(215 days)
Not Found
No
The summary describes a purely mechanical device for membrane fixation and contains no mention of AI, ML, image processing, or data-driven algorithms.
No.
A therapeutic device is one that treats, mitigates, or cures a disease or condition. This device is used to fixate and stabilize barrier membranes; it does not directly treat or cure any condition.
No
The device description states its purpose is to "fixate and stabilize bioresorbable and non-resorbable barrier membranes," which is a treatment or procedural function, not a diagnostic one.
No
The device description explicitly states it is a "metal device" made of "Titanium Alloy," indicating it is a physical hardware component, 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, screening, and prognosis.
- J Tac Function: The J Tac is a physical device used to mechanically fixate and stabilize barrier membranes within the oral cavity. It does not analyze or test any biological specimens. Its function is purely mechanical and structural.
The provided information clearly describes a surgical/dental device used for fixation, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The J Tac is intended for use to fixate and stabilize bioresorbable and 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
DZL
Device Description
The J - Tac is a metal device intended to stabilize a barrier membrane. It is made of Titanium Alloy and supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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 to confirm that the J - Tac has the safe and effective physical properties through the compression force test and torsion test. The testing result meets the requirements of its pre-defined acceptance criteria and intended uses.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
#702 Kolon Science Guro-Dona, Guro-Gu, Seoul, 1 Tel : +82 2 850 3500 / Fax : +82
01902 510(k) Summary
FEB - 8 2011
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 7, 2010
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | Jeil Medical Corporation |
| Address | #702, kolon science valley 2nd |
| 811, Guro-Dong, Guro-Gu | |
| Seoul, Republic of Korea 152-050 | |
| Phone | +82 2 850-3544 |
| Fax | +82 2 850-3525 |
| Contact | Jieun Kim |
2. Device:
Proprietary Name - J - Tac Common Name - Membrane fixation pin Classification Name - Screw, fixation, intraosseous
3. Predicate Device:
The AutoTac System Titanium Tack, K022790
-
- Classifications Names & Citations: DZL, CFR872.4880, Class 2
-
- Description:
The J - Tac is a metal device intended to stabilize a barrier membrane. It is made of Titanium Alloy and supplied non-sterile.
-
- Indication for use:
The J - Tac is intended to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.
- Indication for use:
1
#702, Kolon Science Valley 2 Guro-Dong, Guro-Gu, Seoul, 152-050 I Tel : +82 2 850 3500 / Fax : +82 2 850 3535
7. Non-clinical testing data
Bench testing was conducted to confirm that the J - Tac has the safe and effective physical properties through the compression force test and torsion test. The testing result meets the requirements of its pre-defined acceptance criteria and intended uses.
8. Review:
The J - Tac has the same device characteristics as the predicate device, the AutoTac; intended use, material, design and use concept are similar.
The differences between them are the dimension of the tack, compression strength, torsion strength, etc.
Based on the comparison of intended use and technical features, the J - Tac is 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 Jeil Medical Corporation concludes that the J tack are safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
-
Jeil Medical Corporation will update and include in this summary any other 10. information deemed reasonably necessary by the FDA.
END
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the department's name around the edge. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Jeil Medical Corporation C/O Ms. Cathy Cambria Arkin Consulting Group 1733 Canton Lane Marietta. Georgia 30062
FEB - 8 201
Re: K101902
Trade/Device Name: J tack Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: January 16, 2011 Received: January 18, 2011
Dear Ms. Cathy Cambria:
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- Ms. Cambria
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Nh 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 K101902
Device Name: J tack
Indication for use:
The J Tac is intended for use to fixate and stabilize bioresorbable and non-resorbable barrier membranes used for regeneration of tissue in the oral cavity or in dental situations that require membrane use or fixation.
Over-The-Counter Use Prescription Use_ OR (Per 21CFR801 Subpart D) (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Veang
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: k10902