MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM by BLUE SKY BIO, LLC

For implantation into any area of the fully edentulous maxilla and mandible for the support of a . removable or fixed dental prosthesis
For implantation into any area of the partially edentulous maxilla and mandible for the support of . a removable or fixed dental prosthesis
For single tooth or multiple unit prosthesis .
For single stage or two stage surgical procedure .
One piece implants for single stage procedure only ●
For immediate placement and immediate function when multiple units are splinted and for single . units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.

Device Description

The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained and overdenture-type restorative options. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants are supplied sterile or not sterile and are labeled accordingly. The system is suitable for a one-stage and two-stage protocol.

AI/ML Overview

This submission is for a Traditional 510(k) for a Class II medical device, specifically a "Blue Sky Bio Dental Implant System." This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials to establish de novo safety and efficacy criteria. Therefore, the information typically requested in your prompt (such as acceptance criteria with reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is generally not part of a Traditional 510(k) submission.

Explanation Based on Document Content:

The provided document (K051507) is a 510(k) summary and the FDA's clearance letter for the "Blue Sky Bio Dental Implant System." Here’s why it doesn't contain the requested information in the typical format for device performance studies:

Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. It does not usually require de novo clinical studies with specific acceptance criteria and performance metrics against a defined standard.
"Modification of the Blue Sky Bio Dental Implant System": The device description explicitly states, "The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems... Modifications to the existing system do not introduce new issues of safety or efficacy." This further reinforces that the submission is for a modification of an already cleared device, making extensive new performance studies unlikely to be required.
FDA Letter Confirmation: The FDA's letter states, "We have reviewed your Section 510(k) premarket notification of intent to market the device... We have determined the device is substantially equivalent... to legally marketed predicate devices." This is the basis of the clearance, not evidence of meeting specific numerical performance criteria from a clinical study.
Lack of Performance Data Section: Traditional performance data sections, including benchmarks, study designs, sample sizes, and ground truth methods, are absent from the provided document, as they are not standard requirements for this type of submission unless specific new safety/efficacy questions are raised by the modification, which the submitter explicitly denies.

Therefore, based on the provided document, I cannot fulfill your request for the following reasons:

No explicit acceptance criteria or reported device performance table: The submission relies on substantial equivalence to a predicate device, not on meeting new quantitative acceptance criteria from a performance study.
No sample sizes, data provenance, or details on ground truth for test/training sets: These are components of clinical or performance studies, which are not detailed in this 510(k) submission.
No information on experts for ground truth or adjudication methods: Again, related to detailed studies which are not present.
No MRMC comparative effectiveness study or related effect size: This type of study is not mentioned or required for a 510(k) submission focused on substantial equivalence for this device.
No standalone (algorithm-only) performance data: The device is a physical dental implant system, not a software algorithm, so this concept is not applicable.
No specific type of ground truth mentioned: Directly related to the absence of detailed performance studies.
No sample size for the training set or how ground truth for the training set was established: These details pertains to the development and validation of machine learning algorithms or specific clinical trials, neither of which are described here.

This document describes a regulatory filing for a medical device that relies on demonstrating equivalence to an existing device rather than presenting new clinical study data with specific performance metrics and acceptance criteria.

Summary

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K05/507

SEP - 2 2005

888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: 718-376 0422 Fax: 888-234 3685 Email: azickmann@blueskybio.com

510(K) Summary

General Information

Classification Name:	Endosseous Implant
Common Name:	Prosthetic Dental Implant System
Trade Name:	Blue Sky Bio Dental Implant System
Submitter's Name:	Blue Sky Bio, LLC
Address:	888 E Belvidere Rd., Suite 212
	Grayslake, IL 60030
Telephone:	847-548 8499
Fax:	847-548 8491
Contact:	Michele Vovolka
Date of Summary	May 2005

Device Description

Intended Use

For implantation into any area of the fully edentulous maxilla and mandible for the support of a . removable or fixed dental prosthesis
For implantation into any area of the partially edentulous maxilla and mandible for the support of . a removable or fixed dental prosthesis
For single tooth or multiple unit prosthesis .
For single stage or two stage surgical procedure .
One piece implants for single stage procedure only ●
For immediate placement and immediate function when multiple units are splinted and for single . units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2005

Dr. Albert Zickmann Blue Sky Bio, LLC 888 East Belvidere, Suite 212 Grayslake, Illinois 60030

Re: K051507

Trade/Device Name: Blue Sky Bio Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 10, 2005 Received: June 7, 2005

Dear Dr. Zickmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your become mined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use surced in the encreating of the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Antichunches, or to ab roos and in the entire Act (Act) that do not require approval of a premarket the rederal I ood, Drug, Drug, therefore, market the device, subject to the general approvin approvisions of the Act. The general controls provisions of the Act include controls providents or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is enabilional controls. Existing major regulations affecting (1 Mrx), it may of such 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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Page 2 - Dr. Zickmann

Please be advised that FDA's issuance of a substantial equivalence determination does not r least oc advisor that I Da determination that your device complies with other requirements modifine and regulations and regulations administered by other Federal agencies. of the Act of ally I outeral but is requirements, including, but not limited to: registration 1 od must comply with an all are i 100 bing (21 CFR Part 801); good manufacturing practice and ilsting (21 OF Reviews (QS) regulation (QS) regulation (21 CFR Part 820); and if requirements as set for in als qualify ijon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w your of substantial equivalence of your device to a premarket notification. - The results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire speome at 100 Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylette K. Michael, Cins.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

Page 1 of 1

KD51507 510(k) Number (if Known):_____________________________________________________________________________________________________________________________________________________

Device Name: Blue Sky Bio Dental Implant System

Indications for Use:

For implantation into any area of the fully edentulous maxilla and mandible for the support of a . removable or fixed dental prosthesis
removation into any area of the partially edentulous maxilla and mandible for the support of . a removable or fixed dental prosthesis
For single tooth or multiple unit prosthesis .
For single stage or two stage surgical procedure .
One picce implants for single stage procedure only .
One prece implane for and immediate function when multiple units are splinted and for single . r of minediate placement and ministration in type I or type II bone and under appropriate unns when daequate mitted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	✓ OR
(Division Sign-Off)	Susan Runne

Over-The-Counter Use (Optional Format 1-2-96)

Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number: K051507

Blue Sky Bio, LLC 510(k)

Page 9 Proprietary & Confidential

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.