(190 days)
No
The document describes a physical medical device (dental implants and abutments) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is a medical implant used to restore esthetics and chewing function, but it does not directly treat a disease or condition in a therapeutic sense.
No
The device is a surgical implant system designed to restore esthetics and chewing function, not to diagnose a condition.
No
The device description clearly outlines physical components (threaded root-form dental implants and mating abutments made of titanium alloy) and performance studies related to these physical components (biocompatibility, engineering analysis, dimensional analysis, and dynamic compression-bending testing). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for restoring patient esthetics and chewing function in cases of severe jaw resorption. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is described as threaded root-form dental implants and mating abutments made of titanium alloy. These are physical devices implanted into the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
- Performance Studies: The performance studies focus on mechanical properties (biocompatibility, engineering analysis, dimensional analysis, dynamic compression-bending testing) relevant to a physical implant, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The previously cleared abutment screws also are made of material conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
zygoma region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K102034 and K060957), engineering analysis, dimensional analysis, and dynamic compression-bending testing of the Taper Hex 4.3 mm body diameter implant with the NP platform according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. No clinical data were included in this submission.
Dynamic testing of worst case subject device constructs consisting of the smallest diameter implant (Taper Hex 4.3 mm body diameter) and largest angulation (30°) demonstrated fatigue performance substantially equivalent to that of the primary predicate K141777.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K141777, K102034, K060957, K093562
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol of three stylized human profiles facing to the right, with three wave-like lines below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2016
Blue Sky Bio, LLC c/o Kevin A. Thomas, Ph.D. Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K153064
Trade/Device Name: Blue Sky Bio Zygomatic Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 31, 2016 Received: March 31, 2016
Dear Dr. Thomas:
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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Tina Kiang S
for Erin I. Keith, M.S. Director 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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Indications for Use
510(k) Number (if known)
Device Name
Blue Sky Bio Zygomatic Implant System
Indications for Use (Describe)
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
| ☑ Prescription (Part 21 CFR 201.5 Subpart D) | □ Over-The-Counter (Part 21 CFR 201.6 Subpart E) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | -------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Blue Sky Bio, LLC Blue Sky Bio Zygomatic Implant System
April 28, 2016
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Blue Sky Bio, LLC | |
|---|---|---|
| 888 E Belvidere Road, Suite 212 | ||
| Grayslake, IL 60030 | ||
| Telephone | +1 718-376-0422 | |
| Fax | +1 888-234-3685 | |
| Official Contact | Michele Vovolka | |
| Vice President of RA/QA | ||
| Representative/Consultant | Kevin A. Thomas, PhD | |
| Linda K. Schulz, BSDH, RDH | ||
| PaxMed International, LLC | ||
| 12264 El Camino Real, Suite 400 | ||
| San Diego, CA 92130 | ||
| Telephone: | +1 (858) 792-1235 | |
| Fax: | +1 (858) 792-1236 | |
| Email: | kthomas@paxmed.com | |
| lschulz@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Blue Sky Bio Zygomatic Implant System |
|---|---|
| Common Name | Endosseous dental implant |
| Endosseous dental implant abutment | |
| Classification Regulations | 21 CFR 872.3640 |
| Product Code | DZE |
| NHA | |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
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PREDICATE DEVICE INFORMATION
Primary predicate device:
K141777, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA
Reference predicate devices:
K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K060957, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC K093562, Zygomatic Implant System, Southern Implants, Inc.
INTENDED USE
Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
DEVICE DESCRIPTION
Blue Sky Bio Zygomatic Implant System submission includes threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. The zygomatic implants are provided with an internal hexagon connection and a tapered internal hexagon interface for connection to the subject abutments. The internal hexagon connection implants are provided with a body diameter of 4.7 mm and platform diameters of 3.5 mm and 4.5 mm. The tapered internal hexagon connection implants are provided with a body diameter of 4.3 mm and a narrow platform (NP) connection, and with a body diameter of 5.0 mm with a regular platform (RP) connection. All implants are provided in multiple overall threaded lengths ranging from 35 mm to 55 mm. This submission includes mating abutments with platform diameters of 3.5, 4.3, and 4.5 mm. and each abutment diameter is provided with 17° and 30° of angulation. All subject device abutments are for support of screw-retained overdenture prosthetic restorations. The abutment screws compatible with the subject device abutments were cleared in K060957 and K102034. The subject device zygomatic implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The previously cleared abutment screws also are made of material conforming to ASTM F136.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K102034 and K060957), engineering analysis, dimensional analysis, and dynamic compression-bending testing of the Taper Hex 4.3 mm body diameter implant with the NP platform according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. No clinical data were included in this submission.
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EQUIVALENCE TO MARKETED DEVICE
Blue Sky Bio, LLC submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K141777, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA;
K102034, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC;
K060957, Blue Sky Bio Dental Implant System, Blue Sky Bio, LLC; and
K093562, Zygomatic Implant System, Southern Implants, Inc.
A comparison of the technological characteristics of the subject device and the primary predicate device K141777 is provided in the following table.
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Comparison | Blue Sky Bio, LLC | |
| Blue Sky Bio Zygomatic Implant System | ||
| K153064 | JJGC Indústria e Comércio de Materiais Dentários SA | |
| Neodent Implant System | ||
| K141777 | ||
| Indications for Use | Blue Sky Bio Zygomatic Implant System is indicated | |
| for surgical installation in the zygoma region, in cases | ||
| of severe jaw resorption, in order to restore patient | ||
| esthetics and chewing function. Blue Sky Bio | ||
| zygomatic implants are recommended for the posterior | ||
| (pre-molar/molar) region, one implant on each side, | ||
| with at least two standard dental implants in the | ||
| anterior region to support a fixed restoration. Blue Sky | ||
| Bio zygomatic implants may be loaded immediately | ||
| when good primary stability is achieved and with | ||
| appropriate occlusal loading. | Zygomatic Implants are indicated for surgical | |
| installation in the zygoma region, in cases of severe | ||
| jaw resorption, in order to restore patient esthetics and | ||
| chewing function. Zygomatic Implants are | ||
| recommended for the posterior (pre-molar/molar) | ||
| region, one implant on each side, with at least two | ||
| standard dental implants in the anterior region to | ||
| support a fixed restoration. Zygomatic Implants may | ||
| be loaded immediately when good primary stability is | ||
| achieved and with appropriate occlusal loading. | ||
| Implants | ||
| Design | Threaded root-form implant to be used with mating | |
| abutments | Threaded root-form implant to be used with mating | |
| abutments | ||
| Implant body Ø | ||
| and | ||
| Platform Ø | Internal hex connection | |
| Implant body Ø: 4.7 mm | ||
| Abutment platform Ø: 3.5 mm, 4.5 mm | ||
| (implant body tapers at apical portion) | ||
| Tapered internal hex connection | ||
| Implant body Ø: 4.3 mm with NP 3.5 mm | ||
| abutment platform | ||
| Implant body Ø: 5.0 mm with RP 4.3 mm | ||
| abutment platform | ||
| (implant body tapers at apical portion) | External hex and Morse taper | |
| Implant body Ø: 4.4 mm tapering to 3.9 mm | ||
| Platform Ø: 4.1 mm | ||
| Implant Lengths | All implants: | |
| 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55 mm | External hex: | |
| 30, 35, 40, 45, 47.5, 50, 52.5 mm | ||
| Morse taper: | ||
| 30, 35, 40, 42.5, 45, 47.5, 50, 52.5 mm | ||
| Implant-Abutment Interface | ||
| Type | Internal hex with 12° taper | |
| Internal hex with 45° bevel | External hex | |
| Morse taper | ||
| Implant body-abutment | ||
| connection angle | n/a | 45° |
| Abutments | ||
| Platform Diameter | Internal hex connection: 3.5 mm, 4.5 mm | |
| Tapered internal hex connection: 4.3 mm | 4.1 mm | |
| Abutment Angle | 17°, 30° | 0° (straight) |
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| Subject Device | Primary Predicate Device | |
|---|---|---|
| Comparison | Blue Sky Bio, LLC | |
| Blue Sky Bio Zygomatic Implant System | ||
| K153064 | JJGC Indústria e Comércio de Materiais Dentários SA | |
| Neodent Implant System | ||
| K141777 | ||
| Materials | ||
| Implants | Ti-6Al-4V | F67 unalloyed titanium, grade 4 |
| Implant Surface | Grit blasted and acid etched | Machined |
| Abutments | Ti-6Al-4V | F136 Ti-6A1-4V ELI |
| Abutment Screws | Ti-6Al-4V | External hex: F136 Ti-6A1-4V ELI |
The subject device and the primary predicate K141777 have substantially equivalent indications for use, including restoration of patient esthetics and chewing function, and immediate loading when used with standard dental implants placed in the anterior region to support a fixed restoration. The implants of the subject device and the predicate device K141777 have similar designs and dimensions, including lengths appropriate for zygomatic placement.
The subject zygomatic implants are very similar in design to endosseous dental implants from Blue Sky Bio cleared in K102034 and K060957. except for a slight change in the endosseous thread and the longer lengths appropriate for zygomatic placement. The subject zygomatic implants are provided in a range of implant body diameters (maximum endosseous thread diameters) of 4.3 mm to 5.0 mm, the same as the predicate implants cleared in K102034 and K060957. The smaller subject device implant body (4.3 mm diameter) as compared to the primary predicate K141777 (4.4 mm diameter) is supported by the reference predicate K093562 (4.05 mm body diameter), and by and dynamic compression-bending testing according to ISO 14801.
The subject device implants are provided in the same range of overall lengths as the primary predicate K141777 (35 mm to 52.5 mm), and the subject device 55 mm length implant is supported by the reference predicate K093562.
This submission includes abutments with an internal hexagon and tapered internal hexagon interfaces for connection to the subject zygomatic implants. The subject device abutments are provided with platform diameters of 3.5. 4.3. and 4.5 mm. and angulation of 17° or 30°. The subject device abutments are substantially equivalent to the abutments cleared in K102034 and K060957 in terms of implant-abutment connections, platform diameters, angulation, and materials. The subject abutments are to be used with compatible abutment screws cleared in K102034 and K060957.
Differences between the subject device and the primary predicate K141777 include the location of angulation correction (subject device includes abutments with angulation, versus K141777 implant designs included angulation at the abutment-implant connection), and the amount of angulation (subject device 17° or 30°, versus K141777 only 45°). These differences between the subject device and the primary predicate are supported by dynamic compression-bending testing according to ISO 14801. Dynamic testing of worst case subject device constructs consisting of the smallest diameter implant (Taper Hex 4.3 mm body diameter) and largest angulation (30°)
7
demonstrated fatigue performance substantially equivalent to that of the primary predicate K141777.
The subject device implants and abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same as these components cleared in K102034 and K060957. The endosseous surface finish of the subject device implants is the same as the predicate implants cleared in K102034 and K060957.
The subject device implants have similar packaging and are sterilized using the same materials and processes as described in K102034 and K060957. The subject device abutments are provided nonsterile in similar packaging and are to be sterilized using the same processes as described in K102034 and K060957.
CONCLUSION
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and the diameter and angulation of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.