(78 days)
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 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 height of 13 mm for 11.5 mm implant and 14.5 mm for 13.0 implant and minimum width of 6-7 mm).
- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- Implant-supported prosthetics seated directly on dedicated implants
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 Trefoil Implants are made of CP4 titanium. The implants are parallel walled and have an internal conical abutment connection. The implants have a 13.0 mm threaded portion and are available with both a 4.5 and 6.0 mm collar height. The apex of the implants have cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning an AI/algorithm-based diagnostic device. The document is a 510(k) premarket notification for a dental implant system (TREFOIL System) and discusses its substantial equivalence to previously marketed predicate devices.
The text does not include details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or training sets for an AI/algorithm.
- Number or qualifications of experts, or ground truth adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for any training set was established.
The document primarily focuses on:
- Device Description: The TREFOIL System is a dental implant system consisting of implants, surgical components, and prosthetic components for restoring chewing function in fully edentulous mandibles.
- Predicate Devices: It compares the subject device to two predicate TREFOIL Systems (K152836 and K170135).
- Technological Characteristics Comparison: The key difference noted is a change in implant length from 11.5 mm to 13.0 mm, which is already present in a reference predicate. All other technological characteristics (design, material, surface modification) are stated to be the same as the predicate devices.
- Non-Clinical Testing Summary: The document explicitly states that "No clinical data was used to support the decision of safety and effectiveness." Instead, the manufacturer leveraged data from the predicate devices because the subject device "does not represent a new worst case" for aspects like sterilization, packaging, shelf life, biocompatibility, and fatigue testing.
Therefore, I cannot fulfill your request for information about acceptance criteria and an AI/algorithm study based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 20, 2017
Nobel Biocare AB Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K172352
Trade/Device Name: TREFOIL System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 2, 2017 Received: August 3, 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.
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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K172352 |
| 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 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 height of 13 mm for 11.5 mm implant and 14.5 mm for 13.0 implant and minimum width of 6-7 mm). | |
| - 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) |
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| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
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ພອງຣຽວ ອັນນາ ແລະ ແລະ ແລະ ສອນສາ
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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: October 19, 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
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 - TREFOIL System (K170135) 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 Trefoil Implants are made of CP4 titanium. The implants are parallel walled and have an internal conical abutment connection. The implants have a 13.0 mm threaded portion and are available with both a 4.5 and 6.0 mm collar height. The apex of the implants have cutting
A.4.
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chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment.
V. INDICATIONS FOR USE
The TREFOIL System is used to restore chewing function in fully edentulous mandibles.
The three implants of the Trefoil Implants 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 height of 13 mm implant and 14.5 mm for 13.0 implant and minimum width of 6-7 mm).
-Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants
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Comparison of Technological Characteristics VI.
Comparison of intended use and indication for use statement
| Technological | Subject Device | Primary Predicate | Reference Predicate | |||
|---|---|---|---|---|---|---|
| characteristics | TREFOIL System | TREFOIL System (K152836) | TREFOIL System (K170135) | |||
| Intended use | The TREFOIL System is intended for theintraoral treatment of totally edentulousmandibles by providing anchorage of theframework in order to restore chewingfunction and esthetics. By the aid of thesurgical components (guides and templatesetc.) three implants are placed inpredetermined positions, corresponding tothe pre-fabricated prosthetic Framework thatis used. | The TREFOIL System is intended for theintraoral treatment of totally edentulousmandibles by providing anchorage of theframework in order to restore chewing functionand esthetics. By the aid of the surgicalcomponents (guides and templates etc.) threeimplants are placed in predeterminedpositions, corresponding to the pre-fabricatedprosthetic Framework that is used. | The TREFOIL System is intended for theintraoral treatment of totally edentulousmandibles by providing anchorage of theframework in order to restore chewingfunction and esthetics. By the aid of thesurgical components (guides and templatesetc.) three implants are placed inpredetermined positions, corresponding tothe pre-fabricated prosthetic Framework thatis used. | |||
| Indication foruse statement | The TREFOIL System is used to restorechewing function in fully edentulousmandibles. | The TREFOIL System is used to restorechewing function in fully edentulousmandibles. | The Trefoil system is used to restorechewing function in fully edentulousmandibles. | |||
| The three implants of the TREFOIL Systemare placed between the mental foramina infully edentulous mandibles in a 1-stagesurgical technique combined with animmediate function loading protocol, providedsufficient primary stability for the selectedtechnique is achieved. In cases wheresufficient primary stability for two implants ormore is not reached, the implants along withthe Framework may also be used with anearly or delayed loading protocol. | The three implants of the TREFOIL Systemare placed between the mental foramina infully edentulous mandibles in a 1-stagesurgical technique combined with animmediate function loading protocol, providedsufficient primary stability for the selectedtechnique is achieved. In cases wheresufficient primary stability for two implants ormore is not reached, the implants along withthe Framework may also be used with an earlyor delayed loading protocol. | The three implants of the Trefoil system areplaced between the mental foramina in fullyedentulous mandibles in a 1-stage surgicaltechnique combined with an immediatefunction loading protocol, provided sufficientprimary stability for the selected technique isachieved. In cases where sufficient primarystability of one or more implants is notreached, the implants along with the barmay also be used with an early or delayedloading protocol. | ||||
| The following prerequisites must be fulfilled:-Adequate quantity of bone (minimum heightof 13 mm for 11.5 mm implant and 14.5 mmfor 13.0 implant and minimum width of 6-7mm).-Adequate mouth opening (minimum 40 mm)to accommodate the guided surgeryinstruments.-Implant-supported prosthetics seated directlyon dedicated implants | The following prerequisites must be fulfilled:- Adequate quantity of bone (minimum heightof 13mm and minimum width of 6- 7mm).- Adequate mouth opening (minimum 40 mm)to accommodate the guided surgeryinstruments.- Implant-supported prosthetics seated directlyon dedicated implants | The following prerequisites must be fulfilled:- Adequate quantity of bone (minimum widthof 7mm; and minimum heights of 13mm for11.5 mm implant and 14.5mm for 13.0 mmimplant).- Adequate mouth opening (minimum 40mm) to accommodate the guided surgeryinstruments.- Implant-supported prosthetics seateddirectly on dedicated implants. | ||||
| Comparison of Intended use/Indications for Use: The intended use of the TREFOIL System is the same as the primary predicate TREFOIL System. Theindications for use of the subject device is the primary predicate with the one change. The first bullet in the prerequisite list of the Indications for use |
statement has been modified to reflect the change in implant length and is the same as the reference predicate.
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Comparison of Implant Technological Characteristics
| Technologicalcharacteristics | Subject Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Implant Design Features | TREFOIL System | TREFOIL System (K152836) | TREFOIL System (K170135) | |
| Implant Body Design | Parallel walled | Parallel walled | Parallel walled | |
| Implant Tip Design | Tapered self cutting | Tapered self cutting | Tapered self cutting | |
| Implant Thread Length | 13 mm | 11.5 mm | 11.5, 13.0 mm | |
| Implant Diameter | 4.93 mm | 4.93 mm | 4.3, 5.0, 5.5 mm | |
| Collar Diameter | 4.5 mm | 4.5 mm | 4.5 mm | |
| Collar Height | 4.5, 6.0 mm | 4.5, 6.0 mm | 4.5 mm | |
| Connection Type | Morse taper with Internal Hex | Morse taper with Internal Hex | Morse taper with Internal Hex | |
| Device Material | CP titanium | CP titanium | CP titanium | |
| Surface modification | TiUnite (anodic oxidation) | TiUnite (anodic oxidation) | TiUnite (anodic oxidation) |
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Analysis of Differences Between Subject Device and Predicate
Indications for use
The indications for use of the subject device is the same as the primary predicate with the one change. The first bullet in the prerequisite list of the Indications for use statement has been modified to reflect the change in implant length and is the same as the reference predicate.
Technological characteristics
The subject TREFOIL System is an extension of the primary predicate TREFOIL System (K152836) implant length from 11.5 mm to 13.0 mm. All other technological characteristics are the same. The 13.0 mm length is the same as the reference predicate TREFOIL System (K170135)
Summarv:
- The only design difference between the subject and primary predicate is the implant ● length. This length is the same as the reference predicate.
- There is a trade name change to implant name (per K152836). Implant Conical Connect . RP used with TREFOIL System will be called Trefoil Implants CC RP.
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 subject device is the same as the primary o predicate (K152836). 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 primary predicate O (K152836). This is a plastic vial with PVC shrink-wrap cap. Therefore, no additional testing was required.
- -Shelf Life
- The packaging for the subject device is the same as the primary predicate O (K152836) and is labeled with a 5 year expiration date. Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
- -Biocompatibility
- O The subject device is manufactured from the same material as the primary predicate (K152836), uses the same manufacturing method as the primary predicate, has the same intended use, and the same patient contact type and duration as the primary predicate. Therefore, no additional testing was required.
- -Fatigue Testing
No clinical data was used to support the decision of safety and effectiveness.
Nobel Biocare Traditional 510(k) Notification TREFOIL System October 2017 K172352
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VIII. CONCLUSIONS
The TREFOIL System was evaluated for substantial equivalence. 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, the TREFOIL System was shown to be substantially equivalent to the TREFOIL System (K152836).
§ 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.