Clear Aligner

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 13, 2023 Wuxi EA Medical Instruments Technologies Limited. % Breanne Butler Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043 Re: K223517 Trade/Device Name: Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 12, 2023 Received: May 15, 2023 Dear Breanne Butler: 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 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 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. # Michael E. Adjodha - ## S Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K223517 Device Name Clear Aligner Indications for Use (Describe) Indicated for use in alignment of teeth through orthodontic treatment of malocclusion. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | X 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." {3}------------------------------------------------ ### 510(k) Summary #### 510(k) SUMMARY - K223517 A summary of 510(k) safety and effectiveness information for this special 510(k) in accordance with the requirements of 21 CFR 807.92. | Submitter: | Wuxi EA Medical Instruments Technologies Limited<br>No.1619 Huishan Avenue, Huishan Economic Development Zone<br>Wuxi, Jiangsu Province<br>China | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | Company Contact Person:<br>Phone:<br>Email: | Jessica Luo, Regulatory Affairs, Angel Align<br>+86.0510.83591717(181)<br>luoyuqing@angelalign.com | | Submission Correspondent:<br>Address:<br>Phone:<br>Email: | Breanne Butler, Regulatory Affairs Consultant<br>1321 Upland Dr. Suite 6792 Houston, TX 77043<br>860-810-5594<br>bbutler@primepathmedtech.com | | Date Prepared: | November 15, 2022 | | Proprietary Name: | Clear Aligner | | Common Name: | Orthodontic plastic bracket. | | Product Code: | NXC – Orthodontic plastic bracket. | | Device Classification: | Class II, 21 CFR 872.5470 | | Predicate Device: | Invisalign MAF Aligners (K181739) | | Reference Predicate: | Clear Aligner (K203688) | #### Device Description: This premarket notification is submitted to notify the FDA of Wuxi EA Medical Technologies' intent of changes to the Clear Aligner (hereafter referred to as "Proposed Device") to the currently marketed reference device's, Clear Aligner (K203688, cleared October 8, 2021) (hereafter referred to as "Reference Device") indications for use to include mixed dentition, a wear time of at least 10 days, and mandibular repositioning features. The Proposed Device consists of multiple stages of thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental move teeth by way of gentle {4}------------------------------------------------ continuous force and reposition the mandible to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for cleaning. Patients can be prescribed with more than one aligner of different materials within a single stage. The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. The Proposed Device includes mandibular repositioning features known as "A6" on each upper and lower aligner. A6 is intended for use in patients with growing mandibles presenting with retrognathic Class II malocclusions in permanent dentition or stable late mixed dentition. Once the treatment plan is reviewed and approved by a dental health professional, the 3D model of each stage from the treatment plan is manufactured by 3D printed models are then thermoformed over with a suitable dental thermoplastic sheet. The final manufactured aligner stages are then delivered to the patient. The patients' dental health professional then monitors their treatment from the placement of delivered initial aligner stage to the final aligner stage. #### Intended Use: The Proposed Device is indicated for use in the alignment or mixed dentition teeth through orthodontic treatment of misalignment and malocclusion, with 20 to 22 hours of daily wear for at least 10 days. The Proposed Device allows the option of forward repositioning of the mandible to a more optimal bite profile. #### Comparison to Predicate and Reference Devices: The Proposed Device is functionally equivalent to the following predicate device, Invisalign System with Mandibular Advancement Features (Invisalign MAF) (K181739, cleared October 26, 2018) (hereafter referred to as "Predicate Device"), and possesses minor differences to the previously cleared Reference Device. The following table demonstrates the functional specifications of the Proposed Device is substantially equivalent to the Predicate Device, minorly different to Reference Device, and raises no questions regarding safety and effectiveness of the device. | | Subject Device: | Predicate Device: | Reference Device: | Comparison | | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Specification | Clear Aligner | Invisalign MAF | Clear Aligner | Result | | | | (K223517) | (K181739) | (K203688) | | | | Regulation<br>Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same | | | Classification<br>Name | Orthodontic Plastic<br>Bracket | Orthodontic Plastic<br>Bracket | Orthodontic Plastic<br>Bracket | Same | | | Product Code | NXC | NXC | NXC | Same | | | Classification | Class II | Class II | Class II | Same | | | OTC or Rx | Rx | Rx | Rx | Same | | | Material | (1) Multilayer<br>thermoformed<br>copolyester and<br>polyurethan<br>composite and<br>(2) Thermoplastic<br>Polyurethane | Thermoplastic<br>polyurethane-<br>polyester composite<br>resin | (1) Multilayer<br>thermoformed<br>copolyester and<br>polyurethan<br>composite or<br>(2) Thermoplastic<br>Polyurethane | Similar to<br>Predicate (1),<br>Same as<br>Reference (1<br>& 2) | | | | Specification | Subject Device:<br>Clear Aligner<br>(K223517) | Predicate Device:<br>Invisalign MAF<br>(K181739) | Reference Device:<br>Clear Aligner<br>(K203688) | Comparison<br>Result | | | Material<br>Properties | Acceptable material<br>properties<br>established for use<br>as an aligner. | Acceptable<br>materials properties<br>established for use<br>as an aligner. | Acceptable<br>materials<br>properties<br>established for use<br>as an aligner. | Same | | | Material<br>Testing | Tested for<br>performance in<br>accordance with<br>internal design<br>specification and<br>with the applicable<br>performance<br>standards. | Tested for<br>performance in<br>accordance with<br>internal design<br>specification and<br>with the applicable<br>performance<br>standards. | Tested for<br>performance in<br>accordance with<br>internal design<br>specification and<br>with the applicable<br>performance<br>standards. | Same as<br>Reference<br>Device | | | Biocompatible | Biocompatible<br>according to ISO<br>10993-1 (Biological<br>evaluation of<br>medical devices –<br>Part 1: Evaluation<br>and testing within a<br>risk management<br>system). | Biocompatible<br>according to ISO<br>10993-1 (Biological<br>evaluation of<br>medical devices –<br>Part 1: Evaluation<br>and testing within a<br>risk management<br>system). | Biocompatible<br>according to ISO<br>10993-1 (Biological<br>evaluation of<br>medical devices –<br>Part 1: Evaluation<br>and testing within<br>a risk management<br>system). | Same | | | Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | | Device<br>Description | Sequential<br>thermoformed<br>plastic aligners | Sequential<br>thermoformed<br>plastic aligners | Sequential<br>thermoformed<br>plastic aligners | Same | | | Patient<br>Removable? | Yes | Yes | Yes | Same | | | Indication for<br>Use | Indicated for use in<br>alignment of teeth<br>through orthodontic<br>treatment of<br>malocclusion. | Indicated for the<br>orthodontic<br>treatment of<br>malocclusion. | Indicated for the<br>alignment of teeth<br>during orthodontic<br>treatment of<br>malocclusion in<br>patients with<br>permanent<br>dentition (i.e. all<br>second molars). | Similar | | | Intended Use | Orthodontic tooth<br>movement | Orthodontic tooth<br>movement | Orthodontic tooth<br>movement | Same | | | Mode of<br>Action | Continuous gentle<br>force applied to<br>teeth following the<br>prescribed and<br>approved treatment | Continuous gentle<br>force applied to<br>teeth following the<br>prescribed and<br>approved treatment | Continuous gentle<br>force applied to<br>teeth following the<br>prescribed and<br>approved | Same | | Specification | Subject Device:<br>Clear Aligner<br>(K223517) | Predicate Device:<br>Invisalign MAF<br>(K181739) | Reference Device:<br>Clear Aligner<br>(K203688) | Comparison<br>Result | | | | plan to achieve<br>orthodontic<br>movement. | plan to achieve<br>orthodontic<br>movement | treatment plan to<br>achieve<br>orthodontic<br>movement | | | | Lower Jaw<br>Adjustment<br>Mechanism | Mandibular<br>repositioning<br>features known as<br>"A6" | Mandibular<br>Advancement<br>Features also known<br>as "Precision Wings" | N/A | Same as<br>predicate<br>device | | #### Table 5.1: Device Comparison {5}------------------------------------------------ Wuxi EA Medical Instruments Technologies Limited {6}------------------------------------------------ Wuxi EA Medical Instruments Technologies Limited #### Comparison of Indications for Use to Predicate Devices and Previously Cleared Devices: The Proposed Device in this submission is the same as the Predicate Device as they are both indicated for use in the alignment of teeth and mandibular repositioning through orthodontic treatment of malocclusion. It can be used for both permanent and mixed dentition with a wear time 20 to 22 hours a day for at least 10 days. The differences between the indications for use of the Proposed Device, Predicate Device, and the previously cleared Reference Device do not raise questions of substantial equivalence. The Proposed Device guides patients' teeth and mandible to their desired treated position by way of continuous gentle forces in sequential aligner stages. Thus, the Proposed Device can be considered substantially equivalent to the Predicate Device and Reference Device. The difference between the Proposed Device in this submission and the Reference Device is the inclusion of mandibular repositioning and of teeth for treatment of malocclusion. The Proposed Device additionally differs from the Predicate Device in allowing the use of multiple aligner materials. The Thermoplastic Polyurethane material of the Proposed Device is the same as the Reference Device and the Copolyester and Polyurethane Multilayer material is similar to the Predicate Device and raises no questions in the safety or effectiveness of the Proposed Device, demonstratial equivalence to the Predicate Device. #### Comparison of Technological Characteristics to Predicate Devices: Based on the above comparison, the design, construction, and performance characteristics of the Proposed Device are similar to the Predicate Device. Thus, Proposed Device can be considered substantially equivalent to the Predicate Device. #### Non-clinical performance testing: The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces. An internal manufacturing validation was performed to test the manufacturing process for Proposed Device. The robustness of the process was demonstrated from 3D printing through thermoforming. The thermoplastic materials used for the Proposed Device has passed the required testing for material characterization. Material testing was conducted on the aligner materials according to internal design specification and with the applicable performance standards. Biocompatibility testing for the aligner materials, the only patient contacting aspect, was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." #### Clinical performance testing: {7}------------------------------------------------ Retrospective clinical data has been provided the Proposed Device. The data collected for the study showed that successful alignment of teeth through orthodontic treatment of misalignment and malocclusion with at 20 to 22 hours of daily wear for at least 10 days was achieved when using the Proposed Device. #### Conclusion: Based on similarities in indications for use, technological characteristics, non-clinical performance data, the Proposed Device is substantially equivalent to the Predicate Device, Invisalign MAF (K181739) and the previously cleared Reference Device, Angel Align System (K203688).