(269 days)
Not Found
No
The summary describes a set of bone plates and screws for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical testing.
Yes
The device is described as "Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries," which aims to treat or alleviate a disease, injury, or handicap.
No
This device is described as a set of bone plates, screws, and instruments used for the fixation of bone fragments (treatment of fractures and other bone injuries), making it a therapeutic device, not a diagnostic one.
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 for the "Fixation of various long bones... for treatment of bone fractures and other bone injuries." This describes a surgical implant used to physically stabilize bone, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as "Bone plates and screws are used for fixation of bone fragments... Bone plates and bone screws are implants." This confirms it's a physical implant for surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, femur and tibia
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.
Type of test: Static and dynamic 4-point-bending test of bone plates according to ASTM F 382-99.
Assessment of test results: 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. 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
oap Implantate AG aap LOQTEQ Large Fragment Set
Summary of Safety and Effectiveness
. . . 2 PAGE
ﺎ ﭘﺎ
| Sponsor: | aap Implantate AG
Lorenzweg 5
D-12099 Berlin Germany | | | SEP 6 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® Large Fragment Set | | | |
| Common Name: | Large Fragment Set | | | |
| Classification: | | | | |
| Classification Name and
Reference: | 21 CFR 888.3030 Single/multiple com-ponent metallic
bone fixation appliances and accessories - Class II and
21 CFR 888.3040 Smooth or threaded metallic bone fixation fas-
tener - Class II | | | |
| Device Product Code and
Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone
Orthopedics/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 plates
and 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) | | | |
1
| Indications: | 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. |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 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 show
the 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 results
gained. The subject device is safe and effective, and whose per-
formance 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
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
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,
Erind Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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