Blue Sky Bio TAD

K201919 · Blue Sky Bio, LLC · OAT · Dec 17, 2020 · Dental

Device Facts

• Record ID: K201919
• Device Name: Blue Sky Bio TAD
• Applicant: Blue Sky Bio, LLC
• Product Code: OAT · Dental
• Decision Date: Dec 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

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 Story

Blue Sky Bio TAD is a titanium alloy bone screw used as a temporary fixed anchorage point for orthodontic appliances. The device features a proximal head with a recess for wire attachment, a neck with a through-hole for fixation, a tapered collar for soft tissue protection, and a threaded distal portion for bone insertion. It is used by orthodontists in a clinical setting to facilitate tooth movement; the screw is removed upon completion of treatment. The device provides mechanical stability for orthodontic forces. It is supplied in sterile or non-sterile versions, with the latter requiring end-user steam sterilization. The device is intended for single use only.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through non-clinical bench testing, including axial pull-out strength (ASTM F543), peak torque, insertion torque, and sterile barrier integrity testing (ASTM D4169, ASTM F88, dye penetration).

Technological Characteristics

Material: Titanium alloy (ASTM F136). Form factor: Threaded bone screw with proximal head recess, neck through-hole, and tapered collar. Diameters: 1.6mm, 1.8mm. Lengths: 6mm, 9mm. Sterilization: Radiation (ISO 11137) or steam (ISO 17665). Connectivity: None. Software: None.

Indications for Use

Indicated for adolescents >12 years and adults requiring fixed anchorage for orthodontic tooth movement.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OrthoFix Screw (K113650)

Reference Devices

• Dual Top Anchor System Screw (K033767)
• Blue Sky Bio Dental Implant System (K102034)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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Image /page/2/Picture/1 description: The image shows the logo for Blue Sky Bio. The logo consists of a light blue swirl on the left and the text "BlueSkyBio" in yellow on the right. The swirl is a stylized representation of a vortex or spiral. The text is in a sans-serif font and is slightly bolded.

# 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)

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.

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 [e-mail]

"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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Image /page/3/Picture/1 description: The image shows the logo for BlueSkyBio. The logo consists of a light blue swirl on the left and the text "BlueSkyBio" in yellow on the right. The swirl is made up of several curved lines that create a circular shape.

# 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: [phone]

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: [phone] e-mail: [e-mail]

### 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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Image /page/4/Picture/1 description: The image contains the logo for Blue Sky Bio. The logo consists of a light blue swirl on the left and the words "BlueSkyBio" in yellow on the right. The swirl is a stylized representation of a vortex or spiral.

## 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

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.

## 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, LLC<br>Blue Sky Bio TAD<br>K201919 | BonaFix Surgical &<br>Dental Implants, LLC<br>OrthoFix Screw<br>K113650 | Jeil Medical Corp.<br>Dual Top Anchor<br>System Screw<br>K033767 | Blue Sky Bio, LLC<br>Blue Sky Bio Dental<br>Implant System<br>K102034 |
| Material | Medical Grade<br>Titanium Alloy<br>ASTM 136 | Medical Grade<br>Titanium Alloy<br>ASTM 136 | Medical Grade<br>Titanium Alloy<br>ASTM 136 | Medical Grade<br>Titanium Alloy<br>ASTM 136 |
| Surface<br>treatment | No | No | No | Yes |
| Design Screw<br>Head | Incorporates a recess | Incorporates a recess | Incorporates a recess | |
| Design Neck | Through hole | Through hole | Through hole | |
| Design Collar | Tapered | Tapered | Tapered | |
| Principle of<br>Operation | Provide fixed<br>anchorage for<br>orthodontic<br>movement of teeth | Provide fixed<br>anchorage for<br>orthodontic<br>movement of teeth | Provide fixed<br>anchorage for<br>orthodontic<br>movement 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 for<br>Use | The proposed Blue<br>Sky Bio TAD is | The device is<br>intended to provide | The device is<br>intended to provide | |

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Image /page/5/Picture/1 description: The image contains the logo for BlueSkyBio. On the left side of the logo is a light blue swirl. To the right of the swirl is the company name, BlueSkyBio, in yellow font.

| | intended to provide a<br>fixed anchorage point<br>for attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of teeth. It<br>is used temporarily<br>and is removed after<br>orthodontic<br>treatment has been<br>completed. Screws<br>are intended for a<br>single use only. For<br>use in adolescents<br>greater than age 12<br>and adults. | fixed anchorage point<br>for attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of teeth. It<br>is used temporarily<br>and is removed after<br>orthodontic<br>treatment has been<br>completed. Screws<br>are intended for<br>single use only. For<br>use in adolescents<br>greater than age 12<br>and adults | fixed anchorage point<br>for attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of teeth. It<br>is used temporarily<br>and is removed after<br>orthodontic<br>treatment has been<br>completed. Screws<br>are intended for<br>single use only. For<br>use in adults over the<br>age of 12 | |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single use | Yes | Yes | Yes | Yes |
| Sterility | Provided sterile and<br>Non-sterile | Provided sterile | Provided Non-sterile | Provided sterile |
| Packaging | Packaged in as single<br>units sealed in a<br>plastic pouch<br>(polyethylene<br>terephthalate/low<br>density polyethylene,<br>PET/LDPE) with a<br>peelable chevron<br>seal, and each sealed<br>pouch is then<br>inserted into a single<br>unit plastic envelope<br>(polyethylene<br>terephthalate glycol-) | | | Packaged in as single<br>units sealed in a<br>plastic pouch<br>(polyethylene<br>terephthalate/low<br>density polyethylene,<br>PET/LDPE) with a<br>peelable chevron<br>seal, and each sealed<br>pouch is then<br>inserted into a single<br>unit plastic envelope<br>(polyethylene<br>terephthalate 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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Image /page/6/Picture/1 description: The image shows the logo for Blue Sky Bio. The logo consists of a light blue swirl on the left and the words "BlueSkyBio" in yellow on the right. The swirl is a stylized representation of a vortex or spiral.

- . 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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Image /page/7/Picture/1 description: The image shows the logo for Blue Sky Bio. On the left side of the logo is a light blue swirl. To the right of the swirl is the company name, "BlueSkyBio" in yellow font.

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.