Invisalign System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. June 18, 2024 Align Technology, Inc. Nestor Vazquez Salgado Sr. Regulatory Affairs Specialist I 2820 Orchard Parkway San Jose, California 95134 Re: K241412 Trade/Device Name: Invisalign System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC. PNN Dated: May 17, 2024 Received: May 17, 2024 Dear Nestor Vazquez Salgado: 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 (the 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 available 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Michael E. Adjodha -S Michael E. Adjodha, MChE, RAC, CQIA 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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) K241412 Device Name Invisalign System #### Indications for Use (Describe) The Invisalign® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition. 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) #### 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." {4}------------------------------------------------ # K241412 - 510(k) Summary # Align Technology's Invisalign System #### General Information | 510(k) Sponsor | Align Technology, Inc. | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 2820 Orchard Parkway<br>San Jose, CA 95134 | | FDA Registration Number | 2953749 | | Contact Person | Nestor Vazquez Salgado<br>Sr. Regulatory Affairs Specialist<br>Align Technology, Inc.<br><br>cc: Niya Su<br>Sr. Manager, Regulatory Affairs<br>Align Technology Inc. | | Contact Information | Email: nevazquez@aligntech.com<br>Phone: +1 408-470-1000<br>Cell Phone: +1 412-298-4604<br>Fax: +1408-470-1010 | | Date Prepared | June 13, 2024 | # Name of Modified Device and Name/Address of Sponsor | Name of Device | Invisalign System | |-------------------------|----------------------------------------------------------------------| | Name/Address of Sponsor | Align Technology, Inc.<br>2820 Orchard Parkway<br>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 - Aligners<br>PNN – Proprietary 3D Treatment Planning Software | | Regulatory Class | II | {5}------------------------------------------------ | Name of Device | Invisalign System with Mandibular Advancement Featuring Occlusal<br>Blocks | |-------------------------|----------------------------------------------------------------------------| | Name/Address of Sponsor | Align Technology, Inc. | | | 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 | | 510(k) number | K232233 | #### Predicate Device #### Purpose of the Special 510(K) Notice The purpose of this Special 510(k) notice is to request clearance for an additional treatment planning workflow. Additionally, this pre-market notification adds PNN as the appropriate product code for the Invisalign System proprietary 3D treatment planning software and summarizes the non-significant changes that were implemented via Letter to File. #### Intended Use The Invisalign System (subject device) has the same intended use as the cleared predicate device (K232233), which is as follows: "The Invisalian® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition." #### Device Description The subject device, Invisalign System, is a modification to the predicate device, Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233, cleared on September 26, 2023) to introduce an additional treatment planning workflow that does not require any Align Computer Aided Design (CAD) technician interaction. The Invisalign System consists of removable orthodontic appliances (aligners) and proprietary 3D treatment planning software. As part of this submission, there are no proposed design changes made to standard {6}------------------------------------------------ aligners or aligners with Mandibular Advancement Features (MAF) since the clearance of K232233. Further, there are no proposed changes to the proprietary 3D treatment planning software except for the non-significant changes that were implemented via Letter to File. Like the predicate device, the Invisalign System 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 malocclusion. The optional MAF positions patients jaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition. The proposed modification in this premarket notification is to add a completely automated endto-end treatment planning workflow without CAD technician involvement. The subject device, Invisalign System, is the Invisalign System aligners produced with the additional treatment planning workflow. There are no proposed design changes to the Invisalign System components as part of this submission. ## 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 Compared to the predicate device, the modified device does not change the Invisalign System's technological characteristics. All testing passed acceptance criteria and demonstrated the device modification do not affect the safety and effectiveness of Invisalign System, and do not raise any new questions of safety and effectiveness. A high-level device comparison is provided below in Table 1. | | Invisalign System<br>Subject Device | Invisalign System with<br>Mandibular Advancement<br>Featuring Occlusal<br>Blocks (K232233) –<br>Primary Predicate Device | Substantial<br>Equivalence | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use, User Population | | | | | Intended Use/<br>Indication for<br>Use | The Invisalign System is<br>intended for the orthodontic<br>treatment of malocclusion<br>in patients with primary,<br>mixed (primary and<br>permanent), or permanent<br>dentition. The optional | The Invisalign System is<br>intended for the orthodontic<br>treatment of malocclusion<br>in patients with primary,<br>mixed (primary and<br>permanent), or permanent<br>dentition. The optional | Same as predicate<br>device. | | | mandibular advancement<br>feature(s) are indicated for<br>the treatment of skeletal<br>malocclusion in patients<br>with mixed or permanent<br>dentition. | | | | Patient<br>Population | Children, Adolescents_and<br>Adults | Children, Adolescents, and<br>Adults | Same as predicate<br>device. | | Use Location | Dental intraoral Devices | Dental intraoral Devices | Same as predicate<br>device. | | OTC or<br>Prescription<br>(Rx) Device | Rx only | Rx only | Same as predicate<br>device. | | Technological Characteristics | | | | | Principle of<br>Operation | Aligners: Sequential<br>aligners apply continuous<br>gentle force to the teeth and<br>position mandible forward.<br><br>Proprietary 3D Treatment<br>Planning Software:<br>Produces 3D-model file of<br>the PVS impression or the<br>digital scan. Identifies all<br>individual teeth that require<br>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<br>dental practitioner using<br>ClinCheck's doctor facing<br>function to reject or request<br>modifications to the set-up<br>prior to approval.<br><br>Delivery Mechanism of<br>Attachment:<br>1. Attachment Template -<br>attachments are formed<br>by dental practitioner who<br>fills and packs wells in the<br>Template tray with<br>commercially available<br>dental composite. The | Aligners: Sequential<br>aligners apply continuous<br>gentle force to the teeth<br>and/or position mandible<br>forward.<br><br>Proprietary 3D Treatment<br>Planning Software:<br>Produces 3D-model file of<br>the PVS impression or the<br>digital scan. Identifies all<br>individual teeth that<br>require 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<br>dental practitioner using<br>ClinCheck's doctor facing<br>function to reject or<br>request modifications to<br>the set-up prior to<br>approval.<br><br>Delivery Mechanism of<br>Attachment:<br>Attachment Template -<br>attachments are formed by<br>dental practitioner who fills<br>and packs wells in the | Same as predicate<br>device<br><br>Subject device is<br>inclusive of an<br>additional optional<br>attachment delivery<br>mechanism, Invisalign<br>Pre-Formed<br>Attachment System,<br>which has been<br>cleared in 510(k)<br>K222894. | | | final shape &<br>configuration is cured<br>when template is seated<br>on dentition; or,<br>2. Invisalign Pre-formed<br>Attachment System - an<br>optional alternative<br>attachment delivery<br>mechanism. It enables<br>correct placement of<br>attachments and bond<br>attachments to the tooth<br>surface. The attachment<br>shape and configuration<br>defined by the Invisalign<br>System treatment plan,<br>manufactured together<br>with positioner. The<br>attachment shapes are<br>cured to the tooth when<br>the positioner is seated<br>on dentition. | Template tray with<br>commercially available<br>dental composite. The final<br>shape & configuration is<br>cured when template is<br>seated on dentition. | | | Materials | Thermoplastic polymer | Thermoplastic polymer | Same as predicate<br>device. | | | Treatment Planning Workflows | | | | End-to-end<br>Treatment<br>Planning<br>Workflow | Includes the following<br>workflows:<br>● Completely Manual<br>● Combination of<br>Manual and<br>Automated<br>● Fully Automated<br>Workflow | Includes the following<br>workflows:<br>● Completely Manual<br>● Combination of<br>Manual and<br>Automated | Similar to predicate<br>device.<br>The subject device<br>introduces an additional<br>automated end-to-end<br>treatment planning<br>workflow. All existing<br>workflows remain<br>unchanged. Verification<br>and validation (V&V)<br>testing demonstrated<br>the additional workflow<br>achieved the same<br>treatment plan and<br>aligners output as<br>existing workflows;<br>therefore, the change<br>does not affect the<br>safety and | Table 1: Device Comparison Table {7}------------------------------------------------ # Align™ Invisalign System US FDA Special 510(k) — 510(k) Summary {8}------------------------------------------------ {9}------------------------------------------------ | | effectiveness of the | |--|----------------------| | | Invisalign System. | #### Performance Data There are no proposed design changes in the scope of this pre-market notification regarding existing Invisalign System's components (that is aligners and proprietary 3D treatment planning software) or accessories. Verification and validation testing activities were performed to evaluate the modified device. All testing passed acceptance criteria and demonstrated the device modification does not affect the substantial equivalence of the Invisalign System. #### Biocompatibility There are no proposed device design nor packaging changes as part of this submission: therefore, no biocompatibility information is needed. #### Software Testing There are no proposed changes to the Invisalign System proprietary 3D treatment planning software as part of this pre-market notification; however, the software changes required verification and validation (V&V) testing at the unit, integration, and system level. Verification and validation testing activities were performed to evaluate the modified device. All testing passed acceptance criteria and demonstrated the device modification does not affect substantial equivalence of the Invisalign System. #### Substantial Equivalence The Invisalign System (subject device) is a modification to the predicate device, Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233), which was cleared on September 26, 2023. The subject device and the predicate device have the following similarities: - Same Intended Use/Indications for Use ● - Same principles of operation - . Same technological characteristics - . Same device design, such as product specification, material, and product performance The subject device and predicate device have the following differences: - Subject device has an additional completely automated treatment planning workflow . without Align CAD technician involvement. Verification and validation testing activities were performed to evaluate the modified device. All testing passed acceptance criteria and demonstrated the device modification does not affect the Substantial equivalence of the Invisalign System. {10}------------------------------------------------ ## Conclusion The subject/modified device has the same intended use and indications for use, principles of operation, technological characteristics, and device design as the predicate device. The subject device has an additional completely automated treatment planning workflow that is not available in the predicate device. Verification and validation testing demonstrated the differences do not affect the substantial equivalence of the Invisalign System.