(262 days)
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of bone plates and screws, with no mention of AI or ML.
Yes
The device is used for fixation of fractures, osteotomies, and non-unions, which are medical treatments for bone injuries, thus qualifying it as a therapeutic device.
No
Explanation: The device is described as bone plates and screws for fixation of fractures, osteotomies, and non-unions, which falls under therapeutic/interventional devices rather than diagnostic devices.
No
The device description explicitly lists physical components such as bone plates, screws, and a set of instruments, which are hardware implants and surgical tools.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Fixation of fractures, osteotomies, and non-unions of the scapula, olecranon, humerus, radius, ulna, distal tibia, and fibula, particularly in osteopenic bone." This describes a surgical procedure to stabilize bones, not a test performed on biological samples outside the body to diagnose a condition.
- Device Description: The device is described as "Bone plates and screws" which are implants used for "fixation of bone fragments." This is consistent with a surgical implant, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In vitro diagnostic devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a surgical implant used for mechanical support and stabilization of bones.
N/A
Intended Use / Indications for Use
"Fixation of fractures, osteotomies, and non-unions of the scapula, olecranon, humerus, radius, ulna, distal tibia, and fibula, particularly in osteopenic bone"
Product codes
HRS, HWC
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 inter-nal fixator will be realized (internal fixation).
The LOQTEQ® Small Fragment Set consists of:
- LOQTEQ® Straight Plate 3.5
- LOQTEQ® Reconstruction Plate 3.5
- LOQTEQ® 1/3 Tubular Plate 3.5
- LOQTEQ® Cortical Screw 3.5, T15, self-tapping
- LOQTEQ® Cortical Screw 3.5, small head T15, self-tapping
- Cortical Screw 3.5, self-tapping
- Cortical Screw 3.5, small head, self-tapping
- Set of Instruments, Small Fragment Set
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scapula, olecranon, humerus, radius, ulna, distal tibia, and fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 and static and dynamic 4-Point bending tests acc. to ASTM F382
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
oop Implantate AG aap LOQTEQ Small Fragment Set
ర్క్ ( ( ( ( ( ( ) ( ( ( ) ( ( ) ( ( ) ( )
Summary of Safety and Effectiveness
KII 3.652
Page 1 of 2
| Sponsor: | aap Implantate AG
Lorenzweg 5
D-12099 Berlin
Germany | AUG 30 2012 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Company Contact: | Dipl.-Ing. Marc Seegers
Phone: +49-30-750-19 -192
Fax: +49-30-750-19 - 111 | |
| Date | December 5, 2011 | |
| Trade Name: | aap LOQTEQ Small Fragment Set | |
| Common Name: | Small Fragment Set | |
| Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple component metallic
bone fixation appliances and accessories – Class II and
21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener -
Class II | |
| Device Product Code and
Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone
Orthopedics/87/ HWC: Screw, Fixation, Bone | |
| Predicate device: | Small Fragment Locking Compression Plate (LCP®) System,
Synthes (USA), K000684 (APR 28, 2000) and K011335 (JUL 27, 2001) and
Zimmer® Small Fragment Universal Locking System K082527 (DEC 18,
2008) | |
| 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 inter-
nal fixator will be realized (internal fixation). | |
| | The LOQTEQ® Small Fragment Set consists of:
LOQTEQ® Straight Plate 3.5LOQTEQ® Reconstruction Plate 3.5LOQTEQ® 1/3 Tubular Plate 3.5LOQTEQ® Cortical Screw 3.5, T15, self-tappingLOQTEQ® Cortical Screw 3.5, small head T15, self-tappingCortical Screw 3.5, self-tappingCortical Screw 3.5, small head, self-tappingSet of Instruments, Small 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). | |
1
aap Implantate AG aap LOQTEQ Small Fragment Set
Indications:
PAGE 2 of 2
Fixation of fractures, osteotomies, and non-unions of the so ranon, humerus, radius, ulna, distal tibia, and fibula, particularly in osteopenic bone
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 and static and dynamic 4-Point bending tests acc. to ASTM F382
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.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
aap Implante AG % Mr. Marc Seegers, Dipl .- Ing., Director OA/RA Lorenzweig 5 D-12099 Berlin Germany
Re: K113652
Trade/Device Name: aap LOOTEO Small 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 20, 2012 Received: August 22, 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
AUG 30 2012
Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
3
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.
Einell Keith
As-Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K113652
Device Name: LOQTEQ Small Fragment Set
Indications for Use:
The aap LOQTEQ Small Fragment Set includes Straight Plates 3.5, Reconstruction Plates 3.5 and One Third Tubular Plates 3.5. The plates accept 3.5 mm locking screws and 3.5 mm cortical screws. They are intended for
Fixation of fractures, osteotomies, and non-unions of the scapula, olecranon, humerus, radius, ulna, distal tibia, and fibula, particularly in osteopenic bone
Prescription Use ਮ (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)
Aseb
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113652
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