(8 days)
No
The description explicitly states that the aligners are created by a trained technician utilizing software and recommendations from the orthodontist/dentist, with no mention of AI or ML.
Yes
The device is used for orthodontic treatment of misalignment and malocclusion, intending to "gradually move a patient's teeth" to correct these conditions.
No
Explanation: The device, "Clear Image Aligners," is described as a sequential set of removable aligners used for orthodontic treatment to gradually move teeth. Its purpose is therapeutic (corrective force to reposition teeth), not diagnostic.
No
The device description clearly states that the device is a "sequential set of removable aligners" fabricated from plastic, which are physical objects, not software. While software is used in the design process, the final medical device is a physical product.
Based on the provided information, this device 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.
- Device Function: The Clear Image Aligners are physical devices used to mechanically move teeth for orthodontic treatment. They do not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use is for "alignment teeth through orthodontic treatment of misalignment and malocclusion," which is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the fabrication and mechanism of action of the aligners, which involves applying force to teeth, not analyzing biological samples.
Therefore, the Clear Image Aligners fall under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Clear Image Aligners are indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Clear Image Aligners are a sequential set of removable aligners prescribed by an orthodontist or dentist, used to gradually move a patient's teeth in order to treat misalignment and malocclusion. Each aligner in the sequential set is created by a trained technician utilizing 3Shape orthodontic software (K171634/K152086) and tooth movement recommendations from the prescribing orthodontist/dentist. Aligners are then fabricated from plastic. Corrective force to progressively reposition the teeth is delivered via minor changes from one aligner to the next within the series. Each aligner set is patient specific and can only be used for an individual patient for whom it is prescribed. Clear Image Aligners are provided non-sterile and are completely removable by the patient and treatment/use may be discontinued at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthodontist or dentist
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)
Non-Clinical Testing: Specialty Appliance Works, Inc. has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration. The mechanical properties of the Essix Ace plastic (K062828) has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required. Clinical Testing: The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the Clear Image Aligners to the predicate device.
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.
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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & 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 FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Specialty Appliance Works, Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313
Re: K183643
Trade/Device Name: Clear Image Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 21, 2018 Received: December 26, 2018
Dear Mark Job:
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. 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 located 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.
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
January 3, 2019
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, Digitally signed by Mary Mary S. = S. Runner -S3 19.01.03 - 5.3 - Date: 2019.01.03
Runner - 5.3 - Date: 2019.01.03
Runner - 5.3 - 09:06:24 -05'00' 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2020 Indications for Use See PRA Statement below. 510(k) Number (if known)
Device Name Clear Image Aligners
Indications for Use (Describe)
The Clear Image Aligners are indicated for use in the alignment teeth through orthodontic treatment of misalignment and 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:
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."
FORM FDA 3881 (7/17)
FSC Publiching Seessour (306) 443-678)
3
Image /page/3/Picture/0 description: The image shows the logo for Specialty Appliances. The logo consists of a cluster of gray circles on the left, arranged in a circular pattern. To the right of the circles, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller font size.
510(k) Summary
| Date Prepared: | November 16, 2018 |
|---|---|
| Submitter: | Specialty Appliance Works, Inc. |
| 4905 Hammond Industrial Drive | |
| Cumming, GA 30041 | |
| Contact: | Carolyn Thomas |
| Quality Manager | |
| Specialty Appliance Works, Inc. | |
| (678) 513-4408 | |
| Carolyn.Thomas@specialtyappliances.com | |
| Proprietary Name: | Clear Image Aligners |
| Common Name: | Sequential Aligners |
| Classification: | 21 CFR 872.5470: Orthodontic plastic bracket; Class II |
| Product Code: | NXC |
| Predicate Device: | K173785, Derby Dental Laboratory Custom Clear Aligner |
| System |
Intended Use / Indications:
The Clear Image Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
Device Description:
The Clear Image Aligners are a sequential set of removable aligners prescribed by an orthodontist or dentist, used to gradually move a patient's teeth in order to treat misalignment and malocclusion. Each aligner in the sequential set is created by a trained technician utilizing 3Shape orthodontic software (K171634/K152086) and tooth movement recommendations from the prescribing orthodontist/dentist. Aligners are then fabricated from plastic. Corrective force to progressively reposition the teeth is delivered via minor changes from one aligner to the next within the series.
4
Image /page/4/Picture/0 description: The image contains a logo for "Specialty Appliances". The logo features a circular design on the left, composed of multiple smaller circles arranged in a pattern. To the right of the circular design, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller font size.
Each aligner set is patient specific and can only be used for an individual patient for whom it is prescribed. Clear Image Aligners are provided non-sterile and are completely removable by the patient and treatment/use may be discontinued at any time.
Non-Clinical Testing:
Specialty Appliance Works, Inc. has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration. The mechanical properties of the Essix Ace plastic (K062828) has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required.
Clinical Testing:
The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the Clear Image Aligners to the predicate device.
| Property or
Characteristic | Proposed Device
Specialty Appliance Works,
Inc.
Clear Image Aligners | Predicate Device
Derby Dental Laboratory
Custom Clear Aligner
System (K173785) | Comments |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Device Classification
Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same as K173785 |
| Product Code | NXC | NXC | Same as K173785 |
| Classification | II | II | Same as K173785 |
| Indications for Use | The Clear Image Aligners
are indicated for use in the
alignment of permanent
teeth through orthodontic
treatment of misalignment
and malocclusion. | The Custom Clear Aligner
System is indicated for use
in the alignment of
permanent teeth through
orthodontic treatment of
misalignment and
malocclusion. | Same as K173785 |
| Mode of Action | Alignment of teeth by
application of continuous | Alignment of teeth by
application of continuous | Same as K173785 |
Predicate Device Comparison:
5
Image /page/5/Picture/0 description: The image contains the logo for Specialty Appliances. The logo features a circular design composed of several smaller circles on the left side. To the right of the circular design, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller, sans-serif font.
| Property or
Characteristic | Proposed Device
Specialty Appliance Works, Inc.
Clear Image Aligners | Predicate Device
Derby Dental Laboratory
Custom Clear Aligner System (K173785) | Comments |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Method of Use | gentle force, by sequential
use of preformed plastic
trays.
Each preformed plastic tray
is worn by the patient as
prescribed by the
orthodontist/dentist prior to
using the next sequential
aligner tray. | gentle force, by sequential
use of preformed plastic
trays.
Each preformed plastic tray
is worn by the patient as
prescribed by the dental
practitioner, usually a few
weeks prior to using the
next sequential aligner tray. | Same as K173785 |
| | Material | Essix Ace plastic
(K062828) | Thin thermoformed
polyurethane |
| Prescription or OTC | Prescription | Prescription | Same as K173785 |
| Software Used during
manufacturing | Use of 3Shape Ortho
System
(K171634/K152086) | Use of 3Shape Ortho
System (K152086) | Same as K173785 |
| Provided Non-Sterile | Yes | Yes | Same as K173785 |
Summary of Substantial Equivalence:
Based on the information presented in this submission, Specialty Appliance Works, Inc. concludes that the Clear Image Aligners are substantially equivalent to the predicate device in regard to indications for use, design and technology.