(302 days)
For fractures and osteotomies of the calcaneus, including, but not limited to
-extra-articular, intra-articular
-joint depression
-tongue type
-severely comminuted fractures
The LOQTEQ® VA Calcaneus Plate 3.5 is an anatomical, polyaxial angular stable, asymmetrical titanium plate (L/R version) for the treatment of calcaneus fractures. The shape of the plate is adapted to the lateral, anatomical shape of the calcaneus.
The polyaxial, angle-stable plate-screw-connection (VA technology) allows up to 15° angulating of the screws. Thus, the screws can be placed under the posterior articular facet into the sustentaculum tali, ensuring a stable supply of the fracture.
The provided text describes a medical device, the LOQTEQ® VA Calcaneus Plate 3.5, and its substantial equivalence to predicate devices, focusing on mechanical safety testing. However, it does not contain information relevant to the acceptance criteria and study proving device meets the criteria for an AI/ML powered medical device as requested in the prompt.
Specifically, the document discusses:
- Device Name: LOQTEQ® VA Calcaneus Plate 3.5
- Intended Use/Indications for Use: Temporary fixation, correction or stabilization of the calcaneus for fractures and osteotomies (extra-articular, intra-articular, joint depression, tongue type, severely comminuted fractures).
- Predicate Devices: Synthes Locking Calcaneal Plate (K991407 - Primary) and aap Bone Plate and Screw Implants (K072411).
- Testing Performed: Customized static and dynamic 3-point-bending tests of bone plates according to ASTM F2193 and ASTM F382, and mechanical testing for screws according to ASTM F543.
- Conclusion: The device functioned as intended, had similar results to predicate devices, and was found to be substantially equivalent.
The document does NOT contain any of the following information:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample size used for the test set or data provenance
- Number of experts used to establish ground truth or their qualifications
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone (algorithm only) performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
Therefore, I cannot fulfill your request using the provided text. The document describes a traditional medical device (bone plate and screws) and its mechanical testing, not an AI/ML medical device.
{0}------------------------------------------------
August 1, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
aap Implantate AG Annesha Lahiri Head of Regulatory Affairs Lorenzweg 5 Berlin, D-12099 De
Re: K182818
Trade/Device Name: LOQTEQ VA Calcaneus Plate 3.5 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: June 28, 2019 Received: July 2, 2019
Dear Annesha Lahiri:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K182818
Device Name LOQTEQ® VA Calcaneus Plate 3.5
Indications for Use (Describe)
For fractures and osteotomies of the calcaneus, including, but not limited to
-extra-articular, intra-articular -joint depression -tongue type -severely comminuted fractures
Type of Use (Select one or both, as applicable)X 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 aap LOQTEQ® VA Calcaneus Plate 3.5
Image /page/3/Picture/1 description: The image shows a logo with the letters 'aap' in a bold, sans-serif font. The letters are a deep blue color, and there is a teal circle with a white outline positioned near the letter 'p'. The background is white, providing a clean contrast to the logo elements.
510(k) Summary LOQTEQ® VA Calcaneus Plate 3.5
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Submitter: | aap Implantate AG |
|---|---|
| Address: | Lorenzweg 5D-12099 Berlin, Germany |
| Telephone: | +49-30-750-19-193 |
| Telefax: | +49-30-750-19-111 |
| Contact: | Dr. Annesha Lahiri |
| Date Prepared: | 2019-07-19 |
Name of Device and Name/Address of Sponsor
| Trade Name: | LOQTEQ® VA Calcaneus Plate 3.5 |
|---|---|
| Common Name: | Plate, Fixation, Bone; Screw, Fixation, Bone |
| Classification: | Class II per 21 CFR 888.3030, 21 CFR 888.3040 |
| Device: | Orthopedics |
| Product Code: | HRS and HWC |
Predicate Devices
| PREDICATE 510(K) NUMBER | PREDICATE DEVICE NAME | PREDIVATE DEVICE MANUFACTURER |
|---|---|---|
| K991407 - Primary | Synthes Locking Calcaneal Plate | Synthes |
| K072411 | aap Bone Plate and Screw Implants | aap Implantate AG |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows a partial logo with the letters 'aap' in a bold, sans-serif font. The letters are a deep blue color, and there is a small, teal-colored circle positioned to the right of the letter 'p'. The background is white, providing a clean contrast to the logo elements.
Intended Use
The plate and screw implants of the system LOQTEQ® VA Calcaneus Plate 3.5 are intended for temporary fixation, correction or stabilization of the calcaneus. Implants are intended for single use on human bone.
Indications for Use
For fractures and osteotomies of the calcaneus, including, but not limited to
- extra-articular, intra-articular
- joint depression ●
- tongue type ●
- severely comminuted fractures ●
Product Description
The LOQTEQ® VA Calcaneus Plate 3.5 is an anatomical, polyaxial angular stable, asymmetrical titanium plate (L/R version) for the treatment of calcaneus fractures. The shape of the plate is adapted to the lateral, anatomical shape of the calcaneus.
The polyaxial, angle-stable plate-screw-connection (VA technology) allows up to 15° angulating of the screws. Thus, the screws can be placed under the posterior articular facet into the sustentaculum tali, ensuring a stable supply of the fracture.
Substantial Equivalence
The LOQTEQ® VA Calcaneus Plate 3.5 has comparable intended use and identical indications for use as the predicate. The technological characteristics, functionality (both being internal fixatures) and materials (TiCP) are identical whereas dimensions and mechanical properties are comparable.
The cancellous screws which are a part of this submission have been compared to predicate screw approved in the K072411. Bench testing of the subject screws showed that these functioned similar to the predicates.
Hence no questions on the safety and the efficacy of the bone plate and screw system are raised.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows a logo with the letters 'aap' in a bold, sans-serif font. The letters are a deep blue color. There is a teal circle below the right side of the letter 'p'. The background is white.
Performance Testing
In order to evaluate the mechanical safety of the LOQTEQ® VA Calcaneus Plate 3.5, customized static and dynamic 3-point-bending tests of bone plates according to ASTM F2193 and ASTM F382 was performed. Mechanical testing for the subject screws according to ASTM F543 was performed. In all instances, the LOQTEQ® VA Calcaneus Plate 3.5 plate and screw system functioned as intended and had similar results as the predicate devices.
Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the LOQTEQ® VA Calcaneus Plate 3.5 has been shown to be substantially equivalent to the predicate devices and does not present any different issues of safety or effectiveness. The results from the bench testing demonstrate that the device performs as good or better than the predicate devices.
§ 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.