(137 days)
Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.
The aap Plate and Screw System LOQTEQ Distal Fibula Plates consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones. The Distal Fibula Plate System 3.5 is part of the LOQTEQ anatomic plate system. The anatomically preformed plates are available as right and left versions and in different lengths. The tapered end of the plate enables tissue-conserving, submuscular insertion. The 1.8 mm thin anatomic LOQTEQ Distal Fibula Plate 3.5 prevents skin and soft tissue irritation. All plate holes, with the exception of the oblong hole, are compatible with unidirectional locking screws as well as cortical screws (gold). The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The partially threaded Cancellous Screw dia 4.0 engages the remote bone fragment and slides through the bone fragment near the screw head. Thus, partially threaded screws enable interfragmentary compression. Washers in conjunction with aap screws are used to fixate small bone fragments. The aap Plate and Screw System LOQTEQ Distal Fibula Plates 3.5 incorporates: LOQTEQ Distal Fibula Plate 3.5, right and left. LOQTEQ Cortical Screw 3.5, small head, T15, self-tapping. Cortical Screw 3.5, T15, self-tapping. Cancellous Screw 4.0, small head, T15. Washer, I-Ø4.4, A-Ø8.0. Set of Instruments LOQTEQ Distal Fibula Plates 3.5. Material: All implants are made of Ti6Al4V (according ISO 5832-3 or ASTM F136). The surface of the plates is generated by an automatic slide finishing, the so-called "KeramoFinish". Those surfaces correspond to polished surfaces. The surface of the LOQTEQ Cortical Screws are slightly polished and anodised. The surface of the Cortical Screws are fine blasted and anodised as well.
The provided text is a 510(k) Premarket Notification for a medical device, specifically the LOQTEQ® Distal Fibula Plate 3.5, Cancellous Screw 4.0, and Washer. This document primarily focuses on demonstrating the substantial equivalence of this new device to previously marketed predicate devices, rather than on proving the device meets specific performance criteria through a clinical study for a new, novel technology (like an AI algorithm).
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for an AI/ML medical device submission, are not applicable to this document.
Here's why and what information is available in the provided text:
- Type of Device: The device is a bone fixation appliance (metallic plate, screws, washer) used for internal fixation of the distal fibula. This is a traditional mechanical implant, not an AI/software as a medical device (SaMD).
- Regulatory Pathway: The submission is a 510(k) Premarket Notification, which aims to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove efficacy/safety through a de novo clinical trial that would require the kind of detailed study breakdown requested.
- "Study" described: The document mentions "Non-clinical tests" including:
- "Mechanical Safety of aap Implantate AG – LOQTEQ" Distal Fibula Plate, Static and Dynamic 4-point-bending test of bone plates according to ASTM F 382-99 (Reapproved 2008)."
- "Mechanical properties of metallic bone screws in accordance with ASTM F543-13e1"
- "Biocompatibility of Implants and Instruments of aap LOQTEQ Distal Fibula Plates and Screw"
- "Acceptance Criteria" described: For these mechanical tests, the acceptance criteria are implicitly that the device performs "as good as or better than the predicate devices" and "fulfil the relevant demands of ASTM F543-13" and ASTM F382-99.
- Performance: The document states, "Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The screws fulfil the relevant demands of ASTM F543-13. The implants have successfully passed the tests and have hereby been proven to be mechanically as good as or better than the predicate devices."
- Clinical Data: The document explicitly states: "Clinical Data were not needed for these devices to show substantial equivalence." This is a key indicator that the detailed clinical study information requested is not part of this submission.
In summary, none of the specific bullet points regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test set, data provenance, expert numbers/qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) can be extracted from this document because it is for a mechanical orthopedic implant, not an AI/ML diagnostic or therapeutic device. The "study" here refers to mechanical bench testing, not clinical performance or AI algorithm validation.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
AAP Implantate Ag Reni Schaller Manager Regulatory Affairs Lorenzweg 5 Berlin, D-12099 Germany
Re: K161703 Trade/Device Name: LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer 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, HTN Dated: September 19, 2016 Received: September 20, 2016
Dear Ms. Schaller:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K161703
Device Name
LOQTEQ® Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer
Indications for Use (Describe)
Fractures, osteotomies and non-unions of the distal fibula, particularly in osteopenic bone.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Traditional Premarket Notification K161703
aap LOQTEQ® Distal Fibula Plates 3.5
Section 5 510(k) Summary
5. 510(k) Summary
(as required by section 807.92)
| (1) | |
|---|---|
| Sponsor: | aap Implantate AG |
| Lorenzweg 5 | |
| D-12099 Berlin, Germany | |
| Company Contact: | Reni Schaller |
| Phone:+49-30-750-19 - 193 | |
| Fax: +49-30-750-19 – 111 | |
| Email: r.schaller@aap.de | |
| Date(2) | October/27/2016 |
| Trade Name: | LOQTEQ® Distal Fibula Plate 3.5 |
| Cancellous Screw 4.0 | |
| Washer | |
| Common Name: | Distal Fibula Plate and Screw, Cancellous Screw, Washer |
| Classification Nameand Reference: | 21 CFR 888.3030 Single/multiple component metallic bone fixationappliances and accessories - Class II |
| 21 CFR 888.3040 Smooth or threaded metallic bone fixationfastener - Class II | |
| Device Product Code &Panel Code: | Orthopedics/87/HRSOrthopedics/87/HWCOrthopedics/87/HTN |
| (3) | |
| Predicate devices | → LOQTEQ® 1/3 Tubular Plate 3.5 under the premarket notificationK113652 (LOQTEQ ® Small Fragment Set) |
| →Cancellous Screw 4.0 under the premarket notification K072411 | |
| → Washer under the premarket notification K990776 | |
| (4) | |
| Device Description: | The aap Plate and Screw System LOQTEQ Distal Fibula Platesconsists of bone plates and bone screws, to be implanted by asurgeon in order to achieve a repositioning of fragments and aninternal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate screw system guaranteesan additional mechanical fixation and enables the application forosteopenic bones. |
| The Distal Fibula Plate System 3.5 is part of the LOQTEQ anatomicplate system. The anatomically preformed plates are available asright and left versions and in different lengths. | |
| The tapered end of the plate enables tissue-conserving, submuscularinsertion. | |
| The 1.8 mm thin anatomic LOQTEQ ® Distal Fibula Plate 3.5 preventsskin and soft tissue irritation. | |
| All plate holes, with the exception of the oblong hole, arecompatible with unidirectional locking screws as well as corticalscrews (gold). The use of locking screws is state of the art and isparticularly important in osteoporotic bones or for stabilizingcomminuted fractures. The elongated hole can be used to adjust theheight as well as the initial fixation of the plate. | |
| The partially threaded Cancellous Screw dia 4.0 engages the remote |
The partially threaded Cancellous Screw dia 4.0 engages the remote bone fragment and slides through the bone fragment near the screw
{4}------------------------------------------------
head. Thus, partially threaded screws enable interfragmentary compression. Washers in conjunction with aap screws are used to fixate small bone fragments. The aap Plate and Screw System LOQTEQ Distal Fibula Plates 3.5 incorporates: LOQTEQ Distal Fibula Plate 3.5, right and left ● . LOQTEQ Cortical Screw 3.5, small head, T15, self-tapping . Cortical Screw 3.5, T15, self-tapping ● Cancellous Screw 4.0, small head, T15 ● Washer, I-Ø4.4, A-Ø8.0 ● Set of Instruments LOQTEQ Distal Fibula Plates 3.5 Material: All implants are made of Ti6Al4V (according ISO 5832-3 or ASTM F136) The surface of the plates is generated by an automatic slide Surface: finishing, the so-called "KeramoFinish". Those surfaces correspond to polished surfaces. The surface of the LOQTEQ® Cortical Screws are slightly polished and anodised. The surface of the Cortical Screws are fine blasted and anodised as well. (5) Fractures, osteotomies and non-unions of the distal fibula, Indications: particularly in osteopenic bone. (6) The LOQTEQ® Distal Fibula Plate and the legally marketed Technological predicated devices have similar indications, dimensions, geometry characteristics and materials. Comparison The LOQTEQ® Distal Fibula Plate is technologically substantially equivalent to the predicate devices according to the Decision-Making Process for 510(k)s: 1. Predicate device is legally marketed 2. The devices have the identical intended use 3. The devices have the same technological characteristics All characteristics which are known and are relevant for the safety for both devices are described and assessed mainly: 1.Indication for use statement: identical 2. Functionality: identical 3. Components, Materials, Dimensions of components: comparable 4. Mechanical properties (ensured by benchmark tests) at least comparable Documentation including mechanical testing to show the substantial equivalence has been provided with this submission.
{5}------------------------------------------------
510(k) Traditional Premarket Notification K161703 aap LOQTEQ® Distal Fibula Plates 3.5 Section 5 510(k) Summary
(ep)
Performance Data (Non-Clinical and / or Clinical):
Non-clinical tests have been performed and show the substantial equivalence of the device.
Summary of Non-clinical tests:
Type of test:
"Mechanical Safety of aap Implantate AG – LOQTEQ" Distal Fibula Plate, Static and Dynamic 4-point-bending test of bone plates according to ASTM F 382-99 (Reapproved 2008)."
"Mechanical properties of metallic bone screws in accordance with ASTM F543-13e1"
"Biocompatibility of Implants and Instruments of aap LOQTEQ Distal Fibula Plates and Screw"
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 screws fulfil the relevant demands of ASTM F543-13.
The implants have successfully passed the tests and have hereby been proven to be mechanically as good as or better than the predicate devices.
Clinical Data were not needed for these devices to show substantial equivalence.
The LOQTEQ® Distal Fibula Plates and Screws has passed all defined criteria, has performed as well or better than the predicate device and are therefore considered substantially equivalent to the cleared predicate device.
§ 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.