(331 days)
Not Found
No
The description focuses on proprietary 3-D software that generates and interpolates images for a dental practitioner to review and approve, without mentioning AI or ML algorithms for decision-making or automated analysis.
Yes
The device is described as a "series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners)" that "gently move the patient's teeth" for the "alignment of teeth during orthodontic treatment of malocclusion," clearly indicating its therapeutic purpose.
No
The device is described as an orthodontic treatment system for aligning teeth, not for diagnosing medical conditions. Its software is used for planning treatment, not for making a diagnosis.
No
The device description explicitly states that the Invisalign System consists of both software and physical aligners (thin, clear plastic removable orthodontic appliances). While the software is a key component, it is used to design and plan the treatment, which is then executed using the physical aligners. Therefore, it is not a software-only medical device.
Based on the provided information, the Invisalign System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Invisalign System's Function: The Invisalign System is used for the physical alignment of teeth during orthodontic treatment. It uses scans of the patient's teeth to create custom-made aligners that physically move the teeth.
- No Specimen Examination: The system does not involve the collection or examination of any biological specimens from the patient's body for diagnostic purposes. The input is a scan of the teeth, which is a physical representation, not a biological sample.
The Invisalign System is a medical device used for treatment, specifically orthodontic treatment, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Invisalign System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Invisalign System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Invisalign System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.
The proprietary Invisalign System 3-D software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are then manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
Mentions image processing
The Align 3-D Software uses a scan of a PVS impression or a digital scan (which represents an untreated state) to generate the image of a final, treated state and then interprets a series of images that represent intermediate teeth states.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scan of a PVS impression or a digital scan
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner / Not Found
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
Results of verification and validation testing demonstrate the Invisalign System showed conformity with pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate the modified Invisalign System is substantially equivalent to the primary predicate device. Therefore, the results of this testing demonstrate the modified Invisalign System 3-D software is substantial equivalent to the primary predicate 3-D software. Software testing was conducted in accordance with "General Principles of Software Validation: Final Guidance for Industry and FDA Staff", 01/11/2002 and IEC 62304:2006 "Medical Device Software - Software Life-Cycle Processes".
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18,2015
ALIGN TECHNOLOGY, INC. Margaret Anderson, Sr. Regulatory Affairs Analyst 2560 Orchard Parkway, San Jose, CA 95131 US
Re: K143630
Trade/Device Name: Invisalign System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: October 20, 2015 Received: October 21, 2015
Dear Ms. Anderson:
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. 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
1
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 8091); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indication for Use Statement
510(k) Number (if known): K143630
Device Name:
Invisalign System
Indications for Use:
The Invisalign System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-the Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
3
K143630 510(k) Summary
Date Prepared: November 18, 2015
Applicant Information:
Align Technology, Inc. 2560 Orchard Parkway San Jose, CA 95131
| Contact Person: | Margaret Anderson |
|---|---|
| Phone Number: | (408) 470-1410 |
| Fax Number: | (408) 470-1011 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Invisalign System |
| Common Name: | Aligner, Sequential |
| Classification Name: | Orthodontic plastic bracket (21 CFR 872.5470) |
Device Description:
The Invisalign System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Invisalign System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.
The proprietary Invisalign System 3-D software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are then manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
Intended Use:
The Invisalign System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Equivalent Device:
The modified Invisalign System is substantially equivalent in intended use and/or method of operation to the Invisalign System (K081960). A comparison of the current and modified Invisalign System demonstrates that the device is substantially equivalent in terms of technology and performance characteristics.
4
| Characteristic | Invisalign System 3-D Software
(K081960) Primary Predicate Device | Modified Invisalign System 3-D Software - (K143630)
Subject Device | Comparison |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Intended Use
Statement | The Invisalign System is indicated for the
alignment of teeth during orthodontic treatment of
malocclusion. | The Invisalign System is indicated for the alignment of
teeth during orthodontic treatment of malocclusion. | Subject Device is the same as
predicate device. |
| 3-D Software
Description | The Align 3-D Software uses a scan of a PVS
impression or a digital scan (which represents an
untreated state) to generate the image of a final,
treated state and then interprets a series of images
that represent intermediate teeth states. The dental
practitioner then reviews these images and has the
option to reject or request modifications to the set-
up prior to approving it for aligner fabrication.
Once the dental practitioner approves the treatment
plan, the software converts the files to produce the
series of custom-made aligners. | The Align 3-D Software uses a scan of a PVS impression
or a digital scan (which represents an untreated state) to
generate the image of a final, treated state and then
interprets a series of images that represent intermediate
teeth states. The dental practitioner then reviews these
images and has the option to reject or request
modifications to the set-up prior to approving it for
aligner fabrication. Once the dental practitioner
approves the treatment plan, the software converts the
files to produce the series of custom-made aligners | Subject Device is the same as
predicate device. |
| Mode of
Operation for 3-
D Software | Invisalign system 3-D software performs the
following operations:
• Produce 3D-model file of the PVS impression
or digital scan.
• Identifies the individual teeth that will require
treatment (i.e., repositioning).
• Creates a treatment plan (i.e., 3-D models that
represent the treatment plan). The treating
dental practitioner reviews these images using
ClinCheck software and has the option to reject
or request modifications to the set-up prior to
approval. | Invisalign system 3-D software performs the following
operations:
• Produce 3D-model file of the PVS impression or digital
scan.
• Identifies the individual teeth that will require treatment
(i.e., repositioning).
• Creates a treatment plan (i.e., 3-D models that represent
the treatment plan). The treating dental practitioner
reviews these images using ClinCheck software and has
the option to reject or request modifications to the set-up
prior to approval. | Subject Device is the same as
predicate device. |
| Elements of
ClinCheck
Software | An electronic prescription form and process used
to depict, edit, view, monitor and approve an
orthodontic treatment plan. | An electronic prescription form and process used to
depict, edit, view, monitor and approve an orthodontic
treatment plan. | Subject Device is the same as
predicate device. |
| Elements of
ClinCheck
Software | Treatment Plan File:
• The plan downloads to a dental practitioner's | Treatment Plan File:
• The plan downloads to other computing devices (e.g., | The Treatment Plan File is not
downloaded and saved on |
| Characteristic | Invisalign System 3-D Software
(K081960) Primary Predicate Device | Modified Invisalign System 3-D Software - (K143630)
Subject Device | Comparison |
| (continued) | desktop/laptop computer
• The plan is stored on dental practitioner's
desktop/laptop computer | tablets)
• The plan is deleted upon exiting application | desktop/laptop for K143630 as
it is downloaded to a tablet and
deleted upon exiting the
application. |
| | Tool Bar and Buttons (e.g., Rotate/Translate,
PAST, OCCLUS, View Attachment, Number, IPR,
etc.) | Tool Bar and Buttons (e.g., Attachment, Number, IPR,
etc.) | The following are not available
on Subject Device tool Bar:
Rotate/Translate, PAST,
OCCLUS, and View |
| | Menu Bar (e.g., File, View, Export, Tools, Movie,
Printing, Help, etc.) | Menu Bar (e.g., File, View, Export, Tools, Help, etc.) | Subject Device is same as
predicate device, but without
Movie and Printing |
| | Animation Controls (e.g., Display, Play/Stop, Step
Forward, Step Backward, etc.) | Animation Controls: Play/Stop, Step Forward, and Step
Backward | Subject Device controls are
limited to: Play/Stop, Step
Forward, and Step Backward |
| | Viewing options toolbar (e.g., grid, superimposition,
basic buttons, etc.) | Viewing options toolbar (e.g., grid, superimposition,
basic buttons, etc.) | Subject Device is equivalent
to predicate device. |
| | Using text comments | Using text comments | Subject Device is equivalent
to predicate device. |
| | 3-D modification mode (3-D Controls) | Absent | Not available in the Subject
Device |
| | Advanced Software Features (e.g., Bolton Analysis,
Movie generation and Screenshot generation, etc.) | Absent | Not available in the Subject
Device |
| Minimum
Hardware
Requirements | • Intel® Core™ i5, 4 GB RAM, 2 GB free disk
space; Graphics card: Intel HD Graphics;
Windows 7, 32 bit; Internet Explorer 11, Chrome,
Firefox, Edge | • iPad 2 with iOS 8 or higher; 16 GB storage or more
• Android 4.1.2 or higher; 16 GB storage or more | Subject Device is not used on a
laptop/desktop computer as it
operates on a tablet. |
Align Technology, Inc.
CONFIDENTIAL
Section 10 - Page 3 of 5
5
6
The Indication for Use of the modified Invisalign System is the same as the currently marketed device. Also, as supported by the risk analysis and software testing, the minor difference between the modified Invisalign System and the currently marketed device (e.g., downloading ClinCheck to other computing devices) does not raise any new issues of safety and effectiveness. The ease-of-use, communication features that are not available in ClinCheck Mobile (e.g., 3D Controls, Bolton Analysis, Movie generation and Screenshot generation, etc.) can all be performed using text comments. Thus, the currently marketed, predicate device (K081960) and the modified Invisalign System are substantially equivalent.
Test Results:
Results of verification and validation testing demonstrate the Invisalign System showed conformity with pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate the modified Invisalign System is substantially equivalent to the primary predicate device. Therefore, the results of this testing demonstrate the modified Invisalign System 3-D software is substantial equivalent to the primary predicate 3-D software. Software testing was conducted in accordance with "General Principles of Software Validation: Final Guidance for Industry and FDA Staff", 01/11/2002 and IEC 62304:2006 "Medical Device Software - Software Life-Cycle Processes".
Conclusion:
Based on the intended use and performance information provided in this notification, the modified Invisalign System has been shown to be substantially equivalent to the currently marketed predicate device.