(2 days)
K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
The K Line K Clear aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a softwaregenerated sequence of intermediate states. K Clear sequentially reposition teeth by way of continuous gentle force.
This submission describes the K Clear aligners, an orthodontic device intended for the alignment of teeth. The FDA has determined the device is substantially equivalent to a legally marketed predicate device (Smylio Invisible Clear Aligners, K212660).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the device's clinical performance in terms of treatment efficacy (e.g., specific tooth movement targets, reduction in malocclusion). Instead, the substantial equivalence decision is based on comparisons of design, materials, indications for use, and technological characteristics to a predicate device, along with performance data related to manufacturing and biocompatibility.
| Criterion | Reported Device Performance (K Clear) |
|---|---|
| Substantial Equivalence to Predicate | K Clear aligners are determined to be substantially equivalent to Smylio Invisible Clear Aligners (K212660). This is based on: - Indications for Use: Highly similar. K Clear: "alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars)." Smylio: "alignment of teeth during orthodontic treatment of tooth malocclusion." - Technological Principles: Identical process to predicate and other sequential aligner systems. - Regulation, Classification, Product Code, Class: Same as predicate. - Mode of Action: Same (continuous gentle force). - Method of Use: Same (worn 20-22 hours/day, removed for eating/cleaning, replaced sequentially). - Material: Same (Thermoplastic polyurethane-polyester composite resin). - Appliance Application: Same (Patient removable). - Design: Same (Clear aligner). - Biocompatible: Yes (Same as predicate). - Prescription/OTC: Rx (Same as predicate). - Sterile: Non-sterile (Same as predicate). |
| Dimensional Accuracy (Manufacturing) | A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for K Clear aligners. (No specific numerical acceptance criteria or results are provided in this summary). |
| Performance as Intended (Manufacturing) | A qualification was performed to demonstrate the device is manufactured and performs as intended. |
| Shelf-Life/Aging | A shelf-life/aging study was performed to support device labeling. (No specific acceptance criteria or results are provided). |
| Biocompatibility | Evaluation and testing were conducted in accordance with ISO 10993-1. Specific tests performed: - Cytotoxicity: ISO 10993-5:2009 - Sensitization: ISO 10993-10:2010 - Irritation: ISO 10993-10:2010 - Sub-chronic toxicity: ISO 10993-11:2017 - Genotoxicity: ISO 10993-3:2014 (Implied acceptance is that the device passed these tests, indicating biocompatibility). No specific pass/fail criteria or results are provided. |
Regarding the device's ability to 'meet' clinical acceptance criteria, the document states: "The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. No clinical or animal testing data is included in this submission." This indicates reliance on the established clinical performance of the device type rather than novel clinical studies for K Clear.
2. Sample size used for the test set and the data provenance
No specific test set or clinical study was conducted for K Clear as part of this submission for direct patient outcomes. The submission relies on the established clinical effectiveness of the device type (sequential aligners under product code NXC) and "performance data" that includes manufacturing validation, qualification, shelf-life/aging study, and biocompatibility testing. These are not clinical test sets with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set using expert-established ground truth was part of this submission due to reliance on substantial equivalence and established clinical performance of the device type.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication was part of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The K Clear aligners are a physical orthodontic device, not an AI-assisted diagnostic or treatment planning software meant for human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. K Clear aligners are a physical device, not an algorithm. The aligners are used with a "software-generated sequence of intermediate states," but this software's performance as a standalone algorithm is not detailed, nor is it the central point of the device's regulatory review here.
7. The type of ground truth used
For the aspects for which data was presented:
- Manufacturing Validation, Qualification, Shelf-life/Aging: The "ground truth" would be the engineering specifications and quality control standards defined by the manufacturer and relevant to the manufacturing process for dimensional accuracy, intended performance, and material stability over time.
- Biocompatibility: The "ground truth" is defined by the standards listed (ISO 10993 series), which provide criteria for evaluating biological responses to medical devices. Meeting these standards serves as the ground truth for biocompatibility.
- Clinical Effectiveness: The "ground truth" for clinical effectiveness is considered to be the well-established performance of sequential aligners in the clinical environment since their first clearance in 1998. This is based on historical clinical use and published scientific literature for this class of devices, rather than a specific ground truth for K Clear itself.
8. The sample size for the training set
Not applicable in the context of a physical medical device. This term typically refers to machine learning models, which are not the subject of this submission in terms of clinical performance evaluation. The "software-generated sequence of intermediate states" implies some computational component, but details on its training data are not provided or required for this type of submission which focuses on substantial equivalence of the physical device.
9. How the ground truth for the training set was established
Not applicable, as explained in point 8.
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March 16, 2022
K Line Europe GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220726
Trade/Device Name: K Clear Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: March 11, 2022 Received: March 14, 2022
Dear Prithul Bom:
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.
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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, 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
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Indications for Use
510(k) Number (if known) K 220726
Device Name
K Clear
Indications for Use (Describe)
K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
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)
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510(k) Summa K Line Europe, GmbH K Clear 2/2/2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | K Line Europe, GmbHNiederrheinstraße 1640474 Dusseldorf, Germany | |
|---|---|---|
| Telephone: | +49 211 93896976 | |
| Official Contact: | Sherif Kandil, CEO | |
| Email: | sherif@clearxaligners.com | |
| DEVICE NAME AND CLASSIFICATION | ||
| Trade/Proprietary Name: | K Clear | |
| Common Name: | Aligners, sequential | |
| Classification Name: | Orthodontic Plastic Bracket | |
| Classification Regulations: | 21 CFR 872.5470 | |
| Device Class: | Class II | |
| Product Code: | NXC | |
| Review Panel: | Dental Products Panel | |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1B)Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate and reference devices:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K212660 | Smylio Invisible Clear Aligners | Smylio, Inc |
DEVICE DESCRIPTION
The K Line K Clear aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a softwaregenerated sequence of intermediate states. K Clear sequentially reposition teeth by way of continuous gentle force.
The technology and overall process is identical to that used by the Predicate device, Smylio Invisible Clear Aligners (K212660) and other sequential aligner systems currently being legally marketed.
INDICATIONS FOR USE/INTENDED USE
K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
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EQUIVALENCE TO MARKETED DEVICE
Overall, the Subject device is substantially equivalent to the Predicate device with respect to Indications for Use and technological principles. The Comparison table below compares parameters and characteristics of the Subject device and Predicate/reference devices.
| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| K ClearK Line Europe, GmbH | Smylio Invisible Clear AlignersSmylio, IncK212660 | ||
| Regulation # | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Product Code | NXC | NXC | Same |
| Classification | Class II | Class II | Same |
| Indications forUse/Intended Use | K Clear aligners are indicated for the alignment of teethduring orthodontic treatment of tooth malocclusion inpatients with permanent dentition (i.e., all secondmolars). | The Smylio Invisible Clear Aligners are indicated forthe alignment of teeth during orthodontic treatmentof tooth malocclusion. | Highly Similar |
| Intended Population | Individuals with permanent dentition (all second molars). | Not specified. | Similar |
| Mode of action | Continuous gentle force applied to teeth following theprescribed and approved treatment plan to achieveorthodontic movement. | Continuous gentle force applied to teeth following theprescribed and approved treatment plan to achieveorthodontic movement. | Same |
| Method of use | Each aligner is worn by the patient for 20-22 hours a dayand are to be removed for eating and cleaning. Alignersare replaced by the next aligner in sequence as directedby the dental health professional. | Each aligner is worn by the patient for 20-22 hours aday and are to be removed for eating and cleaning.Aligners are replaced by the next aligner in sequenceas directed by the dental health professional. | Same |
| Material | Thermoplastic polyurethane-polyester composite resin | Thermoplastic polyurethane-polyester composite resin | Same |
| Appliance Application | Patient removable | Patient removable | Same |
| Design | Image: Clear aligner | Image: Clear aligner | Same |
| Biocompatible | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Same |
| Sterile | Non-sterile | Non-sterile | Same |
Predicate Device Comparison Table
The wording of the Indications for Use of the Subject device is highly similar to that of the Predicate device, differing slightly in wording and device name. The Predicate device Indications for Use statement does not include a limitation on patient population and is inclusive of the intended population of the Subject device. The intended use of both devices to treat tooth malocclusion is the same for the Subject and Predicate devices.
TECHNOLOGICAL CHARACTERISTICS
Orthodontic tooth movement occurs through forces applied to the teeth by the appliance as each tooth follows the predetermined displacement based on a dental health professional's prescription. The Subject device mode of action, method of use and sterilization status are the same as the Predicate device.
The Subject and Predicate devices are both fabricated of non-sterile, biocompatible thermoplastic polyurethane-polyester composite resin material. The Subject device mode of action and method of use are the same as the Predicate device and supports a determination of substantial equivalence.
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PERFORMANCE DATA
Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for K Clear aligners. A qualitation was performed to demonstrate the device is manufactured and performs as intended. A shelf-life/aging study was performed to support device labeling.
Biocompatibility evaluation and testing for the aligner material 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".
The following biological tests were performed:
| Biological Endpoint | Relevant Standard |
|---|---|
| Cytotoxicity | ISO 10993-5:2009 |
| Sensitization | ISO 10993-10:2010 |
| Irritation | ISO 10993-10:2010 |
| Sub-chronic toxicity | ISO 10993-11:2017 |
| Genotoxicity | ISO 10993-3:2014 |
The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. No clinical or animal testing data is included in this submission.
CONCLUSION
Overall, the Indications for Use statement for the Subject and Predicate devices is highly similar.
Overall, the Technological Characteristics, Materials, Prescription Use and Non-sterile status of the Subject device are the same or highly similar to the Predicate device. The use of Software to produce the Subject and Predicate devices is the same. Minor differences between the Subject and Predicate devices were mitigated through performance testing of the Subject device.
Overall, the K Line K Clear aligners are substantially equivalent to the Predicate device.
§ 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.