(227 days)
Not Found
No
The description of the software focuses on generating models and intermediate states based on a provisional treated state, which is reviewed and edited by a dental practitioner. There is no mention of AI or ML being used in this process, and the decision-making and approval are explicitly stated to be the responsibility of the practitioner.
Yes
The device is described as a system of aligners that "gently move the patient's teeth in small increments from their original state to a more optimal, treated state," indicating a direct therapeutic effect on the patient's teeth.
No
The device is described as an orthodontic treatment system that uses aligners to move teeth, which is a therapeutic rather than diagnostic function. While it uses 3D software to generate models for treatment planning, this falls under treatment execution and not the diagnosis of a medical condition.
No
The device description explicitly states that the Angel Align System consists of both proprietary 3D software and a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners). The aligners are a physical component of the system.
Based on the provided information, the Angel Align System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Angel Align System's Function: The Angel Align System is a device used for the physical alignment of teeth during orthodontic treatment. It uses aligners and software to plan and execute tooth movement.
- Lack of Biological Sample Analysis: The system does not analyze any biological samples from the patient. Its input is a scan of an impression or a digital scan of the teeth, which represents the physical structure of the teeth, not a biological sample.
- Intended Use: The intended use is for the "alignment of teeth during orthodontic treatment of malocclusion," which is a mechanical and structural correction, not a diagnostic test based on biological markers.
Therefore, the Angel Align System falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Product codes
NXC
Device Description
The Angel Align System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.
The Angel Align System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.
The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the 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 manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
a scan of a PVS impression or a digital scan
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
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
Software Validation: PASS
Design Verification and Validation: PASS
ISO10993: PASS
Post-Market Study: PASS
The data shows that the Angel Align System is substantially equivalent to the predicate as a sequential aligner. The data provides evidence of safety and effectiveness for all tooth movements and demonstrates that the Angel Align System is substantially equivalent to the predicate as a sequential aligner.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Smile Development Corp Ian Kitching President & CEO 7179 Cherrywood Ct Highland, California 92346 January 19, 2018
Re: K171674
Trade/Device Name: Angel Align System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: December 6, 2017 Received: December 11, 2017
Dear Ian Kitching:
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 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
1
801); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
5. Indications for Use Statement (FDA Form 3881)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number (if known) | K171674 |
|---|---|
| Device Name | Angel Align |
| Indications for Use (Describe) | Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion. |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart 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:
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"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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
3
| 6. 510(k) Summary | |
|---|---|
| 510(k) SUMMARY | |
| 510(k) Owner | Smile Development Corp. |
| 7179 Cherrywood Court | |
| Highland, CA 92346 | |
| Phone: 408.621.1152 | |
| Contact person | Ian Kitching |
| Smile Development Corp. | |
| 7179 Cherrywood Court | |
| Highland, CA 92346 | |
| Phone: 408.621.1152 | |
| ian@smiledevcorp.com | |
| Submission Date | December 11, 2017 |
| Product Code: | |
| Common Name | Orthodontic Plastic Brackets |
| Trade Name | Angel Align System |
| Classification Name | aligner, sequential |
| Regulation | 872.5470 |
| Class | Class II |
| Panel | Dental |
| Product Code | NXC |
| Predicate | K143630 |
| Invisalign - Align Technology, Inc. | |
| Description |
iption
The Angel Align System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.
The Angel Align System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.
The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to
4
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 manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
Indications for Use
Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Technological Characteristics
The predicate and the Angel Align System were compared in the following areas and found to have similar technological characteristics and to be equivalent:
5
| Angel Align System | K143630 | |
|---|---|---|
| Intended Use | ||
| Statement | SAME | |
| The Angel Align System is | ||
| indicated for the alignment of | ||
| teeth during orthodontic treatment | ||
| of malocclusion. | SAME | |
| The Invisalign System is indicated | ||
| for the alignment of teeth during | ||
| orthodontic treatment of | ||
| malocclusion. | ||
| 3-D Software | ||
| Description | SAME | |
| The Angel 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, provisional | ||
| 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 | SAME | |
| 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 | ||
| Mode of | ||
| Operation for 3-D | ||
| Software | SAME | |
| Angel Align 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 software and | ||
| has the option to reject or | ||
| request modifications to | ||
| the set-up prior to | SAME | |
| 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. | ||
| Material | The Invisalign System uses either: | |
| SAME | ||
| 0.03" thick, thermoformed | ||
| polyurethane | DIFFERENT |
- 0.03" thick, Multilayer aromatic
thermoplastic polyurethane /
copolyester.
or:
SAME - 0.03" thick, thermoformed
polyurethane |
| Mode of Use | SAME
Each appliance is worn by the
patient as determined by the
dental practitioner, generally 2
weeks prior to being replaced by
the next aligner in sequence. | SAME
Each appliance is worn by the dental
practitioner, generally 2 weeks prior
to being replaced by the next aligner
in sequence. |
| Description of
Appliance
Application | SAME
Removable | SAME
Removable |
| Manufacturing
Method | SAME
A digital model of the patient's
teeth is created from either CT
scanning a PVS impression or
directly from an intraoral scan of
the patient's teeth. From the
digital model, following a dental
practitioner's prescription, the
software generates model
transforms describing the
provisional final, treated state and
then interpolates a series of model
transforms that represent
intermediate states of alignment.
The resulting computer "setups"
relay this information to rapid
prototyping machines that produce
physical positive models. The
aligners are produced by
thermoforming on each physical
model to fabricate the sequence of
aligners. | SAME
A digital model of the patient's teeth
is created from either CT scanning a
PVS impression or directly from an
intraoral scan of the patient's teeth.
From the digital model, following a
dental practitioner's prescription, the
software generates model transforms
describing the final, treated state and
then interpolates a series of model
transforms that represent
intermediate states of alignment.
The resulting computer “setups”
relay this information to rapid
prototyping machines that produce
physical positive models. The
aligners are produced by
thermoforming on each physical
model to fabricate the sequence of
aligners. |
Device Comparison Table
6
7
The predicate and the Angel Align System were compared in the following area and found to have minor different technological characteristics. The following differences have been determined to not have any impact on the safety or efficacy of the Angel Align System:
| Angel Align System | K143630 | |
|---|---|---|
| Material | The Invisalign System uses either: | |
| DIFFERENT |
- 0.03" thick, Multilayer aromatic
thermoplastic polyurethane /
copolyester. |
| | SAME
0.03" thick, thermoformed
polyurethane | or:
SAME - 0.03" thick, thermoformed
polyurethane |
The following non-clinical performance tests were conducted:
| Software Validation | PASS |
|---|---|
| Design Verification and Validation | PASS |
| ISO10993 | PASS |
Conclusions from non-clinical performance data
After performing non-clinical performance studies, the data shows that the Angel Align System is substantially equivalent to the predicate as a sequential aligner.
The following post market clinical data was submitted for clinical performance data:
| Post-Market Study | PASS |
|---|---|
| ------------------- | ------ |
Conclusions from the clinical data
The data provides evidence of safety and effectiveness for all tooth movements and demonstrates that the Angel Align System is substantially equivalent to the predicate as a sequential aligner.