(61 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use in the device description or performance studies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Invisalign System is "intended for the orthodontic treatment of malocclusion." Orthodontic treatment is a form of therapy for correcting dental irregularities.
No
The device description and intended use clearly state that the Invisalign System is for orthodontic treatment of malocclusion, acting as a physical appliance to correct teeth and jaw alignment. It does not perform any diagnostic function such as identifying, confirming, or monitoring a disease or condition.
No
The device description explicitly states that the device consists of "removable orthodontic appliances (aligners with mandibular advancement features including occlusal blocks)" in addition to the software. This indicates a hardware component.
Based on the provided information, the Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the orthodontic treatment of malocclusion. This is a therapeutic purpose, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
- Device Description: The device consists of removable orthodontic appliances, software for treatment planning, and attachment templates. These are tools used for treatment, not for analyzing biological samples to provide diagnostic information.
- Lack of Biological Sample Analysis: IVDs typically involve the analysis of biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The input for this device is a PVS impression or digital scan of the teeth, which is used for creating the treatment plan and aligners, not for diagnostic testing of biological material.
The device is clearly intended for the physical manipulation of teeth for orthodontic correction, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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 mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.
Product codes
NXC
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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
primary, mixed (primary and permanent), or permanent dentition.
Intended User / Care Setting
Dental intraoral Devices. Rx only.
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)
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.
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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).
1
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,
2
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
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
Align Technology
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks Traditional 510(k)
Section 7: 510(K) Summary
5
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 Parkway |
| San Jose, CA 95134 | |
| FDA Registration Number | 2953749 |
| Contact Person | John Ray |
| Principal, Regulatory Affairs | |
| Align Technology, Inc. | |
| cc: Shweta Daga | |
| Director, Regulatory Affairs | |
| Align Technology Inc. | |
| Contact Information | Email: jray@aligntech.com |
| Cell 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 Occlusal
Blocks |
|-------------------------|----------------------------------------------------------------------------|
| Name/Address of Sponsor | Align Technology, Inc.
2820 Orchard Parkway, San Jose, CA 95134 |
| Trade/Proprietary Name | Invisalign System with Mandibular Advancement Featuring Occlusal
Blocks |
| 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 |
6
| 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
7
(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.
8
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 with
Mandibular Advancement
Featuring Occlusal Blocks
Subject/Modified Device | Invisalign System
(K220287)
Predicate Device | Invisalign System with
Mandibular
Advancement Feature
(K181739)
Reference Device | Comparison
Assessment |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use, User Population | | | | |
| 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 mandibular
advancement feature(s) are
indicated for the treatment of
skeletal malocclusion in patients
with mixed or permanent
dentition. | The Invisalign System is
intended for the
orthodontic treatment of
malocclusion. | The Invisalign System is
intended for the
orthodontic treatment of
malocclusion. | Similar to predicate
device. See Section
13 for discussion of
non-significant
changes. |
| Patient
Population | Children, Adolescents and
Adults | Children, Adolescents
and Adults | Pediatrics and Adults | Same as predicate
device |
| Use Location | Dental intraoral Devices | Dental intraoral Devices | Dental intraoral Devices | Same as predicate
device |
| OTC or
Prescription
(Rx) Device | Rx only | Rx only | Rx only | Same as predicate
device |
| Technological Characteristics | | | | |
| Principle of
Operation | Aligners: Sequential aligners
apply continuous gentle force to
the teeth and/or position
mandible forward. | Aligners: Sequential
aligners apply continuous
gentle force to the teeth
and position mandible
forward | Aligners: Sequential
aligners apply
continuous gentle force
to the teeth and position
mandible forward | Same as predicate
device |
| | 3D Software: Produces 3D-
model file of the PVS
impression or the digital scan.
ldentifies the individual teeth
that requires 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 | 3D Software: Produces
3D-model file of the PVS
impression or the digital
scan. Identifies the
individual teeth that
requires treatment (i.e.,
repositioning). Creates a
treatment plan (i.e., 3-D
models that represent
the treatment plan) which | 3D Software: Produces
3D-model file of the
PVS impression or the
digital scan. Identifies
the individual teeth that
requires treatment (i.e.,
repositioning). Creates
a treatment plan (i.e., 3-
D models that represent
the treatment plan) | Same as predicate
device |
| | Invisalign System with
Mandibular Advancement
Featuring Occlusal Blocks
Subject/Modified Device | Invisalign System
(K220287)
Predicate Device | Invisalign System with
Mandibular
Advancement Feature
(K181739)
Reference Device | Comparison
Assessment |
| | ClinCheck's doctor facing
function to reject or request
modifications to the set-up prior
to approval. | 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. | 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. | |
| Mandibular
Advancement
Feature | Occlusal blocks | Enhanced precision
wings | Precision wings | Similar to predicate
device
Occlusal block
features added to
achieve same
clinical outcomes as
predicate device |
| Aligner
Materials | Thermoplastic polymer | Thermoplastic polymer | Thermoplastic
polymer | Same as predicate
device |
| Mandibular
Advancement
Feature
materials | Thermoplastic polymer and
coating material used in
manufacturing | Thermoplastic polymer | Thermoplastic
polymer | Similar to predicate
device.
Addition of coating
material to aid in
manufacturing |
| Performance Testing | | | | |
| Durability
(Normal Use) | The Invisalign System,
MAOB sustained cyclic
loading without breakages. | Same design as
Reference Device
(repeat testing not
required) | The Invisalign
System with MA
sustained cyclic
loading without
breakages. | Same as
predicate device |
| Durability
(Misuse
Loading) | The Invisalign System with
MAOB survived without
catastrophic failure. | The Invisalign System
with MA survived
without catastrophic
failure. | The Invisalign
System with MA
survived without
catastrophic failure. | Same as
predicate device |
| Force
Measurement
Apparatus | Force mechanical
verification testing
demonstrated that the
Invisalign System, MAOB
provides adequate force on
teeth. | Same design as
Reference Device
(repeat testing not
required) | Force mechanical
verification testing
demonstrated that
the Invisalign System
provides adequate
force on teeth. | Similar as
predicate device. |
| Bioburden | Bioburden testing per ISO
11737-1 | Bioburden testing per
ISO 11737-1 | Bioburden testing per
ISO 11737-1 | Same as
predicate device |
| Packaging | Packaging validation testing
per ISTA3A | Packaging validation
testing per ISTA3A | Packaging validation
testing per ISTA3A | Same as
predicate device |
9
10
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).
11
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.