(200 days)
The aap LOQTEQ® Proximal Humerus Plate 3.5 System includes LOQTEQ® Proximal Humerus Plate 3.5 short and LOQTEQ® Proximal Humerus Plate 3.5 long. The plates accept 3.5 mm cortical locking screws and 3.5 mm cortical screws as well as 3.8 mm cancellous locking screws. They are intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone
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 with 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® Proximal Humerus Plate 3.5 System consists of: LOQTEQ® Proximal Humerus Plate 3.5, short . LOQTEQ® Proximal Humerus Plate 3.5, long ◆ . LOQTEQ® Cortical Screw 3.5, T15, self-tapping LOQTEQ® Cancellous Screw 3.8, T15 ● . Cortical Screw 3.5, self-tapping . Set of Instruments, Proximal Humerus Plate Material: Plates are made of Ti6Al4V (ASTM F136 or ISO 5832-3) Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3)
The device in question is the LOQTEQ® Proximal Humerus Plate 3.5 System. The study supporting its acceptance is a non-clinical mechanical testing study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in mechanical performance. | Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. |
| Device is safe and effective. | The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. |
| Meets requirements of pre-defined acceptance criteria. | The subject device...meets the requirements of its pre-defined acceptance criteria and intended uses. |
| Meets intended uses. | The subject device...meets the requirements of its pre-defined acceptance criteria and intended uses. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Fatigue implant tests with progressive loadings, representing worst case scenario," but does not give a specific number of implants tested.
- Data Provenance: The study was a non-clinical (mechanical) test, implying it was conducted in a laboratory setting, not on human subjects. The company, aap Implantate AG, is based in Berlin, Germany, suggesting the tests were likely performed in Germany or under their direct supervision. The data is retrospective in the sense that it was conducted before the submission for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this submission. The "ground truth" for a mechanical testing study is typically defined by engineering specifications, material science principles, and established testing standards, not by expert consensus in a clinical context. The "experts" involved would be engineers and material scientists conducting and evaluating the tests, but their number and specific qualifications are not detailed here.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. For mechanical testing, the "adjudication" is based on objective measurements and comparison against predefined engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This was a non-clinical mechanical testing study, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This was a physical medical device (bone plate and screws) being tested for its mechanical properties, not an algorithm.
7. Type of Ground Truth Used
The ground truth used was based on engineering specifications and mechanical performance standards. The study aimed to demonstrate "substantial equivalence with respect to the mechanical performance" to a predicate device, and that the device "meets the requirements of its pre-defined acceptance criteria." These criteria would be derived from biomechanical principles and established performance benchmarks for such implants.
8. Sample Size for the Training Set
No training set was used in this context. This was a non-clinical validation study for a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
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Summary of Safety and Effectiveness
DEC 0 7 2012 aap Implantate AG Sponsor: Lorenzweg 5 D-12099 Berlin. Germany Company Contact: Dipl .- Ing. Marc Seegers-Phone: +49-30-750-19 -192 +49-30-750-19 - 111 Fax: Mav 9th 2012 Date Trade Name: aap LOQTEQ® Proximal Humerus Plate 3.5 System Common Name: Proximal Humerus Plate 3.5 System Classification Name and 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories - Class II and Reference: 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener -Class II Device Product Code and Orthopedics/87/ HRS: Plate, Fixation, Bone Orthopedics/87/ HWC: Screw, Fixation, Bone Panel Code: 3.5 mm LCP® Proximal Humerus Plate, Synthes (USA) Predicate device: with the premarket notifications K011815 (SEP 6, 2001) and K041860 (SEP 8, 2004) 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 with 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® Proximal Humerus Plate 3.5 System consists of: LOQTEQ® Proximal Humerus Plate 3.5, short . LOQTEQ® Proximal Humerus Plate 3.5, long ◆ . LOQTEQ® Cortical Screw 3.5, T15, self-tapping LOQTEQ® Cancellous Screw 3.8, T15 ● . Cortical Screw 3.5, self-tapping . Set of Instruments, Proximal Humerus Plate Material: Plates are made of Ti6Al4V (ASTM F136 or ISO 5832-3) Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3) fractures and fracture dislocations, osteotomies, and nonunions of the Indications: proximal humerus, particularly 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:
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/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: December 7, 2012
Aap Implantate Ag % Mr. Marc Seegers Director QA/RA Lorenzweg 5 D-12099 Berlin Germany
Re: K121495
Trade/Device Name: LOOTEO® Proximal Humerus 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. HWC Dated: October 25, 2012 Received: November 28, 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. Iisting 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
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Page 2 - Mr. Marc Seegers
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2.1 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/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic 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): K121495
Device Name: LOQTEQ® Proximal Humerus Plate 3.5 System
Indications for Use:
The aap LOQTEQ® Proximal Humerus Plate 3.5 System includes LOQTEQ® Proximal Humerus Plate 3.5 short and LOQTEQ® Proximal Humerus Plate 3.5 long. The plates accept 3.5 mm cortical locking screws and 3.5 mm cortical screws as well as 3.8 mm cancellous locking screws. They are intended for
fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone
Prescription Use x · (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)
Page 1 of _1
Krishna Asundi for (Division Sign-Off) Division of Orthopedic Devices
2012.12.06 14:02:58 -05'00'
§ 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.