Inspire ICE aka Inspire ICE Clear Brackets

K171844 · Ormco Corporation · NJM · Jul 18, 2017 · Dental

Device Facts

• Record ID: K171844
• Device Name: Inspire ICE aka Inspire ICE Clear Brackets
• Applicant: Ormco Corporation
• Product Code: NJM · Dental
• Decision Date: Jul 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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.

Device Story

Inspire ICE is a single-use monocrystalline alumina (sapphire) orthodontic bracket. Used by licensed orthodontic/dental professionals in clinical settings to treat malocclusions. Brackets are bonded to teeth using orthodontic adhesive; archwires are threaded through slots and secured with ligature ties. Individual brackets may be ligated to other orthodontic devices to facilitate tooth movement. Debonding is performed using specialized pliers. The device provides a mechanical interface for applying orthodontic forces to teeth. Benefits include correction of dental deficiencies and improved patient appearance.

Clinical Evidence

No clinical performance testing was performed. Substantial equivalence is supported by non-clinical bench testing, including bond strength, tie wing strength, torque strength, and biocompatibility/stability testing per ISO 10993 and ISO 27020 standards.

Technological Characteristics

Material: Monocrystalline alumina (sapphire). Design: Single-piece base and bracket, twin bracket, non-self-ligating. Manufacturing: Grinding. Features: Machined hooks, water-soluble face paint identification system, ball-base technology. Dimensions: In/Out .035"-.050", Torque +17° to -22°, Angulation up to +13°, Rotation up to 4°. Packaging: Non-sterile.

Indications for Use

Indicated for patients requiring orthodontic treatment for malocclusions (imperfect positioning of teeth when jaws are closed).

Regulatory Classification

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.

Predicate Devices

• Radiance Plus (K080749)

Reference Devices

• Vanish Orthodontic Bracket (K844067)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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, 2017<br>See 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 for<br>use during orthodontic treatment of malocclusions. A<br>malocclusion is imperfect positioning of the teeth when<br>the jaws are closed. | |
| Type of Use (Select one or both, as applicable) | | |
| | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke:#000000;stroke-width:2" width="12"></rect> <line style="stroke:#000000;stroke-width:2" x1="2" x2="10" y1="2" y2="10"></line> <line style="stroke:#000000;stroke-width:2" x1="10" x2="2" y1="2" y2="10"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke:#000000;stroke-width:2" width="12"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| | This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| | <b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b> | |
| | 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 Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br><a href="mailto:[e-mail]">[e-mail]</a> | |

"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 Corporation<br>1717 W. Collins Avenue<br>Orange, California 92867 |
|----|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact | Tara Bonny<br>Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 3. | Additional Contact | Wendy Garman<br>Vice President, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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 with<br>Inspire ICE | Manufacturer of Accessory | Premarket<br>Notification |
|------------------------------------|-------------------------------------------------------------|----------------------------------------------------|
| Inspire ICE Debonding Pliers | Ormco<br>1332 S. Lone Hill Avenue<br>Glendora, CA 91741 USA | Exempt from premarket<br>notification 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<br>(Predicate Device) | Vanish<br>(Predicate Reference) | Inspire ICE<br>(Proposed Device) |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K080749 | K844067 | To be assigned |
| Trade Name | Radiance Plus | Vanish Orthodontic<br>Bracket | Inspire ICE,<br>aka Inspire ICE Clear<br>Braces |
| Target Users | Licensed Orthodontic /<br>Dental Professionals | Licensed Orthodontic /<br>Dental Professionals | Licensed Orthodontic /<br>Dental Professionals |
| Device<br>Description | Radiance Plus is a<br>single-use<br>monocrystalline | Vanish is a single-use<br>monocrystalline | Inspire ICE is a single-<br>use monocrystalline |
| Element | Radiance Plus<br>(Predicate Device) | Vanish<br>(Predicate Reference) | Inspire ICE<br>(Proposed Device) |
| | sapphire orthodontic<br>twin bracket. | sapphire orthodontic<br>twin bracket. | sapphire orthodontic<br>twin bracket. |
| Indications for<br>Use | Orthodontic brackets are<br>prescribed for patients<br>with teeth that are not<br>normally positioned in<br>the mouth. Orthodontic<br>treatment is used to<br>correct dental<br>deficiencies and to<br>improve the appearance<br>of the patient. | Orthodontic bracket is<br>intended for use by<br>orthodontists to assist in<br>restoring the natural<br>occlusion of teeth. | Intended for use during<br>orthodontic treatment of<br>malocclusions. A<br>malocclusion is the<br>imperfect positioning of<br>the teeth when the jaws<br>are closed. |
| Common Name | Orthodontic Ceramic<br>Bracket | Orthodontic Metal<br>Bracket | Orthodontic Ceramic<br>Bracket |
| Classification<br>Name | Bracket, Ceramic,<br>Dental | Bracket, Metal,<br>Orthodontic | Bracket, Ceramic,<br>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 and<br>Bracket Construction | 1-Piece Base and<br>Bracket Construction | 1-Piece Base and<br>Bracket Construction |
| Ligation | Non Self-Ligating | Non Self-Ligating | Non Self-Ligating |
| Manufacturing<br>Method | 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<br>(Predicate Device) | Vanish<br>(Predicate Reference) | Inspire ICE<br>(Proposed Device) |
| Bracket<br>Identification<br>and Placement | Color Coded Visual<br>Placement Aids (VPAs)<br>Colored dot to indicate<br>Upper/Lower, Left/Right | Water-Soluble Face<br>Paint™ Identification<br>System<br>Colored dot to indicate<br>Upper/Lower, Left/Right | Water-Soluble Face<br>Paint™ Identification<br>System<br>Colored dot to indicate<br>Upper/Lower, Left/Right |
| Material<br>Composition for<br>Bracket<br>Identification<br>and Placement | Unknown | Supplier's proprietary<br>Red, Purple, Green,<br>Yellow, Blue, Orange or<br>Black water-soluble<br>temporary ink/colorant*.<br>*Per an independent<br>accredited medical<br>research service company,<br>the finished device is<br>considered to have met<br>biological evaluation and<br>risk assessment<br>requirements. | Supplier's proprietary<br>Red, Purple, Green,<br>Yellow, Blue, Orange or<br>Black water-soluble<br>temporary ink/colorant*.<br>*Per an independent<br>accredited medical<br>research service company,<br>the finished device is<br>considered to have met<br>biological evaluation and<br>risk assessment<br>requirements. |
| Bracket Base | Quad Matte™ base that<br>is intended to provide<br>variable bond strength<br>across different locations<br>along the base | Ball-base technology<br>that is evenly distributed<br>and fused onto the<br>bottom of the bracket<br>which provides optimal<br>bond strength between<br>the bracket and tooth | Ball-base technology<br>that is evenly distributed<br>and fused onto the<br>bottom of the bracket<br>which provides optimal<br>bond strength between<br>the bracket and tooth |
| Single Use | Yes | Yes | Yes |
| Non-Sterile<br>Packaging | Yes | Yes | Yes |
| Debonding Hand<br>Instrument<br>Accessory | Radiance Plus<br>Debonding Pliers<br>(REF: 001-343E) or<br>Omega Ceramic<br>Bracket Debonding<br>Pliers (Sushi pliers<br>REF: 001-301E) | ICE Debonding Plier<br>(REF: 866-4020) | ICE Debonding Plier<br>(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).