The GBR System is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

Device Description

The GBR System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The GBR System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V). The device screw is available in three different types, Auto Screw, Tenting Screw and GBR Screw. The device plate is provided in two different types, mesh plate and GBR mesh plate. The device system also includes various manual surgical instruments, such as mesh puncher, screwdriver handle, screw block, driver shaft and drill bit. The GBR System is not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The GBR System is provided as silver color which is casted according to the anodizing technique while apply 5 V ~ 10 V electric energy to the titanium.

AI/ML Overview

The provided text describes a 510(k) summary for the "GBR System" medical device, which consists of bone plates and screws. The submission aims to demonstrate substantial equivalence to a predicate device, the "Jeil Bone Fixation System" (K050669).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum tensile strength), but rather implies that the device is acceptable if its performance is "equivalent" to the predicate device. The performance is assessed through non-clinical testing based on ASTM standards.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent Driving torque per ASTM F543-13 (Screws)	Testing indicates GBR System is equivalent to predicate device.
Equivalent Axial pull-out test per ASTM F543-13 (Screws)	Testing indicates GBR System is equivalent to predicate device.
Equivalent Torsion test per ASTM F543-13 (Screws)	Testing indicates GBR System is equivalent to predicate device.
Equivalent Tensile Strength (Plates)	Testing indicates GBR System is equivalent to predicate device.
Equivalent material (Plates)	Unalloyed Titanium (ASTM F67) - Same as predicate.
Equivalent material (Screws)	Titanium Alloy (Ti-6Al-4V) (ASTM F136) - Same as predicate.
Equivalent sterilization method	Non-sterile, Steam sterilization prior to use - Same as predicate.
Equivalent single use	Yes - Same as predicate.
Equivalent intended use	Stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity - Same as predicate.
No significant differences that would adversely affect use	"No significant differences between the Model GBR System and the predicate device that would adversely affect the use of the proposed device."

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many screws were tested for driving torque). It states that the evaluation was based on ASTM F543-13. The data provenance is presumed to be from laboratory testing conducted by Jeil Medical Corporation. There is no mention of country of origin for the data or whether it was retrospective or prospective, as it's non-clinical lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. The "ground truth" for the non-clinical tests is established by objective engineering measurements against ASTM standards, not by expert interpretation.

4. Adjudication method for the test set

This information is not applicable. Since the testing is non-clinical and objective, there is no need for adjudication by experts.

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

There was no MRMC comparative effectiveness study done. This device is a physical medical implant (bone plates and screws) and not an AI-assisted diagnostic tool or software, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The GBR System is a physical medical device, not an algorithm or software. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the objective measurements against the established ASTM standards for mechanical properties (driving torque, axial pull-out, torsion, tensile strength). For material, it's compliance with ASTM F67 and ASTM F136 specifications.

8. The sample size for the training set

This information is not applicable. This is a 510(k) submission for a physical medical device, not a machine learning model. There is no "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

Summary

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2018

Jeil Medical Corporation Ms. Hyeroung Lee RA Manager 702-706, 804, 805,807, 812-HO, 55, Digital-ro34-gil, Guro-gu, Seoul, 152-728 Korea

Re: K143730

Trade/Device Name: GBR System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: May 8, 2015 Received: May 11, 2015

Dear Ms. Lee:

This letter corrects our substantially equivalent letter of June 10, 2015

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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Page 2 - Ms. Lee

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang-S

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) K143730

Device Name

GBR System

Indications for Use (Describe) Indications for Use (Describe)

The GBR System is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity.

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)

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Image /page/3/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by the address and contact information. The address is 5, Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea. The phone number is +82 2 850 3500, and the fax number is +82 2 850 3535.

K143730 510(k) Summary

[As required by 21 CRF 807.92]

1. Date Prepared: 4 June 2015

2. Submitter's Information

• Name of Sponsor:	Jeil Medical Corporation
- Address:	702•703•704•705•706•804•805•807•812-ho,55, Digital-ro34-gil, Guro-Gu, Seoul, 152-728,Korea
• Contact Name:	Hyeroung LEE (Ms.) / RA Manager

+82 2 850 3535

carine@jeilmed.co.kr

Telephone: +82 2 850 3500 -
- Fax:
- Email Address: -
. Registration Number: 3004049923
Name of Manufacturer: Same as Sponsor
- Same as Sponsor i Address:

3. Trade Name, Common Name, Classification

Trade Name: GBR System .
Common Name: Bone Screw, Bone Plate .

Product Code	Device Name	Device Classification	Regulation Number	Regulation Description
JEY	Plate, Bone	2	872.4760	Bone Plate
DZL	Screw, FixationIntraosseous	2	872.4880	Intraosseous FixationScrew or Wire

4. Identification of Predicate Device(s)

The identified predicate device within this submission is shown as follows:

510(k) Number: ● K050669
. Applicant: Jeil Medical Corporation
Common Name: Bone Screw, Bone Plate ●
Device Name: Jeil Bone Fixation System

There are no significant differences between the Model GBR System and the predicate

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device that would adversely affect the use of the proposed device. It is equivalent to the predicate in design, function, materials, and operational principles as internal fixation components.

5. Description of the Device

The GBR System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follows:

	Screw			Plate
	AutoScrew	GBR AutoScrew	TentingScrew	Mesh Plate	GBRMesh
Type/Configuration	14-AT-003,14-AT-004,14-AT-005,14-AT-006,14-AT-008,14-AT-010,14-AT-012,16-AT-003,16-AT-004,16-AT-005,16-AT-006,16-AT-008,16-AT-010,16-AT-012	14-AT-003G,14-AT-004G,14-AT-005G,14-AT-006G,14-AT-008G,14-AT-010G,14-AT-012G,14-AT-003G-25,14-AT-004G-25,14-AT-005G-25,14-AT-006G-25,14-AT-008G-25,14-AT-010G-25,14-AT-012G-25	16-TT-010	12-ME-001-01,12-ME-001-02,12-ME-002-01,12-ME-002-02,12-ME-003-01,12-ME-003-02,12-GM-001-01,12-GM-001-02,12-GM-002-01,12-GM-002-02	12-GM-P01,12-GM-P02,12-GM-J01,12-GM-L01
Material	ASTM F136, Titanium Alloy (Ti-6Al-4V)			ASTM F67, Unalloyed Titanium

The GBR System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67. Standard Specification for Unalloved Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surqical implants with well-known biocompatibility.

The device screw is available in three different types, Auto Screw, Tenting Screw and GBR Screw. The Auto Screw is for stabilizing the mesh plate. The GBR Auto Screw has wide head design which is well suited for GBR mesh. The Tenting Screw is comprised with a body and a cap. It is effective in maintaining the space between the mesh and the bone.

The GBR Auto Screw is provided with head diameter 2.5 mm or 3.0 mm, thread diameter . 1.4 mm, and length from 3.0 mm to 12.0 mm.
. The Auto Screw is provided with head diameter 2.0 mm or 2.5 mm, thread diameter 1.4 mm or 1.6 mm, and length from 3.0 mm to 12.0 mm
. The Tenting Screw is proved with head diameter 2.7 mm, thread diameter 1.4 mm and length 10.0 mm.

The device plate is provided in two different types, mesh plate and GBR mesh plate.

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. The Mesh Plate is very thin, soft and elastic but has strong membrane with good suture retention. The extremely high flexibility of this mesh plate allows free fitting, even to irreqular surfaces.
. The GBR Mesh Plate is suited for horizontal and vertical bone volume augmentation of implants sites using guided bone. The GBR Mesh Plate is suitable for multi-case situations; the product allows bone formation and spatial retention for stable implant. The GBR Mesh Plate has flexibility with thin thickness, and the pre-cut design makes the desired shape form easier.

The device system also includes various manual surgical instruments, such as mesh puncher, screwdriver handle, screw block, driver shaft and drill bit.

The GBR System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the hospital prior to surgery. The sterilization method is presented in the instruction, which was validated per ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The GBR System is provided as silver color which is casted according to the anodizing technique while apply 5 V ~ 10 V electric energy to the titanium.

Screw
Type	Catalog Number	510(k) Number
AutoScrew	14-AT-003,14-AT-004,14-AT-006,14-AT-008,14-AT-010,14-AT-012,16-AT-004,16-AT-006,16-AT-008,16-AT-010,	K050669
	14-AT-005,16-AT-003,16-AT-005,16-AT-012	K143730

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Image /page/6/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo features a stylized graphic with blue, green, and orange elements, followed by the text "JEIL" in a bold, orange font. To the right of "JEIL" is the text "MEDICAL CORPORATION" in a smaller, gray font.

-ro34-gil, Guro-gu, Seoul, Tel : +82 2 850 3500 / Fax : +82 2 850

GBR AutoScrew	14-AT-003G,14-AT-004G,14-AT-005G,14-AT-006G,14-AT-008G,14-AT-010G,14-AT-012G,14-AT-003G-25,14-AT-004G-25,14-AT-005G-25,14-AT-006G-25,14-AT-008G-25,14-AT-010G-25,14-AT-012G-25	K143730
TentingScrew	16-TT-010	K143730
Plate
Type	Catalog Number	510(k) Number
MeshPlate	12-ME-001-01,12-ME-001-02,	K050669
	12-ME-002-01,12-ME-002-02,12-ME-003-01,12-ME-003-02,12-GM-001-01,12-GM-001-02,12-GM-002-01,12-GM-002-02	K143730

The GBR System is consisted of a previously cleared screw and plate (K050669) as well as new screws and plates with different lengths and sizes.

The new types of Auto Screw include different lengths for user's convenience. For 14-ATseries, we added a new product with a length of 5mm. For 16-AT-series, we added products with lengths of 3mm, 5mm, and 12mm. Also, for the new type of GBR Auto Screw, the diameter of the screw head was extended so that it would improve the stability when fixing the mesh plate. The new type of Tenting Screw is for implanting the screw body during Guided Bone Regeneration procedure and it is also for fixing the Plate through the Cap Screw in order to maintain enough space for bone graft materials.

General Information

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Image /page/7/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea. The phone and fax numbers are also listed: Tel: +82 2 850 3500 / Fax: +82 2 850 3535.

The new types of mesh plates include various products with different sizes, thickness, and pore sizes for the user's convenience. 12-GM-P01 and 12-GM-P02 of the new types of GBR Mesh Plates are designed to be used together when Guided Bone Regeneration procedure is needed during dental implant surgery. 12- GM-J01 and 12-GM-L01 are the new types with slots for easy modification to suit the surgical site.

6. Intended Use

The GBR System 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.

7. Technological Characteristics

The GBR System is a rigid fixation consisting of plates and screws in various configurations, shapes and sizes as follows:

				Unit (mm)
Type		Head Diameter	Thread Diameter	Length
Auto Screw		Ø 2.0, 2.5	Ø 1.4, 1.6	3, 4, 5, 6, 8, 10, 12
GBR Auto Screw		Ø 2.5, 3.0	Ø 1.4	3, 4, 5, 6, 8, 10, 12
Tenting	Body	Ø 2.7	Ø 1.6	10
Screw	Cap	Ø 2.5	Ø 1.4	1.6

· Screw

• Plate

Unit (mm)

Type	Size	Thickness	Pore Diameter
MeshPlate	ME	37.0 * 24.049.0 * 37.099.0 * 74.0	0.10.2	Ø 1.48 ~ 1.88
	GM	37.0 * 25.175.0 * 51.0	0.10.2	Ø 0.8
GBR Mesh Plate		16.6 * 10.028.0 * 10.053.0 * 29.041.0 * 21.9	0.15	Ø 0.8

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Non-Clinical Test Summary:

A non-clinical evaluation, based on ASTM F543-13, has been done. The evaluation of the applicable market data showed that the bone screw does not pose known or new clinical concerns from the similar medical devices that are currently on the market. Based on those results clinical test have not been executed.

The following tests were performed with the predicate devices:

Driving torque test per ASTM F543-13 . Screws
- Axial pull-out test per ASTM F543-13
  - Torsion test per ASTM F543-13
Tensile Strength . Plate

The results of this testing indicate that the GBR System is equivalent to the predicate device.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

8. Substantial Equivalence

	Proposed	Predicate
Parameter	GBR System	Jeil Bone FixationSystem	Remark
510(k) Number	K143730	K050669	-
Manufacturer	Jeil Medical Corporation	Jeil Medical Corporation	-
Indications for Use	The GBR System isintended for use in stabilizingand fixating bone grafts,bone filling material and/orbarrier membranes used forguided bone/tissueregeneration in the oralcavity.	The Jeil Bone FixationSystem is intended for use instabilizing and fixating bonegrafts, bone filling materialand/or barrier membranesused for guided bone/tissueregeneration in the oralcavity.	Same
Parameter	Proposed		Predicate	Remark
	GBR System		Jeil BoneFixation
Catalog Number	Bone Plate12-ME-001-01,12-ME-001-02,12-ME-002-01,12-ME-002-02,12-ME-003-01,12-ME-003-02,12-GM-001-01,12-GM-001-02,12-GM-002-01,12-GM-002-02,12-GM-P01,12-GM-P02,12-GM-J01,12-GM-L01		Bone Plate12-ME-001-01,12-ME-001-02	PerformanceTesting
	Bone Screw14-AT-003,14-AT-004,14-AT-005,14-AT-006,14-AT-008,14-AT-010,14-AT-012,16-AT-003,16-AT-004,16-AT-005,16-AT-006,16-AT-008,16-AT-010,16-AT-012,		Bone Screw14-AT-003,14-AT-004,14-AT-006,14-AT-008,14-AT-010,14-AT-012,16-AT-004,16-AT-006,16-AT-008,16-AT-010	PerformanceTesting

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Image /page/9/Picture/0 description: The image contains the logo for JEIL MEDICAL CORPORATION. The logo features a stylized graphic with green, blue, and gray circles connected by an orange arc. To the right of the graphic, the word "JEIL" is written in orange, followed by "MEDICAL CORPORATION" in gray, stacked on top of each other.

702•703•704•705•706•804•805•807•812-ho, 55, Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea
Tel : +82 2 850 3500 / Fax : +82 2 850 3535

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Image /page/10/Picture/0 description: The image shows the logo for JEIL MEDICAL CORPORATION. The logo includes a graphic of three stylized figures in green, blue, and gray, along with the company name in orange and gray. Below the logo is a series of numbers, including 702, 703, 704, 705, 706, 804, 805, 807, and 812.

702-703-704-705-704-705-706-804-805-807-812-ho,
55, Digital-ro34-gil, Guro-gu, Seoul, 152-728, Korea
Tel : +82 2 850 3500 / Fax : +82 2 850 3535

Parameter	ProposedGBR System	PredicateJeil Bone Fixation	Remark
	14-AT-003G,14-AT-004G,14-AT-005G,14-AT-006G,14-AT-008G,14-AT-010G,14-AT-012G,14-AT-003G-25,14-AT-004G-25,14-AT-005G-25,14-AT-006G-25,14-AT-008G-25,14-AT-010G-25,14-AT-012G-25,16-TT-010
Plate Shape	Mesh Type	Mesh Type	PerformanceTesting
Plate Thickness	12-ME/GM-Series-01: 0.1 mm12-ME/GM-Series-02: 0.2 mm12-GM-Series: 0.15 mm	12-ME-Series-01: 0.1 mm12-ME-Series-02: 0.2 mm	PerformanceTesting
Screw Type	Self-Drilling,Tenting	Self-Drilling	PerformanceTesting
Screw Diameter	14-Series: 1.4 mm,16-Series: 1.6 mm	14-Series: 1.4 mm,16-Series: 1.6 mm	Same
Bone plates are usedwith general surgicalinstrumentation	Yes	Yes	Same
Material	Plate	Titanium (ASTM F67)	Titanium (ASTM F67)	Same
	Screw	Titanium Alloy(ASTM F136)	Titanium Alloy(ASTM F136)	Same
Surface casting		Plate - Anodizing	Plate - Anodizing	Same

{11}------------------------------------------------

	Proposed	Predicate
Parameter	GBR System	Jeil BoneFixation	Remark
Sterilization	Non-sterile,Steam sterilization priorto use	Non-sterile,Steam sterilization priorto use	Same
Single Use	Yes	Yes	Same

Some of the plates and screws of the subject devices are the same with several models of predicate device (K050669), but the subject device added more types of plates and screws. When compared to the predicate devices, the GBR System presented in this submission is equivalent, in terms of the following:

Intended Use ●
Technological characteristics
. Operating principle
Design features ●
Performance
Biocompatibility ●
. Materials
Method of sterilization and sterility assurance level ●

9. Conclusion [21 CFR 807.92(b)(3)]

The GBR System is equivalent to currently marketed devices. Both the subject and the predicate devices share the same intended use. The subject device is made of the same materials and has similar dimensions and characteristics as does the predicate device. These devices are manufactured from titanium alloys used generally in this type of bone screw and bone plate device, manufactured and sold around the world. The subject device, the GBR System, is equivalent in design and uses the same principle of operation of the predicate device.

To summarize, the subject device is equivalent in design, material, intended use and function to the predicate device. It is concluded that the information included in this summary supports the substantial equivalence of the subject device.

Regulation Number and Section

§ 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.