(331 days)
The aap LOQTEQ® Proximal Lateral Tibia Plates 4.5 System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.
Bone plates used for fixation, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed with bone screws. Bone plates and bone screws are implants. The aap LOQTEQ® Proximal Lateral Tibia Plates 4.5 are anatomically shaped osteosynthesis plates, which met in combination with the use of special screws the function of a Internal Fixator. The following products are required for application: LOQTEQ® Proximal Lateral Tibia Plate 4.5, LOQTEQ® Cortical Screw 4.5, T25, self-tapping, LOQTEQ® Cortical Screw 4.5, small head, T25, self-tapping, Cortical Screw 4.5, self-tapping, Cortical Screw 4.5, small head, self-tapping, Instruments, Proximal Lateral Tibia Plate 4.5. Plates and Screws are made of titanium alloy according to ASTM F136 or ISO 5832-3.
Acceptance Criteria and Study Details for LOQTEQ® Proximal Lateral Tibia Plate 4.5 System
This document outlines the acceptance criteria and the study conducted to demonstrate that the aap LOQTEQ® Proximal Lateral Tibia Plate 4.5 System meets these criteria.
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the LOQTEQ® Proximal Lateral Tibia Plate 4.5 System was substantial equivalence to its predicate device, specifically regarding mechanical performance. This was assessed through non-clinical fatigue implant tests.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Performance: Substantial equivalence to the predicate device (4.5 mm Titanium LCP® Proximal Tibia Plating System, Synthes (USA), K023802) in terms of safety and effectiveness, specifically under worst-case clinical loading scenarios, as demonstrated by fatigue implant tests. | "Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses." The non-clinical fatigue implant tests were performed with progressive loadings, representing worst-case scenarios with respect to clinical use. The results supported the conclusion that the device is safe and effective and meets the specified acceptance criteria. |
2. Sample Size and Data Provenance (Test Set)
- Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data. The study primarily relies on non-clinical fatigue implant tests of the device itself. Therefore, the "sample size" refers to the number of devices or constructs tested in the mechanical studies. This exact number is not specified in the provided text.
- Data Provenance: The data is from non-clinical testing conducted by aap Implantate AG. The country of origin for the testing is not explicitly stated, but the company is located in Germany. These would be considered prospective tests performed on newly manufactured devices.
3. Number and Qualifications of Experts (Ground Truth for Test Set)
- This question is not applicable as the provided study is a non-clinical mechanical performance test, not a study involving human readers or expert radiologists to establish ground truth for a diagnostic or imaging device. The "ground truth" here is the established mechanical properties and performance standards for bone fixation plates.
4. Adjudication Method (Test Set)
- This question is not applicable as the provided study is a non-clinical mechanical performance test, and does not involve adjudication of expert assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical mechanical equivalency study for a bone fixation plate, not a study involving human readers' performance with or without AI assistance.
6. Standalone Performance (Algorithm Only)
- This question is not applicable. The device is a physical medical implant (bone plate), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
- The "ground truth" used for this study was based on established mechanical performance standards and expectations for bone fixation plates, particularly as benchmarked against the predicate device. This "ground truth" is derived from engineering principles, material science, and regulatory requirements for medical device safety and effectiveness in the context of mechanical loads.
8. Sample Size for the Training Set
- This question is not applicable as the study did not involve a training set for an algorithm. The study described is a non-clinical mechanical performance test of a physical device.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there was no training set for an algorithm.
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aop Implantate AG
oop LOQTEQ® Proximal Lateral Tibia Plate 4.5 System
K113602
PAGE 1 OF 2
Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AGLorenzweg 5D-12099 Berlin Germany |
|---|---|
| Company Contact:Phone:Fax: | Dipl.-Ing. Marc Seegers+49-30-750-19 -192+49-30-750-19 - 111 |
| Date | November 28, 2011 |
| Trade Name: | aap LOQTEQ® Proximal Lateral Tibia Plate 4.5 System |
| Common Name: | Proximal Lateral Tibia Plate System |
| Classification: | |
| Classification Nameand Reference: | 21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories - Class II and21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener -Class II |
| Device Product Codeand Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, BoneOrthopedics/87/ HWC: Screw, Fixation, Bone |
| Predicate device: | 4.5 mm Titanium LCP® Proximal Tibia Plating System, Synthes (USA)premarket notification K023802 (JAN 28 2003). |
| Device Description: | Bone plates used for fixation, i.e., for treatment of bonefractures and other bone injuries. Bone plates are fixedwith bone screws. Bone plates and bone screws areimplants.The aap LOQTEQ® Proximal Lateral Tibia Plates 4.5 are anatomicallyshaped osteosynthesis plates, which met in combination with the use ofspecial screws the function of a Internal Fixator. |
| The following products are required for application:● LOQTEQ® Proximal Lateral Tibia Plate 4.5● LOQTEQ® Cortical Screw 4.5, T25, self-tapping● LOQTEQ® Cortical Screw 4.5, small head, T25, self-tapping● Cortical Screw 4.5, self-tapping● Cortical Screw 4.5, small head, self-tapping● Instruments, Proximal Lateral Tibia Plate 4.5 | |
| Material: | Plates and Screws are made of titanium alloy according to ASTM F136 orISO 5832-3 |
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aap Implantate AG aap LOQTEQ® Proximal Lateral Tibia Plate 4.5 System
K113602
PAGE 2 of 2
The aap LOQTEQ® Proximal Lateral Tibia Plate 4.5 System is intended for Indication: treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.
Substantial The Substantial Equivalence of the new device and the predicate device Equivalence: is based on similar intended use, design, functionality, components and materials in use.
Documentation including mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.
Performance Data (Non-Clinical and / or Clinical):
Non-clinical tests have been performed and show the effectiveness and safety of the device:
Summary of Non-clinical tests:
Type of test:
Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use.
Assessment of test results:
Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
aap Implantate % Mr. Marc Seegers, Dipl .- Ing., Director QA/RA Lorenzweig 5 D-12099 Berlin Germany
OCT 31 2012
Re: K113602
Trade/Device Name: aap LOQTEQ Proximal Lateral Tibia Plate 4.5 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 19, 2012 Received: October 22, 2012
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Dear Mr. Seegers:
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 vour 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 -- Mr. Marc Seegers
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. product raination vonator post of your device on our labeling regulation (21 CFR Part 801), please rr you dostte opeofics ao ://AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please the Ocher Tot Doriett and Wisbranding by reference to premarket notification" (21CFR Part note the regalations 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 rou may 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,
yours,
For
Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K113602
Device Name: LOQTEQ® Proximal Lateral Tibia Plate 4.5 System
Indications for Use:
The aap LOQTEQ® Proximal Lateral Tibia Plates 4.5 System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashl
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K113602
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.