Carriere Motion Clear Class II

• K Number: K160720
• Device Name: Carriere Motion Clear Class II
• Manufacturer: ORTHO ORGANIZERS, INC.
• Date Cleared: 2016-11-28 ( 257 days)
• Product Code: DYW EJF
• Regulation Number: 872.5470

Intended Use

The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical malocclusions and Class I cases with mesially positioned maxillary molars.

Device Description

The Carriere Motion Clear Class II is a direct bond, esthetic, orthodontic appliance that attaches the maxillary canine or premolar to molar to provide a treatment solution for patients with malocclusions of primary, permanent or mixed dentition. The orthodontic appliance is a two-piece design comprised of an integrated polyethersulfone, a clear thermoplastic, anterior pad and rigid arm that connects to a 17-4 stainless steel posterior pad in a "ball and socket" relationship. The orthodontic appliance is intended to be used at the beginning of orthodontic treatment when there are no competing forces in the mouth. The device allows the distalization of the posterior segments. The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping. The Carriere Motion Clear Class II's application and removal is similar to that of a plastic orthodontic bracket. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for debonding.

Predicate Devices

Carriere Motion Class II, Ortho Organizers, Inc., Class I 510(k) Exempt, Product Code EJF

Reference Devices

K140807

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the mechanical design and materials of the orthodontic appliance. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

Yes
The device is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment, which is a therapeutic intervention.

Diagnostic

No

The device is an orthodontic appliance designed for moving and aligning teeth, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical orthodontic appliance made of polyethersulfone and stainless steel, requiring bonding and debonding procedures. It does not describe a software-only product.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is to provide orthodontic movement and alignment of teeth. This is a direct treatment applied to the patient's body.
• Device Description: The device is a physical appliance that attaches to teeth to exert forces for movement. It does not involve testing samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
• Anatomical Site: The device is applied to the teeth, which are part of the patient's anatomy.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic appliance used for physical manipulation of teeth.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical malocclusions and Class I cases with mesially positioned maxillary molars.

Product codes (comma separated list FDA assigned to the subject device)

DYW, EJF

Device Description

The Carriere Motion Clear Class II is a direct bond, esthetic, orthodontic appliance that attaches the maxillary canine or premolar to molar to provide a treatment solution for patients with malocclusions of primary, permanent or mixed dentition. The orthodontic appliance is a two-piece design comprised of an integrated polyethersulfone, a clear thermoplastic, anterior pad and rigid arm that connects to a 17-4 stainless steel posterior pad in a "ball and socket" relationship. The orthodontic appliance is intended to be used at the beginning of orthodontic treatment when there are no competing forces in the mouth. The device allows the distalization of the posterior segments.

The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping.

The Carriere Motion Clear Class II's application and removal is similar to that of a plastic orthodontic bracket. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for debonding.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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)

Biocompatibility Testing: The biocompatibility evaluation for the Carriere Motion Clear Class II orthodontic appliance was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The biocompatibility testing included the following tests:

1. Cytotoxicity
2. Sensitization
3. Irritation
4. Chemical Characterization Study (Toxicological Risk Assessment)

Bond Strength Testing: Bond strength testing was performed on the Carriere Motion Clear Class II orthodontic appliance and compared to the primary predicate and reference devices and was substantially equivalent to these devices.

Clinical Studies: No human clinical testing was conducted to support substantial equivalence.

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

Bond Strength: 22.05 lbf / 5.28 MPa, which is higher than the predicate and reference devices, but all are below 8.2 MPa, a value in literature that shows no risk of enamel damage.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Carriere Motion Class II, Ortho Organizers, Inc., Class I 510(k) Exempt, Product Code EJF

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Composite Brackets, Ortho Specialties, Inc., K140807

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

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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be connected.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 28, 2016

Ortho Organizers, Inc. Colleen Boswell Director, RA/OA 1822 Aston Avenue Carlsbad, California 92008

Re: K160720

Trade/Device Name: Carriere Motion Clear Class II Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: DYW, EJF Dated: October 26, 2016 Received: October 27, 2016

Dear Colleen Boswell:

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 (reporting of medical devicerelated 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.

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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" (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 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 yours,

Susan Runna DDS, MA

Tina Kiang 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K160720

Device Name Carriere Motion Clear Class II

Indications for Use (Describe)

The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical malocclusions and Class I cases with mesially positioned maxillary molars.

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.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Image /page/3/Picture/1 description: The image contains the logo for Ortho Organizers, a Henry Schein company. The logo features a blue circle with the text "O2" inside, followed by the word "ORTHO" in gold lettering. Below "ORTHO" is the word "Organizers" in a smaller font, and below that is the text "A HENRY SCHEIN COMPANY" with a small logo to the left.

510(k) Summary

• 1. Submitter:
     Ortho Organizers, Inc. 1822 Aston Avenue Carlsbad, California 92008

Contact Person:	Colleen Boswell
Telephone Number:	[phone]
Fax Number:	[phone]

Date Prepared: November 17, 2016

• 2. Device:

Name of Device:	Carriere Motion Clear Class II
Common Name:	Orthodontic Appliance
Classification Name:	Orthodontic Plastic Bracket, per 21 CFR § 872.5470
Device Class:	II
Product Code:	DYW

• 3. Predicate Device:
     Primary Predicate: Carriere Motion Class II, Ortho Organizers, Inc., Class I 510(k) Exempt, Product Code EJF

Reference Device: Composite Brackets, Ortho Specialties, Inc., K140807

4. Device Description

The Carriere Motion Clear Class II is a direct bond, esthetic, orthodontic appliance that attaches the maxillary canine or premolar to molar to provide a treatment solution for patients with malocclusions of primary, permanent or mixed dentition. The orthodontic appliance is a two-piece design comprised of an integrated polyethersulfone, a clear thermoplastic, anterior pad and rigid arm that connects to a 17-4 stainless steel posterior pad in a "ball and socket" relationship. The orthodontic appliance is intended to be used at the beginning of orthodontic treatment when there are no competing forces in the mouth. The device allows the distalization of the posterior segments.

The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or

4

premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping.

The Carriere Motion Clear Class II's application and removal is similar to that of a plastic orthodontic bracket. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for debonding.

• 5. Statement of Intended Use:
     The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars.
• 6. Summary of Technological Characteristics with the Predicate Devices
     The technological characteristics of the proposed Carriere Motion Clear Class II are very similar to the predicate device, Carriere Motion Class II (Class I, 510(k) Exempt) and the reference device, Composite Brackets (K140807). There are no substantial or functional differences between the Carriere Motion Clear Class II appliance and the predicate and reference devices in terms of design, function, biocompatibility and intended use. See Table 1 below for technological characteristics and comparisons of the orthodontic appliances.

| Element | Carriere Motion Clear
Class II | Predicate Device
Carriere Motion Class II
(Class I, 510(k) Exempt) | Reference Device
Composite Brackets
(K140807) | Comparison |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Ortho Organizers, Inc. (02) | Ortho Organizers, Inc. (02) | Ortho Specialties, Inc. | N/A |
| Indications for
Use | The Carriere Motion Clear
Class II orthodontic
appliance is intended to
provide orthodontic
movement and alignment
of teeth during
orthodontic treatment for
Class II cases with
symmetrical and
asymmetrical
malocclusions and Class I
cases with mesially
positioned maxillary
molars. | The Carriere Motion Class II
orthodontic appliance is
intended to provide
orthodontic movement and
alignment of teeth during
orthodontic treatment for
Class II cases with
symmetrical and
asymmetrical malocclusions
and Class I cases with
mesially positioned
maxillary molars. | The Composite
Brackets are intended
for use as a clear,
plastic bracket system
to provide orthodontic
movement of natural
teeth. | Indicated for same
purpose - movement of
teeth. |
| Target Users | Dental Professionals | Dental Professionals trained | Dental Professionals | Same |
| Element | Carriere Motion Clear
Class II | Predicate Device
Carriere Motion Class II
(Class I, 510(k) Exempt) | Reference Device
Composite Brackets
(K140807) | Comparison |
| | trained in orthodontics | in orthodontics | trained in orthodontics | |
| Appliance
Material | Polyethersulfone/
17-4 Stainless Steel | 17-4 Stainless Steel | Polycarbonate | Both thermoplastic
materials (same as
reference) with 17-4
stainless steel identical
to predicate |
| Features | Two-piece design
comprised of an
integrated plastic anterior
pad and rigid arm that
connects to a 17-4
stainless steel posterior
pad in a "ball and socket"
relationship. | Two-piece design
comprised of an integrated
17-4 stainless steel anterior
pad and rigid arm that
connects to a 17-4 stainless
steel posterior pad in a "ball
and socket" relationship. | One-piece design that
connects to other
brackets via archwires
and/or elastics. | 2-piece design identical
to predicate vs. 1-piece
bracket design of
reference. The rigid
arm across a posterior
segment of 3-4 teeth
allows teeth to be
positioned into a Class
II relationship with
more predictability and
uniformity as opposed
to the reference
device's reliance on
multiple brackets
connected via an
archwire |
| | Translucent plastic
anterior pad that bonds to
the facial surface of teeth. | 17-4 stainless steel anterior
pad that bonds to the facial
surface of teeth. | Translucent bracket
pad that bonds to the
facial surface of teeth. | Both thermoplastic
pads (same as
reference) and 17-4
stainless steel pad of
predicate bonds to
teeth with different
retention geometries of
the pad. However, the
pad's use as anchorage
to the tooth serves the
same purpose. |
| | The anterior pad includes
an integrated clear plastic
hook for elastic activation. | The anterior pad includes
an integrated 17-4 stainless
steel hook for elastic
activation. | The brackets are
available with
integrated hooks for
elastic activation. | Same. All have
integrated hooks for
elastic activation. |
| | The posterior pad bonds
to the facial surface of
teeth and is made of 17-4
stainless steel. The pad
serves as the socket in the
"ball and socket"
relationship with the
polyethersulfone arm.
Color coded for appliance
identification | The posterior pad bonds to
the facial surface of teeth
and is made of 17-4
stainless steel. The pad
serves as the socket in the
"ball and socket"
relationship with the 17-4
stainless steel arm.
Color coded for appliance
identification | The base bonds to the
facial surface of teeth.
Mechanical Retention
eliminates the need for
plastic condition pre-
treatment. | Posterior pad identical
with predicate and
bonds to facial surface
of teeth. |
| | Color coded for appliance
identification | Color coded for appliance
identification | Color coded for bracket
identification | Same |
| Element | Carriere Motion Clear
Class II | Predicate Device
Carriere Motion Class II
(Class I, 510(k) Exempt) | Reference Device
Composite Brackets
(K140807) | Comparison |
| | | | | |
| Mode of Use | Removable elastics
(provided by clinician and
worn by patient) are
attached to the device and
anchored to the opposing
dental arch to provide
vector forces required to
move teeth per dental
professional's technique
and treatment goals. | Removable elastics
(provided by clinician and
worn by patient) are
attached to the device and
anchored to the opposing
dental arch to provide
vector forces required to
move teeth per dental
professional's technique
and treatment goals. | Archwire
implementation by
dental professional's
technique. | Use of elastics to apply
the proper amount of
force to move teeth is
identical with
predicate. Archwire
used to apply the force
to move teeth with the
reference device. This
is not a significant
difference as the forces
used in both scenarios
are equivalent as
prescribed by the
clinician. |
| Application | Bonded with Orthodontic
Adhesive | Bonded with Orthodontic
Adhesive | Bonded with
Orthodontic Adhesive | Same |
| Bond Strength
(lbf/MPa) | 22.05/5.28 | 16.52/4.04 | 10.72/3.87 | Higher bond strength
than predicate and
reference devices. All
below 8.2 MPa, a value
in literature that shows
no risk of enamel
damage. |
| Manufacturing
Method | Molded | Molded | Molded,
thermoformed. | Same |

Table 1: Comparison of Proposed and Predicate/Reference Devices

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7. Performance Data

Biocompatibility Testing

The biocompatibility evaluation for the Carriere Motion Clear Class II orthodontic appliance was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The biocompatibility testing included the following tests:

• 1. Cytotoxicity
• 2. Sensitization
• 3. Irritation
• 4. Chemical Characterization Study (Toxicological Risk Assessment)

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Bond Strength Testing

Bond strength testing was performed on the Carriere Motion Clear Class II orthodontic appliance and compared to the primary predicate and reference devices and was substantially equivalent to these devices.

Clinical Studies

No human clinical testing was conducted to support substantial equivalence.

8. Conclusion as to Substantial Equivalence

The similarities in design, function, safety and intended use of the Carriere Motion Clear Class II orthodontic appliance with the legally marketed predicate device, Carriere Motion Class II (Class I, 510(k) Exempt) and reference device, Composite Brackets (K140807), support substantial equivalence.