(28 days)
Inspire ICE, a ceramic orthodontic bracket, is intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed.
Inspire ICE, is a single-use orthodontic bracket made from monocrystalline alumina. The brackets are intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. An archwire is then threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Inspire ICE Debonding Pliers. This step is also known as debonding.
This document is a 510(k) premarket notification for the Inspire ICE™ aka Inspire ICE™ Clear Brackets, an orthodontic plastic bracket. The document details the device's characteristics and its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the non-clinical performance data and the comparison to predicate devices, demonstrating the device performs "as safe, as effective, and performs as well as the predicate devices". Specific quantitative acceptance criteria or pass/fail thresholds for each test are not explicitly stated in this summary. The table below summarizes the reported non-clinical performance data categories.
| Test Element | Acceptance Criteria (Implied) | Reported Device Performance (Inspire ICE) |
|---|---|---|
| Bond Strength | Demonstrates comparable bond strength to predicate devices and meets relevant standards. | Testing results performed. Implied to be acceptable based on the conclusion of substantial equivalence. |
| Tie Wing Strength | Demonstrates comparable tie wing strength to predicate devices and meets relevant standards. | Testing results performed. Implied to be acceptable based on the conclusion of substantial equivalence. |
| Torque Strength | Demonstrates comparable torque strength to predicate devices and meets relevant standards. | Testing results performed. Implied to be acceptable based on the conclusion of substantial equivalence. |
| Biocompatibility | Meets the requirements of ISO 10993 series for biological evaluation of medical devices. | Testing results performed, utilizing relevant ISO 10993 standards. The finished device is considered to have met biological evaluation and risk assessment requirements. |
| Stability Testing | Demonstrates stability over time under specified conditions. | Testing results performed. Implied to be acceptable based on the conclusion of substantial equivalence. |
| Material (Alumina) | Material composition similar to predicate, ensuring equivalent performance and safety. | Made from monocrystalline alumina, identical to predicate and predicate reference materials. |
| Physical Dimensions | Conformity to established ranges/values for orthodontic brackets (In/Out, Torque, Angulation, Rotation). | In/Out: .035" - .050" Torque: +17° thru -22° Angulation: Up to +13° Rotation: Up to 4° These are within or comparable to the ranges of predicate devices. |
| Manufacturing Method (Grinding) | Manufacturing method consistent with predicate, ensuring similar structural integrity. | Grinding, identical to predicate and predicate reference manufacturing methods. |
| Ligation (Non Self-Ligating) | Ligation mechanism consistent with predicate, ensuring proper orthodontic function. | Non Self-Ligating, identical to predicate and predicate reference ligation methods. |
| Debonding Performance | Compatible with a specific debonding instrument, ensuring safe removal. | Debonding Pliers (REF: 866-4020) are used, similar to the predicate reference and comparable/compatible with predicate device debonding. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical performance testing (Bond Strength, Tie Wing Strength, Torque Strength, Biocompatibility, Stability testing). It mentions that "internal test methods" were utilized alongside applicable ISO standards.
The data provenance is from non-clinical performance data (laboratory testing) conducted by the manufacturer, Ormco Corporation, or accredited research service companies. The country of origin of the data is not explicitly stated, but the submitter (Ormco Corporation) is based in Orange, California, USA, suggesting the testing was likely conducted in the USA or by labs adhering to international standards (ISO). The testing is prospective for the Inspire ICE device, comparing its performance to already marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes non-clinical performance testing and a comparison to predicate devices for substantial equivalence. It does not involve a "test set" in the context of human interpretation or diagnostic accuracy where expert ground truth would be established by panels of human experts. Instead, the "ground truth" for material properties and mechanical performance would be derived from:
- Established international standards (e.g., ISO 27020, ISO 10993 series).
- Validated laboratory testing methodologies.
Therefore, the concept of "number of experts" or their qualifications for establishing ground truth as typically understood in studies involving diagnostic accuracy is not directly applicable here. The experts involved would be engineers, material scientists, and toxicologists familiar with the respective ISO standards and testing procedures.
4. Adjudication Method for the Test Set
As this study focuses on non-clinical performance data and comparison to predicate devices, there is no "adjudication method" in the context of resolving discrepancies in expert interpretations (e.g., 2+1, 3+1). The performance is assessed against established technical specifications and international standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This device is an orthodontic bracket, a physical medical device, not a software algorithm that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical orthodontic bracket, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this submission is based on:
- Established performance specifications and standards: Primarily ISO 27020 for orthodontics brackets and tubes, and the ISO 10993 series for biological evaluation of medical devices.
- Validated laboratory testing methodologies: Used to measure Bond Strength, Tie Wing Strength, Torque Strength, Biocompatibility, and Stability.
- Comparison to legally marketed predicate devices: The "ground truth" for demonstrating safety and effectiveness relies on showing that the new device performs equivalently to previously cleared devices which have an established history of safe and effective use.
8. The Sample Size for the Training Set
Not applicable. This device is a physical orthodontic bracket and does not involve AI or machine learning models requiring a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is involved.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of three overlapping shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
Ormco Corporation c/o Mr. Dave Yungvirt Third Party Review Group, LLC The Old Station House, 24 Lackawanna Place Millburn, New Jersey 07041
Re: K171844
Trade/Device Name: Inspire ICETM aka Inspire ICETM Clear Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: June 18, 2017 Received: June 20, 2017
Dear Mr. Dave Yungvirt:
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. Isting 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.
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -A
Lori A. Wiggins, MPT, CLT 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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Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
| Food and Drug Administration | ||
|---|---|---|
| Indications for Use | ||
| Expiration Date: January 31, 2017See PRA Statement below. | ||
| 510(k) Number (if known) | TBD | |
| Device Name | Inspire ICE™, aka Inspire ICE™ Clear Braces | |
| Indications for Use (Describe) | Inspire ICE, a ceramic orthodontic bracket, is intended foruse during orthodontic treatment of malocclusions. Amalocclusion is imperfect positioning of the teeth whenthe jaws are closed. | |
| 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) | ||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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SECTION 5. 510(k) SUMMARY K171844
For Inspire ICE (Ceramic Orthodontic Brackets)
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
| 1. | 510(k) Submitter | Ormco Corporation1717 W. Collins AvenueOrange, California 92867 |
|---|---|---|
| 2. | Contact | Tara BonnyRegulatory AffairsPhone: 909-962-5856Fax: 909-962-5694Email: Tara.Bonny@kavokerr.com |
| 3. | Additional Contact | Wendy GarmanVice President, Regulatory AffairsPhone: 909-962-5666Fax: 909-962-5694Email: Wendy.Garman@kavokerr.com |
| 4. | Date Prepared | May 15, 2017 |
| 5. | Device | |
| Proprietary Name | Inspire ICE™, aka Inspire ICE™ Clear Braces | |
| Classification Name | Bracket, Ceramic Dental | |
| Regulation Number | 21 CFR 872.5470 | |
| Product Code | NJM | |
| Medical Specialty Panel | 76 Dental | |
| Classification | Medical Device, Class II |
6. Predicate Device
Inspire ICE is substantially equivalent to American Orthodontics', Radiance Plus® brackets, K080749, product code NJM, cleared on August 4, 2008.
7. Predicate Reference Device
The Inspire ICE orthodontic ceramic bracket is the next generation of the original Vanish Orthodontic Bracket, K844067, cleared on November 23, 1984. The Vanish bracket is included in this 510(k) submission as a 'predicate reference'. Although the Inspire ICE bracket is substantially equivalent to the Vanish bracket, Vanish could not be declared as the predicate because it was cleared under Product Code EJF, Metal Orthodontic Brackets.
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8. Device Description
Inspire ICE, is a single-use orthodontic bracket made from monocrystalline alumina. The brackets are intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed. After following standard office protocols for tooth preparation, the brackets are bonded to the teeth with an orthodontic adhesive or cement. An archwire is then threaded through the bracket's archwire slot and is held in place with a ligature tie. These ligatures are tightened, or ligated, around the 'wings' of the bracket and over the archwire. To aid in optimal teeth movement, the individual brackets can also be ligated to other brackets or other orthodontic devices. After the teeth have moved into their proper positions, the orthodontic / dental professional will remove the brackets with the Inspire ICE Debonding Pliers. This step is also known as debonding.
| Accessory Used withInspire ICE | Manufacturer of Accessory | PremarketNotification |
|---|---|---|
| Inspire ICE Debonding Pliers | Ormco1332 S. Lone Hill AvenueGlendora, CA 91741 USA | Exempt from premarketnotification requirements |
9. Indications for Use
Inspire ICE, an orthodontic ceramic bracket, is intended for use during orthodontic treatment of malocclusions. A malocclusion is imperfect positioning of the teeth when the jaws are closed.
10. Description of Safety and Substantial Equivalence
Technological Characteristics
The designs of Inspire ICE are similar to the predicate American Orthodontics', Radiance Plus® (K080749), Product Code NJM, cleared on August 4, 2008 and to the reference predicate Vanish Orthodontic Bracket, K844067, Product Code EJF, cleared on November 23, 1984. All three are clear ceramic twin brackets, created from a single crystal of pure grown sapphire.
Non-Clinical Performance Data
Non-clinical performance data included testing results for Bond Strength. Tie Wing Strength and Torque Strength, as well as Biocompatibility and Stability testing. Along with internal test methods, the following applicable standards were utilized for the nonclinical performance testing:
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- . ISO 27020 Dentistry - Brackets and Tubes for use in Orthodontics
- . ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
- ISO 10993-2:2006 Biological evaluation of medical devices Part 2: Animal . welfare requirements
- . ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- . ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-6:2007 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for . irritation and skin sensitization
- . ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- . ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials (available in English only)
- ISO 10993-17:2002 Biological evaluation of medical devices Part 17: . Establishment of allowable limits for leachable substances
- . ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
- . ISO 14971:2007 Medical Devices – Application of risk management to medical devices, Annex 1: Guidance on Risk Analysis Procedures for Biological Hazards
| Element | Radiance Plus(Predicate Device) | Vanish(Predicate Reference) | Inspire ICE(Proposed Device) |
|---|---|---|---|
| 510(k) | K080749 | K844067 | To be assigned |
| Trade Name | Radiance Plus | Vanish OrthodonticBracket | Inspire ICE,aka Inspire ICE ClearBraces |
| Target Users | Licensed Orthodontic /Dental Professionals | Licensed Orthodontic /Dental Professionals | Licensed Orthodontic /Dental Professionals |
| DeviceDescription | Radiance Plus is asingle-usemonocrystalline | Vanish is a single-usemonocrystalline | Inspire ICE is a single-use monocrystalline |
| Element | Radiance Plus(Predicate Device) | Vanish(Predicate Reference) | Inspire ICE(Proposed Device) |
| sapphire orthodontictwin bracket. | sapphire orthodontictwin bracket. | sapphire orthodontictwin bracket. | |
| Indications forUse | Orthodontic brackets areprescribed for patientswith teeth that are notnormally positioned inthe mouth. Orthodontictreatment is used tocorrect dentaldeficiencies and toimprove the appearanceof the patient. | Orthodontic bracket isintended for use byorthodontists to assist inrestoring the naturalocclusion of teeth. | Intended for use duringorthodontic treatment ofmalocclusions. Amalocclusion is theimperfect positioning ofthe teeth when the jawsare closed. |
| Common Name | Orthodontic CeramicBracket | Orthodontic MetalBracket | Orthodontic CeramicBracket |
| ClassificationName | Bracket, Ceramic,Dental | Bracket, Metal,Orthodontic | Bracket, Ceramic,Dental |
| Class | II | I | II |
| Product Code | NJM | EJF | NJM |
| Material | Alumina (Al2O3) | Alumina (Al2O3) | Alumina (Al2O3) |
| Clarity | Transparent | Transparent | Transparent |
| Bracket Design | 1-Piece Base andBracket Construction | 1-Piece Base andBracket Construction | 1-Piece Base andBracket Construction |
| Ligation | Non Self-Ligating | Non Self-Ligating | Non Self-Ligating |
| ManufacturingMethod | Grinding | Grinding | Grinding |
| Hooks | Machined Hooks | Machined Hooks | Machined Hooks |
| In/Out | Unknown | .035" - . 059" | .035" - .050" |
| Torque | +17° thru -22° | +17° thru -22° | +17° thru -22° |
| Angulation | Up to +10° | Up to +13° | Up to +13° |
| Rotation | Up to 4° | Up to 4° | Up to 4° |
| Element | Radiance Plus(Predicate Device) | Vanish(Predicate Reference) | Inspire ICE(Proposed Device) |
| BracketIdentificationand Placement | Color Coded VisualPlacement Aids (VPAs)Colored dot to indicateUpper/Lower, Left/Right | Water-Soluble FacePaint™ IdentificationSystemColored dot to indicateUpper/Lower, Left/Right | Water-Soluble FacePaint™ IdentificationSystemColored dot to indicateUpper/Lower, Left/Right |
| MaterialComposition forBracketIdentificationand Placement | Unknown | Supplier's proprietaryRed, Purple, Green,Yellow, Blue, Orange orBlack water-solubletemporary ink/colorant*.*Per an independentaccredited medicalresearch service company,the finished device isconsidered to have metbiological evaluation andrisk assessmentrequirements. | Supplier's proprietaryRed, Purple, Green,Yellow, Blue, Orange orBlack water-solubletemporary ink/colorant*.*Per an independentaccredited medicalresearch service company,the finished device isconsidered to have metbiological evaluation andrisk assessmentrequirements. |
| Bracket Base | Quad Matte™ base thatis intended to providevariable bond strengthacross different locationsalong the base | Ball-base technologythat is evenly distributedand fused onto thebottom of the bracketwhich provides optimalbond strength betweenthe bracket and tooth | Ball-base technologythat is evenly distributedand fused onto thebottom of the bracketwhich provides optimalbond strength betweenthe bracket and tooth |
| Single Use | Yes | Yes | Yes |
| Non-SterilePackaging | Yes | Yes | Yes |
| Debonding HandInstrumentAccessory | Radiance PlusDebonding Pliers(REF: 001-343E) orOmega CeramicBracket DebondingPliers (Sushi pliersREF: 001-301E) | ICE Debonding Plier(REF: 866-4020) | ICE Debonding Plier(REF: 866-4020) |
Predicate and Proposed Device Comparison
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Clinical Performance Data
Clinical performance testing has not been performed for Inspire ICE.
Conclusion as to Substantial Equivalence
Although there are semantic differences between the indications for use of Radiance Plus brackets (predicate device), Vanish brackets (predicate reference) and Inspire ICE brackets (proposed device), these differences do not change the indications. Therefore, the indication of use for Inspire ICE brackets is equivalent to the predicate device Radiance Plus (K080749) and predicate reference Vanish (K844067).
The Radiance Plus (predicate device), Vanish (predicate reference) and Inspire ICE bracket systems (proposed device) all offer a hand instrument accessory designed for bracket debonding.
The technological characteristics of Inspire ICE brackets are very similar to the predicate device Radiance Plus brackets (K080749) and the predicate reference Vanish brackets (K844067). Results of the nonclinical testing, demonstrate that Inspire ICE is as safe, as effective, and performs as well as the predicate devices in terms of the design, intended use, indications for use, manufacturing method, mechanical properties and biocompatibility. The information provided herein, demonstrates that Inspire ICE brackets are substantially equivalent to the legally marketed predicate device Radiance Plus brackets (K080749) and predicate reference Vanish brackets (K844067).
§ 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.