(242 days)
The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
Orthocaps TwinAligner® System consists of a series of custom made removable clear plastic orthodontic aligners that sequentially positions teeth by way of continuous gentle force.
An electronic scan or mold impression of the patient's teeth in an untreated state is provided by a dental or orthodontic professional. From the digital scan, Orthocaps technicians design a series of intermediate models corresponding to each stage of treatment intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Orthocaps produces the aligner trays formed from clear, thin thermoformed plastic. The trays are sent back to the physician for patient fit and treatment. Additional trays are provided sequentially to gradually move the target teeth to the designed position, which is monitored throughout treatment by the physician. The aligner trays are held in place by pressure and can be removed by the patient at any time. Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printed files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation for this subject device is the 3Shape reference predicate.
The Orthocaps TwinAligner® System is a medical device for orthodontic treatment. The information provided does not detail specific acceptance criteria for performance metrics (such as accuracy of tooth movement or treatment efficacy). Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices based on indications for use, technological characteristics, and safety (biocompatibility).
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Since specific quantitative performance acceptance criteria are not explicitly stated for the device's functional efficacy (e.g., degree of tooth movement precision), the acceptance criteria primarily revolve around demonstrating substantial equivalence to predicate devices and acceptable biocompatibility.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence (Indications for Use) | Indications for Use of the subject device are essentially the same as currently marketed predicate devices. | "The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces." This is presented as substantially equivalent to the predicate devices. |
| Substantial Equivalence (Technological Characteristics) | Design, materials, and treatment of malocclusions through sequential thermoplastic aligners follow the same technological principles as predicate devices. The use of dental software for treatment planning is similar. | Design: Clear aligner, similar to predicates.Material: Thermoplastic, similar to predicates.Mode of Action: Orthodontic movement through continuous gentle forces via sequential removable thermoplastic aligners, similar to predicates.Software Description for Tooth Movement: Standard dental software to generate intermediate tooth states based on digital scan and physician's prescription, then converting files to produce 3D models for aligner manufacturing. This is presented as similar to predicate devices. |
| Biocompatibility | Device materials meet ISO 10993-1 and its applicable parts (Cytotoxicity, Irritation, Sensitization). | Cytotoxicity: PASS (ANSI/AAMI/ISO 10993-5)Irritation: PASS (ISO 10993-10)Sensitization: PASS (ISO 10993-10) |
| Manufacturing Accuracy (Verification & Validation) | No measurable deviation between physical and digital models established in the process workflow using a physical model cast impression. | "Results of verification and validation testing demonstrate device conformity with preestablished specifications using a physical model cast impression. There was no measurable deviation between physical and digital models established in the process workflow." |
2. Sample Size Used for the Test Set and Data Provenance:
- Biocompatibility Testing: The document does not specify a "sample size" in terms of number of devices tested for biocompatibility. The tests were performed "in accordance to ISO 10993-1 and its applicable parts," but the number of samples or batches is not mentioned.
- Verification and Validation Testing: The document mentions using "a physical model cast impression" but does not specify the sample size (i.e., how many casts or digital models were compared).
- Data Provenance: Not explicitly stated for biocompatibility or V&V testing, but it can be inferred that these were laboratory-based tests conducted by/for Ortho Caps GmbH. No country of origin for patients or specific retrospective/prospective study design is relevant here as no clinical data was submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Biocompatibility Testing: The ground truth is established by the specified ISO standards (e.g., ISO 10993-5, 10993-10). No human experts were used to "establish ground truth" beyond the standard laboratory procedures and interpretation of results according to ISO guidelines.
- Verification and Validation Testing: This involved comparing physical and digital models. The "ground truth" here is the design specification or the intended digital model. The comparison would likely be performed by engineers or technicians, but no specific "experts" for ground truth establishment are mentioned.
4. Adjudication Method for the Test Set:
- Biocompatibility Testing: No human adjudication method (like 2+1 or 3+1) is described. The results are based on standardized laboratory assays and their interpretation against pass/fail criteria defined by the ISO standards.
- Verification and Validation Testing: No adjudication method is mentioned. The comparison of physical and digital models would likely involve quantitative measurements and adherence to pre-established specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not included in this submission." The submission relies on substantial equivalence to predicate devices which have established clinical safety and effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device is a physical product (aligners) manufactured using software for treatment planning. The "software application used for the manufacturing validation for this subject device is the 3Shape reference predicate."
Verification and validation testing confirmed "no measurable deviation between physical and digital models." This can be considered a standalone performance assessment of the manufacturing process driven by the software, ensuring the physical output matches the digital plan. However, this is not a standalone clinical performance study of the algorithm's ability to predict tooth movement in patients.
7. The Type of Ground Truth Used:
- Biocompatibility: The ground truth is defined by the objective pass/fail criteria specified in the international ISO 10993 standards for biological evaluation of medical devices.
- Verification and Validation: The ground truth is the "preestablished specifications" and the intended digital model for the aligners.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product (aligners) and the manufacturing process uses "standard dental software" (like 3Shape Ortho System) which is a reference predicate. There is no mention of a proprietary AI algorithm developed by Ortho Caps GmbH that underwent a training phase.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no described training set for a proprietary algorithm. The software used is described as "standard dental software" or a "reference predicate." The ground truth for such software would typically be derived from extensive orthodontic principles, biomechanical models, and clinical experience embedded in their design and development, rather than a specific "training set" in the context of machine learning.
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September 28, 2018
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Ortho Caps GmbH % Angelica Ayala Regulatory Affairs Specialist RMO, Inc. 650 W. Colfax Ave Denver, Colorado 80204
Re: K180241
Trade/Device Name: Orthocaps Twinaligner® Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: August 28, 2018 Received: August 29, 2018
Dear Angelica Ayala:
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/ofdocs/ofpmn.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 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
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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical on-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 -S3
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
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Indications for Use
510(k) Number (if known) K180241
Device Name Orthocaps TwinAligner® System
Indications for Use (Describe)
The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
| 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) |
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510(k) Summary
- Date Prepared: September 27, 2018 1.
2. Submitter Information:
Ortho Caps GmbH An der Bewer 8 59069 Hamm Germany
| Contact Person: | Wajeeh Khan |
|---|---|
| Telephone Number: | +49 2385 92190 |
| Fax Number: | +49 2385 9219080 |
| Email: | wajeehkhan@orthocaps.de |
3. Submission Correspondent:
RMO, Inc 650 W. Colfax Avenue Denver, CO 80204
| Contact Person: | Angelica Ayala |
|---|---|
| Telephone Number: | (303) 592-8217 |
| Fax Number: | (303) 592-8257 |
| Email: | aayala@rmortho.com |
4. Device Information:
| Trade/Proprietary Name: | Orthocaps TwinAligner® System |
|---|---|
| Common Name: | Aligner, Sequential |
| Classification Name: | Orthodontic plastic bracket |
| Classification Regulation: | 872.5470 |
| Device Classification: | Class II |
| Product Code: | NXC |
5. Predicate Devices:
| Invisalign® System | Primary Predicate | K081960 | Align Technology, Inc |
|---|---|---|---|
| ClearCorrect System | Reference Predicate | K113618 | ClearCorrect LLC |
| 3Shape Ortho System™ | Reference Predicate | K152086 | 3Shape A/S |
6. Device Description:
Orthocaps TwinAligner® System consists of a series of custom made removable clear plastic orthodontic aligners that sequentially positions teeth by way of continuous gentle force.
An electronic scan or mold impression of the patient's teeth in an untreated state is provided by a dental or orthodontic professional. From the digital scan, Orthocaps technicians design a series of intermediate models corresponding to each stage of treatment intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Orthocaps produces the aligner trays formed from clear, thin thermoformed
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plastic. The trays are sent back to the physician for patient fit and treatment. Additional trays are provided sequentially to gradually move the target teeth to the designed position, which is monitored throughout treatment by the physician. The aligner trays are held in place by pressure and can be removed by the patient at any time. Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printed files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation for this subject device is the 3Shape reference predicate.
7. Intended Use:
The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
8. Substantial Equivalence:
The Orthocaps TwinAligner® System is substantially equivalent to the predicate devices with respect to indications for use, technological characteristics, principles of operation, and materials, as demonstrated in the comparison below:
| Element | Subject Device | Primary Predicate | Reference Predicate |
|---|---|---|---|
| Device Name | Orthocaps TwinAligner®System | Invisalign® System | ClearCorrect |
| Manufacturer | Ortho Caps GmbH | Align Technology, Inc. | ClearCorrect LLC |
| 510(k)Number | K180241 | K081960 | K113618 |
| RegulationNumber | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 |
| DeviceClassificationName | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket |
| DeviceClassification | Class II | Class II | Class II |
| Product Code | NXC | NXC | NXC |
| Indicationsfor use | Orthocaps TwinAligner®System is indicated for thealignment of teeth duringorthodontic treatment ofmalocclusions by way ofcontinuous gentle forces. | The Invisalign System isindicated for the alignmentof teeth during orthodontictreatment of malocclusion. | ClearCorrect System isindicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e. all secondmolars), The ClearCorrectSystem positions teeth byway of continuous gentleforce. |
| Mode ofAction | Orthodontic movementoccurs through continuousgentle forces applied to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription | Orthodontic movementoccurs through continuousgentle forces applied to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription | Orthodontic movementoccurs through continuousgentle forces applied to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription |
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| Method ofUse | Each preformed plastic trayis worn in sequence by thepatient as prescribed by thedental practitioner | Each preformed plastic trayis worn in sequence by thepatient as prescribed by thedental practitioner | Each preformed plastic trayis worn in sequence by thepatient as prescribed by thedental practitioner |
|---|---|---|---|
| SoftwareDescriptionfor toothmovement | Standard dental software fortooth alignment uses digitalscan (untreated state) togenerate the image of afinal, provisional treatedstate and then interprets aseries of images thatrepresent intermediateteeth states. The dentalpractitioner then reviewsthese images and has theoption to reject or requestmodifications to the set-upprior to approving it foraligner fabrication. Once thedental practitioner approvesthe treatment plan, thesoftware converts the filesto produce the series of 3Dmodels used to producethermoformed aligners. | A digital scan of thepatient's teeth. From thedigital model, following adental practitioner'sprescription, the softwaregenerates modeltransforms describing thefinal, treated state and theninterpolates a series ofmodel transforms thatrepresent intermediatestates of alignment. Theresulting computer"setups" relay thisinformation to rapidprototyping machines thatproduce physical positivemodels. The aligners areproduced bythermoforming on eachphysical model to fabricatethe sequence of aligners. | Standard dental softwarefor tooth alignment usesdigital scan (untreatedstate) to generate the imageof a final, provisionaltreated state and theninterprets a series of imagesthat represent intermediateteeth states. The dentalpractitioner then reviewsthese images and has theoption to reject or requestmodifications to the set-upprior to approving it foraligner fabrication. Once thedental practitioner approvesthe treatment plan, thesoftware converts the filesto produce the series of 3Dmodels used to producethermoformed aligners. |
| Material | Thermoplastic | Thermoplastic | Thermoplastic |
| OTC or Rx | Rx | Rx | Rx |
| Sterilization | No | No | No |
| Design | Image: clear aligner | Image: clear aligner | Image: clear aligner |
The Indications for Use of the subject device are essentially the same as currently marketed predicate devices. The verbiage of the Indications of Use of the subject device is slightly different than predicate devices; however, these slight differences do not affect the intended therapeutic treatment of malocclusions as compared to the predicates.
The technological characteristics of the subject device regarding the design, materials, and treatment of malocclusions through sequential thermoplastic aligners follow the same technological principles as predicate devices. While there are different trays worn during daytime and nighttime, these slight differences from predicate devices do not alter the intended therapeutic treatment of malocclusions using clear aligners.
The mode of action for the subject device is fundamentally the same to predicate devices and supports the determination of substantial equivalence. Orthodontic tooth movement
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occurs through continuous gentle forces applied to dentition using sequential removable thermoplastic aligners.
The use of dental software to translate tooth movements in developing the model scheme in the subject device is essentially the same to predicate devices. The subject and reference predicate devices allow the dental practitioner to review and approve the model scheme before aligner fabrication.
9. Non-Clinical Performance Data
Biocompatibility Testing:
The biocompatibility testing for the device was conducted in accordance to ISO 10993-1 and its applicable parts. The results of the testing satisfy the requirements of the study protocols and comply with ISO 10993-1 for the intended use. The results of the studies further support a determination of substantial equivalence. The battery of testing included the following tests:
| Test | Standard | Result |
|---|---|---|
| Cytotoxicity | ANSI/AAMI/ISO 10993-5 | PASS |
| Irritation | ISO 10993-10 | PASS |
| Sensitization | ISO 10993-10 | PASS |
Verification and Validation Testing:
Results of verification and validation testing demonstrate device conformity with preestablished specifications using a physical model cast impression. There was no measurable deviation between physical and digital models established in the process workflow.
Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
10. Clinical Performance Data:
Clinical data was not included in this submission.
11. Conclusion
The Orthocaps TwinAligner® System has substantially equivalent Indications for Use and technological characteristics to the previously cleared predicate devices.
The conclusions drawn from the data included in this submission demonstrate that Orthocaps TwinAligner® System is substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mode of action, method of use, performance, materials, and biocompatibility.
§ 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.