(55 days)
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 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® Distal Anterolateral Tibia Plate 3.5 consists of:
LOQTEQ® Distal Anterolateral 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-tapp. Cortical Screw 3.5, small head, self-tapping
Implants are made of Ti6A14V (ASTM F136 or ISO 5832-3)
The provided text describes the "aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5" and its premarket notification (K133675). The study conducted focuses on the mechanical performance of the device through non-clinical testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance for clinical use | Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. |
| Safety and effectiveness | The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. "Non-clinical tests have been performed and show the effectiveness and safety of the device." |
| Meet pre-defined acceptance criteria | The device's performance meets the requirements of its pre-defined acceptance criteria. |
| Substantial equivalence to predicate device (Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates, K092812) | "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..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text only mentions "Implant Fatigue tests with progressive loadings, representing worst case scenario with respect to clinical use." This suggests a series of tests, but the specific number of implants or test cycles is not given.
- Data Provenance: The tests are "Non-clinical tests," implying laboratory-based testing rather than patient data. The manufacturer, aap Implantate AG, is based in Berlin, Germany. Therefore, the tests were likely conducted in Germany or by a contract lab on behalf of the German manufacturer. The data is prospective in the sense that the tests were designed and conducted specifically for this submission, not retrospectively collected from existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This study is a non-clinical, mechanical performance study, not one involving expert assessment of medical images or patient outcomes. The "ground truth" here is objective mechanical measurements against engineering standards or comparisons to the predicate device's known performance.
4. Adjudication Method for the Test Set
- Not applicable. As a non-clinical mechanical test, there is no expert adjudication process. The assessment of test results would be based on comparison to pre-defined technical specifications and measurement outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This was a non-clinical mechanical performance study, not a study involving human readers or cases. Therefore, no MRMC study was conducted, and no effect size for human reader improvement with AI assistance is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone plate, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this study is based on mechanical test results (specifically implant fatigue tests with progressive loadings) compared against pre-defined acceptance criteria and against the known performance of the predicate device (Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates). This is objective, quantitative data from physical testing.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set exists for this device.
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oop Implantate AG
aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 ﻧ
K133675 page 1 of 2
Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AGLorenzweg 5D-12099 Berlin GermanyJAN 2 3 2014 |
|---|---|
| Company Contact: | Dr. Christian ZietschPhone: +49-30-750-19 -193Fax: +49-30-750-19 - 111 |
| Date | November 25 / 2013 |
| Trade Name: | aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 |
| Common Name: | Distal Anterolateral Tibia Plate |
| Classification Name andReference: | 21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories - Class II |
| Product Code | HRS |
| Predicate device: | Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral DistalTibia Plates under the pre-market notification K092812(May 11, 2010) |
| Device Description: | The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5consists of bone plates and bone screws, to be implantedby a surgeon 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® Distal Anterolateral Tibia Plate 3.5consists of: | |
| LOQTEQ® Distal Anterolateral Tibia Plate 3.5 (leftand 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-tapp. Cortical Screw 3.5, small head, self-tapping | |
| Material: | Implants are made of Ti6A14V (ASTM F136 or ISO 5832-3) |
| Indications: | The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 isindicated for fractures, osteotomies, and non-unions of thedistal tibia, especially in osteopenic bone. |
.
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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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
January 23, 2014
aap Implantate AG Dr. Christian Zietsch Manager, Regulatory Affairs Lorenzweg 5. D-12099 Berlin GERMANY
Re: K133675
Trade/Device Name: aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 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: November 25, 2013 Received: November 29, 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. Drue, 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 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 - Dr. Christian Zietsch
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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ronald Nean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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aop Implantate AG aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 : - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Indications for Use Statement
510(k) Number (if known): K133675
Device Name: aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5
Indications for Use:
The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Elizabeth ank -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.