Invisalign System, Pre-Formed Attachment System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration." December 22, 2022 Align Technology, Inc. John Ray Principal, Regulatory Affairs 2820 Orchard Parkway San Jose. California 95134 Re: K222894 Trade/Device Name: Invisalign System, Pre-Formed Attachment System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 23, 2022 Received: September 23, 2022 Dear John 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. {1}------------------------------------------------ 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 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 -S Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222894 Device Name Invisalign System with Pre-Formed Attachment System Indications for Use (Describe) The Invisalign System is intended for the orthodontic treatment of malocclusion. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 7: 510(K) Summary Align Technology's Invisalign System with Pre-Formed Attachment System #### General Information | 510(k) Sponsor | Align Technology, Inc. | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 2820 Orchard Parkway<br>San Jose, CA 95134 | | FDA Registration Number | 2953749 | | Contact Person | Manjunath Bisalehalli<br>Manager, Regulatory Affairs<br>Align Technology, Inc.<br><br>cc: Shweta Daga<br>Director, Regulatory Affairs<br>Align Technology Inc. | | Contact Information | Email: mbisalehalli@aligntech.com<br>Phone: +1 408-789-1743<br>Cell Phone: +1 412-298-4604<br>Fax: +1408-470-1010 | | Date Prepared | September 23, 2022 | #### Name of Modified Device and Name/Address of Sponsor | Name of Device | Invisalign System with Pre-Formed Attachment System | |-------------------------|--------------------------------------------------------------------| | Name/Address of Sponsor | Align Technology, Inc.<br>2820 Orchard Parkway, San Jose, CA 95134 | | Trade/Proprietary Name | Invisalign System<br>Pre-Formed Attachment System | | Common Name | Aligner, Sequential | | Classification Name | Orthodontic Plastic Bracket | | Regulation Number | 21 CFR 872.5470 | | Product Code | NXC | | Regulatory Class | II | #### Predicate Device | Name of Device | Invisalign System | |-------------------------|--------------------------------------------------------------------| | Name/Address of Sponsor | Align Technology, Inc.<br>2820 Orchard Parkway, San Jose, CA 95134 | | Trade/Proprietary Name | Invisalign System | | Common Name | Aligner, Sequential | | Classification Name | Orthodontic Plastic Bracket | | Regulation Number | 21 CFR 872.5470 | | Product Code | NXC | | Regulatory Class | II | {4}------------------------------------------------ ## Purpose of the Traditional 510(k) notice The purpose of this Traditional 510(k) notice is to request clearance for the addition of Pre-Formed Attachment (PFA) System to the Invisalign System's existing components. The PFA system is an optional alternative attachments bonding mechanism for Invisalign treatment. Additionally, the Traditional 510(k) introduces the proprietary, 3D device-generation manufacturing software, labeling documentation associated with the PFA system, and the nonsignificant changes to the Invisalign System implementation since the last 510(k) clearance. #### Intended Use The Invisalign System with the Pre-Formed Attachment System (Modified device) has the same intended use as the cleared Predicate device, the Invisalign System (K220287), which is as follows: The Invisalign System is indicated for the orthodontic treatment of malocclusion. # Device Description The subject device, Invisalign System with Pre-Formed Attachments (PFA) System, is a modification to the predicate device, the Invisalign System (K220287, cleared on April 7th, 2022). The Invisalign System with PFA system consists of removable orthodontic appliances (aligners), proprietary treatment planning 3D software, attachment templates and/or PFA system. Like the predicate device, the Invisalign system with PFA (subject device) consists of a series of doctor prescribed, customized, thin, clear plastic aligners that gently move the patient's teeth in small increments from their original state to a more optimal, treated state to address dental malocclusion. The Invisalian system aligners are used in patients with primary, mixed (primary and permanent), and permanent dentition. The Invisalign system aligners with mandibular advancement feature(s) are used in patients with mixed and permanent dentition to correct Class II malocclusions. The Invisalign system is intended to treat dental and skeletal malocclusion in patients with Class I, II and III including Antero-Posterior (A-P), vertical (open bite, deep bite), transverse (narrow arch or jaw, crossbite), or inter-arch (spacing and crowding) correction at all severity levels. In some cases, surgical intervention, or addition of other appliances in addition to Invisalign treatment may be needed at the doctor's discretion. The proprietary ClinCheck (CC) 3-D software is inclusive of both dental practitioner-facing functions and internal Align personnel-facing functions. The Align facing software enables Align's computer-aided design (CAD) designers to create a treatment plan based on a doctor's prescription and inputs (e.g., dental scans). The treatment plans created using the Align personnel-facing software are then reviewed and approved by doctors before the aligners are manufactured. The doctors' reviews and approvals are exchanged via ClinCheck software {5}------------------------------------------------ (dental practitioner-facing software). Once the treatment plan is approved by the dental practitioner, the information is sent to the manufacturing facility for creation of the aligners. When attachments are prescribed as part of the treatment plan, the subject device has the option of delivering them preformed with PFA system or with a disposable attachment template. The attachment templates are disposable polyurethane appliances which match the patient's existing dentition and include wells for the placement of dental composite (sold separately). During the first visit, the dental practitioner uses the template in bonding dental composite to the tooth surface to create attachments on the teeth. These attachments help create forces on the tooth which can assist aligner retention or optimized aligner force system for tooth movement. The PFAs are made of a fully cured proprietary photo-polymerizable methacrylate-based resin (similar to dental composite material). PFA system is intended to enable correct placement of attachments and bond attachments to the tooth surface for aligner retention and to optimize aligner force system for tooth movement. The patient-customized PFA are manufactured using additive manufacturing technologies and configured to individual patient's treatment plans and teeth anatomy using a proprietary internal facing 3D device-generation manufacturing software. {6}------------------------------------------------ ## Comparison with Predicate Device In accordance with 21 CFR 807.92(a)(6) a summary of the technological characteristics' comparison of the proposed modified device to the predicate Device is provided below. #### Technological Characteristics comparison with the Predicate Device The Invisalign System with Pre-Formed Attachment (PFA) System (subject device) introduces an alternative attachment delivery mechanism to Invisalign treatment. The proposed change does not alter the aligners' technological characteristics and does not impact the current safety and effectiveness profile of the Invisalign System. | | Invisalign System with PFA System<br>Subject/Modified Device | Invisalign System (K220287)<br>Predicate/ Existing Device | Comparison<br>Assessment | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/<br>Indication for<br>Use | The Invisalign System is<br>intended for the orthodontic<br>treatment of malocclusion. | The Invisalign System is<br>intended for the orthodontic<br>treatment of malocclusion. | Same as predicate device | | Patient<br>Population | Children, Adolescents and<br>Adults | Children, Adolescents and<br>Adults | Same as predicate device | | Use Location | Dental intraoral Devices | Dental intraoral Devices | Same as predicate device | | OTC or<br>Prescription<br>(Rx) Device | Rx only | Rx only | Same as predicate device | | | Technological Characteristics | | | | Principle of<br>Operation | Aligners: Sequential aligners<br>apply continuous gentle force<br>to the teeth and/or position<br>mandible forward. | Aligners: Sequential aligners<br>apply continuous gentle force<br>to the teeth and position<br>mandible forward | Same as predicate device | | | 3D Software: Produces 3D-<br>model file of the PVS<br>impression or the digital scan.<br>Identifies the individual teeth<br>that requires treatment (i.e.,<br>repositioning). Creates a<br>treatment plan (i.e., 3-D<br>models that represent the<br>treatment plan) which is<br>reviewed by the treating dental<br>practitioner using ClinCheck's<br>doctor facing function to reject<br>or request modifications to the<br>set-up prior to approval. | 3D Software: Produces 3D-<br>model file of the PVS<br>impression or the digital scan.<br>Identifies the individual teeth<br>that requires treatment (i.e.,<br>repositioning). Creates a<br>treatment plan (i.e., 3-D<br>models that represent the<br>treatment plan) which is<br>reviewed by the treating dental<br>practitioner using ClinCheck's<br>doctor facing function to reject<br>or request modifications to the<br>set-up prior to approval. | Same as predicate device | | | Delivery Mechanism of Attachment | | | | | 1) Attachment Template -<br>Bonds dental composite<br>(material provided by doctor)<br>to the tooth surface to create<br>attachments used for aligner<br>retention or optimized aligner | 1) Attachment Template -<br>Bonds dental composite<br>(material provided by doctor)<br>to the tooth surface to create<br>attachments used for aligner<br>retention or optimized aligner | Same as predicate device | | | Invisalign System with PFA<br>System<br>Subject/Modified Device | Invisalign System (K220287)<br>Predicate/ Existing Device | Comparison<br>Assessment | | | force system for tooth<br>movement.<br>Delivery Mechanism: formed<br>by dental practitioner who fills<br>and packs wells in the<br>Template tray with<br>commercially available dental<br>composite. The final shape &<br>configuration is cured when | force system for tooth<br>movement.<br>Delivery Mechanism: formed<br>by dental practitioner who fills<br>and packs wells in the<br>Template tray with<br>commercially available dental<br>composite. The final shape &<br>configuration is cured when | | | | tray is seated on dentition.<br>2) PFA System –<br>enables correct placement of<br>attachments and bond<br>attachments to the tooth<br>surface for aligner retention<br>and to optimize aligner force<br>for tooth movement.<br>Delivery of Mechanism: the<br>attachment shape and<br>configuration defined by the<br>treatment plan, manufactured<br>together with positioner. The<br>shapes are cured to the tooth<br>when the positioner is seated<br>on dentition | tray is seated on dentition.<br>2) Not applicable | Similar to predicate<br>device<br>The attachment<br>configuration prescribed<br>by treatment is identical to<br>the predicate device,<br>however the mechanism<br>of delivery attachments<br>onto the dentition is<br>different. Therefore, the<br>subject device is<br>substantially equivalent to<br>the predicate device | | Material | Aligners and Attachment<br>Templates - Thermoplastic<br>polymer | Aligners and Attachment<br>Templates - Thermoplastic<br>polymer | Same as predicate device | | | PFA System - Photo-<br>polymerizable methacrylate-<br>based resin | Not applicable | Similar to predicate<br>device<br>Although the material is<br>different when the<br>alternative attachment<br>delivery mechanism, pre-<br>formed attachments, is<br>prescribed by the Doctor.<br>The pre-formed<br>attachments material is<br>biocompatible and has<br>demonstrated that it can<br>deliver the force system<br>with the Invisalign System. | | Lower Jaw<br>Adjustment<br>Mechanism | Invisalign System aligners with<br>mandibular advancement<br>feature (MAF) such as<br>enhanced precision wings with<br>a curved design. For Invisalign<br>system with standard aligners<br>this is not applicable. | Invisalign System aligners with<br>mandibular advancement<br>feature (MAF) such as<br>enhanced precision wings with<br>a curved design. For Invisalign<br>system with standard aligners<br>this is not applicable. | Same as predicate device | {7}------------------------------------------------ {8}------------------------------------------------ # Performance Data The existing Invisalign System's components: aligners, 3D software and attachment template, remain unchanged from the predicate device. The newly added PFA system as an optional alternative attachment delivery mechanism, underwent a complete set of functional and performance testing; including, but not limited to bond strength, stain resistance, wear, force measurement, volume precision, and usability testing. Based on the performance testing outcomes, the proposed addition of PFA system does not impact the current safety and effectiveness profile of the Invisalign System and is substantially equivalent to the predicate device. No animal or clinical testing was required to validate these modifications implemented to the Invisalign System. # Biocompatibility The existing Invisalign System's components: aligners, 3D software and attachment template, remain unchanged from the predicate device. Biocompatibility testing was completed for the proposed PFA system and assessed in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and ISO 7405, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. The results demonstrate that the PFA system does not pose any significant biologicals risks and is considered safe for its intended use in humans. # Software Testing In accordance with IEC 62304. Medical device software - Software life cycle processes; successful software verification and validation (V&V) testing at the unit, integration, and system level was performed to qualify the newly added software with the subject device. ## Substantial Equivalence The subject device is a modification to the predicate device, Invisalign System (K220287), which was cleared on April 7th, 2022. The subject device and the previously cleared predicate device are similar in that they have: - same intended use, - same indications for use, - . similar principles of operation, and - similar technological characteristics The minor differences in the principles of operation and technological characteristics between the subject device and predicate device do not raise different questions of safety or efficacy. Therefore, the subject device is found to be substantially equivalent to the legally marketed predicate device, Invisalign System (K220287). {9}------------------------------------------------ # Conclusion Align Technology's Invisalign system with the PFA system has the same intended use and indications for use as the previously cleared Invisalign system (K220287). The minor principles of operation and technological differences between the subject device and its predicate device do not raise new issues of safety or effectiveness. Performance data and biocompatibility testing demonstrate that the subject device is as safe and effective as the predicate Invisalign System. Thus, the modified Invisalign system with PFA system is substantially equivalent to the predicate device.