Neo GBR System is intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.

Device Description

The Neo GBR System is made of Titanium Alloy. This product is a sterilized single use medical device. This system consists of Tent screw and CTi Cover Screw. The function of the Tent Screw is temporarily Intraosseous Fixation Screw that places in the maxilla or mandible bone area to be combined with a titanium membrane of K 111761 and CT cover screw. Second surgery for removal is required. The product diameters are 2.0mm and the lengths are 7.2/8.7/10.2/11.7/13.2/15.2/18.2mm. The Tent Screw and CTi-Cover screw are always packaged together. But CTi-Cover Screw is packaged separately for the convenience. 4 pcs of Tent Screw can be packaged in a box as a bundle set.

AI/ML Overview

The provided document does not describe a study that uses acceptance criteria to prove the device meets these criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for the "Neo GBR System," which is an implantable medical device (intraosseous fixation screw or wire).

The document details bench testing conducted for the Neo GBR System to confirm its physical properties, but this testing is not an AI/ML performance study as typically described with acceptance criteria like sensitivity, specificity, or AUC, nor does it involve human readers or ground truth derived from expert consensus, pathology, or outcomes data in the way an AI/ML study would.

Here's an analysis based on the information available, noting the absence of AI/ML specific information:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "The testing results meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific quantitative acceptance criteria and the detailed performance results for each test (visual test, compressive loads, pull out, driving torque, and insertion-elimination tests) are not provided in this summary. It only states that they meet the requirements.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available in the provided summary. The document mentions "bench testing," which implies physical tests on the manufactured device, not a test set of data (images, clinical records, etc.) as would be used for an AI/ML algorithm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is a physical fixation system, not an AI/ML algorithm requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable. The device is a physical implant, not an AI/ML system that enhances human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable as it is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be the physical properties and mechanical thresholds established for the device's function (e.g., maximum compressive load before failure, torque required for insertion/removal). The biocompatibility tests also have established standards (ISO 10993-1). However, specific quantitative values are not provided in the summary.

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a 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 of Non-Clinical Testing Performed (from the document):

Tests: Visual test, compressive loads, pull out, driving torque, and insertion-elimination tests.
Standards: Conducted in accordance with ASTM F543-13.
Biocompatibility: Cytotoxicity, irritation, and sensitization tests in accordance with ISO 10993-1.
Stability and Compatibility: Tests between the tent screw and CTi-cover screw to evaluate adaptation accuracy.

Conclusion from document: "The testing results meet the requirements of its pre-defined acceptance criteria and intended uses."

In essence, the provided document describes the regulatory submission for a physical medical device and does not contain the kind of AI/ML performance study information requested in the prompt.

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

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

January 10, 2017

Neobiotech Co., Ltd. % April Lee Consultant Withus Group Inc 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K160991

Trade/Device Name: Neo Gbr System Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: December 6, 2016 Received: December 12, 2016

Dear April Lee:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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,

Michael J. Ryan -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160991

Device Name Neo GBR System

Indications for Use (Describe)

Neo GBR System is intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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510(k) Summary

Submitter

Neobiotech. Co., Ltd. Kim, In Ho #312-2, 36, Digital-ro 27 gil Guro-gu, Seoul 08381 South Korea Email: samw728(@neobiotech.co.kr Tel. +82-2-582-2885 Fax. +82-2-3282-3646

Official Correspondent

Withus Group Inc April Lee 2531 Pepperdale Drive, Rowland Heights. CA 91748 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: Neo GBR System
Common Name: Membrane fixation pin
Classification Name: Intraosseous Fixation Screw or Wire
Product Code: DZL
Panel: Dental
Regulation Number: 872.4880
Device Class: Class II ●
Date Prepared: 01/10/2017

General Description

The Neo GBR System is made of Titanium Alloy. This product is a sterilized single use medical device. This system consists of Tent screw and CTi Cover Screw.

The function of the Tent Screw is temporarily Intraosseous Fixation Screw that places in the maxilla or mandible bone area to be combined with a titanium membrane of K 111761 and CT cover screw. Second surgery for removal is required.

The product diameters are 2.0mm and the lengths are 7.2/8.7/10.2/11.7/13.2/15.2/18.2mm. The Tent Screw and CTi-Cover screw are always packaged together. But CTi-Cover Screw is packaged separately for the convenience. 4 pcs of Tent Screw can be packaged in a box as a bundle set.

Indication for Use:

Neo GBR System is intended to fixate and stabilize non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.

Materials:

The devices are fabricated from Ti-6A1-4V ELI of ASTM F136.

Non-clinical testing data:

Bench testing was conducted with the predicate device to confirm that the Neo GBR System has the safe and effective physical properties through the visual test, compressive loads, pull out, driving torque, and insertion-elimination tests in accordance with ASTM F543-13. The testing results meet the requirements of its pre-defined acceptance criteria and intended uses. Biocompatibility tests such as cytotoxicity, irritation and sensitization tests were performed in accordance with ISO 10993-1. The stability and compatibility tests between the tent screw and CTi-cover screw were performed to evaluate adaptation accuracy.

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Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

K143730, GBR system manufactured by Jeil Medical Corporation .

Comparison to Predicate Devices:

	Subject Device	Predicate Device
Company	Neobiotech. Co., Ltd	Jeil Medical Corporation
Device Name	Neo GBR System	GBR system
510(k) Number	K160991	K143730
DeviceClassificationName	Screw, fixation, intraosseous	Screw, fixation, intraosseous
Product Code	DZL	DZL
RegulationNumber	872.4880	872.4880
Intended Use	Neo GBR System is intended to fixateand stabilize non-resorbable barriermembranes used for regeneration oftissue in the oral cavity or in dentalsituations that require membrane useor fixation.	The GBR System is intended for use instabilizing and fixating bone grafts, bonefilling materials and/or barrier membranesuse for guided bone/tissue regeneration inthe oral cavity.
Material	Ti-6Al-4V ELI of ASTM F136,	Ti-6Al-4V ELI of ASTM F136
Design	Image: Neo GBR System Screw	Image: GBR System Screw
Component	Tent screw and CTi cover screw	Bone screw body and Bone screw cap
Screw Diameters	Ø2.0 mm	Ø 1.6mm / 1.4mm
Screw Lengths	7.2, 8.7, 10.2, 11.7, 13.2,15.2, 18.2 mm	3.0, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 mm
Pitch Size	0.85	0.2
Cover ScrewDiameter	1.55 mm	Ø 1.4mm
Cover ScrewLength	3 mm	2.4 mm
Sterilization	Gamma Sterilization	Non-Sterile
Principle ofOperation	identical	The function of Bone screw body istemporary dental implant (Screw) thatplace in maxilla or mandible bone area tobe combined with titanium membrane andcover screw or cover cap. It helps tosupport the membrane. Second surgery forremoval is required.

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Substantial Equivalence Discussion

The subject device has similar in indications, technology, functions, and materials with the predicate K143730, GBR system by Jeil Medical Corporation.

The differences between the subject device and the predicate device are sterilization and Tent Screw's dimensions and design.

Our product is Gamma sterilized and predicate device is provided non sterile. We performed the sterilization validation testing for the subject device.

The difference of design of the Tent screw is the head part of the screw part of Tent screw has same function and structure with other predicate GBR screw. However the head part of tent screw has wide structure and have an inner hole connected with Cover screw to hold the titanium membrane for GBR. Therefore, there is no different risk and same stability compared with predicate. The predicate's diameters are smaller than the subject device. The subject device's lengths is wide and includes predicate's length size.

Based on the comparison of intended use and technical features, the Neo GBR system is substantially equivalent to the predicate device.

Conclusion

The Neo GBR System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Through non-clinical testing, it has been demonstrated that the different design and indications of the subject device are as safe and as effective as the predicate device. Therefore, Neo GBR System and its predicate are substantially equivalent.

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.