(201 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of the titanium mesh and membrane, with no mention of AI or ML technologies.
No
The device is used for stabilization and support of bone grafts, which is a structural and supportive role, not a therapeutic (treatment-providing) one.
No
The device is described as a mesh and membrane for stabilizing and supporting bone grafts, which is a therapeutic function, not a diagnostic one. Its intended use is to aid in the physical stabilization of grafts, not to identify or characterize diseases or conditions.
No
The device description explicitly states the device is fabricated from Grade 2 Titanium and supplied as meshes and membranes, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a mesh and membrane intended for "stabilization and support of bone grafts in dento-alveolar bony defect sites." This is a device that is implanted within the body to provide structural support during a surgical procedure.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, detect substances, or provide any diagnostic information about a patient's condition. Its function is purely mechanical and supportive.
Therefore, based on the provided information, this device falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Neo Titanium mesh and CTi-mem are meshes and membranes intended to be used for stabilizing and supporting bone grafts in dento-alveolar bony defect sites. The devices are fabricated from Grade 2 Titanium (ASTM F-67) and supplied in various sizes and shapes, non-coated, sterile, for single-use and disposable.
The membranes are shaped and/or trimmed by the user for the intended target shape. The Neo Titanium mesh is the common shape of the membrane. The Cti-mem series are customized titanium membranes allowing minimum cutting and bending for attaching to the location of the part used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dento-alveolar bony defect sites
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)
Performance testing conducted included visual, dimension, packaging, and package seal efficacy testing.
The biocompatibility of Titanium has been established through a long history of use in implantable medical devices. No additional biocompatibility testing was necessary for this device.
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.
Not Found
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
§ 872.4760 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.
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: _October 16, 2011
"
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | neobiotech Co., Ltd. |
| Address | 103, E-Space, 212-26 |
| Guro-dong, Guro-gu, Seoul, Korea 152-050 | |
| Phone | |
| Fax | |
| Contact | +82 2 582-2885 |
| +82 2 582-2883 | |
| Shin, Seon Woo |
- Device:
Proprietary Name - Neo Titanium mesh, CTi-mem Common Name - Titanium Ridge Augmentation Mesh Classification Name - Bone Plate
-
- Predicate Device:
Osteo-Mesh TM-300, K984230, Osteogenics Biomedical
- Predicate Device:
-
- Device Classification:
JEY, CFR872.4760, Class 2
- Device Classification:
-
- Device Description:
The Neo Titanium mesh and CTi-mem are meshes and membranes intended to be used for stabilizing and supporting bone grafts in dento-alveolar bony defect sites. The devices are fabricated from Grade 2 Titanium (ASTM F-67) and supplied in various sizes and shapes, non-coated, sterile, for single-use and disposable.
- Device Description:
The membranes are shaped and/or trimmed by the user for the intended target shape. The Neo Titanium mesh is the common shape of the membrane. The Cti-mem series are customized titanium membranes allowing minimum cutting and bending for attaching to the location of the part used.
Image /page/0/Picture/16 description: The image shows the word "neobiotech" in lowercase letters. To the right of the word is a logo. The logo is a rounded square with a stylized letter "n" inside.
1
-
- Indication for use:
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
- Indication for use:
-
- Non-Clinical Performance Testing:
Performance testing conducted included visual, dimension, packaging, and package seal efficacy testing.
- Non-Clinical Performance Testing:
The biocompatibility of Titanium has been established through a long history of use in implantable medical devices. No additional biocompatibility testing was necessary for this device.
-
- Comparison to Predicate Devices:
The Neo Titanium mesh and CTi-mem have the same device characteristics, composition, function, and intended use as the predicate device, such as the Osteo-Mesh TM-300.
- Comparison to Predicate Devices:
The differences between the devices are material thickness, dimensions, hole size and method of sterilization.
Based on the comparison of intended use and technical features, the Neo Titanium mesh and CTi-mem are substantially equivalent to the predicate device.
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification neobiotech Co., Ltd. concludes that the Neo Titanium mesh and CTi-mem are safe and effective, perform at least as well, and are substantially equivalent to the predicate devices as described herein.
- Conclusions:
END
Image /page/1/Picture/12 description: The image shows the word "neobiotech" in lowercase letters. To the right of the word is a logo that appears to be a stylized letter "n" inside of a shield-like shape. The text and logo are black against a white background. The image is simple and clean.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is depicted in a simple, black-and-white design, and the text is in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neobiotech Company, Limited C/O Mr. Ronald Arkin President Arkin Consulting Group 1733 Canton Lane Marietta, Georgia 30006
JAN 1 0 2012
Re: K111761
Trade/Device Name: Neo Titanium mesh, CTi-mem Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: January 4, 2012 Received: January 6, 2012
Dear Mr. Arkin:
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.
3
Page 2 - Mr. Atkin
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number K 111741
Device Name: Neo Titanium mesh, CTi-mem
Indication for use:
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
Prescription Use______________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use (Per 21CFR807 Subpart C) (Per 21CFR801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| |
| [Signature] | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | 1411761 |