(43 days)
Not Found
No
The description focuses on mechanical vibration and data display, with no mention of AI or ML capabilities.
Yes
The device is described as an "orthodontic accessory for the treatment of tooth malocclusion" and used as an "adjunctive therapy for patients with orthodontic appliances," indicating its role in providing therapeutic benefit by facilitating tooth movement.
No
The device description clearly states its intended use is to "help facilitate minor anterior tooth movement" as an "adjunctive therapy for patients with orthodontic appliances," not to diagnose medical conditions or diseases.
No
The device description explicitly states that the device includes hardware components such as the Activator, Mouthpiece, Travel Case, USB port, USB Cable, and Power Adaptor.
Based on the provided information, AcceleDent® Aura is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AcceleDent® Aura's Function: AcceleDent® Aura is a mechanical device that applies vibration to the teeth to facilitate tooth movement during orthodontic treatment. It interacts directly with the patient's teeth and does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for use during orthodontic treatment to help facilitate tooth movement, not for diagnostic purposes.
Therefore, AcceleDent® Aura falls under the category of a medical device, specifically an orthodontic accessory, but not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OYH
Device Description
AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. It is used as an adjunctive therapy for patients with orthodontic appliances such as braces to help facilitate tooth movement. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
AcceleDent® Aura includes the Activator, Mouthpiece and Travel Case. The Activator and connected Mouthpiece are used by patients to provide a light vibration to the teeth – the Activator vibrates at a 0.25 N (25 grams) force level and 30 Hz frequency for 20 minutes when turned-on; the vibration is transmitted from the Activator through the Mouthpiece to the patient's teeth as they lightly bite down on the Mouthpiece.
The Activator and Mouthpiece assembly is light, comfortable, hands-free, and can be used while multi-tasking or while engaged in a variety of other daily activities. The Travel Case is an enclosure that may be used to conceal, protect, and keep the AcceleDent® Aura Activator and Mouthpiece clean while not in use. The device includes a USB port, which can connect directly into a computer or power supply to recharge the battery. The USB port can also be connected to a computer to display usage data. A USB Cable and Power Adaptor are included to complete the system.
AcceleDent® Aura is a modified version of the predicate FDA-cleared AcceleDent® [[510(k) Number K110661]. The fundamental scientific technology of delivering therapeutic vibrations to teeth and the intended use have not changed with the subject AcceleDent® Aura device.
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
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)
Risk Analysis was performed according to ISO 14971 and the results supported implementation of the modifications. Verification testing to IEC 60601 and device specifications supplemented the analysis performed. Results of the analysis and testing showed that performance of the modifications met device specifications and further demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
AcceleDent®, 510(k) Number K110661
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo features the company name in a bold, sans-serif font, with three curved lines above the "O" in "OrthoAccel", which may represent radio waves. Below the company name, in a smaller font, is the company's legal designation, "Technologies, Inc.". The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.
AcceleDent Aura Special 510(k) NOTIFICATION
APR 2 3 2013
510(k) Summary
· AcceleDent® Aura
April 11, 2013
This summary of Special 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 Vibratory Accessory |
| Regulation number: | 21 CFR 872.5470 |
| Classification: | Class II |
| Panel: | Dental |
| Product code: | OYH |
| Predicate Device: | AcceleDent®, 510(k) Number K110661 |
Device Description:
AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. It is used as an adjunctive therapy for patients with orthodontic appliances such as braces to help facilitate tooth movement. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
AcceleDent® Aura includes the Activator, Mouthpiece and Travel Case. The Activator and connected Mouthpiece are used by patients to provide a light vibration to the teeth – the Activator vibrates at a 0.25 N (25 grams) force level and 30 Hz frequency for 20 minutes when turned-on; the vibration is transmitted from the Activator through the Mouthpiece to the patient's teeth as they lightly bite down on the Mouthpiece.
The Activator and Mouthpiece assembly is light, comfortable, hands-free, and can be used while multi-tasking or while engaged in a variety of other daily activities. The Travel Case is an enclosure that may be used to 510(K) Page 5 - 2
1
Image /page/1/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. Below the logo is the text "AcceleDent Aura TM" and "Special 510(k) NOTIFICATION". The text is black and the background is white.
conceal, protect, and keep the AcceleDent® Aura Activator and Mouthpiece clean while not in use. The device includes a USB port, which can connect directly into a computer or power supply to recharge the battery. The USB port can also be connected to a computer to display usage data. A USB Cable and Power Adaptor are included to complete the system.
AcceleDent® Aura is a modified version of the predicate FDA-cleared AcceleDent® [[510(k) Number K110661]. The fundamental scientific technology of delivering therapeutic vibrations to teeth and the intended use have not changed with the subject AcceleDent® Aura device. A comparison table of the AcceleDent® Aura to the predicate AcceleDent® is shown below.
2
Image /page/2/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo features a stylized symbol resembling sound waves emanating from the letter 'O', followed by the text "OrthoAccel" in a bold, sans-serif font. Below "OrthoAccel" is the text "technologies, inc." in a smaller, lighter font.
AcceleDent Aura™ Special 510(k) NOTIFICATION
Comparison of AcceleDent® and AcceleDent® Aura
| AcceleDent® (Predicate Device) | AcceleDent® Aura (Subject Device) | |
|---|---|---|
| Indication for Use | AcceleDent® is an orthodontic | |
| accessory intended for use during | ||
| orthodontic treatment. It is used in | ||
| conjunction with orthodontic | ||
| appliances such as braces and | ||
| helps facilitate minor anterior | ||
| tooth movement. | AcceleDent® Aura is an orthodontic | |
| accessory intended for use during | ||
| orthodontic treatment. It is used in | ||
| conjunction with orthodontic | ||
| appliances such as braces and | ||
| helps facilitate minor anterior | ||
| tooth movement. | ||
| Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Product Code | ΟΥΗ | ΟΥΗ |
| Device Class | II | II |
| 510(k) Number | K110661 | K130643 |
| For use with orthodontics | Yes | Yes |
| Material | Elastomer | Elastomer |
| Duration of Use | 20 minutes per day during | |
| Orthodontic treatment | 20 minutes per day during | |
| Orthodontic treatment | ||
| Power Source | Lithium Polymer Battery | Lithium Polymer Battery |
| Output Force | 0.25 N (25 g) | 0.25 N (25 g) |
| Frequency | 30 Hz | 30 Hz |
| Weight - Activator (grams) | 65 | 33 |
| Dimensions - Activator | ||
| (HxLxW -mm-) | 76x41x28 | 79x36x30 |
| Rechargeable | Yes | Yes |
| Automatic Timer | Yes | Yes |
| Usage Data | Yes - Displayed on charging port | Yes - Displayed on PC |
| (FastTrac Usage Report) | ||
| Activator | Yes | Yes |
| Mouthpiece Attachments | Same | Same |
| Storage | Travel Shell | Travel Case |
| USB Connector | No | Yes |
| Charging Port | Yes | No |
| Travel Shell | Yes | No |
| Travel Case | No | Yes |
| LED Battery Charge Indicator | Yes | Yes |
| Audible On/Off Switch | No | Yes |
| Shelf Life | 2.0 years | 2.0 years |
| Battery Life | 2.5 years | 2.0 years* |
3
Image /page/3/Picture/0 description: The image contains the logo for OrthoAccel Technologies, Inc. The logo features the company name in a bold, sans-serif font, with a stylized graphic above the name. The graphic consists of three curved lines that resemble sound waves or vibrations. Below the company name, the words "Technologies, Inc." are printed in a smaller font size.
AcceleDent Aura Special 510(k) NOTIFICATION
*Device deactivates after equivalent of 18 months of 20 minute daily sessions.
Intended Use:
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.
Substantial Equivalence Discussion:
A thorough design control review of the modifications made in the AcceleDent® Aura has demonstrated that the device will perform safely and as intended when compared to the AcceleDent®. As a result, the AcceleDent® Aura is substantially equivalent to the predicate AcceleDent®.
Performance Testing:
Risk Analysis was performed according to ISO 14971 and the results supported implementation of the modifications. Verification testing to IEC 60601 and device specifications supplemented the analysis performed. Results of the analysis and testing showed that performance of the modifications met device specifications and further demonstrated substantial equivalence.
Clinical Testing:
No further clinical data were collected for AcceleDent® Aura.
Conclusions:
Based on the information provided in this premarket notification, it is concluded that the AcceleDent® Aura is safe and effective and is substantially equivalent to the predicate device which was the original AcceleDent®.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2013
Mr. Zaffer Syed Director, Clinical & Regulatory Affairs OrthoAccel® Technologies, Incorporated 6575 West Loop South, Suite 200 BELLAIRE TX 77401
Re: K130643
Trade/Device Name: AcceleDent® Aura Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: OYH Dated: March 21, 2013 Received: March 26, 2013
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.
5
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.
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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
ﺴﺴ
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kwame O. Ulmer for
-S HDA
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
O: Incaccel
AcceleDent Aura™ جcial 510(k) NOTIFICATION
Indication for Use
K130643 510(k) Number (if known): Not Assignet
Device Name: AcceleDent® Aura
Indication For Use:
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.
Prescription Use __ × (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)
Mary S. Runner -S 013:04.23 12:11:09 00 04'00'
Division Sign-Off
510(k) K130643