Inspire ICE aka Inspire ICE Clear Brackets

• K Number: K171844
• Device Name: Inspire ICE aka Inspire ICE Clear Brackets
• Manufacturer: Ormco Corporation
• Date Cleared: 2017-07-18 ( 28 days)
• Product Code: NJM
• Regulation Number: 872.5470

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 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.

Predicate Devices

K080749

Reference Devices

K844067

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical orthodontic bracket, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
It is intended for use during orthodontic treatment of malocclusions, which involves correcting imperfections in the positioning of teeth, thus providing a therapeutic benefit.

Diagnostic

No

This device is an orthodontic bracket used for treating malocclusions by moving teeth, not for diagnosing them.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical orthodontic bracket made from monocrystalline alumina, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• Device Function: The Inspire ICE orthodontic bracket is a physical device that is bonded to teeth to mechanically move them into proper alignment. It does not analyze any biological samples.
• Intended Use: The intended use is for the orthodontic treatment of malocclusions, which is a mechanical correction of tooth positioning.
• Device Description: The description details the material, how it's bonded to teeth, and how it's used with other orthodontic components. There is no mention of analyzing biological samples.

Therefore, the Inspire ICE orthodontic bracket falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device used for diagnosis or monitoring through the analysis of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

NJM

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Teeth / Jaws

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Licensed Orthodontic / Dental Professionals

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 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:

• . 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 10993-6:200za7 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

Clinical Performance Data: Clinical performance testing has not been performed for Inspire ICE.

Key Results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K080749

Reference Device(s)

K844067

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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
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
use during orthodontic treatment of malocclusions. A
malocclusion is imperfect positioning of the teeth when
the 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 Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[e-mail]

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