(179 days)
The KITE Distal Fibula Kit is indicated for:
- Diaphyseal and metaphyseal fractures of the distal fibula
- Intra and extra articular fractures of the distal fibula
- Non-unions of the distal fibula
The KITE Distal Fibula Kit is intended for the stabilization of distal lateral and posterior fibular fractures including those of the diaphysis and metaphysis and intra-articular fractures. The system is comprised of various plates and screws which allow it to be customized to a patient's anatomy and fracture pattern. The plate is secured in place via autolocking and cortical screws.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KITE Distal Fibula Kit, formatted as requested:
KITE Distal Fibula Kit Acceptance Criteria and Study Analysis
Below is a summary of the acceptance criteria and the studies performed to demonstrate the device meets these criteria, based solely on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria Source | Reported Device Performance |
|---|---|---|
| Plates | ||
| Static 4-point Bending | ASTM F382-17 Annex A1 and "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Screws | ||
| Torsional Test | ASTM F543-17 and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Insertion & Removal Test | ASTM F543-17 and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Pullout Test | ASTM F543-17 and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Self-Tapping Test | ASTM F543-17 and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" | Device performance demonstrates alignment with acceptance criteria. (Specific quantitative results not provided in the summary) |
| Sterility/Biocompatibility | ||
| LAL Testing | FDA Guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff" issued January 21, 2016 | Testing was performed according to the guidance. (Specific results like endotoxin levels or pass/fail not explicitly stated but implied success for clearance) |
Notes on Reported Performance: The summary states that performance data "demonstrates alignment" or "demonstrate substantial equivalence" and "demonstrate alignment acceptance criteria," indicating that the device met the specified criteria. However, explicit quantitative results for each test (e.g., specific bending strength values, torque values, pullout forces) are not provided in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes bench testing for mechanical properties and sterility, not clinical testing with human subjects or patient data. Therefore, the concepts of "test set" in terms of patient data, data provenance, and retrospective/prospective studies are not applicable here.
- Sample Size for Mechanical Testing: The specific number of plates or screws tested for each mechanical test (e.g., how many plates for 4-point bending, how many screws for torsional tests) is not specified in the provided summary.
- Data Provenance: Not applicable as it's mechanical bench testing, not clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for mechanical and sterility testing is established by the specified ASTM standards and FDA guidance documents, which define the testing methodology and acceptance criteria. This does not involve human expert adjudication of results in the way clinical image analysis or diagnostic studies would.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1 consensus. The tests are either pass/fail based on objective mechanical properties or sterility criteria defined in standards and guidance documents.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., AI for medical imaging) to assess the impact of AI assistance on human reader performance. The KITE Distal Fibula Kit is a bone fixation appliance, and its clearance is based on mechanical performance and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a bone fixation kit, not an algorithm or AI-based diagnostic tool. The performance studies described are for the physical components of the kit.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Mechanical Standards: ASTM F382-17 (for plates) and ASTM F543-17 (for screws). These standards define the methods for measuring specific mechanical properties.
- FDA Guidance Documents: "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" for mechanical performance, and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff" for LAL testing. These documents define the acceptance criteria that demonstrate safety and performance for these types of devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical medical implant.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/machine learning algorithm, there is no ground truth to establish for it.
{0}------------------------------------------------
September 1, 2023
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.
Intrauma S.p.A Stefano Pullega Quality and Regulatory Director Via Genova 19 Rivoli (TO), 10098 Italy
Re: K230623
Trade/Device Name: KITE Distal Fibula Kit 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: August 3. 2023 Received: August 3, 2023
Dear Stefano Pullega:
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.
{1}------------------------------------------------
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 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 (QS) 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 medical devices and radiation-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.
Image /page/1/Picture/5 description: The image contains the letters "FDA" in a light blue color on the left side of the image. To the right of the letters, the name "Tejen D. Soni -S" is written in black. The text is aligned to the left and the font is sans-serif.
For Shumaya Ali, M.P.H. 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)
Device Name KITE Distal Fibula Kit
Indications for Use (Describe)
The KITE Distal Fibula Kit is indicated for:
- Diaphyseal and metaphyseal fractures of the distal fibula
- Intra and extra articular fractures of the distal fibula
- Non-unions of the distal fibula
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) Summary
| 510(k) Number | K230623 |
|---|---|
| Device Trade Name: | KITE Distal Fibula Kit |
| Manufacturer: | Intrauma S.p.A.Via Genova, 19Rivoli (TO) Italy 10098 |
| Primary Contact: | Stefano PullegaQuality and Regulatory DirectorIntrauma S.p.A.Via Genova 19Rivoli (TO) Italy 10098Office: +39.011.9539496Mobile: +39.344.3488351stefano.pullega@intrauma.com |
| Prepared by: | MCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: 202.552.5800 |
| Date Prepared: | August 30, 2023 |
| Classifications: | 21 CFR 888.3030, Bone Fixation Plate (Primary)21 CFR 888.3040, Screw Fixation Bone |
| Class: | II |
| Product Codes: | HRS, HWC |
| Primary Predicate: | Synthes 2.7mm/3.5mm LCP Distal Fibula Plate (K073460) |
| Additional Predicates: | Synthes Small Fragment Dynamic Compression Locking (DCL)System (K000684), and Baby Gorilla®/Gorilla® Plating System(K203511) |
Indications For Use:
The KITE Distal Fibula Kit is indicated for:
- Diaphyseal and metaphyseal fractures of the distal fibula -
- Intra and extra articular fractures of the distal fibula :
- Non-unions of the distal fibula
{4}------------------------------------------------
Device Description:
The KITE Distal Fibula Kit is intended for the stabilization of distal lateral and posterior fibular fractures including those of the diaphysis and metaphysis and intra-articular fractures. The system is comprised of various plates and screws which allow it to be customized to a patient's anatomy and fracture pattern. The plate is secured in place via autolocking and cortical screws.
Predicate Device:
Intrauma S.p.A. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, KITE Distal Fibula Plate is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to preamendment devices:
Primary Predicate: Synthes 2.7mm/3.5mm LCP Distal Fibula Plate (K073460) Additional Predicates: Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684), and Baby Gorilla®/Gorilla® Plating System (K203511)
Performance Testing Summary:
Static 4-point bending tests were performed on the subject plates in order to measure the bending stiffness, the bending structural stiffness, and the bending strength using a 4-Point Bending test according to ASTM F382-17 Annex A1. Testing of the subject plates was also compared to acceptance criteria from the "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" to support subject device safety and performance.
The screws were tested according to ASTM F543-17 and results from testing were compared to acceptance criteria from the FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway" to support subject device safety and performance. The following tests were performed for each screw type included in the KITE Distal Fibula Kit:
- Torsional Test
- Insertion and Removal Test
- . Pullout Test
- Self-Tapping Test ●
Additionally, LAL testing was performed on the KITE Distal Fibula Kit according to FDA Guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile Guidance for Industry and Food and Drug Administration Staff" issued January 21, 2016.
Substantial Equivalence:
The KITE Distal Fibula Kit is substantially equivalent to the predicate devices with respect to indications, design, function, and performance. Additionally, the KITE Distal Fibula Kit is substantially equivalent to the additional predicates with respect to the full size range and types of plates and screws offered.
Technological Comparison
The subject and predicate devices use the same inherent technology (i.e., screw and plate components) to fix bone fragments to allow for bone healing in the distal fibula. The subject and
{5}------------------------------------------------
predicate devices are comprised of both locking and cortical screws to achieve bone fixation of the plate. The plates contain various quantities and types of holes specific to each size offering for use with the included bone screws.
Conclusion:
The subject and predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The performance data included in this submission demonstrate substantial equivalence to the predicate device listed above. Additionally, performance testing data collected on the subject device demonstrate alignment acceptance criteria within FDA guidance documents. Therefore, the KITE Distal Fibula Plate is substantially equivalent to 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.