(339 days)
No
The 510(k) summary describes a system of bone plates and screws for fracture fixation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies described are non-clinical mechanical tests.
Yes
The device is described as a system for the fixation of bone fragments for the treatment of bone fractures and other bone injuries, which is a therapeutic intervention.
No
Explanation: The device is a bone plate and screw system intended for the fixation of bone fragments and osteotomies of the distal tibia, which is a therapeutic function, not diagnostic.
No
The device description explicitly lists physical components such as bone plates, screws, and instruments, which are hardware.
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 bone fractures and osteotomies of the distal tibia. This is a surgical procedure involving implants, not a diagnostic test performed on samples from the human body.
- Device Description: The device consists of bone plates, screws, and instruments used for surgical implantation. This aligns with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies described are non-clinical fatigue tests on the implants, demonstrating their mechanical effectiveness and safety for surgical use. This is typical for surgical implants, not IVDs which would have performance studies related to diagnostic accuracy (sensitivity, specificity, etc.).
In summary, the device is a surgical implant system used for fixing bone fractures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The aap LOQTEQ® Distal Medial Tibia Plate 3.5 System is intended for
- Fixation of complex intra- and extra- articular fractures of the distal tibia
- Osteotomies of the distal tibia.
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 (internal fixation) will be realized.
The LOQTEQ® Distal Medial Tibia Plate 3.5 System consists of:
• LOQTEQ® Distal Medial Tibia Plate 3.5, left and right version
• LOQTEQ® Cortical Screws 3.5, self-tapping (locking bone screw)
• LOQTEQ® Cortical Screws 3.5 small head, self-tapping (locking bone screw)
• Cortical Screws 3.5, self-tapping
• Cortical Screws 3.5 small head, self tapping
• Instruments, Distal Medial Tibia Plate 3.5
Plates and Screws are made of titanium alloy Ti6Al4V according to ASTM F136 or ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal 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
Non-Clinical tests have been performed and show the effectiveness and safety of the device.
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.
Key Metrics
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
oap Implantate AG oap LOQTEQ® Distal Medial Tibla Plate 3.5 System
K 113601
Image /page/0/Picture/2 description: The image contains a handwritten word "MOK". The letters are written in a cursive style, with the "M" having a distinct shape. The "O" is a closed loop, and the "K" has a sharp angle in its form. The handwriting appears to be done with a dark ink or marker on a white background.
Summary of Safety and Effectiveness
Summary of Safety and Effectiveness
| Sponsor: | aap Implantate AG
Lorenzweg 5
D-12099 Berlin Germany |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dipl.-Ing. Marc Seegers
Phone: +49-30-750-19 -192
Fax: +49-30-750-19 - 111 |
| Date: | November 28, 2011 |
| Trade Name: | aap LOQTEQ® Distal Medial Tibia Plate 3.5 System |
| Common Name: | Distal Medial Tibia Plate System |
| Classification: | |
| 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: | 3.5 LCP® Distal Medial Tibia Plates, Synthes (USA) premarket notification K013248 (DEC 19 2001) |
| 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 (internal fixation) will be realized. |
| | The LOQTEQ® Distal Medial Tibia Plate 3.5 System consists of: |
| | • LOQTEQ® Distal Medial Tibia Plate 3.5, left and right version |
| | • LOQTEQ® Cortical Screws 3.5, self-tapping (locking bone screw) |
| | • LOQTEQ® Cortical Screws 3.5 small head, self-tapping (locking bone screw) |
| | • Cortical Screws 3.5, self-tapping |
| | • Cortical Screws 3.5 small head, self tapping |
| | • Instruments, Distal Medial Tibia Plate 3.5 |
| Material: | Plates and Screws are made of titanium alloy Ti6Al4V according to ASTM F136 or ISO 5832-3. |
NOV 8 2012
Page 1 of 2
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aop Implantate AG aap LOQTEQ® Distal Medial Tibia Plate 3.5 System
| Indication: | The aap LOQTEQ® Distal Medial Tibia Plates 3.5 System is intended for Fixation of complex intra- and extra-articular fractures of the distal tibia Osteotomies of the distal tibia |
|---|---|
| Substantial | |
| Equivalence: | The Substantial Equivalence of the new device and the predicate |
| device is based on similar intended use, design, functionality, compo- | |
| nents 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 | Non-Clinical tests have been performed and show the effectiveness and
safety of the device. |
Clinical):
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 8, 2012
aap Implante AG % Mr. Marc Seegers Director QA/RA Lorenzweig 5 D-12099 Berlin Germany
Re: K113601
Trade/Device Name: LOQTEQ® Distal Medial Tibia 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 19, 2012 Received: October 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
3
Page 2 - Mr. Marc Seegers
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 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/ReportalProblem/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/Industrv/default.htm.
Sincerely yours.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K113601
Device Name: LOQTEQ® Distal Medial Tibia Plate 3.5 System
Indications for Use:
The aap LOQTEQ® Distal Medial Tibia Plate 3.5 System is intended for
- Fixation of complex intra- and extra- articular fractures of the distal tibia ●
- Osteotomies of the distal tibia .
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) | |
|---|---|
| -------------------------------------------------------- | -- |
K
Page 1 of 1
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113601