The Invisalign System (subject device) consists of removable orthodontic appliances (aligners), proprietary 3D software and attachment template. The 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 mandibular advancement feature positions patients iaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition. The Invisalign System is intended for treating dental and skeletal malocclusion in patients with Class I, II and III including Antoro-Posterior (A-P), vertical (open 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 treatment may be needed at the doctor's discretion.

The Invisalign System aligners consist of a series of customized orthodontic devices made from proprietary thermoformed polyurethane sheeting material. The first device in the series matches the patient's dentition in its current state and then each subsequent aligner stage has the shape of the dentition shifted gradually toward the final desired position. The aligners can accommodate use of tooth attachments and elastics (through use of precision cut outs or buttons or power arms). The system can also be ordered with additional aligner features such as precision cut outs, bite ramps, compliance indicators, and mandibular advancement features (MAF). MAF is also referred to as precision wings and is prescribed by the dental practitioner to position the lower jaw forward during correction of skeletal malocclusion. The subject device system of this Special 510(k), referred to as the Invisalign System, is a modification to the predicate device the Invisalign System with Mandibular Advancement Feature (MAF) (K181739, cleared on Oct 26, 2018) and is inclusive of both standard aligners and aligners with mandibular advancement feature.

The proprietary ClinCheck (CC) 3-D software is inclusive of both dental practitioner-facing functions and internal Align personnel-facing functions. The Align personnel-facing functions are termed 'Treat' internally. This internal 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 (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, a disposable template is provided to assist the dental practitioner in positioning and forming the attachments from dental composite (sold separately). Attachment templates are disposable polyurethane appliances which match the patient's existing dentition and include wells for the placement of dental composite. 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 in aligner retention or optimized aligner force system for tooth movement.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for the Invisalign System. It outlines the regulatory clearance for the device based on its substantial equivalence to a predicate device.

Crucially, this document states that there were no proposed design changes and that the changes submitted were minor labeling updates. Therefore, no new performance data, clinical testing, or animal testing was required for this particular submission (K220287). The document explicitly states:

"There are no proposed design changes in the scope of this pre-market notification. The proposed labelling changes do not trigger any performance testing as the changes are minor clarifications and additions that do not impact the current safety and effectiveness profile of the Invisalign System."
"No animal or clinical testing was required to validate these labeling modifications."

Given this information, it is not possible to describe acceptance criteria or a study that proves the device meets actual performance criteria based on the provided text, as no such study was conducted for this specific 510(k) submission.

The information requested in your prompt (acceptance criteria, sample size, expert ground truth, MRMC studies, standalone performance, training set details) pertains to a typical performance study for a medical device. Since this 510(k) was based on "substantial equivalence" due to minor labeling changes and no design changes, these types of performance studies were not a part of this particular submission for the new clearance (K220287). The safety and effectiveness were considered established by the predicate device (K181739).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using only the provided text, as the text explicitly states no such studies were required or conducted for this specific submission.

Summary

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April 7, 2022

Align Technology, Inc. Shweta Daga Director, Regulatory Affairs 2820 Orchard Parkway San Jose, California 95134

Re: K220287

Trade/Device Name: Invisalign System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: March 10, 2022 Received: March 11, 2022

Dear Shweta Daga:

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 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

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Indications for Use

510(k) Number (if known) K220287

Device Name

Invisalign 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart G)
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Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Align Technology's Invisalign System

General Information

510(k) Sponsor	Align Technology, Inc.
Address	2820 Orchard ParkwaySan Jose, CA 95134
FDA Registration Number	2953749
Contact Person	Shweta DagaDirector, Regulatory AffairsAlign Technology, Inc.
Contact Information	Email: sdaga@aligntech.comPhone: +1 408-470-1000Fax: +1408-470-1010
Date Prepared	Jan 31, 2022

Name of Device and Name/Address of Sponsor

Name of Device	Invisalign System
Name/Address of Sponsor	Align Technology, Inc.2820 Orchard ParkwaySan Jose, CA 95134
Trade/Proprietary Name	Invisalign System
Common Name	Aligner, Sequential
Classification Name	Orthodontic Plastic Bracket

Predicate Device

Name of Device	Invisalign System with Mandibular Advancement Feature (MAF)
Name/Address of Sponsor	Align Technology, Inc.2820 Orchard ParkwaySan Jose, CA 95134
Trade/Proprietary Name	Invisalign System with Mandibular Advancement Feature
Common Name	Aligner, Sequential
Classification Name	Orthodontic Plastic Bracket

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Purpose of the Special 510(k) notice.

The purpose of this Special 510(k) notice is to request clearance for proposed changes related to labeling material which include the Doctor's Instructions for Use (IFU), and Patient's IFU, with minor changes and clarifications made based on post-market data. Additionally, this Special 510(k) premarket notification describes all non-significant changes implemented through documentation since the last 510(k) clearance.

Intended Use

The Invisalign System is indicated for the orthodontic treatment of malocclusion.

Device Description

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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 in aligner retention or optimized aligner force system for tooth movement.

All these components and features were available with the predicate device.

Comparison with Predicate Device

Proposed modified device and predicate device have the same indications for use, intended use, technological characteristics, and principle of operation. The material of the Modified Device is identical to the Predicate Device.

The differences between the modified device and the predicate device are minor labeling updates which do not raise any questions regarding safety and effectiveness. 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 (subject device) has no proposed changes to its technological characteristics. The proposed labeling changes do not alter any technological characteristics and do not impact the current safety and effectiveness profile of the Invisalign System.

The Invisalign System with minor modifications implemented to date through documentation to file has similar technological characteristics as the predicate device - Invisalign System with Mandibular Advancement Feature (cleared in K181739). The material and mode of action are unchanged and no new aligner features have been introduced.

ComparisonCriteria	Subject/ Modified Device	Predicate/ Existing Device(K181739)	ComparisonAssessment
Indications forUse	The Invisalign System isintended for the orthodontictreatment of malocclusion.	The Invisalign System isintended for the orthodontictreatment of malocclusion.	Same as predicatedevice
In Use Duration	Aligners are worn forapproximately 1-2 weeks of 20-22 hours of wear per day, afterwhich it is replaced by the nextstage aligners. This is repeatedfor duration as prescribed bythe Dental Practitioner.	Aligners are worn forapproximately 1-2 weeks of 20-22 hours of wear per day, afterwhich it is replaced by the nextstage aligners. This is repeatedfor duration as prescribed bythe Dental Practitioner.	Same as predicatedevice
PatientPopulation	Children, Adolescents andAdults	Pediatrics and Adults	Same as predicatedevice
Use Location	Dental intraoral Devices	Dental intraoral Devices	Same as predicatedevice
OTC orPrescription (Rx)Device	Rx only	Rx only	Same as predicatedevice

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ComparisonCriteria	Subject/ Modified Device	Predicate/ Existing Device(K181739)	ComparisonAssessment
		Design
OperatingPrinciple	Aligners: Sequential alignersapply continuous gentle force tothe teeth and/or positionmandible forward.3D Software: Produces 3D-model file of the PVSimpression or the digital scan.Identifies the individual teeththat require treatment (i.e.,repositioning). Creates atreatment plan (i.e., 3-D modelsthat represent the treatmentplan) which is reviewed by thetreating dental practitioner usingClinCheck's doctor facingfunction to reject or requestmodifications to the set-up priorto approval.	Aligners: Sequential alignersapply continuous gentle force tothe teeth and position mandibleforward3D Software: Produces 3D-model file of the PVSimpression or the digital scan.Identifies the individual teeththat require treatment (i.e.,repositioning). Creates atreatment plan (i.e., 3-D modelsthat represent the treatmentplan) which is reviewed by thetreating dental practitioner usingClinCheck's doctor facingfunction to reject or requestmodifications to the set-up priorto approval.	Same as predicatedeviceNote, mandibleadvancement featuresuch as precisionwings is an optionalfeature offeredthrough the predicatedevice.
Materials	Thermoplastic polymer	Thermoplastic polymer	Same as predicatedevice
Lower JawAdjustmentMechanism	Invisalign System aligners withmandibular advancementfeature (MAF) such asenhanced precision wings witha curved design.For Invisalign system withstandard aligners this is notapplicable.	Invisalign System MandibularAdvancement Feature wingssuch as enhanced precisionwings with a curved design	Same as predicatedeviceNote, mandibleadvancement featuresuch as precisionwings is an optionalfeature offeredthrough predicatedevice.

Performance Data

There are no proposed design changes in the scope of this pre-market notification. The proposed labelling changes do not trigger any performance testing as the changes are minor clarifications and additions that do not impact the current safety and effectiveness profile of the Invisalign System. No animal or clinical testing was required to validate these labeling modifications.

Substantial Equivalence

The Invisalign System (Subject Device) and the previously cleared predicate Invisalign System with Mandibular Advancement are similar in that they have:

same intended use,
. same indications for use,
. same principles of operation, and
same technological characteristics.

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The primary change introduced to the Invisalign System through the Special 510(k) submission is proposed labeling updates to the doctor and patient instruction for use. There are no proposed design changes as part of this submission.

Conclusion

Align Technology's Invisalign System has the same intended use and indications for use as the previously cleared Invisalign System with Mandibular Advancement Feature (MAF) (K181739). In addition, the Invisalign System has the same technological characteristics, and principles of operation as its predicate. The minor labeling differences between the Invisalign System and its predicate device do not raise new questions of safety or efficacy. Thus, the Invisalign System is substantially equivalent.

Regulation Number and Section

§ 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.