The MVP Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The MVP Aligners position teeth by way of continuous gentle force.

Device Description

The MVP Aligner system is a prescription (Rx) device comprised of a series of dentist prescribed clear, biocompatible, plastic shells that fit over the teeth designed to incrementally improve malocclusion by providing progressive force and moving patient dentition from an initial condition to a preferred corrected condition. After a scan or physical impression of the patient's teeth is taken by or under the direct supervision of the patient's orthodontically trained dentist, each aligner in the sequential set is created by a trained technician utilizing Ortho System software (K180941) according to the orthodontic screening and tooth movement recommendations provided by the same prescribing orthodontically trained dentist. The recommendations are patient specific and can only be relied upon for an individual patient for whom the device is prescribed. Furthermore, the orthodontically trained dentist reviews and approves the model scheme before the molds are produced. Once approved, the trays which are formed of clear, thin, thermoformed plastic are fabricated.

The indirect fabrication process involves a 3D print of a plastic model representing the patient specific upper and lower dentition of the patient's jaw. The models are cured. Biocompatible plastic sheets are thermoformed over the cured models with pressure and heat, marked with a patient identifier on the occlusal surface, and trimmed in a 5-axis CNC machine. The aligner containing an individualized trim line is polished, cleaned, sorted and packaged with a UDI.

MVP Aligners are provided non-sterile and are completely removable by the patient. Once approved, the trays are sent back to the orthodontically trained dentist who then provides them to the patient, in sequential stages confirming fit and design. The orthodontically trained dentist monitors treatment from the delivery of the first to final aligner.

AI/ML Overview

This document is a 510(k) Pre-market Notification summary for MVP Aligner System, seeking substantial equivalence to existing devices. As such, it does not contain information about a study proving that the device meets acceptance criteria for an AI/ML powered device, nor does it contain a table of acceptance criteria or performance metrics for such a device.

The "Clinical Data" section explicitly states: "The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. There is sufficient information available from scientific literature to support safety and efficacy. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the MVP Aligners to the predicate device."

This means:

No specific acceptance criteria or device performance data is presented. The device is considered substantially equivalent based on its similarities to already cleared devices and existing scientific literature on aligners in general.
No study to prove the device meets acceptance criteria was conducted or necessary according to this document. The FDA cleared this device based on predicate similarity, not on a new clinical study.
All other points in your request (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, ground truth, training set size, training ground truth) are not applicable because no such clinical study for this specific device's performance was performed or submitted as part of this 510(k).

Summary

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August 7, 2020

MVP Aligners, LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K193130

Trade/Device Name: MVP Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: July 28, 2020 Received: August 3, 2020

Dear Prithul Bom:

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.

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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 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,

Srinivas Nandkumar, Ph.D. 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)

K193130

Device Name MVP Aligner System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K193130

Date Prepared:	September 1, 2019		MVP Aligner System	Ormco (predicate)(K182826)	ClearCorrect (reference)(K113618)
Submitter:	MVP Aligners5-9 Union Square West, 7th FloorNew York, NY 10003	Indications for Use	The MVP Aligners areindicated for thealignment of teeth duringorthodontic treatment ofmalocclusion in patientswith permanent dentition(i.e., all second molars).The MVP Alignersposition teeth by way ofcontinuous gentle force.	The OrmcoTM SparkTMAligner System is indicatedfor the alignment of teethduring orthodontic treatmentof malocclusion in patientswith permanent denitition (i.e.,all second molars). TheOrmcoTM SparkTM AlignerSystem positions teeth by wayof continuous gentle force.	ClearCorrectSystem is indicated forthe treatment of tooth malocclusionin patients with permanent dentition(i.e. all second molars). TheClearCorrect System positions teethby way of continuous gentle force.
Contact:	Jim Churchill1 (831) 247-1415	Product Code	NXC	NXC	NXC
Proprietary Name:	MVP Aligner System	Classification	872.5470	872.5470	872.5470
Common Name:	Sequential Aligners	Material	Thermoplasticpolyurethane	ThermoplasticPolyurethane	Thermoplastic polyurethane
Classification:	21 CFR 872.5470: Orthodontic plastic bracket; Class II	Mode of Action	Continuous gentle forceapplied to teeth toachieve movement.Orthodontic toothmovement occurs throughforces applied by theappliance to the dentitionas each tooth follows theprogrammeddisplacement based on adoctor's prescription.	Orthodontic tooth movementoccurs through forces appliedby the appliance to thedentition as each tooth followsthe programmed displacementbased on a doctor'sprescription.	Continuous gentle forceapplied to teeth to achieve movement
Predicate Device	Ormco K182826	Patient Removable	Yes	Yes	Yes
Reference Device(s):	3Shape K180941, Clearcorrect K113618	Duration of use	20-22 hours/day	20-22 hours/day	20-22 hours/day
Biocompatability	cytotoxicity (ISO 7405 6.2,6.3 and ISO 10993-5),delayed-type hypersensitivity(ISO 10993-10), irritation(ISO 10993-10), acute systemstoxicity (ISO 10993-11),subchronic systemic toxicity(ISO 10993-11) andgenotoxicity (ISO 10993-3)	ISO 7405:2008 Dentistry -Evaluation of biocompatibilityof medical devices used indentistry	ISO 10993-5 Cytotoxicity, ISO10993-10 Intracutaneous reactivity,oral mucosa irritation test, maximumtest for delayed type hypersensitivity
OTC or Rx	Rx	Rx	Rx

The MVP Aligner system is a prescription (Rx) device comprised of a Device Description: series of dentist prescribed clear, biocompatible, plastic shells that fit over the teeth designed to incrementally improve malocclusion by providing progressive force and moving patient dentition from an initial condition to a preferred corrected condition. After a scan or physical impression of the patient's teeth is taken by or under the direct supervision of the patient's orthodontically trained dentist, each aligner in the sequential set is created by a trained technician utilizing Ortho System software (K180941) according to the orthodontic screening and tooth movement recommendations provided by the same prescribing orthodontically trained dentist. The recommendations are patient specific and can only be relied upon for an individual patient for whom the device is prescribed. Furthermore, the orthodontically trained dentist reviews and approves the model scheme before the molds are produced. Once approved, the trays which are formed of clear, thin, thermoformed plastic are fabricated.

Indications for use / Intended use: The MVP Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The MVP Aligners position teeth by way of continuous gentle force.

Clinical Data: The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. There is sufficient information available from scientific literature to support safety and efficacy. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the MVP Aligners to the predicate device.

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Manufacturing/Mechanical: The material properties of thermoplastic polyurethane have been received from and demonstrated by the manufacturer through biocompatability, crack resistance and stress relaxation testing and have been proven effective with over eight years of clinical use in the clear aligner field. Validation and verification tests confirmed the accuracy of each step of the manufacturing process and that the clarity and fit met the predetermined requirements.

Non-clinical data

Biocompatatility: Biocompatibility of the base plastic was evaluated by the manufacturer according to ISO 10993-1, including cytotoxicity (ISO 7405 6.2, 6.3 and ISO 10993-5), delayed-type hypersensitivity (ISO 10993-10), irritation (ISO 10993-10), acute systems toxicity (ISO 10993-11), subchronic systemic toxicity (ISO 10993-11) and genotoxicity (ISO 10993-3).

Summary of Substantial Equivalence: The MVP Aligner system has the identical indications for use as the Ormoo aligner system (K182826). The MVP Aligner, has the same mode of action, duration of use, is similarly patient removable, and utilizes the same base material, which has passed biocompatibility testing both in its native form and as a finished medical device, as was cleared by Ormco (K182826) and Clearcorrect (K113618). Based on a comparison of these factors, we believe that the MVP Aligner system is substantially equivalent to the predicate.

Regulation Number and Section

§ 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.