(242 days)
No
The description mentions "standard dental software" and "Orthocaps technicians design a series of intermediate models," indicating human-driven design using conventional software, not AI/ML.
Yes
The device, Orthocaps TwinAligner® System, is intended for the alignment of teeth during orthodontic treatment of malocclusions by applying continuous gentle forces, which is a therapeutic purpose.
No
The device is described as custom-made removable clear plastic orthodontic aligners used for the alignment of teeth. It functions by applying continuous gentle forces to sequentially position teeth, not by diagnosing conditions.
No
The device description explicitly states that the system consists of "a series of custom made removable clear plastic orthodontic aligners," which are physical hardware components. While software is used in the design and manufacturing process, the final medical device delivered to the patient is a physical product.
Based on the provided information, the Orthocaps TwinAligner® System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "alignment of teeth during orthodontic treatment of malocclusions." This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is a series of custom-made physical aligners that apply force to move teeth. While it uses digital scans and software in the design process, the device itself is a physical appliance used for treatment.
- No mention of analyzing biological specimens: The device works directly on the patient's teeth, not on samples taken from the patient (like blood, urine, tissue, etc.).
- No diagnostic claims: The documentation does not claim that the device is used to diagnose any condition or provide information for diagnosis.
The use of digital scans and software for planning and manufacturing is a part of the device's production process, but it doesn't make the final physical aligner an IVD. The software itself might have some characteristics that could be considered in a different regulatory context, but the Orthocaps TwinAligner® System as a whole is a therapeutic device.
N/A
Intended Use / Indications for Use
The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.
Product codes
NXC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
electronic scan or mold impression
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental or orthodontic professional / 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 battery of testing included the following tests:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
September 28, 2018
Image /page/0/Picture/1 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.
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
1
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
2
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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3
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
4
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 |
| 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 |
| Device | |||
| Classification | Class II | Class II | Class II |
| Product Code | NXC | NXC | NXC |
| Indications | |||
| for use | Orthocaps TwinAligner® | ||
| System is indicated for the | |||
| alignment of teeth during | |||
| orthodontic treatment of | |||
| malocclusions by way of | |||
| continuous gentle forces. | The Invisalign System is | ||
| indicated for the alignment | |||
| of teeth during orthodontic | |||
| treatment of malocclusion. | ClearCorrect System is | ||
| indicated for the treatment | |||
| of tooth malocclusion in | |||
| patients with permanent | |||
| dentition (i.e. all second | |||
| molars), The ClearCorrect | |||
| System positions teeth by | |||
| way of continuous gentle | |||
| force. | |||
| Mode of | |||
| Action | Orthodontic movement | ||
| occurs through continuous | |||
| gentle forces applied to the | |||
| dentition as each tooth | |||
| follows the programmed | |||
| displacement based on a | |||
| doctor's prescription | Orthodontic movement | ||
| occurs through continuous | |||
| gentle forces applied to the | |||
| dentition as each tooth | |||
| follows the programmed | |||
| displacement based on a | |||
| doctor's prescription | Orthodontic movement | ||
| occurs through continuous | |||
| gentle forces applied to the | |||
| dentition as each tooth | |||
| follows the programmed | |||
| displacement based on a | |||
| doctor's prescription |
5
| Method of
Use | Each preformed plastic tray
is worn in sequence by the
patient as prescribed by the
dental practitioner | Each preformed plastic tray
is worn in sequence by the
patient as prescribed by the
dental practitioner | Each preformed plastic tray
is worn in sequence by the
patient as prescribed by the
dental practitioner |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software
Description
for tooth
movement | Standard dental software for
tooth alignment uses digital
scan (untreated state) to
generate the image of a
final, provisional treated
state and then interprets a
series of images that
represent intermediate
teeth states. The dental
practitioner then reviews
these images and has the
option to reject or request
modifications to the set-up
prior to approving it for
aligner fabrication. Once the
dental practitioner approves
the treatment plan, the
software converts the files
to produce the series of 3D
models used to produce
thermoformed aligners. | A digital scan of the
patient's teeth. From the
digital model, following a
dental practitioner's
prescription, the software
generates model
transforms describing the
final, treated state and then
interpolates a series of
model transforms that
represent intermediate
states of alignment. The
resulting computer
"setups" relay this
information to rapid
prototyping machines that
produce physical positive
models. The aligners are
produced by
thermoforming on each
physical model to fabricate
the sequence of aligners. | Standard dental software
for tooth alignment uses
digital scan (untreated
state) to generate the image
of a final, provisional
treated state and then
interprets a series of images
that represent intermediate
teeth states. The dental
practitioner then reviews
these images and has the
option to reject or request
modifications to the set-up
prior to approving it for
aligner fabrication. Once the
dental practitioner approves
the treatment plan, the
software converts the files
to produce the series of 3D
models used to produce
thermoformed 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
6
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.