(119 days)
- Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular incisors and maxillary lateral incisors
- Blue Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws
- Implants can be placed in immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
- Multi-unit abutments for fixed restorations are to be used only for multiple splinted restorations.
- In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
- Blue Sky Bio 3mm Double Hex Dental Implant System is compatible with Astra Osseospeed Narrow Dental Implant System.
- Blue Sky Bio 3mm Double Hex Dental Implants are compatible with Astra Osseospeed Narrow abutments.
- Blue Sky Bio 3mm Double Hex Abutments are compatible with Astra Osseospeed Narrow Implants.
The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and associated abutment systems, which provide the clinician with cement retained, screw retained and overdenture-type restorative options. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants and components are supplied sterile or not sterile and are labeled accordingly.
The provided document describes a 510(k) premarket notification for the Blue Sky Bio Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical studies or performance against specific acceptance criteria for novel devices.
Therefore, the document does not contain a table of acceptance criteria and reported device performance in the way typically found for new AI/diagnostic devices. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices through technical comparisons and performance tests designed to show compatibility and equivalence.
Here's a breakdown of the information available based on the request:
1. A table of acceptance criteria and the reported device performance
As mentioned above, the document does not present a formal table of acceptance criteria and reported performance metrics (e.g., sensitivity, specificity, accuracy) like for a standalone diagnostic device. The "acceptance criteria" for this 510(k) submission are met by demonstrating:
| Acceptance Criterion (Implied by Substantial Equivalence Goal) | Reported Device Performance (Summary from Document) |
|---|---|
| Material Equivalence | The device uses CP Titanium Grade 4 and Ti-6Al-4V, which is compared to the predicate device's CP Titanium Grade 4. The document states, "The material, technology and facilities used to produce the modified Blue Sky Bio Dental Implant Systems are the same." |
| Functional Equivalence (Design & Features) | The "Technological Characteristic Comparison" table (provided in the prompt's input) directly compares features such as 2-stage implantation, surface treatment (blasted with resorbable medium/aluminum oxide and acid etched vs. blasted with titanium oxide and acid etched), body/platform diameter (both 3mm), lengths, external screw threads, anti-rotational feature (internal double hex with taper), sterilization method (gamma), and abutment types. |
| Compatibility with Predicate Devices | "Compatibility tests with other systems according to Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document; Root-form Endosseous Dental Implants and Endosseous Dental Abutments: These tests were performed to assess compatibility with predicate devices. The tests showed that the new devices are compatible with predicate devices and the fit is adequate." |
| Mechanical Strength/Fatigue Equivalence | "Fatigue testing for angled abutments and narrow diameter implants: This test has been conducted according to ISO 14801 for predicate devices. The new devices have the same wall thickness and equal or smaller angulation than the predicate devices and are therefore equivalent or stronger than the predicate devices." |
| Safety and Efficacy (Overall) | "The 3mm Blue Sky Bio dental implant system is as safe and effective as the predicate devices." "The device constitutes a safe, reliable and effective medical device... and does not introduce new risks and does not present any adverse health effects or safety risks to patients when used as intended." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for specific 'test sets' in the context of clinical studies.
- The "compatibility tests" and "fatigue testing" are engineering/bench tests, not clinical trials with human subjects. The document refers to "systems" for compatibility tests and "new devices" for fatigue tests, but does not provide specific sample numbers of implants tested.
- Data provenance is not mentioned as these are largely in-vitro/bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this submission. The tests performed are engineering/bench tests (compatibility, fatigue), not studies requiring expert interpretation of clinical data or images to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there were no clinical studies described that would require an adjudication method for a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done. This is a dental implant system, not a diagnostic AI device requiring human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance tests mentioned:
- Compatibility Tests: The "ground truth" would be established by physical fit measurements and functional assessment with predicate device components, guided by engineering specifications and relevant ISO standards.
- Fatigue Testing: The "ground truth" is established by adherence to the ISO 14801 standard and the mechanical properties (e.g., fracture resistance, cycles to failure) observed, compared to the predicate device or a defined strength threshold.
There is no mention of clinical ground truth (e.g., pathology, patient outcomes data) in the context of a dedicated study for this submission. The substantial equivalence argument relies on the predicate device's established safety and efficacy.
8. The sample size for the training set
Not applicable. This device is a physical dental implant, not a machine learning model, so there is no training set mentioned or used.
9. How the ground truth for the training set was established
Not applicable. (See point 8).
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Blue Sky Bio, LLC
JAN 2 7 2012
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 Taper Hex 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 | June 2011 |
Device Description
The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and associated abutment systems, which provide the clinician with cement retained , screw retained and overdenture-type restorative options. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants and components are supplied sterile or not sterile and are labeled accordingly.
Intended Use .
- Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular . incisors and maxillary lateral incisors
- Blue Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the . fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws
- Implants can be placed in immediate function on single-tooth and/or multiple tooth applica-. tions when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
- Multi-unit abutments for fixed restorations are to be used only for multiple splinted restora-. tions.
- In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded . cases.
- Blue Sky Bio 3mm Double Hex Dental Implant System is compatible with Astra Osseospeed . Narrow Dental Implant System.
Blue Sky Bio, LLC 510(k)
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ
Page 9
August 2011
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... ..........................................................................................................................................................................
.
Technological Characteristic Comparison
| Feature | Subject DeviceBlue Sky Bio 3mm DentalImplant System (Double Hex3mm) | Predicate DeviceAstra Tech 3mm DentalImplant System K080396. |
|---|---|---|
| Material | CP Titanium Grade 4,Ti-6Al-4V | CP TitaniumGrade 4 |
| 1 Stage/ 2 Stage | 2 Stage | 2 Stage |
| Surface | Blasted with resorbablemedium, or Aluminum Oxideand acid etched | Blasted with titanium oxide and acidetched |
| Body Diameter(mm) | 3 mm | 3mm |
| PlatformDiameter(mm) | 3mm | 3mm |
| Lengths (mm) | 10, 11, 13, 15, 17 mm | 11, 13, 15, 17 mm |
| External ScrewThreads | Yes | Yes |
| Anti-rotationalFeature | Internal Double Hex with taper, | Internal Double Hex with taper |
| Gamma Sterilized | Yes | Yes |
| Solid abutment | Yes | Yes |
| Two-PieceScrewedAbutment | Yes | Yes |
| Overdentureabutment | Yes | Yes |
| Instruments(surgical andrestorative) | Yes | Yes |
| Angled Abutment | Yes Multiunit | Yes TiDesign |
| Single Unit | Yes | Yes |
| Multiple Unit | Yes | Yes |
Blue Sky Bio, LLC 510(k)
August 2011
: |
{2}------------------------------------------------
Safety and Efficacy
The material, technology and facilities used to produce the modified Blue Sky Bio Dental Implant Systems are the same. Therefore it is substantially equivalent to other commercially available Dental Implant Systems including predicate devices Osseospeed Narrow Dental Implant System Astratech (K080396) and to Blue Sky Bio Dental Implant System (K073713)
The technical comparison charts list the primary technical aspects and specifications that are pertinent to Dental Implant Systems. The 3mm Blue Sky Bio dental implant system is as safe and effective as the predicate devices.
Non-Pyrogenic Statement
No claims are made that the products are non-pyrogenic.
Performance Tests
Compatibility tests with other systems according to Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document; Root-form Endosseous Dental Implants and Endosseous Dental Abutments: These tests were performed to assess compatibility with predicate devices. The tests showed that the new devices are compatible with predicate devices and the fit is adequate.
Fatigue testing for angled abutments and narrow diameter implants: This test has been conducted according to ISO 14801 for predicate devices. The new devices have the same wall thickness and equal or smaller angulation than the predicate devices and are therefore equivalent or stronger than the predicate devices.
Conclusion
The Blue Sky Bio Dental Implant system, subject to this submission and the predicate devices are believed to be substantially equivalent. The device constitutes a safe, reliable and effective medical device. meeting all declared requirements of its intended use and the device does not introduce new risks and does not present any adverse health effects or safety risks to patients when used as intended.
Blue Sky Bio, LLC 510(k)
August 2011
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 7 2012
Ms. Michele Vovolka Correspondent Blue Sky Bio, LLC 888 E Belvidere Road, Suite 212 Grayslake, Illinois 60030
Re: K112875
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, NHA Dated: January 8, 2012 Received: January 19, 2012
Dear Ms. Vovolka:
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 Eederal Register.
{4}------------------------------------------------
Page 2 - Ms. Vovolka
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
G. ler. Anthony Watson
Anthony D. Watson, B.S., M.S., M.B.A. 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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Blue Sky Bio, LLC
888 E BELVIDERE SUITE 212 GRAYSLAKE, IL 60030 Tel: 718-376 0422 Fax: 888-234 3685 Email: azickmann@blueskybio.com
Indications for Use Statement
Page 1 of 1
510(k) Number (if Known): K112875
Device Name: Blue Sky Bio Dental Implant System
Indications for Use:
- Blue Sky Bio 3mm Double Hex implants are primarily intended for restoration of mandibular . incisors and maxillary lateral incisors
- more Sky Bio 3mm Double Hex Dental Implant System is intended for implantation into the . fully and partially edentulous ridge for the support of a dental prosthesis, and for single tooth replacement in the anterior area of the jaws
- Implants can be placed in immediate function on single-tooth and/or multiple tooth applica-. tions when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
- enowing raileriem.
The abutments for fixed restorations are to be used only for multiple splinted restora-. tions. - In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded ◆ cases.
- Blue Sky Bio 3mm Double Hex Dental Implants are compatible with Astra Osseospeed . Narrow abutments.
- Rurow abutinents!
Blue Sky Bio 3mm Double Hex Abutments are compatible with Astra Osseospeed Narrow . Implants.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801:109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Anesthesiologie Befleral Hospital
Page 14
Proprietary & Confidentianfection Control, Dental Devices
510(k) Number:
(Division Sigh-Off)
Blue Sky Bio, LLC 510(k)
§ 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.