(366 days)
AcceleDent® Aura (K153048)
Not Found
No
The device description and performance studies focus on mechanical vibration and its effect on tooth movement. There is no mention of AI or ML in the text provided.
Yes.
The device is intended to facilitate minor anterior tooth movement, which is a therapeutic intervention for orthodontic treatment.
No
The device is a high-frequency vibration device intended to facilitate tooth movement during orthodontic treatment, not to diagnose a condition.
No
The device description explicitly lists hardware components (Oscillator, Mouthpiece, charging cable, wall charging adapter) and describes a physical mechanism of action (high-frequency vibration applied to teeth). While it has a USB port for data, it is fundamentally a hardware device with some potential software functionality for data display.
No, 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. They are used outside the body (in vitro).
- VPro5® Function: The VPro5® is a device that applies mechanical vibration directly to the teeth inside the patient's mouth. It is used to facilitate tooth movement during orthodontic treatment.
- Intended Use: The intended use clearly states it's for use by the orthodontic patient during treatment with aligners to facilitate tooth movement. This is a therapeutic/treatment-related use, not a diagnostic one involving in vitro analysis of specimens.
The description and intended use of the VPro5® align with a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VPro5 is intended for use by the orthodonic patient during treatment with aligners to facilitate minor anterior tooth movement.
Product codes (comma separated list FDA assigned to the subject device)
OYH
Device Description
The VPro5® is a rechargeable, hand-held, powered, high-frequency vibration device. The device consists of the following components: the VPro5 Oscillator, the VPro5 Mouthpiece, a charging cable, and a wall charging adapter. The oscillator and mouthpiece are coupled together prior to use.
During use, the C-shaped mouth piece adapter is manually applied to the occlusal surface of the teeth. The VPro5® is to be used 5 minutes per day in a single session in conjunction with aligner orthodontic treatment.
The mouthpiece is connected to the oscillator and turned on by depressing a white on-switch located on the unit. When turned on the device will slowly ramp up to full vibration frequency of 120Hz. The vibrations are applied to the occlusal surface of the teeth. The device will automatically shut off after a duration of 5 minutes. The oscillator also contains LED light notifications which indicate status of the cycle progression.
The mouthpiece is to be cleaned and stored in a dry place. The USB port can also be connected to a computer to display usage data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
occlusal surface of the teeth
Indicated Patient Age Range
The clinical study "Effect of VPro5 Therapy on Clear Aligner Tracking: A Prospective Randomized Controlled Clinical Trial" included subjects aged 18-45 years.
The clinical study "Effect of the Application of High-Frequency Mechanical Vibration on Tooth Concurrent with Orthodontic Treatment Using Clear Aligners: A Retrospective Study" included subjects with a mean age of 26 years.
Intended User / Care Setting
orthodontic patient
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 and clinical performance testing completed with the VPro5® has demonstrated that the device performs safely and as intended.
Non-Clinical Performance Testing:
The VPro5® was tested to ensure conformance with the following electrical safety and electromagnetic compatibility (EMC) standards:
- IEC 60601-1 Medical Electrical Equipment Part 1 General Requirements for Basic . Safety and Essential Performance
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2 General Requirements for . Basic Safety and Essential Performance
- . IEC 60601-1-11 (2nd Edition): 2015 Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
A biocompatibility risk assessment was conducted for all components of the device per the FDA Guidance Document for Use of ISO 10993-1. Results of biocompatibility testing demonstrate that the VPro5® is biocompatible for use as intended. Cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and intracutaneous irritation (ISO 10993-5) biocompatibility testing was conducted on the final finished device.
Software documentation of moderate level of concern was provided per the FDA Guidance Document for the "Content of Premarket Submissions for Software Contained in Medical Devices."
Bench testing conducted on 40 units of the VPro5® demonstrated that all the devices tested met criteria by being within the product specifications including evaluation of the ramp-up, vibratory frequency, acceleration, and time functionality of the device.
A two-year shelf life validation study was conducted to evaluate the performance and integrity of real time 2-year shelf-life of the mouthpiece and vibration device including through mechanical wear and exposure to artificial saliva to simulate the usage environment in the patient mouth.
Clinical Performance Testing:
-
Study Type: Prospective Randomized Controlled Clinical Trial - "Effect of VPro5 Therapy on Clear Aligner Tracking"
Sample Size: 63 subjects
Key Results: Subjects in the 7-Day VPro5 and 5-Day VPro5 arms achieved a statistically significant faster rate of tooth movement compared to subjects in the Control arm. In addition, subjects in the 5-Day VPro5 arm achieved statistically significantly greater tracking (i.e., percentage of prescribed study tooth movement achieved) as compared to subjects in the 7-Day Sham arm. Both VPro5 arms had tracking comparable to the Control arm. No serious device related adverse events were observed. No differences were seen in VPro5 performance between male and female subjects or based upon age. -
Study Type: Retrospective Study - "Effect of the Application of High-Frequency Mechanical Vibration on Tooth Concurrent with Orthodontic Treatment Using Clear Aligners"
Sample Size: 30 subjects
Key Results: The control group showed a statistically significant decrease in tooth lengths compared to the VPro5 group, which showed change of tooth lengths that was not statistically significant.
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® Aura (K153048)
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
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November 1, 2019
Propel Orthodontics LLC Bryce Way President and CEO 394 South Abbott Avenue Milpitas, California, 95035
Re: K183018
Trade/Device Name: VPro5 Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: OYH Dated: October 14, 2019 Received: October 15, 2019
Dear Bryce Way:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183018
Device Name
VPro5
Indications for Use (Describe)
The VPro5 is intended for use by the orthodonic patient during treatment with aligners to facilitate minor anterior tooth movement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K183018
510(k) Summary
| Submitter Name: | Propel Orthodontics LLC |
|---|---|
| Submitter Address: | 394 South Abbott Ave Milpitas, CA 95035 |
| Contact Person: | Bryce Way |
| Phone Number: | 408-394-5851 |
| Fax Number: | 914-560-2056 |
| Date Prepared: | October 31, 2019 |
| Device Trade Name: | VPro5® |
| Classification Name: | Orthodontic Vibratory Accessory |
| Product Code: | OYH |
| Classification: | Class II pursuant to 21 C.F.R. § 872.5470 |
| Predicate Device: | AcceleDent® Aura (K153048) |
| Device Description: | The VPro5® is a rechargeable, hand-held, powered, high-frequency vibration device. The device consists of the following components: the VPro5 Oscillator, the VPro5 Mouthpiece, a charging cable, and a wall charging adapter. The oscillator and mouthpiece are coupled together prior to use. |
| During use, the C-shaped mouth piece adapter is manually applied to the occlusal surface of the teeth. The VPro5® is to be used 5 minutes per day in a single session in conjunction with aligner orthodontic treatment. | |
| The mouthpiece is connected to the oscillator and turned on by depressing a white on-switch located on the unit. When turned on the device will slowly ramp up to full vibration frequency of 120Hz. The vibrations are applied to the occlusal surface of the teeth. The device will automatically shut off after a duration of 5 minutes. The oscillator also contains LED light notifications which indicate status of the cycle progression. | |
| The mouthpiece is to be cleaned and stored in a dry place. The USB port can also be connected to a computer to display usage data. | |
| Indications for Use: | The VPro5® is intended for use by the orthodontic patient during treatment with aligners to facilitate minor anterior tooth movement. |
4
Performance Data:
Non-clinical and clinical performance testing completed with the VPro5® has demonstrated that the device performs safely and as intended.
Non-Clinical Performance Testing:
The VPro5® was tested to ensure conformance with the following electrical safety and electromagnetic compatibility (EMC) standards:
- IEC 60601-1 Medical Electrical Equipment Part 1 General Requirements for Basic . Safety and Essential Performance
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2 General Requirements for . Basic Safety and Essential Performance
- . IEC 60601-1-11 (2nd Edition): 2015 Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
The VPro5® is patient-contacting. The only patient-contacting component in the VPro5® is the C-shaped mouthpiece. A biocompatibility risk assessment was conducted for all components of the device per the FDA Guidance Document for Use of ISO 10993-1. Results of biocompatibility testing demonstrate that the VPro5® is biocompatible for use as intended. Cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and intracutaneous irritation (ISO 10993-5) biocompatibility testing was conducted on the final finished device.
Software documentation of moderate level of concern was provided per the FDA Guidance Document for the "Content of Premarket Submissions for Software Contained in Medical Devices."
Bench testing conducted on 40 units of the VPro5® demonstrated that all the devices tested met criteria by being within the product specifications including evaluation of the ramp-up, vibratory frequency, acceleration, and time functionality of the device.
A two-year shelf life validation study was conducted to evaluate the performance and integrity of real time 2-year shelf-life of the mouthpiece and vibration device including through mechanical wear and exposure to artificial saliva to simulate the usage environment in the patient mouth.
5
Clinical Performance Testing:
Two clinical studies were performed using the VPro5®, one prospective, pivotal clinical trial and one retrospective study examining the effect of high-frequency vibration on root resorption. The two clinical studies are summarized in Tables 1A and 1B, belov:
Table 1A.
Effect of VPro5 Therapy on Clear Aligner Tracking: A Prospective Randomized Controlled Clinical Trial
| Study Design | Randomized, controlled multicenter, prospective | |
|---|---|---|
| Arms | Control: Subjects received clear aligners only and progressed to the next aligner every 14 days 7-Day Sham: Subjects received a sham device and progressed to the next aligner every 7 days 7-Day VPro5: Subjects received the VPro5 and progressed to the next aligner every 7 days 5-Day Sham: Subjects received a sham device and progressed to the next aligner every 5 days 5-Day VPro5: Subjects received a VPro5 and progressed to the next aligner every 5 days | |
| Inclusion | ||
| Criteria | Subjects must be 18-45 years of age Subject is willing and able to comply with all study procedures and sign informed consent/HIPAA forms Subject must have complete adult dentition (excluding third molars) Subjects must have class I malocclusion or mild class II/III malocclusions Subject is at least one month into aligner treatment Subject has history of and currently healthy oral hygiene (PD is |