(11 days)
No
The summary describes a physical device (clear plastic aligners) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies section refers to previous submissions for the predicate device, which also do not suggest AI/ML.
Yes.
The device is used to align teeth during orthodontic treatment of malocclusion, which is a therapeutic purpose.
No
Explanation: The device is described as a series of clear plastic aligners used for the alignment of teeth during orthodontic treatment of malocclusion. Its purpose is to correct tooth malocclusions, which is a treatment function, not a diagnostic one.
No
The device description explicitly states the device is a series of clear plastic aligners, which are physical objects, not software.
Based on the provided information, the 3M™ Clarity™ Aligners are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for the alignment of teeth during orthodontic treatment of malocclusion." This describes a physical intervention on the teeth for therapeutic purposes.
- Device Description: The description details a series of clear plastic aligners used to physically move teeth.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The information provided about the 3M Clarity Aligners does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, the 3M Clarity Aligners fall under the category of a medical device used for treatment, not an IVD device used for diagnosis.
N/A
Intended Use / Indications for Use
3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Product codes
NXC
Device Description
The 3M Clarity Aligners are a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
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
Not Found
Intended User / Care Setting
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
No additional testing has been included on this submission. Biocompatibility tests, performance testing and software verification and validation testing data was previously submitted and reviewed to support clearance of the predicate device 3M Clear Tray Aligner under premarket notification K163689.
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)
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
November 26, 2018
Image /page/0/Picture/1 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' in a larger, bold blue font, with the word 'ADMINISTRATION' underneath in a smaller font.
3M Company % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K183159
Trade/Device Name: 3M Clarity Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: November 13, 2018 Received: November 15, 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/cfpmp/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
1
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 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 (QS) 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 S. Mary 3. S. - Mary S. Runner -S3
Runner -S3 - 13:11:50 -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
Section 4
Indications for Use Statement
3M™ Clarity™ Aligners
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
3M™ Clarity™ Aligners
Indications for Use (Describe)
3MIM Clarity M Aligners are 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:
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)
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Section 3
510(k) Summary
3M™ Clarity™ Aligners
5
510(k) Summary
Image /page/5/Picture/3 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The "3" is larger than the "M". The logo is simple and recognizable.
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter | 3M Company, 3M Health Care
2510 Conway Avenue
St. Paul, MN 55144
Owner/Operator No.: 2110898
Establishment Registration No.: 2110898 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Yanine Garcia-Quezada
Regulatory Affairs
Phone: (651) 736-8238
Fax: (651) 736-1599
ygarcia-quezada@mmm.com |
| Secondary Contact | Mark Burville
Regulatory Affairs Manager
Phone: (651) 737-2027
Fax: (952) 918-5242
mcburville@mmm.com |
| Submission Date | 08 November 2018 |
| Proprietary Trade Name | 3M™ Clarity™ Aligners |
| Device Name | Aligner |
| Common Name | Sequential Aligner |
| Classification Name | Orthodontic Plastic Bracket |
| Regulation Number | 21 CFR 872.5470 |
| Product Code | NXC |
| Classification Panel | Dental Products Panel 76 |
| Classification | Medical Device, Class II |
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Indications for Use:
3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Predicate Devices:
Invisalign® System (K081960) [Primary Predicate] 3M Clear Tray Aligner (K163689) [Predicate Device]
Description of Device:
The 3M Clarity Aligners are a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
3M Company, 3M Health Care is submitting this 510(k) Premarket Notification because the Indications for Use are changing with the removal of the treatment limitation of patients with permanent dentition (i.e., all second molars). The updated indications for use are the same as the primary predicate Invisalign. Both devices are indicated for the correction of malocclusions. Neither of the indications specify the types of tooth movement to be used.
The change in indications for use to remove specific tooth movement types for the 3M Clarity Aligners does not affect the design, material composition, manufacturing processes and related software, these remain the same as the cleared 3M Clear Tray Aligner (K163689). There are no changes to the current contraindications. There is the addition of a precaution addressing the need to wear gloves when handling adhesives, and the expansion of one note where examples have been added as the original note did not include examples of supplemental treatments. Warning and precautions associated with the use of attachments, and one warning associated with the use of aligner tools to seat and/or remove aligners were also added.
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Technological Characteristics:
The material composition of the 3M Clarity Aligners is different from the material composition of the primary predicate Invisalign System. However, the material composition remains identical to the previously cleared 3M Clear Tray Aligner (K163689). The 3M Clarity Aligners and the previously cleared 3M Clear Tray Aligner have the same technological characteristics, such as design, material composition, device features, as well as their manufacturing processes.
Software
There are no changes in the software compared to the existing 3M Clarity Aligners. The software design and development, software development methodology, software development process and environment are identical for the existing predicate device and the modified 3M Clarity Aligners.
Testing
No additional testing has been included on this submission. Biocompatibility tests, performance testing and software verification and validation testing data was previously submitted and reviewed to support clearance of the predicate device 3M Clear Tray Aligner under premarket notification K163689.
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Substantial Equivalence Comparison
The following table compares the 3M Clarity Aligners to the primary predicate device Invisalign System, and to the predicate device 3M Clear Tray Aligner with respect to intended use, technological characteristics and principles of operation.
Table #1
| Feature | Invisalign® System
(Primary Predicate) | 3M™ Clear Tray
Aligner
(Predicate Device) | 3M™
Clarity™ Aligners |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K081960 | K163689 | To be determined |
| Manufacturer | Align Technology, Inc. | 3M Company, 3M Unitek | 3M Company, 3M Health
Care |
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Device
Classification
Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| Product Code | NXC | NXC | NXC |
| Device Class | Class II | Class II | Class II |
| Indications for
Use | The Invisalign System is
indicated for the alignment of
teeth during orthodontic
treatment of malocclusion. | The 3M Clear Tray Aligner
system is a series of clear,
lightweight, plastic
appliances indicated for the
treatment of tooth
malocclusions in patients
with permanent dentition
(i.e., all second molars).
Utilizing a series of
incremental tooth
movements, it sequentially
positions teeth by way of
continuous gentle force. | 3M Clarity Aligners are
indicated for the alignment of
teeth during orthodontic
treatment of malocclusion. |
| Mode of
Action | Orthodontic tooth movement
occurs through forces applied
by the appliance to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription | Orthodontic tooth movement
occurs through forces applied
by the appliance to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription. | Orthodontic tooth movement
occurs through forces applied
by the appliance to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription. |
| Material | Thermoplastic | Thermoplastic | Thermoplastic |
| Software Used
for Ordering
Workflow | Yes | Yes | Yes |
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| Feature | Invisalign® System
(Primary Predicate) | 3M™ Clear Tray
Aligner
(Predicate Device) | 3M™
Clarity™ Aligners |
|---------|-------------------------------------------|-------------------------------------------------|----------------------------|
| Design | Image: Invisalign aligner | Image: 3M Clear Tray Aligner | Image: 3M Clarity Aligners |
Substantial Equivalence Conclusion:
3M Clarity Aligners are substantially equivalent to the predicate device Invisalign cleared under K081960 in that both systems have the same indications for use. This premarket notification is being submitted to expand the indications for use and to update labeling. There are no changes in the technological characteristics, design, material composition, device features to the previously cleared 3M Clear Tray Aligner (K163689).