(366 days)
The VPro5® is intended for use by the orthodontic patient during treatment with aligners to facilitate minor anterior tooth movement.
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.
The provided document describes the VPro5 device, intended for use by orthodontic patients with aligners to facilitate minor anterior tooth movement. The submission seeks to demonstrate substantial equivalence to a predicate device, AcceleDent® Aura (K153048).
Acceptance Criteria and Device Performance:
The document describes performance testing, but it does not present a formal table of explicit acceptance criteria with corresponding performance metrics for an AI/CADeX device as one might expect for software. Instead, it describes two clinical studies that demonstrate the device's effectiveness and safety, and non-clinical tests for electrical safety, EMC, biocompatibility, and bench testing of the device's physical functionality.
Therefore, I will interpret "acceptance criteria" here based on the successful demonstration of:
- Clinical Efficacy: Achieving statistically significant faster rates of tooth movement and comparable tracking to the control arm.
- Safety: No serious device-related adverse events, and demonstration of biocompatibility.
- Functional Performance: Meeting product specifications for ramp-up, vibratory frequency, acceleration, and time functionality.
- Conformity to Standards: Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.
Since this is a physical device, not an AI/CADeX system for diagnostic analysis, the "reported device performance" is the successful outcome of the clinical trials and the conformance to the non-clinical tests.
Table of Acceptance Criteria (Inferred from study outcomes) and Reported Device Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Clinical Efficacy (Prospective Study) | |
| 1. Achieve statistically significant faster rate of tooth movement compared to control. | 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. |
| 2. Achieve comparable or better tracking (percentage of prescribed tooth movement) to the Control arm. | Subjects in the 5-Day VPro5 arm achieved statistically significantly greater tracking as compared to subjects in the 7-Day Sham arm. Both VPro5 arms had tracking comparable to the Control arm. (5-Day Sham arm discontinued due to inadequate tracking and discomfort.) |
| 3. No serious device-related adverse events. | No serious device related adverse events were observed. |
| Clinical Safety (Retrospective Study) | |
| 4. Not cause statistically significant decrease in tooth lengths (root resorption). | The VPro5 group showed change of tooth lengths that was not statistically significant, whereas the control group (no vibration device) showed a statistically significant decrease in tooth lengths. This indicates the VPro5 does not exacerbate root resorption. |
| Non-Clinical Performance | |
| 5. Conformance to Electrical Safety and EMC Standards (IEC 60601-1, -1-2, -1-11). | VPro5 was tested and demonstrated conformance with IEC 60601-1, IEC 60601-1-2:2014, and IEC 60601-1-11 (2nd Edition): 2015. |
| 6. Biocompatibility for patient-contacting components (Mouthpiece). | Biocompatibility risk assessment conducted per FDA Guidance, with testing (Cytotoxicity, Sensitization, Intracutaneous Irritation per ISO 10993-5 and ISO 10993-10) demonstrating the VPro5 is biocompatible for intended use. |
| 7. Meet product specifications (ramp-up, vibratory frequency, acceleration, time functionality). | Bench testing conducted on 40 units demonstrated all devices met criteria by being within product specifications (evaluation of ramp-up, vibratory frequency, acceleration, and time functionality). |
| 8. Two-year shelf life validation. | A two-year shelf life validation study was conducted to evaluate the performance and integrity of the mouthpiece and vibration device, including through mechanical wear and exposure to artificial saliva. (Implied successful validation, as it contributes to the overall safety and performance claim.) |
(Regarding the specific questions about AI/CADeX systems, which this device is not):
Given that the VPro5 is a physical medical device (an orthodontic vibratory accessory) and not an AI/CADeX diagnostic or therapeutic software, many of the requested fields are not directly applicable. I will address them by stating their non-applicability or reinterpreting them where possible for a physical device.
1. A table of acceptance criteria and the reported device performance: (Provided above)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Prospective Pivotal Clinical Trial (Table 1A):
- Sample Size: 63 subjects.
- Data Provenance: Prospective, randomized, controlled multicenter trial. The document does not specify the country of origin, but FDA submissions typically include data from studies primarily conducted in the USA or internationally recognized for their quality.
- Retrospective Study (Table 1B):
- Sample Size: 30 subjects.
- Data Provenance: Retrospective, controlled, multicenter study. Country of origin not specified.
- Bench Testing: 40 units of the VPro5.
- Shelf Life Validation: (Number of units not specified, but done to evaluate shelf life of mouthpiece and vibration device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable in the context of ground truth for diagnostic image interpretation. For this physical device, "ground truth" relates to the physiological outcomes (tooth movement, tracking, root resorption) measured directly from the subjects, which are objective and quantifiable (e.g., mm/week, percentage tracking, tooth length). These measurements would typically be performed by trained clinical staff or using specialized equipment. The document does not specify the number or qualifications of clinicians involved in measurements, though it would be overseen by orthodontists as part of a clinical trial.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of expert consensus for difficult or subjective ground truth labeling (e.g., in radiology image interpretation). For the VPro5, the outcomes (tooth movement, tracking, root resorption) are objective measurements, not subjective interpretations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical device, not an AI or CADeX system. Therefore, MRMC studies involving human readers or AI assistance are not relevant to its evaluation. The clinical studies compare the device's effects on tooth movement directly against control arms (e.g., aligners only, sham device) and the predicate device's indicated effect.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm. Bench tests and functional tests evaluate the device's standalone performance in terms of its physical mechanisms (vibration frequency, ramp-up, etc.).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in these studies is based on outcomes data, specifically:
- Rate of tooth movement (mm/week) and Total tooth movement (percent tracking) measured directly from the subjects during orthodontic treatment.
- Root resorption measured by tooth length (e.g., using imaging like periapical radiographs or CBCT scans, though not specified).
These are objective, quantifiable physiological changes.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The studies described are performance studies for device validation.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML training set, this question is not relevant.
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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
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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
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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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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. |
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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.
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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 | |
| InclusionCriteria | 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 <4 mm, GI<1, PI=1) | |
| ExclusionCriteria | Subjects who have received periodontal treatment in the previous 6 months Subjects who are taking medication that could affect the level of inflammation, such as chronic antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, or calcium channel blockers Subjects with severe class II or class III malocclusion Subjects with skeletal class I but extreme dental malocclusion Severe crowding that requires extraction Subjects with more than 4 mm positive overjet or more than 2 mm negative overjet Subjects with extreme deep bite (more than 90%) Subjects with severe open bite (more than 2 mm) Pregnant women Subjects with any systemic diseases affecting bone metabolism Smoking |
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| Subjects with active, untreated caries Subjects that require interproximal reduction or attachments during the study period | |
|---|---|
| Number ofSubjects | 63 |
| Mean Age(years) | 29 |
| PrimaryOutcomeMeasure | Rate of tooth movement (mm/week) Total tooth movement (percent tracking) |
| Study Duration | 20-56 days (depending on study arm) |
| Results | Subjects in the 7-Day VPro5 and 5-Day VPro5 arms achieved a statistically significant faster rate of tooth movement compared tosubjects 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 hadtracking comparable to the Control arm. (The 5-Day Sham arm was discontinued due to inadequate tracking and subject discomfort.)No serious device related adverse events were observed. No differences were seen in VPro5 performance between male and femalesubjects or based upon age. Appropriate statistical adjustments were made for the use of multiple comparisons. |
Table 1B.
Effect of the Application of High-Frequency Mechanical Vibration on Tooth Concurrent with Orthodontic Treatment Using Clear Aligners: A Retrospective Study
| Study Design | Retrospective, controlled, multicenter |
|---|---|
| Arms | VPro5 Control (no vibration device or sham) |
| Inclusion Criteria | Class I malocclusion Good oral hygiene Complete permanent dentition except for third molars Initial anterior crowding ranging from 3 to 5 mm |
| Exclusion Criteria | External apical root shortening observed at the preoperative radiographic examination Proposed treatment included extraction of premolars and dental stripping |
| Number of Subjects | 30 |
| Mean Age (years) | 26 |
| Primary Outcome Measure | Root resorption measured by tooth length |
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| Study Duration | 12 months or completion of treatment, whichever was shorter |
|---|---|
| Results | The control group showed a statistically significant decrease in tooth lengths compared to the VPro5 group, which showed changeof tooth lengths that was not statistically significant. |
These studies demonstrate that the VPro5® is substantially equivalent to the predicate device for use by the orthodontic patient during treatment with aligners to facilitate minor anterior tooth movement.
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Substantial Equivalence:
The VPro5® is substantially equivalent to AcceleDent® Aura, cleared under K153048.
Table 2 below provides a comparison of the characteristics of the proposed device and legally marketed predicate device.
| Specification | VPro5® | AcceleDent® Aura | Comparison |
|---|---|---|---|
| (TBD) | (K153048) | ||
| Intended Use | Facilitation of minoranterior tooth movementduring orthodontictreatment with aligners. | Facilitation of minoranterior tooth movementduring orthodontictreatment with bracketsand wires or aligners. | Similar. The predicatedevice is intended for usewith brackets and wiresor aligners, and theproposed device isintended for use onlywith aligners. |
| Indications for Use | The VPro5® is intendedfor use by the orthodonticpatient during treatmentwith aligners to facilitateminor anterior toothmovement. | AcceleDent® Aura isintended for use duringorthodontic treatment. Itis used in conjunctionwith brackets and wiresor aligners and helpsfacilitate minor anteriortooth movement. | Similar. The predicatedevice is intended for usewith brackets and wiresor aligners, and theproposed device isintended for use onlywith aligners. |
| Classification Regulation | 21 C.F.R. § 872.5470 | 21 C.F.R. § 872.5470 | Same. |
| Product Code | OYH | OYH | Same. |
| Device Class | II | II | Same. |
| Duration of Use | 5 minutes per day duringorthodontic treatment | 20 minutes per dayduring orthodontictreatment | Different. The proposeddevice has a shorterduration of use than thepredicate device. |
| TechnologicalCharacteristics | Intraoral applianceIntegrated,rechargeable batteryVibration mechanismof action | Intraoral applianceIntegrated,rechargeable batteryVibrationmechanism of action | Same. |
| Vibration Frequency | High frequency (120 Hz) | Low frequency (30 Hz) | Different. The proposeddevice operates at ahigher vibrationfrequency than thepredicate device. Thesubstantial equivalenceof high frequencyvibration for facilitatingtooth movement issupported by the clinicaldata included in thissubmission. |
| Specification | VPro5®(TBD) | AcceleDent® Aura(K153048) | Comparison |
| Components | Mouthpiece Battery-powered oscillator Charging cable (USB) Wall charging adapter | Mouthpiece Battery-powered oscillator Charging cable (USB) Wall charging adapter | Same. |
| Power Source | Rechargeable battery | Rechargeable battery | Same. |
| Sterilization | Not supplied sterile Intended to be rinsed with water after use | Not supplied sterile Intended to be rinsed with water after use | Same. |
| Rx Only? | Yes | Yes | Same. |
Table 2. Comparison of Proposed VPro5® Device and Predicate Device
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The VPro5® has similar intended use and indications for use as the previously cleared AcceleDent® Aura, use by the orthodontic patient during treatment to facilitate minor anterior tooth movement. The AcceleDent® Aura is intended for use with aligners or brackets and wires, and the VPro5® is intended for use with aligners only. In addition, the VPro5® has similar technological characteristics and principles of operation as its predicate. Although there are technological differences between the VPro5® and its predicate device, these differences do not raise different questions of safety or efficacy as confirmed by the company's testing and validation activities described in this submission.
As demonstrated by the clinical testing, summarized above, the VPro5® is substantially equivalent for facilitating minor anterior tooth movement as the predicate device. The pivotal clinical study demonstrates that the VPro5® is substantially equivalent to the predicate and that the VPro5® does not raise different questions of safety or effectiveness.
§ 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.