(197 days)
No
The summary describes a system for fabricating aligners based on digital scans and a doctor's prescription, utilizing existing software (Suresmile® System) for processing and planning. There is no mention of AI or ML in the device description, performance studies, or key metrics. The process appears to be rule-based and technician-driven, guided by the doctor's input.
Yes
The device is a Sureclear™ aligner, which is indicated for the treatment of tooth malocclusion. By actively treating a condition, it functions as a therapeutic device.
No
Explanation: The device is an orthodontic aligner used for treatment of tooth malocclusion, not for diagnosing a condition. It is used after evaluation by a dentist or orthodontist.
No
The device description clearly states that the device is "orthodontic aligners fabricated from a clear, thin thermoformed plastic". This indicates a physical, hardware component, not a software-only device. While software is used in the design and manufacturing process, the final device is a physical product.
Based on the provided information, the Sureclear™ aligners are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of tooth malocclusion, which is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical appliance (aligners) used to physically move teeth. While it uses digital scanning and software for planning and fabrication, the device itself is not used to diagnose a condition by examining samples from the body.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The Sureclear™ aligners do not perform this function.
The device is an orthodontic appliance used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
OraMetrix sureclear™ aligners are orthodontic aligners fabricated from a clear, thin thermoformed plastic in a sequential series, individually customized for each patient based on a doctor's prescription to progressively reposition the teeth via gentle, corrective forces in the upper and lower dental arches.
The patient's dentist or orthodontist will use a digital scanning system to capture the anatomy and locations of the patient's teeth, and then after evaluating those will fill out an electronic prescription form describing the treatment plan using OraMetrix's previously cleared Suresmile® System software (K002620). The digitally scanned tooth data and prescription form are sent electronically via the Suresmile System® to OraMetrix technicians, using the Suresmile® System, separate the tooth scan data into individual tooth models representing the patient's malocclusion.
Additional OraMetrix technicians, also using the Suresmile® System's software, interpret the doctor's instructions provided on the prescription form; produce a setup and a sequence of intermediate models corresponding to each stage of the patient's aligner therapy. The setup and the intermediate stages are sent, via the Suresmile® System, back to the doctor for review, modification or approval. Once the doctor is satisfied with the planned therapy, an order for the production, packaging and shipment of the aligners is made via the Suresmile® System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital scanning system
Anatomical Site
Mouth; mucosal membranes.
Indicated Patient Age Range
patients with permanent dentition.
Intended User / Care Setting
dentist or orthodontist
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)
OraMetrix has submitted finished sureclear™ aligners for the appropriate biocompatibility testing per ISO 10993-1 and its applicable parts, while the physical and mechanical properties of the elastic thermoplastic materials used to fabricate the aligners have previously been demonstrated by the manufacturer of the base materials. The subject device meets all internal OraMetrix specification requirements to support substantial equivalence to the predicate device.
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. Therefore, there was no clinical testing required to support sureclear™ aligners, as the indications for use is equivalent to the predicate device, which was not subjected to any clinical testing. The substantial equivalence of the subject device to the ClearCorrect System is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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January 5, 2018
OraMetrix, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC. 1394 25th Street NW Buffalo, Minnesota 551313
Re: K171860
Trade/Device Name: Sureclear™ aligner system Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 27, 2017 Received: December 29, 2017
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Mary S. Runner -S
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)
Device Name sureclear™ aligners
Indications for Use (Describe)
Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition.
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) Summary
OraMetrix sureclear™ aligners
K
5.1 Submission Sponsor
OraMetrix, Inc.
2350 Campbell Creek Blvd.
Suite 400
Richardson, TX 75082
USA
Phone number: 49-30-24309139
Contact: Sabrina Weitzel
Email: sabrina.weitzel@orametrix.de
5.2 Submission Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road, Bldg. 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327-9997
Contact: Stuart R. Goldman, Senior Consultant, RA
Email: project.management@emergogroup.com
5.3 Date Prepared
May 31, 2017
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5.4 Device Identification
| Trade/Proprietary Name: | sureclear™ aligners |
|---|---|
| Common/Usual Name: | Sequential aligners |
| Classification Name: | Orthodontic plastic bracket |
| Regulation Number: | NXC |
| Product Code: | 872.5470 |
| Device Class: | Class II |
| Classification Panel: | Dental |
5.5 Legally Marketed Predicate Device
ClearCorrect System (K113618)
5.6 Device Description
OraMetrix sureclear™ aligners are orthodontic aligners fabricated from a clear, thin thermoformed plastic in a sequential series, individually customized for each patient based on a doctor's prescription to progressively reposition the teeth via gentle, corrective forces in the upper and lower dental arches.
The patient's dentist or orthodontist will use a digital scanning system to capture the anatomy and locations of the patient's teeth, and then after evaluating those will fill out an electronic prescription form describing the treatment plan using OraMetrix's previously cleared Suresmile® System software (K002620). The digitally scanned tooth data and prescription form are sent electronically via the Suresmile System® to OraMetrix technicians, using the Suresmile® System, separate the tooth scan data into individual tooth models representing the patient's malocclusion.
Additional OraMetrix technicians, also using the Suresmile® System's software, interpret the doctor's instructions provided on the prescription form; produce a setup and a sequence of intermediate models corresponding to each stage of the patient's aligner therapy. The setup and the intermediate stages are sent, via the Suresmile® System, back to the doctor for review, modification or approval. Once the doctor is satisfied with the planned therapy, an order for the production, packaging and shipment of the aligners is made via the Suresmile® System.
5.7 Indication for Use
Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition.
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5.8 Substantial Equivalence Discussion
OraMetrix has chosen the ClearCorrect System cleared by the FDA under K113618 as the predicate device for its sureclear™ aligners. The following table compares the subject device to the predicate device with respect to their indications for use, technology and performance testing, thus demonstrating the basis for determination of substantial equivalence between these devices.
| Regulatory Information | |||
|---|---|---|---|
| Device Name | Sureclear™ Aligners | ClearCorrect System | Similarities/ |
| Differences | |||
| Manufacturer | OraMetrix, Inc. | ClearCorrect, Inc. | na |
| 510(k) | Pending | K113618 | na |
| Product Code | NXC | NXC | Same. |
| Regulation | §872.5470 | §872.5470 | Same. |
| Class | II | II | Same. |
| Indications for | |||
| Use | Sureclear™ aligners are indicated for | ||
| the treatment of tooth malocclusion | |||
| in patients with permanent dentition. | The 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. | Same. | ||
| Prescription use | Yes | Yes | Same. |
| Fundamental Scientific Technology | |||
| Device Images | Image: Sureclear Aligners | Image: ClearCorrect Aligners | Similar. Varies |
| by patient | |||
| prescription. | |||
| Conditions of | |||
| Use | Worn daily by the patient for | ||
| approximately 20 to 22 hours, except | |||
| when performing dental hygiene and | |||
| eating and drinking. The treatment | |||
| plan (and time) varies by individual | |||
| patient prescription. | Worn daily by the patient for | ||
| approximately 20 to 22 hours, except | |||
| when performing dental hygiene and | |||
| eating and drinking. The treatment plan | |||
| (and time) varies by individual patient | |||
| prescription. | Same. |
Table 5-1 – Comparison of Characteristics
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| Mechanism of
Action | Sequential aligners are made from
elastic thermoplastic materials that
apply continuous gentle force to the
teeth. | Sequential aligners are made from
elastic thermoplastic materials that
apply continuous gentle force to the
teeth. | Same. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|----------|
| Material | Elastic thermoplastic material. | Elastic thermoplastic material. | Similar. |
| Sizes | Patient specific. | Patient specific. | Same. |
| Manufacturing
method | Thermoforming. | Thermoforming. | Similar. |
| Body Location | Mouth; mucosal membranes. | Mouth; mucosal membranes. | Same. |
| Relevant Testing Performed | | | |
| Biocompatibility
Testing | Per ISO 10993-1 and applicable parts. | Per ISO 10993-1 and applicable parts. | Similar. |
| Animal Testing | Not required and not performed. | Not required and not performed. | Same. |
| Clinical Testing | Not required and not performed. | Not required and not performed. | Same. |
| Risk Analysis | Per ISO 14971. | Assumed to have been performed. | Similar. |
5.9 Non-Clinical Performance Data
OraMetrix has submitted finished sureclear™ aligners for the appropriate biocompatibility testing per ISO 10993-1 and its applicable parts, while the physical and mechanical properties of the elastic thermoplastic materials used to fabricate the aligners have previously been demonstrated by the manufacturer of the base materials. The subject device meets all internal OraMetrix specification requirements to support substantial equivalence to the predicate device.
5.10 Clinical Performance Data
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. Therefore, there was no clinical testing required to support sureclear™ aligners, as the indications for use is equivalent to the predicate device, which was not subjected to any clinical testing. The substantial equivalence of the subject device to the ClearCorrect System is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission.
5.11 Statement of Substantial Equivalence
Sureclear™ aligners have substantially equivalent Indications for Use as the identified predicate device. While the verbiage of the Indications of Use of the subject device is slightly different than the declared predicate; however, these slight differences do not alter the intended therapeutic use of the device as compared to the predicate device. The conclusions drawn from the data included in this submission,
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demonstrate that sureclear™ aligners are as safe, as effective, and are substantially equivalent to the predicate device in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.