(90 days)
SparkTM Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
SparkTM Software System: The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays, retainers or bracket bonding templatesor based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the Spark™ Clear Aligner System and Spark™ Software System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
The Ormco Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state.
Treatment planning, aligner design and aliqner manufacture are supported by a proprietary software system. The Spark™ Clear Aligner system consists of multiple interfacing software modules; Web, Design, Anatomy, Approver, and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Trained technicians use the Ormco™ Spark™ Aligner Anatomy and Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.
The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time.
The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Several treatment options may be integrated into the Ormco Spark aligner consisting of: Attachments, Hooks, Bite ramps, Pontics, Posterior Bite Turbos.
The provided document is a 510(k) summary for the Spark™ Clear Aligner System, seeking substantial equivalence to predicate devices. It primarily focuses on comparing the subject device to existing devices and outlining performance bench testing, rather than describing a study to prove acceptance criteria for an AI device.
Therefore, the document does not contain the requested information about acceptance criteria and a study proving an AI device meets them.
The document describes a medical device (Spark™ Clear Aligner System) which includes a "Spark™ Software System" intended for treatment simulation and virtual design of dental casts. However, it does not provide details on specific AI acceptance criteria or a study demonstrating the software's performance against such criteria. The "Non-Clinical Test Data" section mentions "Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device," and lists several ISO and ASTM standards for biocompatibility, risk management, software life-cycle, usability engineering, and material properties, but does not offer concrete performance metrics or studies in the context of AI.
The document states that "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product." This further confirms that a study to prove AI performance against acceptance criteria, as typically understood in the context of diagnostic or predictive AI, was not performed or reported here.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2021
Ormco Corporation Frank Ray Director of Regulatory Affairs 200 S Kraemer Blvd Brea, California 92821
Re: K203737
Trade/Device Name: Spark Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC, PNN Dated: December 21, 2020 Received: December 22, 2020
Dear Frank Ray:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203737
Device Name SparkTM Clear Aligner System
Indications for Use (Describe) SparkTM Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
SparkTM Software System:
The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays, retainers or bracket bonding templatesor based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the Spark™ Clear Aligner System and Spark™ Software System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Ormco. The logo is in blue and consists of the word "Ormco" in a bold, sans-serif font. To the right of the word "Ormco" is the trademark symbol. Below the word "Ormco" is the phrase "YOUR PRACTICE. OUR PRIORITY." in a smaller, sans-serif font.
Section V - 510(k) Summary for Spark™ Clear Aligner System K203737
1. Submitter Information:
Ormco Corporation 200 S. Kraemer Blvd, Brea, CA 92821
| Contact Person: | Frank Ray |
|---|---|
| Telephone Number: | (704) 587-7227 |
| Fax Number: | (704) 587-7250 |
Date Prepared: December 21, 2020
2. Device Name:
| Proprietary Name: | Spark™ Clear Aligner System |
|---|---|
| Manufacturer: | Ormco Corporation |
| Common Name: | Aligner, Sequential |
| Classification Name: | Orthodontic Plastic Bracket |
| CFR Number: | 872.5470 |
| Device Class: | II |
| Product Code: | NXC, PNN |
| Predicate Device (Primary): |
- Proprietary Name: Invisalign System (K143630) ●
- Manufacturer: Align Technology, Inc. ●
- Aligner, Sequential ● Common Name:
- Orthodontic Plastic Bracket ● Classification Name:
- CFR Number: 872.5470 ● II
- Device Class:
- NXC Product Code: ●
Reference Device:
| Proprietary Name: | Ormco™ Spark™ Aligner System (K182826) |
|---|---|
| Manufacturer: | Ormco Corporation |
| Common Name: | Aligner, Sequential |
| Classification Name: | Orthodontic Plastic Bracket |
| CFR Number: | 872.5470 |
| Device Class: | II |
- NXC Product Code: ●
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Reference Device #2:
- . Proprietary Name: Arcad SmileStudio and Aligner System (K192244)
- Manufacturer: ●
- Common Name: Aligner, Sequential
ArcadLab
-
Classification Name: Orthodontic Plastic Bracket
= -
CFR Number: 872.5470
-
o Device Class:
-
Product Code: NXC, PNN o
Description of Device: 4.
o
●
0
The Ormco Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state.
Treatment planning, aligner design and aliqner manufacture are supported by a proprietary software system. The Spark™ Clear Aligner system consists of multiple interfacing software modules; Web, Design, Anatomy, Approver, and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Trained technicians use the Ormco™ Spark™ Aligner Anatomy and Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.
The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time.
The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Several treatment options may be integrated into the Ormco Spark aligner consisting of:
- . Attachments: Attachments or "buttons" may be prescribed by the dental practitioner to facilitate tooth movement and aligner anchorage. The dental practitioner may choose a standard dental composite and adhesive to bond the attachments to the dentition.
- . Hooks: Hooks may be designed into the aligner, then connected by an elastic to a tooth-bonded button on the opposite arch, to apply additional forces.
- Bite ramps: Bite ramps are step features built into the lingual surfaces of the upper aligner arch that used by the clinician to prevent movement of the teeth during overbite correction treatment.
- Pontics: Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to fill voids of missing teeth or other gaps that the clinician may wish to retain during treatment.
- Posterior Bite Turbos: Posterior Bite Turbos (PBT) are designed to prevent complete closure of jaws.
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Principle of Operation / Mechanism of Action:
Orthodontic tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental clinician's prescription.
5. Indications for Use:
Spark™ Clear Aligner System:
The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Spark™ Software System:
The Spark™ Software System is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays, retainers or bracket bonding templates based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/ desired treatment objectives.
The use of the Spark™ Clear Aligner System and Spark™ Software System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
6. Description of Substantial Equivalence:
The Spark™ Clear Aligner System design or technical features have not been significantly modified since its clearance in 2018 (Reference Device #1, K182826). This section provides the substantial equivalence rationale for the Spark™ Clear Aligner System and the respective predicate devices with regards to Indications for Use, Technology, and Performance Testing. The differences between the subject device and the predicates do not raise different questions of substantial equivalence.
The similarities between the Spark™ Clear Aligner System (Subject Device) and the Primary Predicate Device Invisalign System (K143630), Reference Device #1 Ormco™ Spark™ Aligner System (K182826), and Reference Device #2 Arcad SmileStudio and Aligner System (K192244) as listed in Table 12.2 below are the Intended Use of the device, Indications for Use, Mode of Action, 3D software description, and treatment process. Also, the Attachments, Hook/Cutouts, Bite Ramps, and Pontics are available options. Furthermore, Biocompatibility testing, Software testing, and Material testing processes are similar.
The difference between the Spark™ Clear Aligner System (Subject Device) and Reference Device #1 Ormco™ Spark™ Aliqner System (K182826) is the material. The Thermoplastic polyurethane-polyester composite resin is the same however the composition slightly varies.
Table 5.2 below compares the Spark™ Clear Aligner System to the Primary predicate device (Invisalign System (K143630)), reference device #1 (Ormco™ Spark™ Aligner
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System (K182826)), and reference device #2 (Arcad SmileStudio and Aligner System (K192244)) with respect to intended use, technological characteristics and performance testing.
Device Comparison Table:
Table 5.2
| DescriptiveInformation | Subject DeviceSpark™ ClearAligner System | Predicate Device(Primary)Invisalign System(K143630) | ReferenceDevice #1Ormco™ Spark™Aligner System(K182826) | ReferenceDevice #2ArcadSmileStudioand AlignerSystem(K192244) | Comparison |
|---|---|---|---|---|---|
| PictorialRepresentation | Image: Spark Clear Aligner System | Image: Invisalign System | Image: Ormco Spark Aligner System | Image: Arcad SmileStudio and Aligner System | N/A |
| Regulatory Classification | |||||
| RegulationNumber | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR872.5470 | Same asPredicates |
| Regulation Title | OrthodonticPlastic Bracket | Orthodontic PlasticBracket | Orthodontic PlasticBracket | OrthodonticPlastic Bracket | Same asPredicates |
| Regulation Class | II | II | II | II | Same asPredicates |
| Product Code | NXC, PNN | NXC | NXC | NXC, PNN | Same asPredicates |
| Indications for Use/Intended Use | |||||
| Indications forUse | Spark™ ClearAligner System:The Spark™ ClearAligner System isindicated for thealignment ofteeth duringorthodontictreatment ofmalocclusion.Spark™ SoftwareSystem:The Spark™Software Systemis intended foruse as a medicalfront-end deviceproviding toolsfor managementof orthodonticmodels,systematicinspection,detailed analysis,treatmentsimulation andvirtual design ofa series of dentalcasts, which maybe used forsequential alignertrays, retainersor bracketbondingtemplates based | The Invisalign Systemis indicated for thealignment of teethduring orthodontictreatment ofmalocclusion. | The Ormco™Spark™ AlignerSystem is indicatedfor the alignment ofteeth duringorthodontictreatment ofmalocclusion inpatients withpermanentdentition (i.e., allsecond molars).The Ormco™Spark™ AlignerSystem positionsteeth by way ofcontinuous gentleforce. | The ArcadSmileStudio isintended foruse as amedical front-end deviceproviding toolsformanagement oforthodonticmodels,systematicinspection,detailedanalysis,treatmentsimulation andvirtual designof a series ofdental casts,whichmay be usedfor sequentialaligner trays orretainers,based on 3Dmodels of thepatient'sdentition beforethe start of anorthodontictreatment. Itcan also beapplied duringthe treatmentto inspect and | Same asPredicatesThe Indicationsfor Use for thebracket issubstantialequivalent tothe PrimaryPredicatedevice.The Indicationsfor Use for thesoftware issubstantialequivalent tothe Referencedevice #2. |
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| Intended Use | on 3D models ofthe patient'sdentition beforethe start of anorthodontictreatment. It canalso be appliedduring thetreatment toinspect andanalyze theprogress of thetreatment. It canbe used at theend of thetreatment toevaluate if theoutcome isconsistent withtheplanned/desiredtreatmentobjectives.The use of theSpark™ ClearAligner Systemand Spark™Software Systemrequires the userto have thenecessarytraining anddomainknowledge in thepractice oforthodontics, aswell to havereceived adedicated trainingin the use of thesoftware. | analyze theprogress of thetreatment. Itcan be used atthe end of thetreatment toevaluate if theoutcome isconsistent withtheplanned/desiredtreatmentobjectives.The ArcadAligner Systemis indicated forthe treatmentof toothmalocclusion inpatients withpermanentdentition (i.e.all secondmolars). TheArcad AlignerSystempositions teethby way ofcontinuousgentle force.The use of theArcad AlignerSystem andSmileStudiorequires theuser to havethe necessarytraining anddomainknowledge in thepractice oforthodontics, aswell to havereceived adedicatedtraining in theuse of thesoftware. | N/A | Same as Predicates | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Description ofApplianceApplication | Orthodontic tooth movement | movement | Orthodontic tooth movement | movement | Orthodontic tooth movement | movement | N/A | Same asPredicates | ||
| Intended User | DentalProfessional | Dental Professional | Dental Professional | N/A | Same asPredicates | |||||
| Technological Characteristics | ||||||||||
| Mode of Action | Orthodontic toothmovement occursthrough forcesapplied by theappliance to thedentition as eachtooth follows theprogrammeddisplacementbased on a | Orthodontic toothmovement occursthrough forces appliedby the appliance tothe dentition as eachtooth follows theprogrammeddisplacement basedon a doctor'sprescription. | Orthodontic toothmovement occursthrough forcesapplied by theappliance to thedentition as eachtooth follows theprogrammeddisplacement basedon a doctor'sprescription. | N/A | Same asPredicates |
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| doctor'sprescription. | |||||
|---|---|---|---|---|---|
| 3-D SoftwareDescription | The Spark™ ClearAligner System 3-D software usesscanned teethdata, landmarksand the clinician'sprescription todesign acorrected casesetup for theclinician's review.The output filesfrom thissoftware are sentto the clinician,who may suggestimprovements orapprove as-is formanufacture. Thesoftware is usedto produce pre-molds and moldsneeded for themanufacturing ofseries of custom-made aligners. | The Align 3-DSoftware uses a scanof a PVS impressionor a digital scan(which represents anuntreated state) togenerate the image ofa final, treated stateand then interprets aseries of images thatrepresentintermediate teethstates. The dentalpractitioner thenreviews these imagesand has the option toreject or requestmodifications to theset-up prior toapproving it foraligner fabrication.Once the dentalpractitioner approvesthe treatment plan,the software convertsthe files to producethe series of custom-made aligners. | The Ormco™Spark™ AlignerSystem 3-Dsoftware usesscanned teeth data,landmarks and theclinician'sprescription todesign a correctedcase setup for theclinician's review.The output filesfrom this softwareare sent to theclinician, who maysuggestimprovements orapprove as-is formanufacture. Thesoftware is used toproduce pre-moldsand molds neededfor themanufacturing ofseries of custom-made aligners. | N/A | Same asPredicates |
| Attachments | Available | Available | Available | N/A | Same asPredicates |
| Hook/Cutouts | Available | Available | Available | N/A | Same asPredicates |
| Bite ramps | Available | Available | Available | N/A | Same asPredicates |
| Pontics | Available | Available | Available | N/A | Same asPredicates |
| Single Use | Yes | Yes | Yes | N/A | Same asPredicates |
| Non-SterilePackaging | Yes | Yes | Yes | N/A | Same asPredicates |
| TreatmentProcess | The Spark™ ClearAligner System 3-D software usesscanned teethdata, landmarksand the clinician'sprescription todesign acorrected casesetup for theclinician's review.The output filesfrom thissoftware are sentto the clinician,who may suggestimprovements orapprove as-is formanufacture. Thesoftware is usedto produce pre-molds and molds | The Align 3-DSoftware uses a scanof a PVS impressionor a digital scan(which represents anuntreated state) togenerate the image ofa final, treated stateand then interprets aseries of images thatrepresentintermediate teethstates. The dentalpractitioner thenreviews these imagesand has the option toreject or requestmodifications to theset-up prior toapproving it foraligner fabrication.Once the dental | The Ormco™Spark™ AlignerSystem 3-Dsoftware usesscanned teeth data,landmarks and theclinician'sprescription todesign a correctedcase setup for theclinician's review.The output filesfrom this softwareare sent to theclinician, who maysuggestimprovements orapprove as-is formanufacture. Thesoftware is used toproduce pre-moldsand molds needed | N/A | Same asPredicates |
| needed for themanufacturing ofseries of custom-made aligners. | practitioner approvesthe treatment plan,the software convertsthe files to producethe series of custom-made aligners. | for themanufacturing ofseries of custom-made aligners. | |||
| Material | Thermoplasticpolyurethane-polyester compositeresin | Thermoplasticpolyurethane-polyester compositeresin | Thermoplasticpolyurethane-polyester compositeresin | N/A | Same asPredicates |
| Demonstratessufficient flexuralstrength, stressretention, stainresistance, andtransparency foruse as a clearaligner. | Demonstratessufficient flexuralstrength, stressretention, stainresistance, andtransparency for useas a clear aligner. | Demonstratessufficient flexuralstrength, stressretention, stainresistance, andtransparency foruse as a clearaligner. | N/A | Same asPredicates | |
| Performance testing | |||||
| Biocompatibilitytesting | Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing withina riskmanagementsystem). | Biocompatibleaccording to ISO10993-1(Biological evaluationof medical devices -Part 1: Evaluation andtesting within a riskmanagementsystem). | Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing within arisk managementsystem). | N/A | Same asPredicates |
| IEC 62304:2015-06CONSOLIDATEDVERSIONEdition 1.1 -Medical devicesoftware -Software life-cycle processes. | N/A | IEC 62304:2015-06CONSOLIDATEDVERSIONEdition 1.1 - Medicaldevice software -Software life-cycleprocesses. | N/A | Same asPredicate #2 | |
| ASTM D790-10:2010-04-01Standard TestMethods forFlexuralProperties ofUnreinforced andReinforcedPlastics andElectricalInsulatingMaterials. | N/A | ASTM D790-10:2010-04-01Standard TestMethods for FlexuralProperties ofUnreinforced andReinforced Plasticsand ElectricalInsulatingMaterials. | N/A | Same asPredicate #2 |
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Non-Clinical Test Data:
Performance bench testing according to international standards for Aligners, Sequential has been conducted to determine conformance in regards to:
- o Biocompatibility has been completed for the applicable components.
- Comparative performance testing of the functions of the Proposed device compared to the . cleared stand-a-lone device.
Furthermore, the performance of the Spark™ Clear Aligner System has been verified utilizing the following standards:
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- ISO 10993-1:2018: Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process.
- o ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
- . ISO 10993-6:2016: Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.
- ISO 10993-10:2010: Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11:2017: Biological evaluation of medical devices—Part 11: Tests for systemic ● toxicity.
- ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
- ISO 14971:2007: Medical devices Application of risk management to medical devices. ●
- . IEC 62304:2015-06: Medical device software - Software life-cycle processes.
- IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical ● devices.
- o ASTM D790-10: 2010: Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials.
- . ASTM F1980-16: 2016: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on wellestablished scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the Spark™ Clear Aligner System is deemed to be substantially equivalent to the predicate device.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.