(443 days)
No
The device description and performance studies focus on the physical and mechanical properties of bone screws and plates, with no mention of AI or ML.
No.
The device is used for stabilizing and fixating bone grafts and materials, which supports a surgical procedure, rather than directly providing therapy.
No
The device is described as a system of bone screws and plates used for bone fixation surgery to stabilize and fix bone grafts and membranes, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is comprised of bone screws and bone plates, which are physical hardware components. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device (GBR System) is comprised of bone screws and plates used for surgical fixation of bone grafts and membranes within the oral cavity. It is a physical implant used directly on the patient's body.
- Intended Use: The intended use clearly states its purpose is for "stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity." This is a surgical procedure, not a diagnostic test performed on a specimen.
The device is a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Product codes
JEY, DZL
Device Description
The GBR System is comprised of bone screws and bone plates that are used for bone fixation surgery. The bone screws and plates are not reusable. The bone screws are composed of the titanium alloy (ASTM F136) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (0.85, 1.4, 2.0 mm) and length (3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 mm). Also, the tip of screw has single type; the self-drilling and self-tapping available type and the type that require the pre-drilling (Surgeon's option). The bone plate is offered in 0.1 mm thickness and in length 22 mm x 15 mm, 36 mm x 22 mm and 44 mm x 44 mm. Each device is provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, maxillary and/or mandibular areas.
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
Bench testing was conducted with the predicate device to confirm that the GBR System has equivalent physical properties through the dimension test, pull out, torsion, tensile and bending tests in accordance with ASTM F543-17. Mechanical properties from bench tests of GBR System found substantially equivalent to the predicate device.
The test results and analysis found that the dental implant material and manufacturing processes were biocompatible according to ISO 10993-3, 10993-6, 10993-10 and 10993-11.
Steam sterilization parameters were validated for 2 methods: gravity displacement and pre-vacuum steam sterilization. The studies were conducted in accordance with ISO 17665-1:2006 and demonstrated a SAL of 10°.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.
Surgident % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213 May 24, 2018
Re: K170697
Trade/Device Name: GBR System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: April 27, 2018 Received: April 27, 2018
Dear Peter Chung:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting 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) K170697
Device Name GBR System
Indications for Use (Describe)
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Type of Use (Select one or both, as applicable)
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
1. Applicant
-
- Company : SURGIDENT Co., Ltd.
-
- Address : #209~210, Woolim Lion's Valley, 27, Dunchon-daero 457beon-gil, Jungwongu, Seongnam-si, Gyeonggi-do, 13219, Korea
-
- Tel : 82-31-737-2875
-
- Fax : 82-31-737-2876
-
- President of company : Duck-su Hur
-
- Contact person : Peter Chung
-
- Contact Person Telephone : 412-687-3976
-
- Contact Person E-mail : peterchung210@gmail.com
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Date : May 21, 2018
2. Device Information
-
- Trade Name : GBR System
-
- Common Name : Bone Fixation System
-
- Classification Name : Bone Plate
-
- Product Code : JEY
-
- Subsequent Product Code: DZL
-
- Regulation Number : 872.4760
-
- Class of device : Class II
-
- Panel : Dental
3. The legally marketed device to which we are claiming equivalence :
Primary Predicate : K141764, TriStar Bone Graft Fixation Predicate Devices: System / Impladent Ltd. Reference Predicate : K050669, Jeil Bone Fixation system / Jeil Medical Corporation Reference Predicate : K011698, Straumann GBR system / Straumann
4. Device description and technological characteristics :
The GBR System is comprised of bone screws and bone plates that are used for bone fixation surgery. The bone screws and plates are not reusable. The bone screws are composed of the titanium alloy (ASTM F136) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (0.85, 1.4, 2.0 mm) and length (3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 mm). Also, the tip of screw has single type; the self-drilling and self-tapping available type and the type that require the pre-drilling (Surgeon's option). The bone plate is offered in 0.1 mm thickness and in length 22 mm x 15 mm, 36 mm x 22 mm and 44 mm x 44 mm. Each device is
4
provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended.
5. Indication for Use:
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
6. Non-clinical Performance Testing:
Mechanical properties
Bench testing was conducted with the predicate device to confirm that the GBR System has equivalent physical properties through the dimension test, pull out, torsion, tensile and bending tests in accordance with ASTM F543-17. Mechanical properties from bench tests of GBR System found substantially equivalent to the predicate device.
Biocompatibility testing
The test results and analysis found that the dental implant material and manufacturing processes were biocompatible according to ISO 10993-3, 10993-6, 10993-10 and 10993-11.
Sterilization Testing
Steam sterilization parameters were validated for 2 methods: gravity displacement and pre-vacuum steam sterilization. The studies were conducted in accordance with ISO 17665-1:2006 and demonstrated a SAL of 10°.
| | Subject Device | Primary Predicate
Device | Reference
Predicate Device | Similarity/Difference
Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K170697 | K050669 | K011698 | - |
| Device Name | GBR System | Jeil Bone Fixation
System | Straumann GBR
System | - |
| Manufacturer | SURGIDENT Co.,
Ltd. | Jeil Medical Corp. | Straumann USA | - |
| Indications
for Use | The device is intended
for use in stabilizing
and fixating bone
grafts, bone filling
material and/or barrier
membranes used for
guided bone/tissue
regeneration in the
oral cavity. Single
patient use only. | The device is
intended for use in
stabilizing and
fixating bone grafts,
bone filling material
and/or barrier
membranes used
for guided
bone/tissue
regeneration in the
oral cavity. Single
patient use only. | The Straumann
Guided Bone
Regeneration
(GBR) System is
used to stabilize
and fixate bone
grafts, bone filling
materials, and/or
barrier membranes
used for
regeneration of
bone in the oral
cavity. The GBR
technique can
make it possible for
the placement of
dental implants in
previously | Similarity |
| | Subject Device | Primary Predicate
Device | Reference
Predicate Device | Similarity/Difference
Discussion |
| Components | Screws | Screws | Screws | Similarity |
| Material | Titanium Alloy (Ti-
6Al-4V) (ASTM F
136) | Titanium Alloy (Ti-
6Al-4V) (ASTM F
136) | Pure Titanium
(ASTM F 67) | Similarity |
| Shape | Image: Subject Device Screw | Image: Primary Predicate Device Screw | Image: Reference Predicate Device Screw | Similarity |
| Screw Type | Self-tapping Screw
Self-drilling Screw | Self-tapping Screw
Self-drilling Screw | Self-tapping Screw
Self-drilling Screw | Similarity |
| Screw
Diameter | 0.85 mm
1.4 mm
1.6 mm
2.0 mm | 1.4 mm
1.6 mm
2.0 mm | 1.2 mm
1.5 mm | Different: The screw diameter and length range of the subject device is within the range of the predicate devices. |
| Screw Length | 3.0 mm
3.5 mm
4.0 mm
5.0 mm
6.0 mm
8.0 mm
10.0 mm
12.0 mm | 3.0 mm
4.0 mm
6.0 mm
8.0 mm
10.0 mm
12.0 mm
16.0 mm | 3.0 mm
4.0 mm
5.0 mm
7.0 mm
8.0 mm
9.0 mm
10.0 mm
12.0 mm
14.0 mm | There is an additions diameter in the subject device comparing to the primary predicate device. However, the difference in diameter is minor; it is not introducing significantly different design, and the performance test results supported that this difference does not raise an issue in performance. |
| Surface
Casting | Anodizing | Anodizing | Anodizing | Similarity |
| Single Use | yes | yes | yes | Similarity |
| Sterilization
method | Non-sterile,
Steam sterilization
prior to use | Non-sterile,
Steam sterilization
prior to use | Non-sterile,
Steam sterilization
prior to use | Similarity |
| Shelf-life | 5 years | Unknown | Unknown | Similarity |
| Biocompatibility | Biocompatible
according to ISO
10993-1, ASTM F
136 | Biocompatible
according to ISO
10993-1, ASTM F
136 | Biocompatible
according to ISO
10993-1 and ASTM
F 67 | Similarity |
| Principle of
Operation | The function of
GBR System is used | The function of
GBR System is used | The function of
GBR System is used | Similarity |
| Subject Device | Primary Predicate Device | Reference Predicate Device | Similarity/Difference Discussion | |
| in applications for maintaining the relative position of and/or bone grafts in reconstruction of maxillary and/or mandibular areas. | in applications for maintaining the relative position of and/or bone grafts in reconstruction of maxillary and/or mandibular areas. | in applications for maintaining the relative position of and/or bone grafts in reconstruction of maxillary and/or mandibular areas. | | |
7. Substantial Equivalence to Predicate Devices Table - Screws
5
6
8. Substantial Equivalence to Predicate Devices Table - Mesh
| | Subject Device | Primary Predicate
Device | Similarity/Difference
Discussion |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K170697 | K141764 | - |
| Device Name | GBR System | TriStar Bone Graft
Fixation System | - |
| Manufacturer | SURGIDENT Co., Ltd. | Impladent Ltd. | - |
| Indications for Use | The device is intended
for use in stabilizing and
fixating bone grafts,
bone filling material
and/or barrier
membranes used for
guided bone/tissue
regeneration in the oral
cavity. Single patient
use only. | The TriStar Bone Graft
Fixation System is
indicated for
stabilization and fixation
of bone grafts, bone
blocks, bone filling
materials, and / or
barrier membranes used
to regenerate bone in
the oral cavity. | Difference : Indication
for use of the subject
device is slightly
different from the
predicate in phrase but
fundamental indication
is similar. |
| Materials | Grade 1 Titanium
(ASTM F67) | Grade 1 Titanium | Similarity |
| Shape | Image: Subject Device Shape | Image: Primary Predicate Device Shape | Similarity |
| Plate Design | Compression Type | Compression Type | Similarity |
| Plate Thickness | 0.1 mm | 0.1 mm | Similarity |
| Size of holes | 0.8 mm | 0.8 mm | Similarity |
| Hole Shape | "O" shape (circle) | "O" shape (circle) | Similarity |
| Dimensions | 22 × 15 mm
36 × 22 mm
44 × 44 mm | 18 × 25 mm
40 × 60 mm | Difference : The plate
dimensions range of the
subject device is within
the range of the
predicate devices. |
| Single Use | yes | yes | Similarity |
| Sterilization method | Non-sterile,
Steam sterilization prior | Non-sterile,
Steam sterilization prior | Similarity |
| | Subject Device | Primary Predicate
Device | Similarity/Difference
Discussion |
| | to use | to use | |
| Shelf-life | 5 years | Unknown | Similarity |
| Biocompatibility | Biocompatible according
to ISO 10993-1 and
ASTM F 67 | Biocompatible according
to ISO 10993-1 and
ASTM F 67 | Similarity |
7
9. Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, SURGIDENT Co., Ltd. concludes that the GBR System is substantially equivalent to the predicated devices as herein.