(153 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any computational processing.
No.
The device is used for fixation of membranes to bone, which is a structural or supportive function, not a direct therapeutic action to treat or cure a disease or condition.
No
The device, "Tacs and Pins," is described as being used for the "fixation of membranes...to the bone structure." This is a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states the device consists of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of membranes... to the bone structure." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (tacs and pins) made of titanium alloy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a surgical implant used in a clinical setting, not a diagnostic tool used in a laboratory or for analyzing biological samples.
N/A
Intended Use / Indications for Use
Tacs and Pins are used for the fixation of membranes (resorbable membranes non-resorbable membranes) to the bone structure.
Tacs and Pins are intended for single use only.
Product codes
DZL
Device Description
The Meisinger Tacs and Pins consist of titanium alloy Grade 5. The Meisinger Pins are a Tac-equivalent with an extra mini- thread.
Both articles are available with a head diameter of 2.51 mm, the Pin is available with overall length of 3.65mm (pin length 2.65mm) and the Tac with a length of 3.5mm (2.8mm)
Tacs and Pins are delivered non sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone structure
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
Clinical Testing: Not applicable
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
K130682
510(k) Traditional Meisinger Tacs and Pins
Section #5
510(k) Summary
AUG 1 3 2013
| Name of Submitter: | Hager & Meisinger GmbH
Hansemannstraße 10
41468 Neuss, Germany
Phone: (0049) 2131 2012-0
Fax: (0049) 2131 2012- 222 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Wiebke Stolten
Management product approval and product
validation (Regulatory Affairs)
wiebke.stolten@meisinger.de |
| Date Prepared: | 04/26/2013 |
| Trade Name: | Meisinger MEITAC, Meisinger Master-Pin-Control |
| Common Name: | Tacs (MEITAC- Kit), Pins (Master-Pin-Control-Kit) |
| Classification Name: | Screw, Fixation, Intraosseous |
| Product Code: | DZL |
| Regulation No: | 872.4880 |
| Class: | II |
| Panel: | Dental |
| Predicate Devices: | K092855 Miltex® Membrane Tack Kit
K973180 IMTEC Bone Tac |
| Device Description: | The Meisinger Tacs and Pins consist of titanium
alloy Grade 5. The Meisinger Pins are a Tac-
equivalent with an extra mini- thread.
Both articles are available with a head diameter of
2.51 mm, the Pin is available with overall length of
3.65mm (pin length 2.65mm) and the Tac with a
length of 3.5mm (2.8mm)
Tacs and Pins are delivered non sterile. |
Meisinger Tacs and Pins 510(k) Traditional
1
510(k) Traditional Meisinger Tacs and Pins K130682
Section #5
510(k) Summary
Tacs and Pins are used for the fixation of Intended Use: (resorbable membranes nonmembranes resorbable membranes) to the bone structure.
Tacs and Pins are intended for single use only.
The Meisinger Tacs and Pins have the same Technological Characteristics: intended use and are substantially equivalent to the legally marketed predicate devices in the United States. The screws use the same biocompatible materials
meeting the requirements from ASTM F136 as the predicated devices.
The design is similar, at least equivalent to predicated devices:
All products have comparable dimensions and design and the intended use is equivalent.
- Clinical Testing: Not applicable
The function and intended use, material, possible Conclusion: product have been evaluated as acceptable and equivalent to predicated devices.
Based on the information provided in the summary we conclude that the Meisinger Tacs and Pins are substantially equivalent to the legally marketed predicate devices described.
Meisinger Tacs and Pins 510(k) Traditional
Page 5.2
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 caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2013
Hager & Meisinger GmbH Mr. Wiebke Stolten Management Regulatory Affairs Hansemannstraße 10 Neuss. Germany 41468
Re: K130682
Trade/Device Name: Meisinger Tacs and Pins Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: July 12, 2013 Received: July 16, 2013
Dear Mr. Stolten:
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. Stolten
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 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 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/Reportal?roblem/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.
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Traditional Meisinger Tacs and Pins K130682
Section #4
Indications for Use Statement
510(k) Number (if known): K130682
Device Name: Meisinger Tacs and Pins
Indications for use:
Tacs and Pins are used for the fixation of membranes (resorbable membranes non-resorbable membranes) to the bone structure.
Tacs and Pins are intended for single use only.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green - S - M 2013.08.07 15:36:42 -04'00
for M. Susan Runner, DDS, MA
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Antrol, Dental Devices
510(k) Number: K130682
Meisinger Tacs and Pins 510(k) Traditional
Page 4.1