AcceleDent Aura

K153048 · Orthoaccel Technologies, Inc. · OYH · Jul 8, 2016 · Dental

Device Facts

• Record ID: K153048
• Device Name: AcceleDent Aura
• Applicant: Orthoaccel Technologies, Inc.
• Product Code: OYH · Dental
• Decision Date: Jul 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

Device Story

AcceleDent Aura is an intraoral orthodontic accessory used by patients at home for 20 minutes daily. The device consists of a mouthpiece and a battery-powered activator that generates mechanical vibrations. It is used in conjunction with standard orthodontic appliances (brackets/wires or aligners) to facilitate minor anterior tooth movement. The patient operates the device independently; the healthcare provider prescribes the device to augment orthodontic treatment. The mechanical vibration is intended to accelerate the rate of tooth movement, potentially reducing overall treatment time. The device is cleaned by the user with water and/or soap.

Clinical Evidence

Retrospective cohort study of 97 subjects (ages 12-45) undergoing Invisalign treatment. Primary endpoints were treatment time and rate of tooth movement. Results showed a statistically significant faster rate of tooth movement (p=0.0129) and shorter overall treatment time (p<0.0001) compared to Invisalign-only patients. Data supports the safety and effectiveness of the device when used with aligners.

Technological Characteristics

Intraoral appliance with mouthpiece and battery-powered activator. Operates via mechanical vibration. Portable, battery-powered, non-sterile. Materials and design are identical to K130643. Includes USB cable, power adaptor, and travel case. No changes to software or hardware from predicate.

Indications for Use

Indicated for patients undergoing orthodontic treatment with brackets and wires or aligners to facilitate minor anterior tooth movement. Suitable for males and females aged 12-45 years.

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

• AcceleDent® Aura (K130643)
• OrthoPulse™ (K143120)

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 8, 2016

Mr. Zaffer Syed Senior Director, Clinical Development & Strategic Marketing OrthoAccel Technologies Inc. 6575 West Loop South, Suite 200 Bellaire, Texas 77401

Re: K153048

Trade/Device Name: AcceleDent® Aura Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: II Product Code: OYH Dated: May 27, 2016 Received: June 1, 2016

Dear Mr. Syed:

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.

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Page 2 - Mr. Zaffer Syed

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Tina Kiang

for Erin I. Keith, M.S. 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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Image /page/2/Picture/1 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo features the company name in a combination of blue and gray text. The word "OrthoAccel" is in blue, while "Technologies, Inc" is in gray and smaller font. There are three curved lines above the word "OrthoAccel" that resemble sound waves.

Modified AcceleD 510(k) Premarket Notification

# Indication for Use

510(k) Number (if known): Not Assigned

Device Name: AcceleDent® Aura

Indication For Use:

AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

Prescription Use X (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Device Evaluation (ODE)

Division Sign-Off

510(k)

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Image /page/3/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo features the company name in a blue, sans-serif font. The word "OrthoAccel" is larger and more prominent than the words "Technologies, Inc.", which are in a smaller, gray font and placed below the company name. The logo has a registered trademark symbol next to the word "Accel".

Modified Accele 510(k) Premarket Notification

510(k) Summary

Modified AcceleDent® Aura

October 16, 2015

This summary of 510(k) substantial equivalence determination is being submitted in accordance with the requirements of 21 CFR part 807.92.

| 510(k) Submitter: | OrthoAccel® Technologies, Inc. |
|-------------------|---------------------------------|
| | 6575 West Loop South, Suite 200 |
| | Bellaire, TX 77401 |
| | Phone: [phone] |
| | Fax: [phone] |

Contact:

Zaffer Syed

| Device trade name: | AcceleDent® Aura |
|-----------------------------|-----------------------------------------|
| Common name: | Orthodontic plastic bracket |
| Classification name: | Orthodontic plastic bracket |
| Regulation number: | 21 CFR 872.5470 |
| Classification: | Class II |
| Panel: | Dental |
| Product codes: | OYH |
| Product code names | Orthodontic vibratory accessory |
| Predicate Device: | AcceleDent® Aura, 510(k) Number K130643 |
| Secondary Predicate Device: | OrthoPulse™, 510(k) Number K143120 |

# Indications for Use:

AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

# Device Description:

The AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.

This Premarket Notification (510(k)) is being submitted because OrthoAccel Technologies, Inc., is making labeling changes that affect the indications for use of our legally marketed AcceleDent® Aura (K130643). The technological characteristics of the device described in this 510(k) and the device described in our previous 510(k) K130643, including design, raw material, and themical composition, and their manufacturing processes and related software, are identical.

The labeling modification includes:

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Image /page/4/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo features a stylized blue symbol resembling sound waves emanating from a central point, followed by the name "OrthoAccel" in a combination of blue and gray lettering. Below the name, in smaller gray font, is the text "Technologies, Inc."

Modified Accelel 510(k) Premarket Notification

- l. Expansion of the indications of use to permit treatment of patients undergoing orthodontic treatment with aligners.
Thus, the modified AcceleDent® Aura with the revised indications for use includes the use of AcceleDent Aura in patients undergoing orthodontic treatment with aligners.

# Indications for Use:

AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

### Software:

There are no changes in the software compared to the existing AcceleDent Aura. The software design and development, software development methodology, software development process and environment are identical for the existing predicate device and the modified AcceleDent Aura.

### Technological Characteristics:

There are no changes in the technological characteristics to the existing AcceleDent Aura. The device design and function are identical for the existing predicate device and the modified AcceleDent Aura.

### Substantial Equivalence Information:

This Premarket Notification is being submitted solely to incorporate the addition to our indications for use for aligner to the existing AcceleDent Aura (K130643).

- There are no changes in the technological characteristics of the modified device when compared to the predicate device. The design, raw material, and chemical composition, device features as well as technical characteristics of the modified device and existing predicate device are identical.
- There are no changes in the manufacturing processes and related software required to accommodate the labeling changes.

AcceleDent Aura has the identical indications for use as the OrthoPulse™ device (K143120) and therefore the same intended use. The technological characteristics are very similar between the AcceleDent Aura and OrthoPulse; both devices are intended for home use under a prescription, and both devices are comprised of portable, battery powered devices that are placed in the user's mouth at regular intervals. Although AcceleDent Aura uses mechanical vibration to accelerate tooth movement, while the predicate OrthoPulse device uses light energy, both devices are designed to achieve the same therapeutic effect of achieving faster tooth movement.

Comparative clinical study outcomes with aligners, which are summarized in Table 5-1, demonstrate that the difference in technological characteristics compared to the predicate (K143120) does not adversely impact performance, and does not raise different questions of safety and effectiveness compared to the predicate device. A comparison of the modified AcceleDent Aura to the predicated devices is shown on Table 5-2.

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Image /page/5/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo is vertically oriented, with the company name stacked on top of each other. The word "OrthoAccel" is in a larger, bolder font than "Technologies, Inc."

Modified AcceleDent® Aura
510(k) Premarket Notification

# Table 5-1 Comparative Clinical Outcomes with Aligners (AcceleDent Aura vs. OrthoPulse)

| | AcceleDent Aura | OrthoPulse | | Modified AcceleDent® Aura<br>(Not assigned) | AcceleDent® Aura<br>(K130643) | OrthoPulse™<br>(K143120) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Source | Retrospective AcceleDent Aligner Study Report<br>(See Attachment 4) | 510k Summary (K143120) | Indication for Use | AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement. | AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement. | The OrthoPulse™ device is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement. |
| Study Design | Retrospective Cohort | Non-Randomized Crossover | Regulation Number | 21 CFR 872.5470 | Identical | Identical |
| Inclusion Criteria | Males or females between and including the ages of 12 and 45 years old that had orthodontic treatment with Invisalign® Permanent dentition with all upper and lower canine, lateral incisor and central incisor teeth present and any premolar and molar combination in the posterior of two teeth in each quadrant Good health as determined by medical history | Males or females between and including the ages of 12 and 70 years old scheduled for Invisalign® treatment Permanent dentition Mild to moderate crowding with no labiolingually displaced teeth Class I or Class II by ½ cusp or less Good oral hygiene | Product Code | OYH | OYH | PLH |
| Exclusion Criteria | Pregnancy Smoker Significant periodontal disease History of use either prior to or during orthodontic treatment of any bisphosphonate medication or other medication for treatment of osteoporosis Chronic daily use of any non-steroidal anti-inflammatory medication, estrogen, calcitonin, or corticosteroids during treatment Any condition or use of medication which in the opinion of the investigator interferes with the biology of tooth movement | Pregnancy Smoker Periodontally involved teeth Bisphosphonate medication use during study Spaces between anterior teeth Enrolled in another study | Device Class | II | Identical | Identical |
| Number of Subjects | 97 | 21 | 510(k) Number | Not assigned | K130643 | K143120 |
| % Male | 35.1% | Unknown | For use with Orthodontics | Yes | Identical | Identical |
| Mean Age (Years) | 28.8 | 34.9 | Duration of Use | 20 minutes per day during Orthodontic treatment | 20 minutes per day during Orthodontic treatment | 10 minutes per day during Orthodontic treatment |
| Outcome Measures | Treatment Time (Weeks) Rate of Tooth Movement (ABO DI per Week) Total time in orthodontic aligner treatment | Perimeter Analysis of Mandibular Arch | Technological Characteristics | Intraoral appliance, similar to plastic mouth guard<br>Integrated, rechargeable battery<br>Vibration mechanism of action | Identical | Same |
| Study Duration | | First 6 months of orthodontic aligner treatment | Components | Mouthpiece<br>Battery-powered activator<br>Firmware | Identical | Mouthpiece with LED lights<br>Battery |
| Results | Statistically significantly faster rate of tooth movement (p=0.0129) and shorter overall treatment time (p<0.0001) as compared to Invisalign patients only | Statistically significantly faster tooth movement compared to baseline (p=0.024) | Accessories | USB Cable<br>Power Adaptor<br>Travel Case | Identical | Carrying/charger case |
| Power Source | Rechargeable Battery | Identical | Same | | | |
| Sterilization | Not supplied sterile<br>Intended to be washed in water and/or soap daily to remove saliva | Identical | Intended to be washed in water daily to remove saliva and cleaned with FDA cleared denture cleaning products | | | |

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Image /page/6/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo features the word "OrthoAccel" in a vertically stacked format, with the "O" in "Ortho" stylized with concentric circles to resemble sound waves. The text "Technologies, Inc" is written in a smaller font size and rotated 90 degrees to the right of "OrthoAccel".

Modified AcceleDent® Aura
510(k) Premarket Notification

guivalence table is provided belo detailed substantial e ﮯ

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Image /page/7/Picture/0 description: The image contains the logo for OrthoAccel Technologies, Inc. The logo features the word "OrthoAccel" in a light blue color, with a stylized symbol resembling radio waves above the word. Below "OrthoAccel", the words "Technologies, Inc" are written in a smaller, gray font. The overall design is clean and professional, suggesting a company in the technology or medical field.

Modified AcceleDen 510(k) Premarket Notification

### Conclusions:

The modified AcceleDent® Aura involves a revised indications for use that permits treatment of patients undergoing orthodontic treatment with aligners. Our modified AcceleDent Aura has the same intended use as the identified predicate devices, it has identical technology as compared to K130643 and different technology as compared to K143120. Due to the similarities in indications for use and technological characteristics associated with the modified AcceleDent Aura, the proposed device is substantially equivalent to the predicate devices (K130643, K143120).