Blue Sky Bio Aligner

K180107 · Blue Sky Bio, LLC · NXC · Feb 9, 2018 · Dental

Device Facts

• Record ID: K180107
• Device Name: Blue Sky Bio Aligner
• Applicant: Blue Sky Bio, LLC
• Product Code: NXC · Dental
• Decision Date: Feb 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device, Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

Clear, thermoformed plastic aligners; used for orthodontic treatment of tooth malocclusions. Dental professional uses standard PC and dental software to assess patient teeth, take molds, and prescribe treatment; Blue Sky Bio designs series of trays based on prescription; physician reviews/approves model scheme. Trays provide continuous gentle force to sequentially position teeth; patient removes trays as needed. Treatment monitored by dental professional from first to final aligner. Benefits include aesthetic, gradual tooth realignment.

Clinical Evidence

No clinical data. Bench testing not performed due to nature of device; material biocompatibility and performance supported by predicate clearance (K062828). Software verification and validation testing conducted.

Technological Characteristics

Clear, thermoformed plastic aligners. Principle: incremental tooth movement via continuous force. Materials: Essix thermoplastic (cleared via K062828). Software: module for ordering/processing integrated with Blue Sky Plan. Connectivity: standard PC-based workflow.

Indications for Use

Indicated for treatment of tooth malocclusions in patients with permanent dentition (all second molars).

Regulatory Classification

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.

Predicate Devices

• 3M Clear Tray Aligner (K163689)

Reference Devices

• Blue Sky Plan (K090607)
• Dentsply Essix (K062828)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

[e-mail]

| 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 Essix<br>K062828 |
| 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.

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.

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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:

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.

## 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 Aligners<br>K163689 | Blue Sky Plan<br>K090607 | Dentsply Essix<br>K062828 | | | | hardware using<br>a Windows<br>operating<br>system. | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 870.2050 | unclassified | Mode of<br>action | Orthodontic tooth<br>movement<br>occurs through forces<br>applied<br>by the appliance to the<br>dentition as each tooth<br>follows the programmed<br>displacement based on a<br>doctor's prescription.<br>Imaging software has<br>added module for<br>ordering and processing<br>of aligners. | Orthodontic tooth<br>movement<br>occurs through forces<br>applied<br>by the appliance to the<br>dentition as each tooth<br>follows the<br>programmed<br>displacement based on a<br>doctor's prescription. | Imaging<br>software | Orthodontic<br>tooth<br>movement<br>occurs<br>through<br>forces applied<br>by the<br>appliance to<br>the<br>dentition as<br>each tooth<br>follows the<br>programmed<br>displacement<br>based on a<br>doctor's<br>prescription. |
| Device<br>Classification<br>Name/Device<br>Common<br>Name | Orthodontic Plastic<br>Bracket | Orthodontic Plastic<br>Bracket | Picture archiving<br>and<br>communications<br>system | Aligner<br>material | Material | Essix Thermoplastic | Thermoplastic | none | Essix<br>Thermoplastic |
| Product Code | NXC, LLZ | NXC | LLZ | NXC | Material<br>Properties | Demonstrates sufficient<br>tensile strength,<br>elasticity,<br>ductility, chemical<br>resistance,<br>and clarity for use as a<br>clear tray aligner.<br>510k cleared sheet<br>material for this<br>indication. | Demonstrates<br>sufficient<br>tensile strength,<br>elasticity,<br>ductility, chemical<br>resistance,<br>and clarity for use as a<br>clear tray aligner. | | Demonstrates<br>sufficient<br>tensile<br>strength,<br>elasticity,<br>ductility,<br>chemical<br>resistance,<br>and clarity for<br>use as a clear<br>tray aligner.<br>510k cleared<br>sheet<br>material for<br>this<br>indication. |
| Classification | II | II | II | none | Function of<br>the software | Software used for<br>ordering workflow.<br>Ortho module facilitates<br>ordering and processing<br>of the aligners.<br>Blue Sky Plan™ is dental<br>imaging software which | Software used for<br>ordering workflow.<br>Facilitates ordering and<br>processing of the<br>aligners. | Blue Sky Plan™ is<br>dental imaging<br>software which<br>loads DICOM<br>images and<br>provides 3D<br>visualization, 2D<br>image<br>reformation for | none |
| Indications<br>for use | Blue Sky Bio Aligners are<br>a series of clear,<br>lightweight, plastic<br>appliances indicated for<br>the treatment of tooth<br>malocclusions in patients<br>with permanent<br>dentition (i.e., all second<br>molars). Utilizing a series<br>of incremental tooth<br>movements, it<br>sequentially positions<br>teeth by way of<br>continuous gentle force. | The 3M Clear Tray<br>Aligner System is a<br>series of clear,<br>lightweight, plastic<br>appliances indicated for<br>the treatment of tooth<br>malocclusions in<br>patients with<br>permanent dentition<br>(i.e., all second molars).<br>Utilizing a series of<br>incremental tooth<br>movements, it<br>sequentially positions<br>teeth by way of<br>continuous gentle<br>force. | Blue Sky Plan is<br>intended to be<br>used as<br>conversion<br>software for<br>Computed<br>Tomography<br>(CT)<br>generated<br>DICOM images<br>into a format<br>that allows a<br>dentist to assess<br>the anatomic<br>topography of<br>the maxilla and<br>mandible as well<br>as location of<br>important<br>structures. It<br>allows the<br>information to<br>be<br>used for pre-<br>surgical<br>treatment<br>planning of<br>dental implant<br>procedures. The<br>Blue Sky Plan<br>software<br>is deployed on<br>standard<br>personal<br>computer | Aligner<br>materials are<br>indicated for<br>the<br>fabrication of<br>orthodontic<br>appliances. | | | | | |

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| | loads DICOM images and<br>provides 3D<br>visualization, 2D image<br>reformation for surgical<br>implant planning and<br>stent fabrication, which<br>allows the virtual<br>position of implants from<br>the images supplied by<br>computerized<br>tomography. | surgical implant<br>planning and<br>stent<br>fabrication,<br>which<br>allows the<br>virtual position<br>of implants from<br>the images<br>supplied by<br>computerized<br>tomography. | |
|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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.