(78 days)
No
The description focuses on software for calculating bracket positions based on orthodontist input and manufacturing aids, with no mention of AI or ML terms or processes like training/testing data.
Yes
The device is used to correct malocclusions in orthodontic patients, which is a therapeutic purpose.
No.
The device is a treatment planning software and orthodontic appliance system used to correct malocclusions. It does not diagnose medical conditions or diseases.
No
The device description explicitly lists hardware components (brackets, jigs, archwires) that are part of the Insignia system, in addition to the software.
Based on the provided information, the Insignia Orthodontic System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Insignia system works with models or impressions of the patient's dentition, which are physical representations, not biological specimens being analyzed for diagnostic purposes.
- IVDs are intended to provide information for the diagnosis, monitoring, or treatment of a disease or condition. While the Insignia system is used in the treatment of malocclusions, its primary function is treatment planning and the creation of customized appliances, not the diagnosis or monitoring of a disease or condition through the analysis of biological samples.
- The description focuses on mechanical correction of teeth position. The system uses software to plan bracket placement and then provides physical components (brackets, jigs, archwires) to achieve this mechanical correction.
The Insignia Orthodontic System falls under the category of a medical device used for treatment planning and providing customized orthodontic appliances. It does not perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.
Product codes
DYW, NJM, EJF
Device Description
The Insignia software creates a computer model of the patient's dentition based on either a stone model or impression of the patient's dentition. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive.
Insignia consists of the following components and accessories:
-
- Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
-
- Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
-
- Patient-specific foam bracket placement jigs to affix the brackets in position.
-
- Either commercially-available or patient-specific shaped traditional archwires.
- The device does not include the adhesive 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
patient's dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthodontic patients, dental professionals trained in orthodontic treatment
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)
Non-Clinical Test Data:
Biocompatibility studies (Cytotoxicity, Irritation and Sensitization) have been completed which demonstrate that the Insignia components including the bracket placement jig, the jig adhesive and the midline marker for the archwire, are safe for their intended use.
Additionally, the Insignia software has been successfully validated to confirm the performance of the device.
Clinical Test Data:
Clinical testing has not been conducted on this product.
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 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
510(k) Summary
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Above the logo are the numbers '6121524'. Below the logo, the words 'SYBRON DENTAL SPECIALTIES' are printed in a smaller, sans-serif font.
AUG 9 · 2012
Submitter:
Sybron Dental Specialties, Inc ... 1717 West Collins Avenue Orange, California 92867_ (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: May 2012
Device Name:
- Trade Name Insignia o
- Common Name Accessory to Orthodontic Brackets o
- Classification Name Orthodontic Plastic Bracket, per 21 CFR § 872.5470 o
- Product Codes Orthodontic Plastic Bracket (DYW), Orthodontic Ceramic Bracket . � (NJM) and Orthodontic Metal Bracket (EJF)
Devices for Which Substantial Equivalence is Claimed:
- OrthoCAD iQ, Cadent, Inc., K082207 o
Device Description:
Principles of Operation
The Insignia software creates a computer model of the patient's dentition based on either a stone model or impression of the patient's dentition. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive.
Ormco Corp. - 510(k) Submission - INSIGNIA
005_510(k) Summary - page 2 of 5 800-537-7824 714-516-7400
1717 West Collins Avenue, Orange, CA 92867
1
Technological Characteristics
Insignia consists of the following components and accessories:
-
- Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
-
- Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
-
- Patient-specific foam bracket placement jigs to affix the brackets in position.
-
- Either commercially-available or patient-specific shaped traditional archwires.
- The device does not include the adhesive that affixes the brackets to the teeth.
Indications for Use:
·
The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.
Summary of Technological Characteristics:
Insignia is substantially equivalent to another legally marketed device in the United States. Insignia functions in a manner similar to and is intended for the same use as OrthoCAD iQ that is currently marketed by Cadent, Inc.
| Features | Insignia | OrthoCad IQ |
|---|---|---|
| Intended Use | Insignia is a computer-guided system | |
| intended for use as an aid in orthodontic | ||
| treatment planning for use by dental | ||
| professionals trained in orthodontic | ||
| treatment including radiographic analyses | ||
| and treatment planning. Insignia is | ||
| intended for use with commercially- | ||
| available and/or individually modified | ||
| brackets and wires that apply continuous | ||
| gentle force to reposition the teeth. It | ||
| also uses patient-specific foam placement | ||
| jigs to affix the brackets in position. | OrthoCad IQ is a computer-guided | |
| system intended for use as an aid in | ||
| orthodontic | ||
| treatment planning for use by dental | ||
| professionals trained in orthodontic | ||
| treatment including radiographic | ||
| analyses and treatment planning. | ||
| OrthoCad IQ is intended for use with | ||
| commercially-available brackets and | ||
| wires that apply continuous gentle | ||
| force to reposition the teeth. It also | ||
| uses molded thermoplastic trays to | ||
| affix the brackets in position. | ||
| Sequence of | ||
| Treatment Plan | • A 3D digital model is created based on | |
| a stone model or a patient's dental | ||
| impression | • A 3D digital model is created from | |
| a patient's impression | ||
| Features | Insignia | OrthoCad IQ |
| A 3D end-of-treatment outcome model is generated | A 3D end-of-treatment outcome model is generated | |
| The 3D model is sent to the orthodontist for review | The 3D model is sent to the orthodontist for review | |
| Foam bracket placement jigs are manufactured to position the brackets on the patient's teeth as prescribed by the orthodontist | Customized trays are created with each bracket in the ideal position to achieve the desired outcome. | |
| Brackets are adhered to the patient's teeth | Brackets are adhered to the patient's teeth | |
| Bracket Material | Stainless Steel / Ceramic / Plastic | Stainless Steel / Ceramic /Plastic |
| Archwire | ||
| Material | Stainless Steel / Nickel Titanium / Beta Titanium | Stainless Steel / Nickel Titanium / Beta Titanium |
| Positioning | ||
| Device Material | Plastic foam | Thermoformed plastic |
| Mode of Use | Either patient-specific (individually modified) or standard appliances are fixed to the patient's teeth using patient-specific foam placement jigs. Patient-specific archwires of traditional metallurgy are provided. The appliances are fixed to the teeth with commercially available adhesives. | Standard appliances are fixed to the patient's teeth using thermoformed trays. Archwires of traditional metallurgy are selected. The appliances are fixed to the teeth with commercially available adhesives. |
| Description of | ||
| Appliance | ||
| Placement | Affixed and removed by clinician | Affixed and removed by clinician |
| Manufacturing | ||
| Method | Final desired arrangement of teeth, brackets, wires and jigs are designed with the guidance of computer software using 3-dimensional models of the patient. In-office software allows the clinician to review, alter and approve desired result and appliances. Software generates code that drives machinery to manufacture the appliances | Final desired arrangement of teeth is designed with the guidance of computer software using 3-dimensional models of the patient. In-office software allows the clinician to select, review, alter and approve desired result and appliances |
2
·
:
.
"
・ :
3
Non-Clinical Test Data:
Biocompatibility studies (Cytotoxicity, Irritation and Sensitization) have been completed which demonstrate that the Insignia components including the bracket placement jig, the jig adhesive and the midline marker for the archwire, are safe for their intended use.
Additionally, the Insignia software has been successfully validated to confirm the performance of the device.
Clinical Test Data:
Clinical testing has not been conducted on this product.
Conclusion:
Based upon the biocompatibility studies, similar technological characteristics to the predicate device, and successful validation of the Insignia software, the performance of Insignia is deemed to be substantially equivalent to OrthoCAD iQ.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, with its wings spread and head turned to the right. The bird is depicted in a simple, abstract manner using thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
9 2012 AUG
ORMCO Corporation C/O Sybron Dental Specialties, Incorporated Ms. Wendy Garman Director, Regulatory Affairs 1717 West Collins Avenue Orange, California 92867
Re: K121524
Trade/Device Name: Insignia Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW. NJM. EJF Dated: July 27, 2012 Received: July 30, 2012
Dear Ms. Garman:
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.
5
Page 2- Ms. Garman
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
hh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: Insignia
Indications For Use:
The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K921524