(30 days)
None
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the treatment planning software focuses on user modification and operator input, not automated decision-making or learning.
Yes
The device is described as "an orthodontic appliance system used to correct malocclusions in orthodontic patients," which is a therapeutic function.
No
The device is described as a treatment planning software and orthodontic appliance system used to correct malocclusions, not to diagnose them. It helps professionals "view and modify cases" and generate prescriptions, focusing on the treatment aspect.
No
The device description explicitly states that the system consists of both treatment planning software and physical components (patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates). The performance studies also focus on the physical properties of the brackets.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Signature Orthodontic System is used for treatment planning and applying orthodontic appliances directly to the patient's teeth to correct malocclusions. It works on the patient's natural teeth, not on samples taken from the body.
- Input: While it uses a scan of a traditional impression (which is a mold of the teeth), this is used to create a digital model for planning, not for diagnostic testing of a biological sample.
- Purpose: The purpose is to physically move teeth, not to diagnose a disease or condition through laboratory testing.
Therefore, the Signature Orthodontic System falls under the category of a medical device used for treatment, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.
Product codes
NJM
Device Description
The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Natural teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals trained in orthodontic treatment (DDS/DMD)
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)
Bench testing was performed to ensure that the patient-specific brackets were substantially equivalent to the SO System predicate, TOMY Orthodontic Ceramic Brackets 1.1. Performance testing consisted of shear bond strength and torque strength. Tensile testing and bracket strength (fracture) testing were also completed as comparison tests.
- Shear bond strength: The average value of the SO System brackets' shear bond strength was statistically significantly higher than that of the predicate device.
- Torque strength: There were no statistically significant differences between the two groups. The average value of the SO System brackets' torque strength was slightly higher than that of the predicate device.
- Friction (wire drag) force: There were no statistically significant differences between the two groups. The average value of the SO System brackets' friction (wire drag) force was slightly lower than that of the predicate device.
- Tensile bond strength: The average value of the SO System brackets' tensile bond strength was statistically significantly higher than that of the predicate device.
- Tie-wing tensile fracture strength: There were no statistically significant differences between the two groups. The average value of the SO System brackets' tie wing fracture strength was slightly lower than that of the predicate device.
Biocompatibility testing performed included genotoxicity, cytotoxicity (agarose and elution methods), sensitization, oral toxicity, irritation, and chemical characterization.
No clinical performance testing was conducted on SO System brackets.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Signature Orthodontics % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K181271
Trade/Device Name: Signature Orthodontic System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: May 11, 2018 Received: May 14, 2018
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.
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
June 13, 2018
1
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 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) K181271
Device Name Signature Orthodontic System
Indications for Use (Describe)
The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
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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TAB 6
510K SUMMARY
510(k) SUMMARY
Signature Orthodontics' Signature Orthodontic System (K181271)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Signature Orthodontics 16 Miner Street, Suite 406 Boston, MA 02215
Phone: 540-229-1236 Facsimile: N/A Email: alfred@soiboston.com
Contact Person: Alfred Charles Griffin III
Date Prepared: June 13, 2018
Name of Device and Name/Address of Sponsor
Signature Orthodontic System
Signature Orthodontics 16 Miner Street, Suite 406 Boston, MA 02215
Trade/Proprietary Name of Device: Signature Orthodontic System
Common or Usual Name: Orthodontic Ceramic Bracket and Accessory
Classification Name: Orthodontic Ceramic Bracket, 21CFR§872.5470
Regulatory Class: II
Product Code: NJM
Predicate Devices:
Primary Predicate: TOMY Orthodontic Ceramic Brackets 1.1 (K160615)
Reference Predicate: Insignia Digicast (K123118)
4
Device Description
The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patientmatched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.
Intended Use / Indications for Use
The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances.
The differences in the SO System indication for use from its predicates does not affect the equivalence of the devices when used as labeled. The treatment planning software refers to the computer aided system which aids orthodontic diagnostics and treatment within the Insignia Digicast indication. The patient-matched orthodontic appliances and correction of malocclusions relate to the ceramic brackets and orthodontic movement discussed in the TOMY indication. The patient-matched brackets do not raise any levels of concern or efficacy as shown through the substantially equivalent performance tests completed between the SO System brackets and the TOMY brackets.
Technological Characteristics
Signature Orthodontic System is substantially equivalent to two other legally marketed devices. The TPS has similar functionally and intended for the same use as Insignia Digicast (K123118) while the patient-specific ceramic brackets are equivalent to the TOMY Orthodontic Ceramic Brackets 1.1 (K160615). Table 6-1 provides a comparison of the SO System to the predicate devices.
The SO System patient-specific brackets, like its predicate TOMY Orthodontic Ceramic Brackets 1.1, are composed of a polycrystalline alumina with a twin bracket design consisting of tie-wings for ligation, a primary arch wire slot and auxiliary slots. There are rounded corners and edges along with a rounded hook on the distal-gingival tie wing of canine brackets to accommodate accessories during orthodontic treatment. These design features allow a ligature wire, in tension, to move the bonded brackets along a designated path until the desired tooth position is achieved. The brackets are non-self-ligating with a mechanical locking base design and built through additive manufacturing methods.
Non-clinical Performance Testing
Bench testing was performed to ensure that the patient-specific brackets were substantially equivalent to the SO System predicate, TOMY Orthodontic Ceramic Brackets 1.1. Performance testing consisted of shear bond strength and torque strength. Tensile testing and bracket strength (fracture) testing were also completed as comparison tests.
5
-
- Shear bond strength is the load per unit area required to remove a bonded bracket from a tooth when a shear force is applied in the occlusal-gingival direction. The shear bond strength of SO System brackets is equivalent to or better than the predicate device because the average value of the SO System brackets' shear bond strength was statistically significantly higher than that of the predicate device.
-
- Torque strength is the torque exerted on the bracket at fracture, when subjected to arch wire torsion. The torque strength of SO System brackets is equivalent to the predicate device because there were no statistically significant differences between the two groups. The average value of the SO System brackets' torque strength was slightly higher than that of the predicate device.
-
- Friction (wire drag) force is the force required to drag a ligated stainless-steel wire through the primary slot of the bracket. The friction (wire drag) force of the SO System brackets is equivalent to the predicate device because there were no statistically significant differences between the two groups. The average value of the SO System brackets' friction (wire drag) force was slightly lower than that of the predicate device.
-
- Tensile bond strength is the load per unit area required to remove a bonded bracket from a tooth when a tensile force is applied to a stainless-steel wire ligated to the primary slot of the bracket. The tensile bond strength of SO System brackets is equivalent to or better than the predicate device because the average value of the SO System brackets' tensile bond strength was statistically significantly higher than that of the predicate device.
-
- Tie-wing tensile fracture strength is the fracture strength of the tie-wing complex when a tensile load is placed directly under the tie wing tensile fracture strength of SO System brackets is equivalent to the predicate device because there were no statistically significant differences between the two groups. The average value of the SO System brackets' tie wing fracture strength was slightly lower than that of the predicate device.
Due to the different methods of manufacturing from its predicate, the SO System brackets were evaluated for ISO 27020: "Dentistry - Brackets and Tubes for Use in Orthodontics" compliance and biocompatibility using standard risk assessment techniques and guidelines according to ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility testing performed included genotoxicity, cytotoxicity (agarose and elution methods), sensitization, oral toxicity, irritation, and chemical characterization.
Clinical Performance Testing
No clinical performance testing was conducted on SO System brackets.
6
Traditional 510(k) Tab 6 — 510(k) Summary
| Table 6-1: Comparison of SO System and Predicates | |||
|---|---|---|---|
| ITEM | Primary PREDICATE K160615 | ||
| TOMY Orthodontic Ceramic | |||
| Brackets 1.1 | Reference PREDICATE | ||
| K123118 Digital Study Model | |||
| (Insignia Digicast) | Signature Orthodontic System | ||
| Description | Orthodontic Ceramic Brackets | ||
| 1.1 are designed to move teeth | |||
| to improve their alignment. | |||
| Orthodontic Ceramic Brackets | |||
| 1.1 are bonded to natural teeth | |||
| by dental professionals to | |||
| connect with orthodontic wires | |||
| to cause tooth movement to a | |||
| more preferred position. | Insignia Digicast is a software | ||
| product and service that creates | |||
| digital models of patients' teeth, | |||
| which are used primarily to record | |||
| the status of a patients' dentition | |||
| prior to treatment. Clinicians may | |||
| also use the digital model to | |||
| support their diagnosis. The | |||
| Insignia Digicast system scans a | |||
| traditional impression, processes | |||
| the scan, and electronically delivers | |||
| a digital study model to the dental | |||
| professional. The dental | |||
| professional may view, measure, | |||
| and analyze the study model using | |||
| the Insignia Digicast three- | |||
| dimensional viewer software. The | |||
| main analysis tools include TJ | |||
| Moyers, Bolton analyses, ABO | |||
| scoring, and Arch and | |||
| Overbite/Overjet measurements. | |||
| There are no accessories or patient | |||
| contacting components of Insignia | |||
| Digicast. | The Signature Orthodontic System (SO | ||
| System) is a treatment planning software | |||
| (TPS) and orthodontic appliance system | |||
| used to correct malocclusions in | |||
| orthodontic patients using patient- | |||
| matched orthodontic appliances. The SO | |||
| System consists of patient-specific | |||
| ceramic brackets, patient-specific bracket | |||
| placement jigs, arch wire templates, and | |||
| a TPS for viewing, measuring, and | |||
| modifying cases. Signature Orthodontics' | |||
| (SO) operators and the orthodontists use | |||
| the TPS to generate a prescription of | |||
| their choosing. SO then manufactures | |||
| the patient-specific brackets and | |||
| placement jigs using proprietary additive | |||
| manufacturing techniques. The | |||
| orthodontist then bonds the brackets to | |||
| the teeth using the optional placement jig | |||
| and ligates wires to enable tooth | |||
| movement. The SO System does not | |||
| contain commercially-available or patient- | |||
| specific shaped arch wires, ligatures, or | |||
| adhesives that affixes the brackets to the | |||
| teeth. | |||
| Product | |||
| Codes/Regulations | NJM (Orthodontic Ceramic | ||
| Bracket, 21CFR§872.5470) | DYW (Orthodontic Plastic Bracket, | ||
| 21CFR§872.5470) | |||
| EJF (Orthodontic Metal Bracket, | |||
| 21CFR§872.5410) | NJM (Orthodontic Ceramic Bracket, | ||
| 21CFR§872.5470) | |||
| NJM (Orthodontic Ceramic Bracket, | |||
| 21CFR§872.5470) | |||
| Indications for Use | Orthodontic Ceramic Brackets | ||
| 1.1 are indicated for orthodontic | |||
| movement of natural teeth. | Insignia Digicast is a computer | ||
| aided system intended for use as | |||
| an aid in orthodontic diagnostics for | |||
| use by dental professionals trained | |||
| in orthodontic treatment including | |||
| radiographic analyses and | |||
| diagnostics. | The Signature Orthodontic System is a | ||
| treatment planning software and | |||
| orthodontic appliance system used to | |||
| correct malocclusions in orthodontic | |||
| patients using patient-matched | |||
| orthodontic appliances. | |||
| Sequence of | |||
| Treatment Plan or | |||
| Mode of Use | The Orthodontic Ceramic | ||
| Brackets 1.1 are bonded to | |||
| natural teeth by dental | |||
| professionals to connect with | |||
| orthodontic wires to cause tooth | |||
| movement to a more preferred | |||
| position. | Scans a traditional impression, | ||
| processes the scan, and | |||
| electronically delivers a digital study | |||
| model to the dental professional | Signature Orthodontics (SO) receives the | ||
| patient's digital data via commercially | |||
| available communications tools from the | |||
| DDS/DMD. SO prepares a final tooth | |||
| setup and bracket placement plan and | |||
| returns the digital data back to the | |||
| DDS/DMD. The orthodontist can then | |||
| view, measure and modify the case using | |||
| the TPS. Once approved, brackets and | |||
| jigs are manufactured and shipped to the | |||
| DDS/DMD. | |||
| Bracket Material | Polycrystalline Alumina | ||
| Ceramic | N/A | Polycrystalline Alumina Ceramic | |
| Manufacturing | |||
| Method | Ceramic Injection Molded | A orthodontal professional takes an | |
| impression of the patient's teeth by | |||
| alginate or PVS. The impression is | |||
| scanned and converted to a digital | |||
| model. This model is then | |||
| uploaded for use by the | |||
| practitioner. | Final desired arrangement of teeth, | ||
| brackets, wires and jigs are designed | |||
| with the guidance of SO internal | |||
| computer software using a 3-D model of | |||
| the patient. The Treatment Planning | |||
| Software allows the clinician to review, | |||
| measure, and modify the case. Internal | |||
| SO software generates the 3D image file | |||
| that proprietary additive manufacturing | |||
| equipment uses to create the brackets | |||
| and indirect bonding (IDB) tray. | |||
| Analysis Methods | N/A | Bolton analysis, Tanaka-Johnson | |
| Moyers Analysis, Space Analysis, | |||
| and ABO Discrepancy Index | |||
| Scoring | N/A | ||
| Non-sterile, single | |||
| use | Yes | N/A | Yes |
| Bracket Base | Mechanical Lock Base | N/A | Mechanical Lock Base |
| Bracket Design | Arch wire slot, tie wings for | ||
| ligature, and identification | |||
| marks for placement. Hooks for | |||
| ligation, for additional tooth | |||
| movement. Molded ceramic | |||
| body with rounded corners and | |||
| edges. Slot to hold orthodontic | |||
| wires. Non-self-ligating and | |||
| self-ligating | N/A | Arch wire slot, tie wings for ligature, and | |
| identification marks for placement. Hooks | |||
| for ligation, for additional tooth | |||
| movement. Printed ceramic body with | |||
| rounded corners and edges. Slot to hold | |||
| orthodontic wires. Non-self-ligating |
7
8
9
Substantial Equivalence
The Signature Orthodontic System) is substantially equivalent to the predicate devices; Insignia Digicast, and TOMY Orthodontic Ceramic Brackets 1.1. The SO System has the same intended uses/indication for uses, technological characteristics, and principles of operation as its predicate devices. The performance data provided above demonstrates that the SO System performs at an equivalent or better level compared to Insignia Digicast, and TOMY Orthodontic Ceramic Brackets 1.1. The minor technological differences between the SO System and the predicate devices, Insignia Digicast, and TOMY Orthodontic Ceramic Brackets 1.1, raise no new issues. There are no alterations in the intended use or the underlying technology or science involved. Thus, the Signature Orthodontic System is substantially equivalent to its predicates.
Conclusion
The difference between the SO System and its predicates is the manufacturing method. Additionally, the SO System has the same intended use, composition, design, function, physical properties and performance as its predicate devices. As shown in our performance data, the difference in manufacturing method does not impact the device's intended use and performance. The results from the nonclinical performance testing and the biocompatibility assessment demonstrate that SO System brackets, along with the appropriate arch wires, constitute standard orthodontic appliances which are equivalent to existing appliances used in the clinical environment.