(85 days)
The SIMPLANT® Guide is intended for use in assisting placement of dental implants.
The SIMPLANT® Guide is intended for use in assisting placement of dental implants.
It is a patient specific surgical template that is produced based upon knowledge of the location and orientation of the implant(s) prior to the surgery.
The design of the SIMPLANT® Guide is made according to the clinician's plan of the implant positions. The final guide is fabricated from an epoxy resin using computerassisted manufacturing to produce a patient specific device.
The SIMPLANT® Guide sits on the patient's oral anatomy, i.e. teeth, mucosa, bone or a combination thereof. Aided by the SIMPLANT® Guide, the implant sites can be prepared and the dental implants placed in the predetermined locations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SIMPLANT® Guide:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated with numerical thresholds in the provided document. Instead, the document indicates that the SIMPLANT® Guide meets the same acceptance criteria as its predicate device (SurgiGuide® guide). The "Results" column for the proposed SIMPLANT® Guide consistently reports "PASS", indicating it successfully met these unstated criteria.
| Bench Test Performed | Implied Acceptance Criteria (Shared with Predicate) | Reported Device Performance (SIMPLANT® Guide) |
|---|---|---|
| Tube Fixation Test- Push Out | Withstands typical vertical loads during surgery. | PASS |
| Tube Fixation Test- Torque | Withstands occasional torque loads during surgery. | PASS |
| Bending Test | Withstands typical bending loads during surgery. | PASS |
| Angulation Deviation Test | Manufactured according to its pre-operative plan regarding the angular position of the guiding tube. | PASS |
| Position Deviation Test | Manufactured according to its pre-operative plan regarding spatial position of the guiding tube. | PASS |
| Vertical Fit Test | Manufactured according to its pre-operative plan regarding the vertical position. | PASS |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each "bench test." It mentions "non-clinical performance tests have been developed in-house" and "were executed to demonstrate substantial equivalence."
The data provenance is internal/in-house bench testing with no mention of country of origin of the data or whether it was retrospective or prospective in the context of human data. Given it's bench testing, it's a prospective series of tests conducted on the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. For bench testing, "ground truth" typically refers to engineering specifications, measurement standards, or the performance of a validated predicate device. The document states that the performance meets the "same acceptance criteria" as the predicate, implying the predicate's performance served as the benchmark.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of bench testing, the adjudication would likely be based on objective measurements and adherence to predefined test protocols and acceptance criteria, rather than a consensus method among human experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not conducted or described for the SIMPLANT® Guide. The device is a surgical guide, not an AI-powered diagnostic or assistive tool for human readers/clinicians in the way typically assessed by MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not directly applicable to the SIMPLANT® Guide in the context of typical AI algorithm performance. The SIMPLANT® Guide is a physical surgical template produced using computer-assisted manufacturing based on a clinician's plan. While "algorithm" might be involved in the manufacturing process (CAD/CAM), the device itself is a physical tool, not a standalone algorithm. The "standalone performance" in this context would be its physical accuracy and durability, which were tested via the bench tests (Tube Fixation, Bending, Angulation, Position, Vertical Fit).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench tests, the ground truth or reference point appears to be:
- Engineering Specifications/Pre-operative Plan: For the Angulation Deviation, Position Deviation, and Vertical Fit Tests, the "ground truth" is the device's design and how closely the manufactured product adheres to it.
- Predicate Device Performance: The primary comparative "ground truth" is that the new device must meet the "same acceptance criteria" and perform identically to the predicate SurgiGuide® guide under the specified test conditions. This implies that the predicate's established performance serves as the benchmark for "acceptable" over typically applied loads.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The SIMPLANT® Guide is a manufactured surgical template, not an AI model that requires a training set. The "design" (which might involve software or CAD) is based on the clinician's pre-operative implant plan, not a learned model from a large dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
Dentsply Sirona Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401
Re: K170849
Trade/Device Name: SIMPLANT® Guide Regulation Number: 21 CFR 872.3980 Regulation Name: Endosseous Dental Implant Accessories Regulatory Class: Class I Product Code: NDP Dated: March 21, 2017 Received: March 22, 2017
Dear Helen Lewis:
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
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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 (OS) 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.
Andrew I. Steen -S
for Lori A. Wiggins, MPT, CLT 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 Food and Drug Administration
Indications for Use
510(k) Number (if known) K170849
Device Name SIMPLANT® Guide
Indications for Use (Describe)
The SIMPLANT® Guide is intended for use in assisting placement of dental 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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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image contains the logo for Dentsply Sirona. The logo consists of a stylized, abstract leaf-like shape on the left, rendered in a dark gray color. To the right of the leaf shape are the words "Dentsply" stacked on top of "Sirona", both in a simple, sans-serif font and also in dark gray. The overall design is clean and modern.
SECTION 5. 510(k) SUMMARY for SIMPLANT® Guide K170849
Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: June 14, 2017
Device Name:
| • Proprietary Name: | SIMPLANT® Guide |
|---|---|
| • Classification Name: | Endosseous dental implant accessories |
| • CFR Number: | 872.3980 |
| • Device Class: | Class I |
| • Product Code: | NDP |
Predicate Device:
| Predicate Device Names | 510(k) | Manufacturer |
|---|---|---|
| SimPlant® Immediate Smile System(Primary Predicate) | K113739 | DENTSPLY Implants NV |
| Frialit-2 Select Components(Reference Predicate) | K993095 | Dentsply ImplantsManufacturing GmbH |
| FRIALIT-2 Bone Profiler(Reference Predicate) | K993560 | Dentsply ImplantsManufacturing GmbH |
Description of Device:
The SIMPLANT® Guide is intended for use in assisting placement of dental implants.
It is a patient specific surgical template that is produced based upon knowledge of the location and orientation of the implant(s) prior to the surgery.
The design of the SIMPLANT® Guide is made according to the clinician's plan of the implant positions. The final guide is fabricated from an epoxy resin using computerassisted manufacturing to produce a patient specific device.
The SIMPLANT® Guide sits on the patient's oral anatomy, i.e. teeth, mucosa, bone or a combination thereof. Aided by the SIMPLANT® Guide, the implant sites can be prepared and the dental implants placed in the predetermined locations.
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Indications for Use: The SIMPLANT® Guide is intended for use in assisting placement of dental implants.
Substantial Equivalence:
Dentsply Sirona received premarket clearance for the prim ary predicate SimPlant Immediate Smile System in May 2012 under premarket notification K113739. The primary predicate, SimPlant® Immediate Smile System (K113739), is composed of the SimPlant® Immediate Smile bridge, SurgiGuide® guide and SimPlant® Software.
Dentsply Sirona modified the SurgiGuide® guide, component of the SimPlant®
Immediate Smile System (K113739). This modified SurgiGuide® guide is herewith submitted as a new 510(k) under the name SIMPLANT® Guide.
The revision to the SurgiGuide® guide relates to the use of a different acrylic epoxy resin for the body of the guide. In addition, a reduced wall thickness of the body of the guide is introduced and the shelf life has been changed. Finally, the recommended sterilization parameters are updated as described in the Instructions For Use.
This modified SurgiGuide guide is herewith submitted as new 510(k) under the name SIMPLANT® Guide.
Table 5.1 shows the similarities and differences between the SIMPLANT® Guide and the SurgiGuide, component of the primary predicate SimPlant® Immediate Smile System (K113739). Throughout this submission we will compare the SIMPLANT® Guide with the SurgiGuide® guide.
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| Element | Proposed Device | Primary Predicate Device | Similarities and Differences |
|---|---|---|---|
| SIMPLANT® Guide | SimPlant® Immediate Smile System | ||
| (K170849) | (K113739) | ||
| Indicationsfor Use | The SIMPLANT® Guide is intended foruse in assisting placement of dentalimplants. | The SimPlant®Immediate Smile Systemisintended for use in treatment planning andplacement of dental implants, in order to restoremasticatory function. | The indications for use of the proposedSIMPLANT® Guide are limitedto theindications for use of the guide only. |
| Function | The SimPlant® Immediate Smile System includesSimPlant® software, which provides a means forthe clinician for image segmentation and advancedpre-operative planning. This enables the clinicianto view three-dimensional CT-scan data as well asto plan the case in a virtual three-dimensionalenvironment.This case planning can be used to produce asurgical template, this transferring the virtual case | The function of the proposed SIMPLANT®Guide is identical to the function of theSurgiGuide® guide, component of the predicateSimPlant®ImmediateSmileSystem(K113739). | |
| The SIMPLANT® Guide is a patient- | planning into physical tools enabling the surgicalinstallation according to the virtual case planning.The SurgiGuide® guide is a patient-specific | ||
| specific surgical template that is producedbased upon knowledge of the location andorientation of the implant(s) prior to thesurgery. | surgical template that is produced based uponknowledge of the location and orientation of theimplant(s) prior to the surgery. | ||
| Aided by the SIMPLANT® Guide, thesites can be prepared and the implantsplaced in the predetermined locations. | Aided by the SurgiGuide® guide, the sites can beprepared and the implantsplacedinthepredetermined locations. | ||
| After placing the implants in the predeterminedlocations, the immediate attachment oftheprefabricated temporaryi.e.prosthesis,theImmediate Smile bridge structurefinalorprosthesis is possible. | |||
| Element | Proposed DeviceSIMPLANT® Guide(K170849) | Primary Predicate DeviceSimPlant® Immediate Smile System(K113739) | Similarities and Differences |
| Technology | • Stereolithography | SurgiGuide® guide:• Stereolithography | The technology of the proposed SIMPLANT® Guide is identical to the technology of the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739). |
| Material | • Acrylic epoxy resin• Glue• Medical grade metal tubes (stainless steel or Titanium) | SurgiGuide® guide• Acrylic epoxy resin• Glue• Medical grade metal tubes (stainless steel or Titanium) | The raw material used for the body of the guide is different for the proposed SIMPLANT® Guide as compared to the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739). A different acrylic epoxy resin is used. Other materials used in the proposed SIMPLANT® Guide are identical to the materials used in the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739). |
| Design andFeatures | • Patient specific surgical template that sits on the patient's oral anatomy, i.e. teeth, mucosa or bone• Minimal wall thickness: 2.5 mm• Metal tubes with position and dimensions based on the pre-operative plan | SurgiGuide® guide:• Patient specific surgical template that sits on the patient's oral anatomy, i.e. teeth, mucosa or bone• Minimal wall thickness: 3mm• Metal tubes with position and dimension based on the pre-operative plan | The design specification of the minimal wall thickness is different for the proposed SIMPLANT® Guide as compared to the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739). All other design aspects and features of the proposed SIMPLANT® Guide are identical to the design aspects and features of the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739). |
| SterilizationMethod | • Delivered non-sterile• Sterilization by the user:Steam-sterilization at 135°C / 275°F for 3 minutes and a minimal drying time of 16 minutes | SurgiGuide® guide:• Delivered non-sterile• Sterilization by the user:Steam-sterilization at 121°C for 20 minutes | The sterilization method of the proposed SIMPLANT® Guide is identical to the sterilization method of the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739). However, the sterilization cycle parameters are different. |
| Element | Proposed DeviceSIMPLANT® Guide(K170849) | Primary Predicate DeviceSimPlant® Immediate Smile System(K113739) | Similarities and Differences |
| Shelf Life | • 2 months | SurgiGuide® guide:• 6 months | The shelf life of the proposed SIMPLANT® Guide is reduced compared to the shelf life of the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739). |
Table 5.1 Substantial Equivalence Table
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The SIMPLANT Guide has similar uses as the reference predicate devices, FRIALIT-2 Select Components (K93095) and FRIALIT-2 Bone Profiler (K993560). The reference predicate, FRIALIT-2 Select Components (K993095) are used to determine available tissue and abutment angle. The reference predicate, FRIALIT-2 Bone Profiler (K993560) consists of a stainless steel drill guide is provided with each dameter drill to ad in the determination of implant angle and implant depth to facilitate removal of bone around the implant site. These reference were cleared under DZE prior to announcement in 65 FR 60099 of reclassification of dental implant accessories under 872.3980 Endoxseous and product code NDP.
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Non-Clinical Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:
Bench Testing
For the proposed SIMPLANT® Guide, non-clinical performance tests have been developed in-house including their related acceptance criteria and were executed to demonstrate substantial equivalence. Table 5.1 gives an overview of these tests and the results that are obtained, when tested against the acceptance criteria. All tests met the acceptance criteria.
The fixation and bending test results show that the proposed SIMPLANT® Guide has sufficient strength for its intended use. The results from the angulation deviation test, position deviation test and vertical fit test demonstrate that the SIMPLANT® Guide is manufactured according to its pre-operative plan. The performance of the SIMPLANT® Guide meets the same acceptance criteria for all bench tests, as compared to the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739).
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Table 5.2 Performance testing
| Bench TestPerformed | Test description | Result forProposedSIMPLANT®Guide(PASS / FAIL) | Result forSurgiGuide® guide,component of thepredicate SimPlant®Immediate SmileSystem (K113739)(PASS / FAIL) |
|---|---|---|---|
| Tube Fixation Test-Push Out | This test is executed to ensurethat the proposed devicewithstands typical verticalloads that may be appliedduring surgery. | PASS | PASS |
| Tube Fixation Test-Torque | This test is executed to ensurethat the proposed devicewithstands occasional torqueloads that may be appliedduring surgery. | PASS | PASS |
| Bending Test | This test is executed to ensurethat the proposed devicewithstands typical bendingloads that may be appliedduring surgery | PASS | PASS |
| AngulationDeviation Test | The deviation is measuredbetween the angulation of themetal tube of the designed andthe manufactured guide.This test is executed to ensurethat the proposedSIMPLANT® Guide ismanufactured according to itspre-operative plan regardingthe angular position of theguiding tube. | PASS | PASS |
| Position DeviationTest | This test is executed to ensurethat the proposedSIMPLANT® Guide ismanufactured according to itspre-operative plan regardingspatial position of the guidingtube. | PASS | PASS |
| Vertical Fit Test | This test is executed to ensurethat the proposedSIMPLANT® Guide ismanufactured according to itspre-operative plan regardingthe vertical position. | PASS | PASS |
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Biocompatibility Testing
A biocompatibility assessment and relevant testing, based on the requirements of ISO 10993-1 (2009, Cor 1:2010) Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and 7405 (2008) Dentistry — Evaluation of biocompatibility of medical devices used in dentistry was performed on the proposed SIMPLANT® Guide.
Following tests for biocompatibility were performed:
- Cytotoxicity test, in accordance to ISO 10993-5 (2009) "Biological evaluation of . medical devices -- Part 5: Tests for in vitro cytotoxicity"
- Intracutaneous reactivity test , in accordance to ISO 10993-10(2010) "Biological . evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization"
- Sensitization test , in accordance to ISO 10993-10(2010) "Biological evaluation . of medical devices -- Part 10: Tests for irritation and skin sensitization"
These tests demonstrated the biocompatibility of the proposed SIMPLANT® Guide.
Sterilization Validation
The steam-sterilization method for the proposed SIMPLANT® Guide is stated in the Instructions For Use of the SIMPLANT® Guide. The steam-sterilization method for the SIMPLANT® Guide is similar to the steam-sterilization method of the SurgiGuide® guide, component of the predicate SimPlant® Immediate Smile System (K113739), but has modified sterilization cycle parameters. The updated steamsterilization method has been successfully validated according to ISO 17665-1 (2006) "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices" and ISO 17665-2 (2009) "Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1."
Shelf life testing
The shelf life of the proposed SIMPLANT® Guide is 2 months. To ensure the stability and performance of the proposed SIMPLANT® Guide through the claimed shelf life, relevant shelf life testing was performed based on real-time aging. These tests include:
- Tube Fixation Test-Torque
- Bending test ●
- Vertical fit test ●
The performance of the SIMPLANT® Guide after real-time ageing for 2 months meets the same acceptance criteria as for the bench tests performed at the time of manufacture.
The proposed SIMPLANT® Guide satisfactorily met the requirements of the non-clinical performance testing conducted to support substantial equivalence.
Clinical Performance Data
No new data from human clinical studies has been included to support the substantial equivalence to the SimPlant® Immediate Smile System (K113739). The clinical data from the previously cleared SurgiGuide® guide, component of SimPlant® Immediate Smile System (K113739) are still valid for the SIMPLANT® Guide, since the clinical indication and performance of both devices are the same.
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Conclusion Regarding Substantial Equivalence
The SIMPLANT® Guide has the same indication for use, incorporates the same fundamental product technology and similar materials as the SurgiGuide® guide, component of the primary predicate SimPlant® Immediate Smile System (K113739). Bench testing shows that performance of the proposed SIMPLANT® Guide meets the same performance acceptance criteria as the primary predicate. SurgiGuide® guide, component of SimPlant® Immediate Smile System (K113739). New biocompatibility testing was successfully performed according ISO 10993-5 (2009), ISO 10993-10 (2010). Shelf life tests confirmed the proposed shelf life of 2 months. Finally, the updated recommended steam-sterilization method was successfully validated according to ISO 17665-1(2006) and ISO 17665-2(2009). These results support substantial equivalence of the proposed device SIMPLANT® Guide to the primary predicate device SurgiGuide® guide, component of the predicate Simond® Immediate Smile System (K113739). Any differences in technological characteristics between the proposed device and the primary predicate device do not raise different questions of substantial equivalence.
§ 872.3980 Endosseous dental implant accessories.
(a)
Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.