(263 days)
No
The summary describes a device that uses mechanical vibration to facilitate tooth movement and does not mention any AI or ML components.
Yes
The device is described as facilitating "minor anterior tooth movement" and is used to treat "tooth malocclusion," which indicates it has a therapeutic effect on a medical condition.
No
While the device facilitates tooth movement during orthodontic treatment and has performance studies related to treatment time, it does not acquire, process, or analyze any physiological signals or images to diagnose a condition. Its purpose is therapeutic/assistive, not diagnostic.
No
The device description explicitly states "AcceleDent® Aura is an orthodontic accessory" and describes its use in conjunction with brackets, wires, or aligners, implying a physical component that interacts with the patient's mouth. The description of use for "twenty minutes per day" also suggests a physical device being worn or used.
Based on the provided information, the AcceleDent® Aura is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- AcceleDent® Aura's Function: The description clearly states that AcceleDent® Aura is an "orthodontic accessory for the treatment of tooth malocclusion." It is used in conjunction with orthodontic treatments like brackets and wires or aligners and helps facilitate tooth movement.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is mechanical or vibrational to aid in tooth movement.
Therefore, the AcceleDent® Aura falls under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis or monitoring through sample analysis.
N/A
Intended Use / 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.
Product codes
OYH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Study Type: Retrospective Cohort
Sample Size: 97
Key Results: Statistically significantly faster rate of tooth movement (p=0.0129) and shorter overall treatment time (p
§ 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.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: 832-803-0339 | |
| Fax: 713-583-9972 |
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
(Not assigned) | AcceleDent® Aura
(K130643) | OrthoPulse™
(K143120) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Source | Retrospective AcceleDent Aligner Study Report
(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
Integrated, rechargeable battery
Vibration mechanism of action | Identical | Same |
| Study Duration | | First 6 months of orthodontic aligner treatment | Components | Mouthpiece
Battery-powered activator
Firmware | Identical | Mouthpiece with LED lights
Battery |
| Results | Statistically significantly faster rate of tooth movement (p=0.0129) and shorter overall treatment time (p