Blue Sky Bio Aligners are a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.

Device Description

Blue Sky Bio Aligners are a series of clear plastic aligners that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions.

A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the Blue Sky Bio Aligners based on an assessment of the patient's teeth, determines the course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using standard dental software used for tooth alignment, Blue Sky Bio then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Blue Sky Bio produces trays, which are formed of clear, then, thermoformed plastic. The trays are sent back to the dental health professional who then provides them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

AI/ML Overview

The provided text describes the 510(k) premarket notification for Blue Sky Bio Aligners, establishing its substantial equivalence to predicate devices. It focuses on the device's characteristics, indications for use, and comparison to existing aligner systems. However, it explicitly states that no performance testing was conducted for the device itself or its materials (Essix) because the material already has 510(k) clearance as an aligner material, and the aligner production technology is considered "essentially identical" to the predicate.

Therefore, the specific information requested about acceptance criteria, study data, sample sizes, expert involvement, and ground truth for performance evaluation is not available in the provided document. The submission relies on the established safety and effectiveness of the existing predicate devices and materials.

Below is a table summarizing the requested information that can be extracted or derived from the text, with an explicit mention where information is not provided:

Acceptance Criteria and Device Performance Study Information

Information Category	Acceptance Criteria	Reported Device Performance
1. Table of Acceptance Criteria and Reported Performance	No specific quantifiable acceptance criteria for device performance (e.g., accuracy of tooth movement, treatment success rate) are stated in this 510(k) submission. The submission's argument for substantial equivalence is based on: - Indications for Use equivalence: To be substantially equivalent to predicate devices. - Technological Characteristics equivalence: Design, technology, materials, and composition must be substantially equivalent to predicate devices. - Mechanism of Action equivalence: Similar to predicate devices. - Material properties: Essix material (the aligner material) must demonstrate "sufficient tensile strength, elasticity, ductility, chemical resistance, and clarity for use as a clear tray aligner," as per its existing 510(k) clearance (K062828). - Software functionality: Software must facilitate ordering and processing of aligners and maintain safety and effectiveness compared to predicates, without changing the functions of Blue Sky Bio Plan.	No specific quantifiable device performance metrics are reported. The submission asserts substantial equivalence based on the following: - Indications for Use: Blue Sky Bio Aligners have "substantially equivalent Indications for Use" to the 3M Clear Tray Aligner (predicate). - Technological Characteristics: "The results of this comparison demonstrate that the design, technology, materials, and composition of Blue Sky Bio Aligners are substantially equivalent to the predicate devices." The technology is described as "essentially identical to that used by a number of sequential aligner systems including the predicate device, 3M Clear Tray Aligners." - Mechanism of Action: "The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence." - Material: The aligners use Essix from Dentsply, which "has a 510k clearance as an aligner material (K062828, MQC unclassified)." Therefore, it is assumed to meet the necessary material properties. - Biocompatibility: No separate biocompatibility testing was performed as the material already has 510(k) clearance. - Software Verification and Validation: "Software verification and validation testing of the aligner showed that the addition of the aligner module did not change the functions of Blue Sky Bio Plan." The software was considered a "moderate" level of concern and documentation was provided as per FDA guidance. Crucially, the document states: "Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting." And "no performance tests were done on it [Essix material]."
2. Sample size and data provenance for test set	Not applicable, as no performance testing was performed on the device or its materials.	Not applicable, as no performance testing was performed on the device or its materials.
3. Number and qualifications of experts for ground truth	Not applicable, as no performance testing was performed on the device or its materials.	Not applicable, as no performance testing was performed on the device or its materials. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
4. Adjudication method for test set	Not applicable, as no performance testing was performed on the device or its materials.	Not applicable, as no performance testing was performed on the device or its materials. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
5. MRMC comparative effectiveness study?	No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement in human reader performance with AI assistance (as this is an aligner, not an AI diagnostic device).	Not applicable. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
6. Standalone (algorithm only) performance study?	No. The document states that "Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting." Performance is assumed through substantial equivalence to existing devices and materials.	Not applicable.
7. Type of ground truth used	Not applicable, as no performance testing was performed on the device or its materials.	Not applicable, as no performance testing was performed on the device or its materials. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
8. Sample size for the training set	Not applicable, as this is a physical dental aligner product, not an AI algorithm that requires a training set. The software module mentioned facilitates ordering and processing, but its development does not involve a "training set" in the machine learning sense.	Not applicable.
9. How ground truth for the training set was established	Not applicable.	Not applicable.

Summary

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Blue Sky Bio LLC % Dave Yungvirt Official Correspondent Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re: K180107

Trade/Device Name: Blue Sky Bio Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: January 11, 2018 Received: January 16, 2018

Dear Dave Yungvirt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

February 9, 2018

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

For Tina Kiang, Ph.D Acting Division Director Science and Policy Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use

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Indications for Use

510(k) Number (if known)

Device Name Blue Sky Bio Aligners

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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Section 5 510(k) Summary or Statement

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510(k) Summary

Blue Sky Bio Aligners

Blue Sky Bio LLC 888 E Belvidere Rd Suite 212 Grayslake. IL 60030

718-376-0422

www.blueskybio.com

Contact Person: Albert Zickmann

azickmann@blueskybio.com

General Information
Trade Name	Blue Sky Bio Aligners
Common Name	Sequential Aligner
Predicate 510(k)	3M Clear Tray Aligner K163689
Reference Predicates	Blue Sky Plan K090607 and Dentsply EssixK062828
Product Code	NXC, LLZ
Regulation No.	872.5470 Orthodontic Plastic Bracket
Classification	Class II

Device Description:

Blue Sky Bio Aligners are a series of clear plastic aligners that offer a solution for aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions.

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The technology is essentially identical to that used by a number of sequential aligner systems including the predicate device, 3M Clear Tray Aligners.

Indications for Use:

Technological Characteristics:

Treatment of tooth malocclusions via a series of plastic appliances that incrementally moves the teeth to a desired final position is the technological principle for both the subject device and the predicate device. A comparison between the technological characteristics of Blue Sky Bio Aligners and that of 3M Clear Tray aligners has been performed. The results of this comparison demonstrate that the design, technology, materials, and composition of Blue Sky Bio Aligners are substantially equivalent to the predicate devices.

Mechanism of Action:

The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied to the teeth by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.

Performance Testing:

Bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting. The material used for the aligners is Essix from Dentsply which has a 510k clearance as an aligner material (K062828, MQC unclassified) so no performance tests were done on it.

Biocompatibility Testing:

The material used for the Blue Sky Bio aligners has a 510k clearance as an aligner material so no biocompatibility testing was performed.

Software Verification and Validation Testing:

Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Blue Sky Bio Aligners to support the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. This software in a module which can be installed along with Blue Sky Bio Plan (K090607). The software verification and validation testing of the aligner showed that the addition of the aligner module did not change the functions of Blue Sky Bio Plan.

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Predicate Device Comparison Table

	Blue Sky Bio Aligners	3M Clear Tray AlignersK163689	Blue Sky PlanK090607	Dentsply EssixK062828				hardware usinga Windowsoperatingsystem.
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	21 CFR 870.2050	unclassified	Mode ofaction	Orthodontic toothmovementoccurs through forcesappliedby the appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.Imaging software hasadded module forordering and processingof aligners.	Orthodontic toothmovementoccurs through forcesappliedby the appliance to thedentition as each toothfollows theprogrammeddisplacement based on adoctor's prescription.	Imagingsoftware	Orthodontictoothmovementoccursthroughforces appliedby theappliance tothedentition aseach toothfollows theprogrammeddisplacementbased on adoctor'sprescription.
DeviceClassificationName/DeviceCommonName	Orthodontic PlasticBracket	Orthodontic PlasticBracket	Picture archivingandcommunicationssystem	Alignermaterial	Material	Essix Thermoplastic	Thermoplastic	none	EssixThermoplastic
Product Code	NXC, LLZ	NXC	LLZ	NXC	MaterialProperties	Demonstrates sufficienttensile strength,elasticity,ductility, chemicalresistance,and clarity for use as aclear tray aligner.510k cleared sheetmaterial for thisindication.	Demonstratessufficienttensile strength,elasticity,ductility, chemicalresistance,and clarity for use as aclear tray aligner.		Demonstratessufficienttensilestrength,elasticity,ductility,chemicalresistance,and clarity foruse as a cleartray aligner.510k clearedsheetmaterial forthisindication.
Classification	II	II	II	none	Function ofthe software	Software used forordering workflow.Ortho module facilitatesordering and processingof the aligners.Blue Sky Plan™ is dentalimaging software which	Software used forordering workflow.Facilitates ordering andprocessing of thealigners.	Blue Sky Plan™ isdental imagingsoftware whichloads DICOMimages andprovides 3Dvisualization, 2Dimagereformation for	none
Indicationsfor use	Blue Sky Bio Aligners area series of clear,lightweight, plasticappliances indicated forthe treatment of toothmalocclusions in patientswith permanentdentition (i.e., all secondmolars). Utilizing a seriesof incremental toothmovements, itsequentially positionsteeth by way ofcontinuous gentle force.	The 3M Clear TrayAligner System is aseries of clear,lightweight, plasticappliances indicated forthe treatment of toothmalocclusions inpatients withpermanent dentition(i.e., all second molars).Utilizing a series ofincremental toothmovements, itsequentially positionsteeth by way ofcontinuous gentleforce.	Blue Sky Plan isintended to beused asconversionsoftware forComputedTomography(CT)generatedDICOM imagesinto a formatthat allows adentist to assessthe anatomictopography ofthe maxilla andmandible as wellas location ofimportantstructures. Itallows theinformation tobeused for pre-surgicaltreatmentplanning ofdental implantprocedures. TheBlue Sky Plansoftwareis deployed onstandardpersonalcomputer	Alignermaterials areindicated forthefabrication oforthodonticappliances.

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	loads DICOM images andprovides 3Dvisualization, 2D imagereformation for surgicalimplant planning andstent fabrication, whichallows the virtualposition of implants fromthe images supplied bycomputerizedtomography.	surgical implantplanning andstentfabrication,whichallows thevirtual positionof implants fromthe imagessupplied bycomputerizedtomography.
Design	Image: clear aligner	Image: clear aligner

Conclusion:

Blue Sky Bio Aligners have substantially equivalent Indications for Use as the identified predicate and reference devices.

Blue Sky Bio Aligners are as safe, as effective, and are substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility. Blue Sky Bio Aligners are made from reference predicate device Essix from Dentsply so there can be no differences between them.

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.