the same materials and basic design but have been modified to accommodate the new Trefoil Implant body profile.
Summary:
The design differences between subject and predicate were evaluated using comparative testing. Differences in technology were evaluated through comparative performance testing.
VII. PERFORMANCE DATA
Summary of Non-Clinical Testing:
Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).
- -Sterile Device Information
- The sterilization method for the Trefoil Implants, drills, and screw taps is the o same as the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
- -Device Packaging
- The packaging for the subject device is the same as the predicate. This is either O a plastic vial with PVC shrink-wrap cap (Trefoil Implants) or a thermoform tray with peel top lid (Trefoil drills and screw taps). Therefore, no additional testing was required.
10
- Shelf Life
- o The packaging for the subject device is the same as the predicate and is labeled with either a 5 vear expiration date (Trefoil Implants) or a 3 vear expiration (Trefoil drills and screw taps). Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- Biocompatibility
- o The Trefoil Implants, drills, screw taps, are manufactured from the same material as the predicate, uses the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.
Fatigue testing was performed to establish that the TREFOIL System will withstand foreseeable mastication forces. Fatique testing was done by using a test scenario developed for splinted implant applications. Fatigue testing was conducted and results analyzed in accordance with ISO 14801. The results demonstrate significantly higher fatigue strength than the predicate TREFOIL System (K152836).
Biocompatibility testing for the TREFOIL framework assembly and Stabilizing Screw V-Template was performed in accordance with CEN EN ISO 10993-5, CEN EN ISO 10993-12, and CEN EN ISO 10993-18.
No clinical data was used to support the decision of substantial equivalence.
VIII. CONCLUSIONS
The TREFOIL System was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the TREFOIL System could be shown to not represent a worst-case with respect to the predicates, data from these predicate devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the TREFOIL System shown to be substantially equivalent to the TREFOIL System (K152836).