(179 days)
Not Found
No
The device description and performance studies focus on mechanical properties and sterility, with no mention of AI/ML or related concepts like image processing or data analysis for diagnosis or treatment planning.
No
The device is a kit of plates and screws used for the stabilization of distal fibular fractures, rather than for therapeutic treatment.
No
The device is described as a "KITE Distal Fibula Kit" which is comprised of "various plates and screws" intended for "stabilization of distal lateral and posterior fibular fractures." This indicates it is a surgical implant used for treatment, not for diagnosis. The performance studies described involve mechanical testing of the plates and screws, not diagnostic accuracy.
No
The device description explicitly states it is comprised of "various plates and screws," which are hardware components, not software. The performance studies also focus on mechanical testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the stabilization of bone fractures (distal fibula). This is a surgical/implantable device, not a diagnostic test performed on samples outside the body.
- Device Description: The description details plates and screws used for bone fixation, which are typical components of orthopedic implants.
- 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 screening.
- Performance Studies: The performance studies described focus on the mechanical properties of the plates and screws (bending, torsional, pullout tests) and sterility, which are relevant to surgical implants, not IVDs.
IVD devices are used to perform tests in vitro (outside the body) on biological samples to provide diagnostic information. This device is used in vivo (inside the body) to treat a physical condition.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
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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.
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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
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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)
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3
510(k) Summary
| 510(k) Number | K230623 |
|---|---|
| Device Trade Name: | KITE Distal Fibula Kit |
| Manufacturer: | Intrauma S.p.A. |
| Via Genova, 19 | |
| Rivoli (TO) Italy 10098 | |
| Primary Contact: | Stefano Pullega |
| Quality and Regulatory Director | |
| Intrauma S.p.A. | |
| Via Genova 19 | |
| Rivoli (TO) Italy 10098 | |
| Office: +39.011.9539496 | |
| Mobile: +39.344.3488351 | |
| stefano.pullega@intrauma.com | |
| Prepared by: | MCRA, LLC |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 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.