(182 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI or ML.
Yes
The device is a system of bone plates and screws intended for the fixation of bone fragments and treatment of bone fractures, which are therapeutic actions.
No
Explanation: The device is an orthopedic implant (bone plate and screws) used for fixation of bone fragments in fractures and other bone injuries. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of bone plates and screws, which are physical implants and instruments, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fragments in the human femur to treat fractures and other bone injuries. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as bone plates and screws, which are implants used for internal fixation. These are physical devices inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The aap LOQTEQ® Distal Lateral Femur Plate 4.5 System include plates for the left and right human femur. The plates accept 4.5 mm locking screws, 4.5 mm cortical screws and 4.5 mm periprosthetic screws. They are intended for:
Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur
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 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® Distal Lateral Femur Plate 4.5 System consists of: LOQTEQ® Distal Lateral Femur Plate 4.5 (left and right version) LOQTEQ® Cortical Screw 4.5, T25, self-tapping (locking bone screw) LOQTEQ® Periprosthetic Screw. 4.5, T25, self-tapping (locking bone screw) Cortical bone screws 4.5 mm, self tapping Set of Instruments, Distal Lateral Femur Plate 4.5
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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: Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use. Mechanical tests of Periprosthetic Screws acc. to ASTM F543-07
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. The Periprosthetic Screws fulfil the relevant requirements of ASTM F543-07 and 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
121494
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aap Implantate AG ααρ LOQTEQ® Distal Lateral Femur Plate 4.5 System
Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AG
Lorenzweg 5
D-12099 Berlin Germany | NOV 1 9 2012 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company Contact: | Dipl.-Ing. Marc Seegers
Phone:+49-30-750-19-192
Fax: +49-30-750-19-111 | |
| Date | May 9, 2012 | |
| Trade Name: | aap LOQTEQ® Distal Lateral Femur Plate 4.5 System | |
| Common Name: | Distal Lateral Femur Plate | |
| 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 fas-
tener - Class II | |
| Device Product Code and
Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone
Orthopedics/87/ HWC: Screw, Fixation, Bone | |
| Predicate device: | LCP® Distal Femur Plates of Synthes (USA) with premarket noti-
fication no. K062564 (OCT 19, 2006). | |
| 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® Distal Lateral Femur Plate 4.5 System consists of:
LOQTEQ® Distal Lateral Femur Plate 4.5 (left and right version) LOQTEQ® Cortical Screw 4.5, T25, self-tapping (locking bone screw) LOQTEQ® Periprosthetic Screw. 4.5, T25, self-tapping (locking bone screw) Cortical bone screws 4.5 mm, self tapping Set of Instruments, Distal Lateral Femur Plate 4.5 | |
| Material: | Plates and Screws are made of Ti6Al4V (ASTM F136
or ISO 5832-3) | |
Page 1 of 2
1
Page 2/2
aap Implantate AG
aop LOQTEQ® Distal Lateral Femur Plate 4.5 Syst
Indications: Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures; fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur 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. Mechanical tests of Periprosthetic Screws acc. to ASTM F543-07
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.
The Periprosthetic Screws fulfil the relevant requirements of ASTM F543-07 and 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 19, 2012
aap Implantate AG % Mr. Marc Seegers Regulatory Affairs Specialist Lorenzweg 5 D-12099 Berlin,Germany
Re: K121494
Trade/Device Name: app LOQTEO® Distal Lateral Femur Plate 4.5 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 26, 2012 Received: October 31, 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
3
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 (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/ResourcesforYou/Industry/default.htm.
Sincerely vours. Erin I. Keith Mark N. Melkerson Director
Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Traditional Premarket Notification oop Implantate AG oop LOQTEQ® Distal Lateral Femur Plate 4.5 System Section 4 Indications for Use Statement
4. Indications for Use Statement
12/444 510(k) Number (if known):
Device Name: LOQTEQ® Distal Lateral Femur Plate 4.5 System
Indications for Use:
The aap LOQTEQ® Distal Lateral Femur Plate 4.5 System include plates for the left and right human femur. The plates accept 4.5 mm locking screws, 4.5 mm cortical screws and 4.5 mm periprosthetic screws. They are intended for:
Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur
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)
Younle
(Division Sign-Off).
Division of Orthopedic Devices
510(k) Number K121494
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