The Nuvola® device is a doctor-prescribed series of removable plastic aligners intended as an alternative to conventional wire and bracket technology. The Nuvola® gently moves teeth in small increments from their original state to a final, treated state for improved dental alignment. The system is used in patients with primary, mixed, and permanent dentition. The system consists of a series of doctor prescribed and customized plastic aligners (thermoformed PET-G sheeting material) that gently move the patient's teeth in rements from their original state to a more optimal, treated state to address malocclusion. The first device of the treatment matches the patient's dentition in its current state and then each subsequent aligner stage of the dentition shifted gradually toward the final desired position.

AI/ML Overview

The provided document for the K222418 submission of the Nuvola aligner does not contain the detailed information necessary to fully address all aspects of acceptance criteria and the study proving device performance as requested. Specifically, it lacks a dedicated section outlining acceptance criteria with corresponding performance metrics from a study dataset.

However, based on the non-clinical studies summarized, we can infer some aspects related to device validation. The document emphasizes that "Non-clinical tests have been conducted to verify that the Nuvola® aligner meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate and reference devices."

Here's an attempt to construct the information based on the provided text, highlighting where data is not available or explicitly stated.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for Nuvola® Aligner

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Invisalign System K220287) and a reference device (Ortho Aligner System K212496) primarily through non-clinical testing and comparison of technological characteristics. A formal study explicitly outlining acceptance criteria and a detailed performance study against a predefined test set with quantified metrics is not presented in the provided text in the typical format for AI/algorithm performance.

The "acceptance criteria" here appear to be framed around meeting pre-established specifications for manufacturing accuracy, biocompatibility, shelf life, packaging, and treatment planning software validation to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Manufacturing Accuracy (Digital to 3D Print)	Digital dentition models from treatment planning and their 3D printed molds measured within predefined tolerance.	"All measurements were within the predefined tolerance of the manufacturing process. There were no differences in the intended and measured in any cases used, meeting the pre-established specification."
Manufacturing Accuracy (Aligner Fitting)	First final thermoformed aligner fitting to align with pre-established specifications and suitable for patient wear as checked by doctor.	"The suitability, function and form of the aligner were checked by the prescribing doctor make the patient worn the first aligner of the 5 treatment plans used for the validation, also in this case the results were comply with the pre-established specifications and acceptance criteria."
Biocompatibility	Compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350, proving insolubility and assessing leachable effects (cytotoxicity, mucosa irritation, acute systemic and sub-chronic toxicity, genotoxicity).	"The results of the testing prove that the insolubility of the Thermoforming Sheet Material is in compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 for the intended dental use." (Note: The material Erkodur was already cleared by FDA (K200125) and its biocompatibility tests were performed by the supplier.)
Shelf Life	Ability to meet specifications after aging.	"The test results showed conformity with the pre-specifications and acceptance criteria. For a conservative choice, it was decided to fix as shelf life to 12 months (1 year)." (Based on 24 months real-time aging under standard storage conditions).
Packaging Integrity	Suitability for transportation and storage.	"Package integrity, via simulated transport test per ISTA 2A, has been performed. The Nuvola® packaging is suitable for transportation and storage."
Treatment Planning Software Validation	Compliance with IEC 62304:2006+AMD1:2015 and 21 CFR Part 11.	"Nuvola®Web is validated by G.E.O in accordance with IEC 62304:2006+AMD1:2015 and it turned out compliance with 21 CFR part 11."

2. Sample Size for the Test Set and Data Provenance:

Manufacturing Validation: "The test has been repeated for 5 times with 5 different patient 3rd party software was used to perform point-to-point and critical displacement."
- Data Provenance: The document does not explicitly state the country of origin for these 5 patient cases or whether they were retrospective or prospective. Given the company is based in Italy, the data could be European. The description suggests these were real patient cases used for validation.

3. Number of Experts Used and Qualifications:

Manufacturing Validation (Aligner Fitting): The "prescribing doctor" checked the suitability, function, and form of the aligners. The number of doctors is not specified beyond "the prescribing doctor" checking the 5 treatment plans.
- Qualifications: "Prescribing doctor" implies a dental practitioner, likely an orthodontist, but no specific years of experience or board certifications are stated.
Other validations (Biocompatibility, Shelf life, Packaging, Software): These appear to be laboratory or engineering tests run against industry standards and regulations, rather than requiring expert adjudication of clinical outcomes.

4. Adjudication Method for the Test Set:

Manufacturing Validation: For aligner fitting, the "prescribing doctor" checked. This implies a single expert review for each of the 5 cases. There is no mention of consensus or multiple adjudicators (like 2+1, 3+1). For manufacturing accuracy via software, it was likely an automated comparison to a tolerance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done.
The clinical performance testing for the device was not conducted, as stated: "Clinical Studies was not conducted for this 510(k) Notification. Clinical Performance testing was not needed to establish substantial equivalence to the predicate and reference devices." This suggests no human-in-the-loop performance evaluation was performed or necessary for this submission.

6. Standalone (Algorithm Only) Performance:

The Nuvola®Web software is a "Treatment Planning platform," and the 3Shape Ortho System software is used for "tooth alignment" and "to produce standard 3D printer files."
While the software components (Nuvola®Web and 3Shape Ortho System) were validated for compliance with specific standards (IEC 62304:2006+AMD1:2015 and 21 CFR part 11 for Nuvola®Web; implicit for 3Shape Ortho System which is an already cleared device K152086), there is no standalone performance study of the algorithm's output (e.g., predicted tooth movement accuracy) independent of the physical aligner or human intervention. The validation focused on the software's ability to manage treatment plans and produce correct 3D printer files, and the physical aligners' fit.

7. Type of Ground Truth Used:

Manufacturing Validation (Digital to 3D Print): The ground truth appears to be the intended digital model (CAD/CAM model) from the treatment planning software, against which the 3D printed molds were measured.
Manufacturing Validation (Aligner Fitting): The ground truth was based on the "pre-established specifications and acceptance criteria" for fit and function, assessed by the "prescribing doctor." This implies a clinical assessment or expert consensus on the desired fit.
Biocompatibility, Shelf Life, Packaging: Ground truth for these was established by industry standards and regulatory guidelines (e.g., ISO 10993-1, ISTA 2A) and manufacturer's pre-defined specifications.
Software Validation: Ground truth was compliance with specified software development and quality standards (IEC 62304, 21 CFR Part 11).

8. Sample Size for the Training Set:

The document describes the device as a physical aligner and associated software for treatment planning. It does not indicate the use of machine learning or AI models developed by G.E.O. requiring a "training set" in the deep learning sense.
The software components (Nuvola®Web and 3Shape Ortho System) are either COTS (Commercial Off-The-Shelf) software (3Shape Ortho System is K152086) or custom-developed traditional software validated per IEC 62304. Therefore, discussions of "training sets" are not applicable in this context.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no AI/ML training set is mentioned or implied. The software validation is based on traditional software engineering principles and regulatory compliance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

October 7, 2022

Gruppo Europeo Ortodonzia srl % Carlo D`Alessandro Director, Quality and Regulatory Donawa Lifescience Consulting srl Piazza Albania. 10 Rome, 00153 ITALY

Re: K222418

Trade/Device Name: Nuvola Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: August 5, 2022 Received: August 10, 2022

Dear Carlo D`Alessandro:

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 mediation-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.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222418

Device Name Nuvola®

Indications for Use (Describe) Nuvola® aligner is intended for the orthodontic treatment of malocclusion

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

Prescription Use (Part 21 CFR 801 Subpart D)

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Image /page/3/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with the letters "GEO" in large, bold, blue font across the center. The text "GRUPPO EUROPEO DI ORTODONZIA" is arranged in a circular fashion around the bottom half of the globe. The globe has visible lines of longitude and latitude.

K222418

510(k) SUMMARY

Gruppo Europeo Ortodonzia srl (G.E.O. srl ) – Nuvola®

General Information

510(k) Sponsor	Gruppo Europeo Ortodonzia srl (GEO S.r.l.)
Address	via Cropani, 118 A/B00173 - Rome, Italy
FDA Registration Number	---
Contact Person	Massimiliano BucceriCEO and Founder
Contact Information	maxbucceri@nuvolaortodonzia.com+39 06 72671754
Date Prepared	05 August 2022

Name of Device and Name/Address of Sponsor

Name of Device	Nuvola
Name/Address of Sponsor	Gruppo Europeo Ortodonzia srl (GEO S.r.l.)via Cropani, 118 A/B00173 - Rome, Italy
Trade/Proprietary Name	Nuvola®
Common Name	Aligner, Sequential
Classification Name	Orthodontic Plastic Bracket

Predicate Device

Name of Device	Invisalign System
Name/Address of Sponsor	Align Technology, Inc. , 2820 Orchard Parkway, San Jose, CA 95134
Trade/Proprietary Name	Invisalign System (K220287)
Common Name	Aligner, Sequential
Classification Name	Orthodontic Plastic Bracket

Image /page/3/Picture/10 description: The image contains the logo for Nuvola. The logo consists of the word "nuvola" in lowercase letters, with a stylized "N" symbol above it. The "N" symbol is made up of four curved shapes that are arranged in a circular pattern. The word "nuvola" is in a dark gray color, and the "N" symbol is in a light teal color.

G.E.O. S.r.I. (Gruppo Europeo di Ortodonzia) Via Cropani, 118 A/B 00173 – Roma (Italia) +39 06 72671754 info@nuvolaortodonzia.it www.nuvolaortodonzia.it

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Image /page/4/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with visible continents and longitudinal lines. The text "GEO" is written in large, bold blue letters across the center of the globe. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA", is written in a circular fashion around the bottom half of the globe.

Reference Device

Name of Device	Ortho Aligner System
Name/Address of Sponsor	Ortho Lab Services LLC, 251 Little Falls Wilmington, DE 19808
Trade/Proprietary Name	Ortho Aligner System (K212496)
Common Name	Aligner, Sequential
Classification Name	Orthodontic Plastic Bracket

Intended Use

1. Device description

The main phases of Nuvola® production are described in the following:

The manufacturing process start with obtaining the dimensions and details of the patient's baseline dentition from the prescribing clinician who takes scans of the patient's teeth and upload them into Nuvola®Web software. The scanned data (digital CAD/CAM model) are imported into specialized dental software for treatment planning (Nuvola®Web). Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the software application used for the manufacturing validation in this submission is the 3Shape Ortho System (K152086).

The Nuvola®Web software displays a series of 3-D dentition images with virtual tooth movements set up based on the doctor's prescription. The treating dental practitioner reviews these images and has the option to reject or request modifications to the set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, based on this set-up a custom-made series of thermoplastic polymer aligners are then manufactured at the aligner manufacturing facility. 3D printers are used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.

The final step is the thermoforming of a plastic sheet material treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. The thermoformed aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the first aligner until treatment is completed.

Image /page/4/Picture/10 description: The image shows the logo for Nuvola. The logo consists of a stylized teal-colored symbol resembling a stylized letter 'N' or a curved shape, positioned above the word "nuvola" in a dark gray, sans-serif font. The 'a' in "nuvola" has a registered trademark symbol next to it.

G.E.O. S.r.I. (Gruppo Europeo di Ortodonzia) Via Cropani, 118 A/B 00173 - Ron into@nuvolaortodonzia.it www.nuvolaortodonzia.it

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Image /page/5/Picture/0 description: The image shows a logo for GEO, which stands for Gruppo Europeo di Ortodonzia. The logo features a blue globe with white outlines of the continents. The letters "GEO" are written in blue across the globe. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA", is written in a circular fashion around the bottom half of the globe.

2. Indications for Use

Nuvola® aligner is intended for the orthodontic treatment of malocclusion.

3. Non-clinical studies and tests performed

Non-clinical tests have been conducted to verify that the Nuvola® aligner meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate and reference devices. The following Non-clinical studies and tests were conducted and are summarized in the table below:

Manufacturing validation	Manufacturing validation was performed to verify that themanufacturing process for Nuvola® Aligner complies with the pre-established specifications and acceptance criteria.
Biocompatibility Testing	Biocompatibility was assessed in accordance with ISO 10993-1. Thetests on the material Erkodur have been performed by the supplierof the material itself.
Shelf life	A 1-year shelf life was determined by real-time aging testing
Packaging	Package integrity, via simulated transport test per ISTA 2A, has beenperformed
Treatment Planning software validation	Nuvola®Web (treatment plan platform) is validated by G.E.O inaccordance with IEC 62304:2006+AMD1:2015 and it turned outcompliance with 21 CFR part 11.

3.1 Manufacturing validation

Manufacturing accuracy validation was performed to demonstrate the manufacturing process for Nuvola® Aligner. Two critical aspects of the manufacturing process were assessed:

digital dentition models from treatment planning and they 3D printed molds, and
. the fitting of the first final thermoformed aligner

The test has been repeated for 5 times with 5 different patient 3rd party software was used to perform point-to-point and critical displacement. All measurements were within the predefined tolerance of the manufacturing process. There were no differences in the intended and measured in any cases used, meeting the pre-established specification. The suitability, function and form of the aligner were checked by the prescribing doctor make the patient worn the first aligner of the 5 treatment plans used for the validation, also in this case the results were comply with the pre-established specifications and acceptance criteria.

3.1.1 Material used

The material used to produce Nuvola aligner is a Thermoforming Sheet Material indication of orthodontic and dental appliances (Erkodur, K200125). The material are pre-shaped flat plastic discs. The sheets are plasticized in appropriate thermoforming units and adapted onto patient's individual plaster models. After cooling the sheets are removed from the model and trimmed to fit. The use of thermoplastic materials for sequential aligners intended to treat malocclusions has been well documented in scientific literature regarding incremental tooth moving forces. All of the components found in Thermoforming Sheet Material have been used in legally marketed devices and/or were found safe for dental use.

Image /page/5/Picture/13 description: The image shows the logo for Nuvola. The logo consists of a stylized letter N in a teal color, positioned above the word "nuvola" in a dark gray sans-serif font. The letter N is designed with rounded edges and a curved shape, giving it a modern and abstract appearance.

Gruppo Europeo di Or Via Cropani. 118 A/B 00173 -

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Image /page/6/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with white grid lines, suggesting a global or international focus. The text "GEO" is prominently displayed across the center of the globe, and the full name of the organization is written in a circular fashion around the bottom half of the globe.

3.2 Biocompatibility Testing

The material that is in direct contact with the patient is a thermoforming sheet material already cleared by FDA (K200125) and it has been tested on its biocompatibility. The tests on the material Erkodur have been performed according to the standard EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350. Biological effects to be considered for leachable are cytotoxicity, mucosa irritation, acute systemic and sub-chronic toxicity, genotoxicity. The results of the testing prove that the insolubility of the Thermoforming Sheet Material is in compliance with EN ISO 10993-1 and FDA Guidance Document No. FDA-2013-D-0350 for the intended dental use.

3.3 Shelf life

A 1-year shelf life was determined by real-time aging testing were conducted after 24 months realtime aging under standard storage condition. The test results showed conformity with the precifications and acceptance criteria. For a conservative choice, it was decided to fix as shelf life to 12 months (1 year)

3.4 Packaging

Package integrity, via simulated transport test per ISTA 2A, has been performed. The Nuvola® packaging is suitable for transportation and storage.

3.5 Treatment Planning software validation

In order to support Nuvola® business, GEO has been developing a web-based platform called Nuvola®Web. This software is a Treatment Planning platform that allows users to manage in digital way the aligner treatment plan. Nuvola®Web is a classic web-based collaborative application dedicated to dentists who wish to request, manage the design and repair Nuvola® device which is a custom-made invisible aligner, upon presentation of a medical prescription.

Nuvola® Web is able to store all information in order to provide the user (doctor/dentist), with access to the application platform, a customized experience according to their preferences. Contact details, telephone and e-mail addresses, shipping and billing addresses. Once registered, the user is able to independently register the references of their patients, upload photographs, digitized dental impressions and diagnostic elements in electronic format (the main graphic standards are supported). Once the necessary information and medical prescription have been completed, it is possible to request and develop a treatment project designed to illustrate, through a three-dimensional (3D) graphic support, the evolution of dental movements, from the initial patient situation to the treatment. The platform includes a sophisticated 3D graphics feature, with the ability to show and store orthodontic information such as attachment points, inter-proximal reduction, etc. Nuvola®Web is able to simultaneously but separately manage the two arches (lower and upper), managing and accounting for the number of aligners necessary to carry out the clinical project goals, in order to meet all the needs of the associated prescription and consequently of the patient treatment. Doctor is able to interact with the laboratory through multi-channel communication techniques (chat, web request, email, etc.) in order to refine and agree on the details of the treatment proposal. Once all the clinical aspects have been determined, the application platform is able to manage doctor's acceptance plan, to be followed up for the production phase. Once the treatment plan is approved by the doctor, the platform sends in digital format the images of the models agreed with the doctor to the 3D printers which will produce the necessary models according to the quantities and methods previously defined. Finally, the application tracks the production activities thus ensuring the correct shipping and billing of the product requested by the doctor.

Nuvola®Web is validated by G.E.O in accordance with IEC 62304:2006+AMD1:2015 and it turned out compliance with 21 CFR part 11.

Image /page/6/Picture/11 description: The image shows the logo for Nuvola. The logo consists of a stylized letter "N" in a teal color, positioned above the word "nuvola" in a gray sans-serif font. The "a" in "nuvola" has a registered trademark symbol next to it.

Via Cropani. 118 A/B 00173

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Image /page/7/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with white lines representing continents and oceans. The acronym "GEO" is written in large, bold, light blue letters across the center of the globe. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA", is written in a semi-circle around the bottom of the globe in black letters.

4. Clinical Studies

Clinical Studies was not conducted for this 510(k) Notification. Clinical Performance testing was not needed to establish substantial equivalence to the predicate and reference devices. The above-mentioned non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles.

5. Comparison with Predicate Device

Proposed device and predicate device have indications for use, intended use, technological characteristics, and principle of operation.

In accordance with 21 CFR 807.92(a)(6) a summary of the technological characteristic's comparison of the proposed modified device to the predicate Device is provided below.

6. Technological Characteristics comparison with the Predicate and Reference Devices

	Subject Device	Predicate DeviceK220287	Reference DeviceK212496	Comparison
Device Name	Nuvola® aligner	Invisalign® System	Ortho Aligner System
Manufacturer	Gruppo Europeo diOrtodonzia S.r.l.(G.E.O srl)	Align Technology, Inc.	Ortho Lab Services, LLC
ClassificationRegulation #	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5470	Same
Name Product	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Same
Code	NXC	NXC	NXC	Same
Class	II	II	II	Same
Indications forUse	Nuvola® aligner is intendedfor the orthodontictreatment of malocclusion.	The Invisalign System isintended for the orthodontictreatment of malocclusion.	The Ortho Aligner System isindicated for the treatment oftooth malocclusion in patientswith permanent dentition(i.e. all second molars).	Same as predicatedevice
Mode of Action	Sequential aligners applycontinuous gentle force tothe teeth and/or positionmandible forward.	Sequential aligners applycontinuous gentle force to theteeth and/or position mandibleforward.	The appliance applies gentleforces on teeth according to theplan prescribed by the doctor.	Same

Image /page/7/Picture/8 description: The image features the logo for Nuvola. The logo consists of a stylized letter 'N' formed by two curved shapes in a light teal color, positioned above the word 'nuvola' in a lowercase, sans-serif font. The word 'nuvola' is in a dark gray color, and a small registration mark is placed to the right of the 'a'.

G.E.O. S.r.l. (Gruppo Europeo di Or Via Cropani, 118 A/B 00173 info@nuvolaortodonzia.it www.nuvolaortodonzia.it

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Image /page/8/Picture/0 description: The image shows a logo for "GEO GRUPPO EUROPEO DI ORTODONZIA". The logo features a blue globe with visible continents and grid lines. The acronym "GEO" is prominently displayed in blue, block letters across the center of the globe. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA", is written in a curved, sans-serif font around the lower portion of the globe.

	Subject Device	Predicate DeviceK220287	Reference DeviceK212496	Comparison
Device Description	Sequential thermoformedplastic aligners	Sequential thermoformedplastic aligners	Sequential thermoformedplastic aligners	Same
Description ofUse	Aligners are worn forapproximately 1-2 weeks of20- 22 hours of wear per day,after which it is replaced bythe next stage aligners. This isrepeated for duration asprescribed by the DentalPractitioner.	Aligners are worn forapproximately 1-2 weeks of 20-22 hours of wear per day, afterwhich it is replaced by the nextstage aligners. This is repeatedfor duration as prescribed bythe Dental Practitioner.	Each removable preformedplastic tray is worn by thepatient as prescribed by thedoctor, usually a few weeksprior to using the nextsequential aligner tray.	Same
PatientPopulation	Children, Adolescents andAdults	Children, Adolescents andAdults	Patients with permanentdentition (i.e. all second molars)	Same
Material	Thermoplastic polymer PET-G	Thermoplastic polymer	Thermoplastic PET-G	Same material asreferencedevice
MaterialProperties	Acceptable materialsproperties established for useas aligner (polyethyleneterephthalate glycol PET-G)Erkodur (K200125)	SmartTrack™ is materialengineered for use withInvisalign orthodontic treatment(Polyurethane)	Polyethylene terephthalateglycol, PET-G)	Similar material topredicate device.Same as referencedevice
ManufacturingProcess	Thermoforming on models	Thermoforming on models	Thermoforming on models	Same
ManufacturingProcess Validation	An internal manufacturingProcess Validation wasperformed	An internal manufacturingProcess Validation wasperformed	Testing to validate themanufacturing process wasperformed.	Same
TreatmentPlanning software	Nuvola® Web software is aweb-based collaborativeapplication that allows theuser to manage in digital waythe aligner treatment plan	ClinChek® software Cloud-basedtechnology that allows you tomanage in digital way thealigner treatment plan	Ortho Lab Services uses theirOrthoWare software to designthe treatment plans for toothmovement	Similar to predicatedevice: samepurpose butdifferenttechnologies

Image /page/8/Picture/2 description: The image shows the logo for Nuvolo. The logo consists of a stylized letter "N" in a light blue color, positioned above the word "nuvolo" in lowercase letters. To the right of the word "nuvolo" is the registered trademark symbol. There are also the letters "DLC" in the image.

G.E.O. S.r.I. (Gruppo Europeo di Ortodonzia) Via Cropani, 118 A/B 00173 – Roma (Italia) +39 06 72671754 info@nuvolaortodonzia.it www.nuvolaortodonzia.it

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Image /page/9/Picture/0 description: The image shows a logo for GEO, which stands for Gruppo Europeo di Ortodonzia. The logo features a blue globe with continents outlined in white. The letters "GEO" are superimposed on the globe in a stylized, blue font. The full name of the organization, "GRUPPO EUROPEO DI ORTODONZIA," is written in a circular fashion around the globe.

	Subject Device	Predicate DeviceK220287	Reference DeviceK212496	Comparison
SoftwareDescription fortooth movement	3Shape Ortho System(K152086) dental softwarefor tooth alignment usesdigital scan (untreated state)to generate the image of afinal, provisional treatedstate and then interprets aseries of images thatrepresent intermediate teethstates. The dentalpractitioner then reviewsthese images and has theoption to reject or requestmodifications to the set-upprior to approving it foraligner fabrication. Once thedental practitioner approvesthe treatment plan, thesottware converts the files toproduce the series of 3Dmodels used to producethermoformed aligners	Invisalign System 3-D Software(K081960) Produces 3Dmodelfile of the PVS impression or thedigital scan. Identifies theindividual teeth that requiretreatment (i.e., repositioning).Creates a treatment plan (i.e., 3-D models that represent thetreatment plan) which isreviewed by the treating dentalpractitioner using function toreject or request modificationsto the set-up prior to approval.	OrthoWare software uses digitalscans to generate images of thefinal treated states, andintermediate steps to achievethe final state, and convertthose files to produce the seriesof customized aligners	Same purpose ofthe predicatedevice
PrescriptionUse	Rx only	Rx only	Rx only	Same
Single Patient	Yes	Yes	Yes	Same
Biocompatibility	Meets ISO 10993-1, -5, -10requirements: CytotoxicityandSensitization/Irritation	Biocompatible in accordingto ISO 10993-1	Meets ISO 10993-1, -5, -10requirements: Cytotoxicityand Sensitization/Irritation	Same
Process FlowValidation Testing	Performed testing tovalidate the finisheddevice matches thesoftware output design.	Performed testing tovalidate the finished devicematches the softwareoutput design.	Performed testing tovalidate the finished devicematches the softwareoutput design.	Same

Image /page/9/Picture/2 description: The image contains the logo for Nuvolo. The logo consists of a stylized teal-colored symbol above the word "nuvolo" in a sans-serif font. There is a registered trademark symbol to the right of the word "nuvolo". The letters "DLC" are present below the word "nuvolo".

G.E.O. S.r.I. (Gruppo Europeo di Ortodonzia) Via Cropani, 118 A/B 00173 – Roma (Italia) +39 06 72671754 info@nuvolaortodonzia.it www.nuvolaortodonzia.it

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Image /page/10/Picture/0 description: The image shows a logo for GEO, which stands for Gruppo Europeo di Ortodonzia. The logo features a blue globe with the letters "GEO" in a stylized font across the center. The text "GRUPPO EUROPEO DI ORTODONZIA" is written around the bottom half of the globe in a semi-circular fashion. The globe has visible lines of longitude and latitude.

7. Differences

	Subject Device	Predicate DeviceK220287	Reference DeviceK212496	Comparison
TreatmentPlanning software	Nuvola® Web software is aweb-based collaborativeapplication that allows theuser to manage in digitalway the aligner treatmentplan	ClinChek® softwareCloud-based technology thatallows you to manage in digitalway the aligner treatment plan	Information not available	Similar to predicatedevice: samepurpose butdifferenttechnologies
3D software fortooth alignment	3Shape Ortho System(K152086)	Invisalign System 3-D Software(K081960)	Information not available	Similar to predicatedevice.
MaterialProperties	Acceptable materialsproperties established foruse as aligner (PET-G).Erkodur (K200125)	SmartTrack™ is materialengineered for use withInvisalign orthodontic treatment(Polyurethane)	Acceptable materials propertiesestablished for use as aligner(PET-G)	Same as theReference device.Similar materialtype to thepredicate device

The subject and predicate device use similar material type, both PET-G and Polyurethane for dental application have similar characteristics. The thermoplastic polymer used by Nuvola® is PET-G, already FDA cleared Erkodur (K200125), that is one of most used the plastic materials to produce dental aligner, and it is the same used by the Reference Device. The software used for the management of the treatment plan between Subject and Predicate device are different: the Nuvola® Web is a web-based software whereas ClinChek® is a Cloud-based technology software; but they have the same purpose and are used in a similar way. Therefore, the using of different Treatment Planning software does not raise any questions regarding safety and effectiveness.

Regarding the dental software for tooth alignment G.E.O uses the already FDA cleared software 3Shape Ortho System (K152086) while Align Inc. uses a proprietary software: Invisalign System 3-D Software (K081960). They both use digital scans to generate images of the final treated states, and intermediate steps to achieve the final state, and convert those files to produce the series of customized aligners.

8. Substantial Equivalence

The Nuvola® (Subject Device) and the previously cleared predicate device Invisalign System are similar in that they have:

same indications for use,
. same principles of operation
same technological characteristics, and
same manufacturing process

9. Conclusion

The Nuvola® device has the same intended use and indications for use as the previously cleared Invisalign System (K220287). In addition, the Nuvola® system has the same technological characteristics, and principles of operation as its predicate and reference device.

The software and materials differences between the Nuvola® system and its predicate device do not raise new questions of safety or efficacy.

Thus, the Nuvola® device is substantially equivalent previously cleared similar devices.

Image /page/10/Picture/15 description: The image shows the logo for Nuvola. The logo features a stylized letter "N" above the word "nuvola". The "N" is formed by two curved shapes that resemble wings or clouds, and it is colored in a light teal. The word "nuvola" is written in a lowercase, sans-serif font and is colored in gray.

G.E.O. S.r.l. (Gruppo Europeo di Or Via Cropani. 118 A/B 00173

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.