(61 days)
The Invisalign 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.
The subject device, Invisalian System with Mandibular Advancement Featuring Occlusal Blocks (Invisalign System, MAOB) is a modification to the predicate device, Invisalign System (K220287, cleared on April 07, 2022) and the reference device. Invisalign System with Mandibular Advancement Features (K181739, cleared on October 26th, 2018). The Invisalign System, MAOB (subject device) consists of removable orthodontic appliances (aligners with mandibular advancement features including occlusal blocks), proprietary treatment planning 3D software (doctor facing - ClinCheck and Align employee facing -Treat) and attachment templates.
The provided text describes a 510(k) premarket notification for a medical device (Invisalign System with Mandibular Advancement Featuring Occlusal Blocks) and its substantial equivalence to a predicate device. However, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria, particularly concerning AI or software performance characteristics.
The document primarily focuses on:
- Regulatory Clearance: The FDA's substantial equivalence determination.
- Device Description: What the device is and how it functions.
- Comparison to Predicate: How the modified device compares to existing, cleared devices.
- Testing Summary: High-level statements about bench testing, biocompatibility, and software V&V.
**Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (since specific performance metrics and acceptance thresholds for the software are not detailed).
- Sample sizes for a test set or data provenance (no specific AI performance study data is presented).
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used for specific AI performance.
- Sample size for the training set.
- How ground truth for the training set was established.**
The document states:
- 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 modified software with the subject device." This indicates that standard software V&V was performed, but details on specific acceptance criteria for performance related to image analysis or treatment planning accuracy that would typically be associated with an AI/ML device are not provided. The phrase "proprietary, 3D treatment planning software" is mentioned, but no performance claims or supporting study data for this software's accuracy are included in this FDA letter/summary.
- No Animal or Clinical Testing: "No animal or clinical testing was required or performed for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks." This further indicates that the detailed performance study you are asking for, especially involving human observers or patient outcomes, was not part of this specific submission.
In summary, the provided text is a regulatory clearance document, not a detailed technical report on AI/ML model performance. It confirms that the device's modifications (addition of occlusal blocks and associated software updates) were deemed substantially equivalent to a predicate device based on bench testing, biocompatibility, and general software V&V, without specific performance metrics or studies relating to AI/ML accuracy or efficacy as you've requested.
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September 26, 2023
Align Technology, Inc. John Ray Principal, Regulatory Affairs 2820 Orchard Parkway San Jose, California 95134
Re: K232233
Trade/Device Name: Invisalign System with Mandibular Advancement Featuring Occlusal Blocks Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: July 26, 2023 Received: July 27, 2023
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 (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.
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).
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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 OS 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).
Sincerely,
Bobak Shirmohammad ાં -ડ
For Michael E. Adjodha, M. ChE., COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
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Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Section 6: Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 | Expiration Date: 06/30/2023 |
|---|---|
| See PRA Statement below. |
| 510(k) Number (if known) | K232233 |
|---|---|
| Device Name | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (OB) |
Indications for Use (Describe)
The Invisalign 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.
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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Align Technology
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks Traditional 510(k)
Section 7: 510(K) Summary
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Section 7: 510(K) Summary
K232233
Align Technology's Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
General Information
| 510(k) Sponsor | Align Technology, Inc. |
|---|---|
| Address | 2820 Orchard ParkwaySan Jose, CA 95134 |
| FDA Registration Number | 2953749 |
| Contact Person | John RayPrincipal, Regulatory AffairsAlign Technology, Inc.cc: Shweta DagaDirector, Regulatory AffairsAlign Technology Inc. |
| Contact Information | Email: jray@aligntech.comCell Phone: +1 425-985-8061 |
| Date Prepared | July 28, 2023 |
Name of Modified Device and Name/Address of Sponsor
| Name of Device | Invisalign System with Mandibular Advancement Featuring OcclusalBlocks |
|---|---|
| Name/Address of Sponsor | Align Technology, Inc.2820 Orchard Parkway, San Jose, CA 95134 |
| Trade/Proprietary Name | Invisalign System with Mandibular Advancement Featuring OcclusalBlocks |
| 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.2820 Orchard Parkway, San Jose, CA 95134 |
| Trade/Proprietary Name | Invisalign System |
| Common Name | Aligner, Sequential |
| Classification Name | Orthodontic Plastic Bracket |
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| Regulation Number | 21 CFR 872.5470 |
|---|---|
| Product Code | NXC |
| Regulatory Class | II |
| 510(k) number | K220287 |
Reference Device
| Name of Device | Invisalign System with Mandibular Advancement Feature |
|---|---|
| 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 | K181739 |
Purpose of the Traditional 510(k) notice
The purpose of this Traditional 510(k) notice is to request clearance for the addition of the Invisalign System with Mandibular Advancement Featuring Occlusal Blocks. The Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is an optional feature for advancing the mandible (lower jaw) in patients with Class 1 and 2 malocclusions, in conjunction with severe open bite, severe overjet, deep bite, skeletally narrow jaw, and/or those patients requiring surgical correction
Additionally, this Traditional 510(k) introduces the proprietary, 3D treatment planning software and labeling documentation associated with the subject device, and all non-significant changes implemented to the Invisalign System implementation since the last 510(k) clearance.
Indications for Use
The Invisalign System with Mandibular Advancement Featuring Occlusal Blocks, (subject device) has similar indications for use as the cleared predicate device, the Invisalign System (K220287), which is as follows:
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.
Device Description
The subject device, Invisalian System with Mandibular Advancement Featuring Occlusal Blocks (Invisalign System, MAOB) is a modification to the predicate device, Invisalign System
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(K220287, cleared on April 07, 2022) and the reference device. Invisalign System with Mandibular Advancement Features (K181739, cleared on October 26th, 2018). The Invisalign System, MAOB (subject device) consists of removable orthodontic appliances (aligners with mandibular advancement features including occlusal blocks), proprietary treatment planning 3D software (doctor facing - ClinCheck and Align employee facing -Treat) and attachment templates. The scope of this premarket submission is:
- addition of aligners with occlusal blocks to induce mandibular skeletal changes in the treatment of Class 1 and 2 malocclusions, in conjunction with severe open bite, severe overjet, deep bite, skeletally narrow jaw, and/or those patients requiring surgical correction. Invisalign aligners with occlusal blocks are another design/feature under previously cleared Invisalign System with Mandibular Advancement Feature such as Enhanced Precision Wings (K220287).
Like the predicate device, the Invisalign System with Mandibular Advancement Featuring Occlusal Blocks 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 and skeletal malocclusion. The Invisalign System is used in patients with primary, mixed (primary and permanent), or permanent dentition. The Invisalign System with mandibular advancement feature(s) such as precision wings (predicate device) and occlusal blocks (subject device) are used in patients with mixed or permanent dentition to correct Class I and II malocclusions. The Invisalign System is used to treat Class I and II dental and skeletal malocclusion in patients with 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 Invisalign System's proprietary 3-D software is inclusive of both dental practitioner-facinq functions (ClinCheck Pro 6) and internal Align personnel-facing functions (Treat). The Align facing software enables Align 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 doctor reviews, optionally modifies, and approves the treatment plans using 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 Invisalign treatment plan, a disposable template is provided to assist the dental practitioner in positioning and bonding the attachments from commercial dental composite. Attachment templates are disposable polyurethane accessory 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.
All these components and features were available with the predicate device.
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Comparison with Predicate and Reference Devices
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 Mandibular Advancement Featuring Occlusal Blocks (subject device) introduces an alternative feature for mandibular advancement. 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 withMandibular AdvancementFeaturing Occlusal BlocksSubject/Modified Device | Invisalign System(K220287)Predicate Device | Invisalign System withMandibularAdvancement Feature(K181739)Reference Device | ComparisonAssessment | |
|---|---|---|---|---|
| Indication for Use, User Population | ||||
| Indication forUse | The Invisalign System isintended for the orthodontictreatment of malocclusion inpatients with primary, mixed(primary and permanent), orpermanent dentition. Theoptional mandibularadvancement feature(s) areindicated for the treatment ofskeletal malocclusion in patientswith mixed or permanentdentition. | The Invisalign System isintended for theorthodontic treatment ofmalocclusion. | The Invisalign System isintended for theorthodontic treatment ofmalocclusion. | Similar to predicatedevice. See Section13 for discussion ofnon-significantchanges. |
| PatientPopulation | Children, Adolescents andAdults | Children, Adolescentsand Adults | Pediatrics and Adults | Same as predicatedevice |
| Use Location | Dental intraoral Devices | Dental intraoral Devices | Dental intraoral Devices | Same as predicatedevice |
| OTC orPrescription(Rx) Device | Rx only | Rx only | Rx only | Same as predicatedevice |
| Technological Characteristics | ||||
| Principle ofOperation | Aligners: Sequential alignersapply continuous gentle force tothe teeth and/or positionmandible forward. | Aligners: Sequentialaligners apply continuousgentle force to the teethand position mandibleforward | Aligners: Sequentialaligners applycontinuous gentle forceto the teeth and positionmandible forward | Same as predicatedevice |
| 3D Software: Produces 3D-model file of the PVSimpression or the digital scan.ldentifies the individual teeththat requires treatment (i.e.,repositioning). Creates atreatment plan (i.e., 3-D modelsthat represent the treatmentplan) which is reviewed by thetreating dental practitioner using | 3D Software: Produces3D-model file of the PVSimpression or the digitalscan. Identifies theindividual teeth thatrequires treatment (i.e.,repositioning). Creates atreatment plan (i.e., 3-Dmodels that representthe treatment plan) which | 3D Software: Produces3D-model file of thePVS impression or thedigital scan. Identifiesthe individual teeth thatrequires treatment (i.e.,repositioning). Createsa treatment plan (i.e., 3-D models that representthe treatment plan) | Same as predicatedevice | |
| Invisalign System withMandibular AdvancementFeaturing Occlusal BlocksSubject/Modified Device | Invisalign System(K220287)Predicate Device | Invisalign System withMandibularAdvancement Feature(K181739)Reference Device | ComparisonAssessment | |
| ClinCheck's doctor facingfunction to reject or requestmodifications to the set-up priorto approval. | is reviewed by thetreating dentalpractitioner usingClinCheck's doctor facingfunction to reject orrequest modifications tothe set-up prior toapproval. | which is reviewed bythe treating dentalpractitioner usingClinCheck's doctorfacing function to rejector request modificationsto the set-up prior toapproval. | ||
| MandibularAdvancementFeature | Occlusal blocks | Enhanced precisionwings | Precision wings | Similar to predicatedeviceOcclusal blockfeatures added toachieve sameclinical outcomes aspredicate device |
| AlignerMaterials | Thermoplastic polymer | Thermoplastic polymer | Thermoplasticpolymer | Same as predicatedevice |
| MandibularAdvancementFeaturematerials | Thermoplastic polymer andcoating material used inmanufacturing | Thermoplastic polymer | Thermoplasticpolymer | Similar to predicatedevice.Addition of coatingmaterial to aid inmanufacturing |
| Performance Testing | ||||
| Durability(Normal Use) | The Invisalign System,MAOB sustained cyclicloading without breakages. | Same design asReference Device(repeat testing notrequired) | The InvisalignSystem with MAsustained cyclicloading withoutbreakages. | Same aspredicate device |
| Durability(MisuseLoading) | The Invisalign System withMAOB survived withoutcatastrophic failure. | The Invisalign Systemwith MA survivedwithout catastrophicfailure. | The InvisalignSystem with MAsurvived withoutcatastrophic failure. | Same aspredicate device |
| ForceMeasurementApparatus | Force mechanicalverification testingdemonstrated that theInvisalign System, MAOBprovides adequate force onteeth. | Same design asReference Device(repeat testing notrequired) | Force mechanicalverification testingdemonstrated thatthe Invisalign Systemprovides adequateforce on teeth. | Similar aspredicate device. |
| Bioburden | Bioburden testing per ISO11737-1 | Bioburden testing perISO 11737-1 | Bioburden testing perISO 11737-1 | Same aspredicate device |
| Packaging | Packaging validation testingper ISTA3A | Packaging validationtesting per ISTA3A | Packaging validationtesting per ISTA3A | Same aspredicate device |
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Performance Data
Bench testing was completed consistent with testing completed for the predicate device system (K220287). In addition, specific bench testing was completed to verify that Invisalign aligners with occlusal block features remain functionally intact and safe, and meet their requirements, when exposed to cycles simulating normal use, wear time, and excessive force misuse. No animal or clinical testing was required or performed for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks.
Biocompatibility
The Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is categorized as a long-term surface device with mucosal contact. Biological risk assessment was performed, and subsequent biocompatibility testing was successfully completed per the ISO 10993 suite of standards. The subject device was found to be non-cytotoxic, non-sensitizer, non-irritating, nonpyrogenic, non-toxic, and non-genotoxic per biocompatibility testing.
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 modified 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, .
- . similar indications for use,
- . similar principles of operation, and
- . similar technological characteristics
The minor differences in the indications for use, 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).
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Conclusion
Align Technology's Invisalign System with Mandibular Advancement Featuring Occlusal Blocks has the same intended use and similar 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 Mandibular Advancement Featuring Occlusal Blocks is 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.