(213 days)
The Meisinger Dental Bone Screws are intended for fixation of bone segments e.g. for horizontal or vertical augmentative grafts. Depending on indication the user choose the matching screw, prepares the pit hole and inserts the screw. The screws are intended for single use only.
The Meisinger Dental Bone Screws consist of Titanium alloy Grade 5 with 1.1mm, 1.3mm and 1.5mm diameter and with lengths between 7mm - 16mm. The bone screws have a self-fapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force. Dental Bone Screws are delivered non sterile.
The Meisinger Dental Bone Screws are a Class II medical device (product code DZL) intended for fixation of bone segments, such as for horizontal or vertical augmentative grafts. The 510(k) summary states that a performance test was conducted to demonstrate that the device's design and function are equivalent to predicted devices. This indicates that the primary acceptance criteria for this device are focused on equivalence to existing predicate devices, rather than specific numerical performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design and function equivalent to predicate devices. | "A performance test has been performed with the result that the design and function are equivalent to the predicted devices." "The Meisinger Dental Bone Screws have the same 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." |
| Biocompatibility requirements met. | "The screws use the same biocompatible materials meeting the requirements from ASTM F136 as the predicated devices." (ASTM F136 is a standard specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications). |
| Compliance with relevant standards. | "The following standards have been followed for the development, production, performance and safety testing of Dental Bone Screws: AAMI ST79, ISO 17664, ISO 11607-1, ISO 2832-3, ASTM F136, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 17665-1, ASTM F543." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The submission focuses on comparison to predicate devices and adherence to standards rather than a specific clinical test set for performance. The "performance test" mentioned likely refers to bench testing rather than a clinical study with a defined patient sample size.
- Data Provenance: Not applicable in the context of clinical data for performance. The data provenance described is related to the materials and design characteristics compared against established standards and predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The submission does not describe a clinical study requiring expert-established ground truth. The evaluation is based on technical equivalence and compliance with standards.
4. Adjudication method for the test set:
- Not applicable. There is no mention of a human-adjudicated test set in the context of this 510(k) submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a bone screw and does not involve AI or human "readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation lies in the established engineering principles, material specifications, and performance characteristics of legally marketed predicate devices as well as compliance with recognized international and national standards (e.g., ASTM F136 for materials, ISO and AAMI standards for sterilization and risk management). The performance is benchmarked against these established norms for similar devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The development and testing adhere to traditional engineering and quality management system approaches.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth to establish in this context.
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510(k) Traditional Meisinger Dental Bone Screw K132212
Section #5
510(k) Summary
1. Applicant's Name and Address
Hager & Meisinger GmbH Hansemannstraße 10 41468 Neuss, Germany (0049) 2131 2012-0 Phone: (0049) 2131 2012- 222 Fax: Contact Person: Wiebke Stolten Management product approval and product validation (Regulatory Affairs)
2. Date Prepared
Date prepared: 10/22/2013
3. Name of the device
| Trade Name: | Meisinger Screw System TX, Screw System Professional |
|---|---|
| Common Name: | Dental Bone Screws |
| Classification Name: | Screw, Fixation, Intraosseous |
| Product Code: | DZL |
| Regulation No: | 872.4880 |
| Class: | II |
| Panel: | Dental |
4. Predicate Devices:
| K051871 - Storz am Markt | Bone Screws |
|---|---|
| K041887 - Synthes | Craniofacial Screws |
5. Device Description:
The Meisinger Dental Bone Screws consist of Titanium alloy Grade 5 with 1.1mm, 1.3mm and 1.5mm diameter and with lengths between 7mm - 16mm.
.
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510(k) Traditional Meisinger Dental Bone Screw K132212
Section #5
510(k) Summary
The bone screws have a self-fapping design and the connection between screw and screw driver is realized by a socket head or a hexalobular connection to obtain a clamping force.
Dental Bone Screws are delivered non sterile.
6. Intended Use:
The Meisinger Dental Bone Screws are intended for fixation of bone segments e.g. for horizontal or vertical augmentative grafts. Depending on indication the user choose the matching screw, prepares the pit hole and inserts the screw. The screws are intended for single use only.
7. Performance tests and used standards / Clinical data
The following standards have been followed for the development, production, performance and safety testing of Dental Bone Screws: AAMI ST79, ISO 17664, ISO 11607-1, ISO 2832-3, ASTM F136, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 17665-1, ASTM F543.
A performance test has been performed with the result that the design and function are equivalent to the predicted devices.
Clinical data and conclusions were not needed for this device.
8. Basis for substantial equivalence
The Meisinger Dental Bone Screws have the same 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. The function and intended use, material, possible product have been evaluated as acceptable and equivalent to predicated devices.
Based on the information provided in the summary we conclude that the Meisinger Dental Bone Screws are substantially equivalent to the legally marketed predicate devices described.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2014
Hager & Meisinger Gmbh Ms.Wiebke Stolten Regulatory Affairs Hansemannstrasse 10 Neuss, D-41468 Germany
Re: K132212
Trade/Device Name: Meisinger Screw System TX, Screw System Professional Regulation Number: 21 CFR 872.4880 Regulation Name: Bone Screw Regulatory Class: Class II Product Code: DZL Dated: November 13, 2013 Received: November19, 2013
Dear Ms. 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. 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
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Page 2 - Wiebke Stolten
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 (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 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" (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 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.
Image /page/3/Picture/7 description: The image shows a signature and some text. The text includes "Sincerely yours," followed by the name "Tejashri Purohit-Sheth, M.D." It also includes the title "Clinical Deputy Director" and the acronym "DAGRID." The word "FOR" is at the bottom right.
Erin I. Keith, M.S. 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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510(k) Traditional Meisinger Dental Bone Screws
Section #4
Indications for Use Statement
510(k) Number (if known): K132212
Device Name: Dental Bone Screws
Indications for use:
ー・・・
The Meisinger Dental Bone Screws are intended for fixation of bone segments e.g. for horizontal or vertical augmentative grafts. Depending on indication the user choose the matching screw, prepares the pit hole and inserts the screw.
The screws are intended for single use only.
Prescription Use X X Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
| Mary S. Runner - PA | |
|---|---|
| 2014.02.14 | |
| 15:42:03 -05'00' | |
| Susan Ringer |
Meisinger Dental Bone Screws S10(k) Traditional
Page 4.1
§ 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.