The proposed Blue Sky Bio TAD is intended to provide a fixed anchorage point for attachment of orthodonic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.

Device Description

The Blue Sky Bio TAD is fabricated from titanium Alloy without surface treatment, which meets the material requirements specified in the standard ASTM F-136-08. The head on the proximal portion of the screw incorporates a recess, which provides an option for the orthodontist to pass through a wire and tie it in the neck of the Blue Sky Bio TAD in the orthodontic treatment. Distal to the recess is a square indentation that is used as a screw head.

The smooth neck distal to the proximal head employs a hole through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Distal to the neck is the collar, which has a tapered design to protect the soft tissue. The distal portion of the proposed Blue Sky Bio TAD is threaded for quick insertion and provides stability and biomechanic retention once the screw is fully inserted. The distal tip of the screw is machined with high precision manufacturing.

AI/ML Overview

The Blue Sky Bio TAD is an endosseous dental implant intended to provide a fixed anchorage point for orthodontic appliances. The provided text describes the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria for device performance.

Therefore, the requested information specifically on acceptance criteria and a study proving the device meets those criteria, as well as details like sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, and standalone performance, cannot be extracted from this document as these types of studies were not conducted or reported for this submission. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Blue Sky Bio TAD to its predicate device."

However, I can provide a summary of the non-clinical tests performed, the general purpose of these tests, and the ground truth used for materials, which is documented in the provided text.

Summary of Non-Clinical Testing for Blue Sky Bio TAD

The Blue Sky Bio TAD was deemed substantially equivalent to predicate devices based on non-clinical performance tests, material equivalence, and manufacturing process equivalence. Clinical testing was not required for this submission.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and reported performance values are not detailed in the provided text for most tests, a table format for "acceptance criteria" and "reported device performance" as typically seen in clinical studies or detailed engineering reports cannot be fully constructed. However, the document outlines the types of tests performed and the standards they followed, which imply that the results met the requirements of those standards.

Test Performed	Implied Acceptance Criteria (Based on Standard/Purpose)	Reported Device Performance
Axial Pull-out Strength	Compliance with ASTM F543 requirements for the effectiveness of the mechanical design and elimination of orthodontic mini-implant.	Not explicitly stated, but implied to meet standard.
Peak Torque Value	Compliance with findings/methodology from the "Article by Drs. Jolley and Chung Published in the Journal of Clinical Orthopedics."	Not explicitly stated, but implied to meet article's criteria.
Insertion Torque Test	Torque required for insertion must validate the surgical procedure provided in the instructions for use, in a worst-case scenario.	Not explicitly stated, but implied to validate procedure.
Sterilization	Validation according to ISO 11137-1 & ISO 11137-2 (for sterile product), and ISO 17665-1 & ISO 17665-2 (for non-sterile product).	Not explicitly stated how values met, but validated.
Shelf Life (Packaging)	Maintain sterile barrier integrity after accelerated and real-time aging, confirmed by ASTM D4169, ASTM F88, and dye penetration testing.	Packaging integrity confirmed for proposed shelf life.
Biocompatibility	Conformance to ASTM F136; history of safe use as dental implant material; identical to predicate device materials and processing.	Device made of ASTM F136 titanium alloy, considered biocompatible due to equivalence.
Pyrogenicity	Meet pyrogen limit specifications for every batch.	Pyrogenicity test conducted on every batch.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set Sample Size: Not specified for any of the non-clinical tests (Axial Pull-out, Peak Torque, Insertion Torque, Sterilization, Shelf Life). These tests are typically conducted on a small number of samples representative of the manufactured device.
Data Provenance: Not specified. These are non-clinical lab tests, likely performed internally or by a contracted lab. There's no mention of country of origin or whether data is retrospective or prospective as these terms are more relevant to clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Ground truth for these non-clinical tests is established by adherence to recognized international standards (e.g., ASTM, ISO) or published scientific methodologies. There is no mention of expert consensus for these specific tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic outcomes. These are not relevant for the engineering and material performance tests described.

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

MRMC Study: No, an MRMC comparative effectiveness study was not reported. The document explicitly states that clinical testing was not required. These studies are relevant for evaluating the performance of AI-assisted diagnostic devices with human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Standalone Performance: No, a standalone performance study was not reported. This is a physical medical device (dental implant), not a software algorithm that would have standalone performance metrics.

7. Type of Ground Truth Used

Ground Truth for Non-Clinical: The ground truth for the non-clinical tests is based on established international standards (e.g., ASTM, ISO) and published scientific literature/methodologies (e.g., "Article by Drs. Jolley and Chung Published in the Journal of Clinical Orthopedics" for peak torque). For biocompatibility, the ground truth is based on the material's conformance to ASTM F136 and its long history of safe use in similar implant applications.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

Blue Sky Bio, LLC % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445

Re: K201919

Trade/Device Name: Blue Sky Bio TAD Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: November 12, 2020 Received: November 19, 2020

Dear Juan Tezak:

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 (OS) 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.

Andrew Steen Assistant Director DHT1B: Division of Dental 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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4. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)
--------------------------

K201919

Device Name

Blue Sky Bio TAD

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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5. 510(k) Summary

K201919 Blue Sky Bio, LLC Blue Sky Bio TAD December 17th, 2020

ADMINISTRATIVE INFORMATION

Applicant

Blue Sky Bio, LLC 800 Liberty Dr. Libertyville, IL 60048

Phone: +1 718-376-0422

Establishment Registration Number

3003402534

Official Contact

Representative/Consultant

Sharon Nichols, Regulatory Representative

Juan Tezak Carlos Marín Compliance4Devices 118 W Prive Cr. Delray Beach Fl, 33445 Tel: +1 561-789-2411 e-mail: compliance4devices@gmail.com

DEVICE AND CLASSIFICATION NAME

Device Trade Name: Common Name: Classification Regulation: Classification Name: Device Classification: Classification Panel: Product Code:

Blue Sky Bio TAD Bone Screw, Orthodontic 21 CFR 872.3640 Endosseous dental implant Class II Dental OAT

PREDICATE DEVICES INFORMATION

Primary predicate K113650, OrthoFix Screw

Reference device K033767, Dual Top Anchor System Screw

K102034, Blue Sky Bio Dental Implant System

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Intended Use

The proposed Blue Sky Bio TAD is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for a single use only. For use in adolescents greater than age 12 and adults.

Device Description

Equivalence to Marketed Devices

Blue Sky Bio TAD is substantially equivalent to the predicated device and reference devices. In further support of a substantial equivalence determination, here-under is a comparison chart with the submitted device, the predicate device and reference device.

Feature	Subject Device	Predicate Device	Reference device	Reference device
	Blue Sky Bio, LLCBlue Sky Bio TADK201919	BonaFix Surgical &Dental Implants, LLCOrthoFix ScrewK113650	Jeil Medical Corp.Dual Top AnchorSystem ScrewK033767	Blue Sky Bio, LLCBlue Sky Bio DentalImplant SystemK102034
Material	Medical GradeTitanium AlloyASTM 136	Medical GradeTitanium AlloyASTM 136	Medical GradeTitanium AlloyASTM 136	Medical GradeTitanium AlloyASTM 136
Surfacetreatment	No	No	No	Yes
Design ScrewHead	Incorporates a recess	Incorporates a recess	Incorporates a recess
Design Neck	Through hole	Through hole	Through hole
Design Collar	Tapered	Tapered	Tapered
Principle ofOperation	Provide fixedanchorage fororthodonticmovement of teeth	Provide fixedanchorage fororthodonticmovement of teeth	Provide fixedanchorage fororthodonticmovement of teeth
Diameter	1.6 and 1.8 mm	1.6 and 1.8 mm	1.4, 1.6 & 2.0 mm
Length	6 and 9mm	6 and 9mm	6, 8, 10 & 12 mm
Indications forUse	The proposed BlueSky Bio TAD is	The device isintended to provide	The device isintended to provide

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	intended to provide afixed anchorage pointfor attachment oforthodonticappliances tofacilitate theorthodonticmovement of teeth. Itis used temporarilyand is removed afterorthodontictreatment has beencompleted. Screwsare intended for asingle use only. Foruse in adolescentsgreater than age 12and adults.	fixed anchorage pointfor attachment oforthodonticappliances tofacilitate theorthodonticmovement of teeth. Itis used temporarilyand is removed afterorthodontictreatment has beencompleted. Screwsare intended forsingle use only. Foruse in adolescentsgreater than age 12and adults	fixed anchorage pointfor attachment oforthodonticappliances tofacilitate theorthodonticmovement of teeth. Itis used temporarilyand is removed afterorthodontictreatment has beencompleted. Screwsare intended forsingle use only. Foruse in adults over theage of 12
Single use	Yes	Yes	Yes	Yes
Sterility	Provided sterile andNon-sterile	Provided sterile	Provided Non-sterile	Provided sterile
Packaging	Packaged in as singleunits sealed in aplastic pouch(polyethyleneterephthalate/lowdensity polyethylene,PET/LDPE) with apeelable chevronseal, and each sealedpouch is theninserted into a singleunit plastic envelope(polyethyleneterephthalate glycol-)			Packaged in as singleunits sealed in aplastic pouch(polyethyleneterephthalate/lowdensity polyethylene,PET/LDPE) with apeelable chevronseal, and each sealedpouch is theninserted into a singleunit plastic envelope(polyethyleneterephthalate glycol-)

Blue Sky Bio TAD is substantially equivalent in design, function, operating principle, material, sizes, and Indications for Use to predicate device OrthoFix Screw (K113650) and reference device Dual Top Anchor System Screw (K033767).

The subject device has two presentations, sterile and non-sterile. Regarding to sterile product, subject device is substantially equivalent to predicate device OrthoFix Screw (K113650); and to non-sterile product is substantially equivalent to the reference device Dual Top Anchor System Screw (K033767).

The packaging of the subject device is going to be the same in design, materials and dimensions as the reference Blue Sky Bio Implant System (K102034). The device reference packaging validation to maintain a sterile barrier for the entirety of the proposed shelf life was applied.

Non-Clinical Testing Summary

Non-clinical performance tests are:

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. Axial pull-out strength testing
According to the test standard (ASTM F543), Pull-out strength testing is performed for the effectiveness of the mechanical design of the orthodontic mini implant and its elimination.
Peak Torque Value . The test was performed according to Article by Drs. Jolley and Chung Published in the Journal of Clinical Orthopedics.
. Insertion Torque Test The test was performed in order to measure the torque required for insertion of the Blue Sky Bio TAD anchor, in the worst-case scenario version into a standard material, and to validate the surgical provided in the instructions for use.
. Sterilization

The subject device TAD implants are provided sterile and non-sterile.

The TAD implants that are provided sterile has been validated according to ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2 Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose.

The TAD implants that are provided non-sterile are to be sterilized by the end user. The recommended moist heat (steam)sterilization cycle has been validated according to ISO 17665-1 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, and ISO 17665-2 Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1.

Shel Life ●
All implant, sterile and non-sterile, are packaged in as single units sealed in a plastic pouch (polyethylene terephthalate/low density polyethylene, PET/LDPE) with a peelable chevron seal, and each sealed pouch is then inserted into a single unit plastic envelope (polyethylene terephthalate glycol-modified, PETG).

The sterile barrier shelf life for the subject device was determined by the following aging methods: Accelerated method and Real-time shelf life. For accelerated and real time, package integrity of the sterile barrier was confirmed by the following test method: Distribution testing according to ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems; Seal strength testing according to ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials; and Sterile barrier system Integrity by dye penetration testing.

Biocompatibility .
The subject device implants are made of titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). This titanium alloy is commonly used in endosseous dental implants and abutments, with a history of safe use, and is the same material used for predicate device OrthoFix previously cleared in K113650. The subject device is manufactured in the same facilities and use the same manufacturing process as used from Blue Sky Bio devices and components previously cleared. Therefore, no new biocompatibility

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testing has been performed as the subject device is identical to the predicate devices and reference devices with regards to materials and processing.

. Pyrogenicity Blue Sky Bio LLC, conducts Pyrogenicity test to meet pyrogen limit specifications. This test will be conducted on every batch.

Clinical Testing Summary

Clinical testing was not required to demonstrate the substantial equivalence of the Blue Sky Bio TAD to its predicate device.

Conclusion

. The subject device is made of the same materials and is identical in regards to dimensions and characteristics as the primary predicate device.
. The subject device is manufactured from Titanium Alloy that is widely used in this kind of endosseous dental implant systems.
. The subject device is manufactured in the same facilities using the same manufacturing processes were Blue Sky Bio LLC manufacture others implants and components that were previously cleared by the FDA.
. The subject device and predicate device are substantially equivalent in their intended use, technological characteristics and performance.

We conclude that the Blue Sky Bio TAD is substantial equivalent to the predicate devices listed above.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.