(269 days)
The aap LOQTEQ® Large Fragment Set is intended for: Fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions.
Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation). The LOQTEQ® Large Fragment Set consists of: • LOQTEQ® Narrow Plate 4.5, • LOQTEQ® Broad Plate 4.5, • LOQTEQ® Cortical Screw 4.5, T25, self-tapping • Cortical Screw 4.5, self-tapping • Set of Instruments, Large Fragment Set
Here's a summary of the acceptance criteria and the study details for the aap LOQTEQ Large Fragment Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance of the aap plates should show substantial equivalence to the predicate device. The device should be safe and effective, and its performance should meet pre-defined requirements and intended uses. | "Substantial equivalence with respect to the mechanical performance of the aap plates 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." |
| Must pass static and dynamic 4-point-bending tests according to ASTM F 382-99. | Tests were performed: "Static and dynamic 4-point-bending test of bone plates according to ASTM F 382-99." The results led to the conclusion of substantial equivalence and safety/effectiveness against acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for the "test set" in terms of number of devices. However, the study involved non-clinical mechanical tests:
- Static and dynamic 4-point-bending tests of bone plates according to ASTM F 382-99.
The data provenance is not specified beyond being "non-clinical tests" performed by the manufacturer, aap Implantate AG in Berlin, Germany. These are in vitro tests and not directly tied to patient data, retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for the mechanical performance is the standard ASTM F 382-99. The assessment of test results against this standard would likely be performed by engineers or technical experts, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided as the study is a non-clinical mechanical performance assessment against a standard, not a clinical study involving human judgment that would typically require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is a non-clinical mechanical performance test of a medical device (bone plates and screws), not an AI-assisted diagnostic or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A (Not Applicable). This is a mechanical device, not an algorithm. The "standalone" performance refers to the device's mechanical integrity and function as assessed by the ASTM F 382-99 standard.
7. The Type of Ground Truth Used
The ground truth used for performance validation is the requirements and specifications outlined in the ASTM F 382-99 standard for static and dynamic 4-point-bending tests of bone plates. This is a scientific and engineering standard.
8. The Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" as this is a non-clinical mechanical device performance study, not a machine learning or AI algorithm development study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as in point 8.
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oap Implantate AG aap LOQTEQ Large Fragment Set
Summary of Safety and Effectiveness
. . . 2 PAGE
ﺎ ﭘﺎ
| Sponsor: | aap Implantate AGLorenzweg 5D-12099 Berlin Germany | SEP 6 2012 | ||
|---|---|---|---|---|
| Company Contact: | Dipl.-Ing. Marc SeegersPhone:+49-30-750-19 -192Fax: +49-30-750-19 - 111 | |||
| Date | December 5, 2011 | |||
| Trade Name: | aap LOQTEQ® Large Fragment Set | |||
| Common Name: | Large Fragment Set | |||
| Classification: | ||||
| Classification Name andReference: | 21 CFR 888.3030 Single/multiple com-ponent metallicbone fixation appliances and accessories - Class II and21 CFR 888.3040 Smooth or threaded metallic bone fixation fas-tener - Class II | |||
| Device Product Code andPanel Code: | Orthopedics/87/ HRS: Plate, Fixation, BoneOrthopedics/87/ HWC: Screw, Fixation, Bone | |||
| Predicate device: | Large Fragment LCP Instrument and Implant Set of Synthes(USA) under the premarket notification K000682 (May - 1,2000). At this time the system was called Synthes Large Frag-ment Dynamic Compression Locking (DCL) System. | |||
| Device Description: | Bone plates and screws are used for fixation of bone fragments,i.e., for treatment of bone fractures and other bone injuries.Bone plates are fixed by the use of bone screws. Bone platesand bone screws are implants. If the plates are used in conjunc-tion with locking screws, a so called internal fixator will be real-ized (internal fixation). The LOQTEQ® Large Fragment Set con-sists of:• LOQTEQ® Narrow Plate 4.5,• LOQTEQ® Broad Plate 4.5,• LOQTEQ® Cortical Screw 4.5, T25, self-tapping• Cortical Screw 4.5, self-tapping• Set of Instruments, Large Fragment Set | |||
| Material: | Plates are made of cp Titanium (ASTM F67 or ISO 5832-2)Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3) |
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| Indications: | The aap LOQTEQ® Large Fragment Set is intended for:Fixation of various long bones, such as the humerus, femur andtibia. It is also for use in fixation of osteopenic bone and fixationof non-unions or malunions. |
|---|---|
| Substantial Equivalence: | The Substantial Equivalence of the new device and the predicatedevice is based on similar intended use, design, functionality,components and materials in use. |
| Documentation including mechanical testing to show the sub-stantial equivalence and safety and effectiveness has been pro-vided with this submission. | |
| Performance Data(Non-Clinical and /or Clinical): | Non-clinical tests have been performed and showthe effectiveness and safety of the device. |
| Summary of Non-clinical tests: | |
| Type of test: | |
| Static and dynamic 4-point-bending test of bone plates accord-ing to ASTM F 382-99. | |
| Assessment of test results: | |
| Substantial equivalence with respect to the mechanical perfor-mance of the aap plates could be stated due to the test resultsgained. The subject device is safe and effective, and whose per-formance meets the requirements of its pre-defined acceptancecriteria and intended uses. | |
| Documentation regarding the mechanical testing to show thesubstantial equivalence and safety and effectiveness has beenprovided 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 & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
SEP 6 2012
aap Implante AG % Mr. Marc Seegers, Dipl.-Ing., Director QA/RA Lorenzweig 5 D-12099 Berlin Germany
Re: K113648
Trade/Device Name: aap LOQTEQ Large Fragment Set 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: August 13, 2012 Received: August 15, 2012
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 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 - Mr. Marc Seegers
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erind Keith
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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aap Implantate AG LOQTEQ Large Fragment Set
Indications for Use Statement
510(k) Number (if known):
Device Name: LOQTEQ Large Fragment Set
Indications for Use:
The aap LOQTEQ Large Fragment Set includes Narrow and Broad Plates 4.5. The plates accept 4.5 mm locking screws and 4.5 mm cortical screws.
The aap LOQTEQ Large Fragment Set is intended for:
Fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions.
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)
.H. Boyle Sr. mxm
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
f1 510(k) Number K113648
§ 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.