(50 days)
The aap LOQTEQ® Proximal Medial Tibia Plate 3.5 is indicated for:
- Metaphyseal fractures of the medial tibial plateau .
- Split fractures of the medial tibial plateau .
- Medial split fractures with depression ●
- Split or depression fracture of the medial tibial plateau ●
In addition, the plates may be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as multi-fragment fractures of the proximal tibia.
The aap LOQTEQ® Proximal Lateral Tibia Plate 3.5 is indicated 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.
The aap LOQTEQ® Proximal Tibia Plate 3.5 System consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap LOQTEQ® Proximal Tibia Plate 3.5 System consists of:
LOQTEQ® Proximal Medial Tibia Plate 3.5 (left and right) LOQTEQ® Proximal Lateral Tibia Plate 3.5 (left and right) to be used with LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping Cortical Screw 3.5, small head, self-tapping
Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)
The aap LOQTEQ® Proximal Tibia Plate 3.5 System is a device used in internal fixation of bone fragments, specifically for fractures of the proximal tibia. The acceptance criteria for this device and the study proving it meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in terms of intended use, design, functionality, components, and materials. | Documented, including mechanical testing, demonstrated substantial equivalence to the predicate device. |
| Safety and effectiveness of the device. | Non-clinical tests were performed and showed the effectiveness and safety of the device. |
| Mechanical performance of the implant system, specifically under fatigue loading representing worst-case clinical scenarios. | The implant fatigue tests with progressive loadings demonstrated substantial equivalence in mechanical performance to the predicate device. The subject device was found to be safe and effective, meeting the requirements of its pre-defined acceptance criteria and intended uses. |
2. Sample size used for the Test set and the Data Provenance
The provided text does not specify a sample size for a test set in the context of clinical trials involving human subjects or real-world data. The evaluation was primarily based on non-clinical tests, specifically mechanical fatigue tests.
The data provenance for these non-clinical tests is not explicitly stated in terms of country of origin, but it can be inferred that the tests were conducted by the manufacturer, aap Implantate AG, located in Berlin, Germany. The tests were retrospective in the sense that they were performed on the device components in controlled laboratory conditions rather than prospectively in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the evaluation was based on non-clinical mechanical testing, not a study requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the evaluation was based on non-clinical mechanical testing, not a study requiring adjudication of expert opinions.
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
This information is not applicable. The device is a bone plate system for internal fixation, not an AI-assisted diagnostic tool. Therefore, an MRMC study and the concept of "human readers improve with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was established by engineering standards and specifications for mechanical performance and fatigue life in medical implants. The objective was to demonstrate substantial equivalence to existing predicate devices through direct comparison of mechanical properties under standardized testing conditions.
8. The sample size for the training set
This information is not applicable as the evaluation was based on non-clinical mechanical testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for a machine learning model. The "ground truth" for the non-clinical tests was based on established engineering principles and comparative analysis with predicate devices.
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Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AGLorenzweg 5D-12099 Berlin Germany |
|---|---|
| Company Contact: | Dr. Christian ZietschPhone:+49-30-750-19-193Fax: +49-30-750-19-111 |
| Date | August 12 / 2013OCT 0 3 2013 |
| Trade Name: | aap LOQTEQ® Proximal Tibia Plate 3.5 System |
| Common Name: | Proximal Tibia Plates 3.5 |
| Classification Name andReference: | 21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories - Class II |
| Device Product Code andPanel Code: | Orthopedics/87/ HRS |
| Predicate device: | Synthes (USA) 3.5 mm LCP® Medial Proximal Tibia Platesunder the premarket notification K050646 (Apr 26, 2005)andSynthes (USA) 4.5 mm Titanium LCP Proximal Tibia Plat-ing System under the premarket notification K023802 (Jan28, 2003). |
| Device Description: | The aap LOQTEQ® Proximal Tibia Plate 3.5 System con-sists of bone plates and bone screws, to be implanted by asurgeon in order to achieve an internal fixation of bonefragments typically after fractures. If the plates are used inconjunction with locking screws, a so called internal fixatorwill be realized (internal fixation). |
| The aap LOQTEQ® Proximal Tibia Plate 3.5 System con-sists of: | |
| LOQTEQ® Proximal Medial Tibia Plate 3.5 (left and right) LOQTEQ® Proximal Lateral Tibia Plate 3.5 (left and right) to be used with LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapping Cortical Screw 3.5, small head, self-tapping |
Material:
Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)
Page 1 of 2
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| Indications: | The aap LOQTEQ® Proximal Medial Tibia Plate 3.5 indicated for: Metaphyseal fractures of the medial tibial plateauSplit fractures of the medial tibial plateauMedial split fractures with depressionSplit or depression fracture of the medial tibial plateau In addition, the plates may be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as multi-fragment fractures of the proximal tibia.The aap LOQTEQ® Proximal Lateral Tibia Plate 3.5 is indicated 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. |
|---|---|
| Substantial Equivalence | The Substantial Equivalence of the new device and the predicate device 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:
Implant Fatigue 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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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3. 2013
aap Implantate AG Dr. Christian Zietsch Manager Regulatory Affairs Lorenzweg S Berlin 12099 GERMANY
Re: K132554
Trade/Device Name: aap LOQTEO® Proximal Tibia Plate 3.5 System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 20, 2013 Received: August 22, 2013
Dear Dr. Zietsch:
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 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
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Page 2 - Dr. Christian Zietsch
CFR Part 807); labeling (21 CFR Part 801); medical device 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 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/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 yours.
Erin Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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gop Implantate AG aap LOQTEQ® Proximal Tibia Plate 3.5 System
Indications for Use Statement
510(k) Number (if known): K132554
Device Name: aap LOQTEQ® Proximal Tibia Plate 3.5 System
Indications for Use:
The aap LOQTEQ® Proximal Medial Tibia Plate 3.5 is indicated for:
- Metaphyseal fractures of the medial tibial plateau .
- Split fractures of the medial tibial plateau .
- Medial split fractures with depression ●
- Split or depression fracture of the medial tibial plateau ●
In addition, the plates may be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as multi-fragment fractures of the proximal tibia.
The aap LOQTEQ® Proximal Lateral Tibia Plate 3.5 is indicated 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 . X | AND/OR |
|---|---|
| (Part 21 CFR 801 Subpart D) |
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)
100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -
Elizabeth L. Frank -S
Division of Orthopedic Devices
Page 1 of 1
§ 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.