(32 days)
Yes
The description explicitly states the addition of a "completely automated end-to-end treatment planning workflow without CAD technician involvement," which strongly suggests the use of AI/ML for automated decision-making in the treatment planning process.
Yes.
The device is intended for "orthodontic treatment of malocclusion," which is a medical condition, making it a therapeutic device.
No
The device is described as an orthodontic treatment system that moves teeth to address malocclusion, and its components are aligners and treatment planning software. It is used for therapeutic purposes (correcting malocclusion) rather than diagnosing conditions.
No
The device description explicitly states that the Invisalign System consists of "removable orthodontic appliances (aligners)" in addition to the software. These aligners are physical components, making the device a combination product, not software-only.
Based on the provided information, the Invisalign System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Invisalign System's Function: The Invisalign System is a medical device used for orthodontic treatment. It involves physical appliances (aligners) that are placed in the mouth to move teeth. The treatment planning software uses patient data (impressions or scans) to design these physical appliances.
- Lack of Specimen Analysis: The system does not analyze biological specimens from the patient's body to provide diagnostic information. Its purpose is to physically alter the position of teeth.
The description clearly states the device is for "orthodontic treatment of malocclusion" and involves "removable orthodontic appliances (aligners)". This aligns with the definition of a dental or orthodontic device, not an IVD.
No
The input indicates "Not Found" for "Control Plan Authorized (PCCP) and relevant text", meaning the letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this device.
Intended Use / Indications for Use
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.
Product codes
NXC, PNN
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 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 end-to-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dental intraoral Devices
Indicated Patient Age Range
primary, mixed (primary and permanent), or permanent dentition. Children, Adolescents and Adults
Intended User / Care Setting
Dental practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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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).
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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
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Indications for Use
Submission Number (if known)
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)
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K241412 - 510(k) Summary
Align Technology's Invisalign System
General Information
510(k) Sponsor | Align Technology, Inc. |
---|---|
Address | 2820 Orchard Parkway |
San Jose, CA 95134 | |
FDA Registration Number | 2953749 |
Contact Person | Nestor Vazquez Salgado |
Sr. Regulatory Affairs Specialist | |
Align Technology, Inc. |
cc: Niya Su
Sr. Manager, Regulatory Affairs
Align Technology Inc. |
| Contact Information | Email: nevazquez@aligntech.com
Phone: +1 408-470-1000
Cell Phone: +1 412-298-4604
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. |
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 - Aligners |
PNN – Proprietary 3D Treatment Planning Software | |
Regulatory Class | II |
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| Name of Device | Invisalign System with Mandibular Advancement Featuring Occlusal
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
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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
Subject Device | Invisalign System with
Mandibular Advancement
Featuring Occlusal
Blocks (K232233) –
Primary Predicate Device | Substantial
Equivalence |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use, User Population | | | |
| Intended Use/
Indication for
Use | The Invisalign System is
intended for the orthodontic
treatment of malocclusion
in patients with primary,
mixed (primary and
permanent), or permanent
dentition. The optional | The Invisalign System is
intended for the orthodontic
treatment of malocclusion
in patients with primary,
mixed (primary and
permanent), or permanent
dentition. The optional | Same as predicate
device. |
| | mandibular advancement
feature(s) are indicated for
the treatment of skeletal
malocclusion in patients
with mixed or permanent
dentition. | | |
| Patient
Population | Children, Adolescents_and
Adults | Children, Adolescents, and
Adults | Same as predicate
device. |
| Use Location | Dental intraoral Devices | Dental intraoral Devices | Same as predicate
device. |
| OTC or
Prescription
(Rx) Device | Rx only | Rx only | Same as predicate
device. |
| Technological Characteristics | | | |
| Principle of
Operation | Aligners: Sequential
aligners apply continuous
gentle force to the teeth and
position mandible forward.
Proprietary 3D Treatment
Planning Software:
Produces 3D-model file of
the PVS impression or the
digital scan. Identifies all
individual teeth that require
treatment (i.e.,
repositioning). Creates a
treatment plan (i.e., 3-D
models that represent the
treatment plan) which is
reviewed by the treating
dental practitioner using
ClinCheck's doctor facing
function to reject or request
modifications to the set-up
prior to approval.
Delivery Mechanism of
Attachment:
- Attachment Template -
attachments are formed
by dental practitioner who
fills and packs wells in the
Template tray with
commercially available
dental composite. The | Aligners: Sequential
aligners apply continuous
gentle force to the teeth
and/or position mandible
forward.
Proprietary 3D Treatment
Planning Software:
Produces 3D-model file of
the PVS impression or the
digital scan. Identifies all
individual teeth that
require treatment (i.e.,
repositioning). Creates a
treatment plan (i.e., 3-D
models that represent the
treatment plan) which is
reviewed by the treating
dental practitioner using
ClinCheck's doctor facing
function to reject or
request modifications to
the set-up prior to
approval.
Delivery Mechanism of
Attachment:
Attachment Template -
attachments are formed by
dental practitioner who fills
and packs wells in the | Same as predicate
device
Subject device is
inclusive of an
additional optional
attachment delivery
mechanism, Invisalign
Pre-Formed
Attachment System,
which has been
cleared in 510(k)
K222894. |
| | final shape &
configuration is cured
when template is seated
on dentition; or,
2. Invisalign Pre-formed
Attachment System - an
optional alternative
attachment delivery
mechanism. It enables
correct placement of
attachments and bond
attachments to the tooth
surface. The attachment
shape and configuration
defined by the Invisalign
System treatment plan,
manufactured together
with positioner. The
attachment shapes are
cured to the tooth when
the positioner is seated
on dentition. | Template tray with
commercially available
dental composite. The final
shape & configuration is
cured when template is
seated on dentition. | |
| Materials | Thermoplastic polymer | Thermoplastic polymer | Same as predicate
device. |
| | Treatment Planning Workflows | | |
| End-to-end
Treatment
Planning
Workflow | Includes the following
workflows:
● Completely Manual
● Combination of
Manual and
Automated
● Fully Automated
Workflow | Includes the following
workflows:
● Completely Manual
● Combination of
Manual and
Automated | Similar to predicate
device.
The subject device
introduces an additional
automated end-to-end
treatment planning
workflow. All existing
workflows remain
unchanged. Verification
and validation (V&V)
testing demonstrated
the additional workflow
achieved the same
treatment plan and
aligners output as
existing workflows;
therefore, the change
does not affect the
safety and |
Table 1: Device Comparison Table
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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.
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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.