(277 days)
K 111761
No
The device description and performance studies focus on the mechanical properties and biocompatibility of titanium screws for bone fixation, with no mention of AI or ML algorithms for image analysis, diagnosis, or treatment planning.
No.
The device is described as a system for fixating and stabilizing non-resorbable barrier membranes for tissue regeneration, which is a structural and mechanical function rather than directly providing therapy.
No
The device is described as a system of screws and membranes used for the physical fixation and stabilization of tissue in the oral cavity for regeneration. It does not perform any diagnostic function.
No
The device description explicitly states it is made of Titanium Alloy and consists of physical components (Tent screw and CTi Cover Screw) intended for surgical implantation.
Based on the provided information, the Neo GBR System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Neo GBR System Function: The Neo GBR System is a surgical device used to physically fixate and stabilize barrier membranes within the oral cavity or dental situations. It is implanted into bone (maxilla or mandible) to support tissue regeneration.
- Lack of Biological Sample Analysis: The description of the Neo GBR System does not involve the analysis of any biological samples from the patient. Its function is purely mechanical and structural within the body.
Therefore, the Neo GBR System falls under the category of a surgical or implantable medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
DZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity or in dental situations, maxilla or mandible bone area
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)
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.
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.
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.
K 111761
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
§ 872.4880 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.
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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
1
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
2
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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3
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.
4
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 |
| Device | ||
| Classification | ||
| Name | Screw, fixation, intraosseous | Screw, fixation, intraosseous |
| Product Code | DZL | DZL |
| Regulation | ||
| Number | 872.4880 | 872.4880 |
| Intended 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. | The GBR System is intended for use in | |
| stabilizing and fixating bone grafts, bone | ||
| filling materials and/or barrier membranes | ||
| use for guided bone/tissue regeneration in | ||
| the 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 Screw | ||
| Diameter | 1.55 mm | Ø 1.4mm |
| Cover Screw | ||
| Length | 3 mm | 2.4 mm |
| Sterilization | Gamma Sterilization | Non-Sterile |
| Principle of | ||
| Operation | identical | The function of Bone screw body is |
| temporary dental implant (Screw) that | ||
| place in maxilla or mandible bone area to | ||
| be combined with titanium membrane and | ||
| cover screw or cover cap. It helps to | ||
| support the membrane. Second surgery for | ||
| removal is required. |
5
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.