(231 days)
The system intended for fixation of fractures, osteotomies, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.
The Avanti Distal Radius and Forearm System includes volar plates, wrist fusion plates, spanning plates, forearm plates, ulnar plates, and cannulated screws, with screw and peg fasteners, for the fixation of fractures, malunions, and osteotomies. Distal radius and forearm fixation plates may be placed on the volar or dorsal surface of the radius and along the shaft of the radius and ulna on the carpal bones. Features of the system include pre-contoured plates to fit the anatomy of the distal radius, a low-profile design to minimize soft tissue irritation, low contact design to optimize blood supply, and bi-planar angulated screw holes for ease of drilling and to optimize fixation and subchrondral support. All plates are manufactured from medical grade stainless steel per ASTM F138 or ASTM F139 and are electropolished per ASTM F-86. The Volar PEEK Plate has a polyetheretherkeytone that is preassembled to the plate and is sourced from Invibio, LTD. The PEEK insert allows insertion of both locking and non-locking fasteners with an infinite variable angle up to 11 degrees using the drill guide provided in the system. All plates include low-profile geometry to minimize soft tissue irritation and the option of compression or locking cortical screws. The Avanti Distal Radius and Forearm System includes self-tapping screws, listed below, that are manufactured from medical grade stainless steel per ASTM F138, electropolished per ASTM F-86, and are compatible with all Avanti plate configurations. All fasteners but the Cannulated Screw are intended to be used with the plates. The cannulated screws can be used for fracture fixation that is appropriately sized for the device which is determined through surgeon discretion.
The provided text describes a 510(k) premarket notification for the "Avanti Distal Radius and Forearm System," a metallic bone fixation appliance and accessories. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of diagnostic or predictive performance.
Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.
Here's why and what information can be extracted:
- This is a 510(k) submission for a physical medical device (orthopedic implants), not a software or AI-based diagnostic/predictive device. The criteria for clearance are based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically through bench testing (non-clinical performance).
- The "study" refers to non-clinical performance testing, not a clinical trial comparing performance against acceptance criteria for a diagnostic measure.
Information that can be extracted relevant to the "study":
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Test Name | Reported Device Performance / Conclusion |
|---|---|
| Non-Clinical Testing Conclusion | The Avanti Distal Radius and Forearm System is substantially equivalent to other predicate devices. |
| Static plate loading (per ASTM F382) | Performed (implies successful demonstration of equivalence to predicate). Specific quantitative results are not provided in this summary. |
| Dynamic plate loading (per ASTM F382) | Performed (implies successful demonstration of equivalence to predicate). Specific quantitative results are not provided in this summary. |
| Screw pullout strength (via ASTM F543) | Performed (implies successful demonstration of equivalence to predicate). Specific quantitative results are not provided in this summary. |
| Locking Mechanism Push-Out Testing | Performed (implies successful demonstration of equivalence to predicate). Specific quantitative results are not provided in this summary. |
| Substantial Equivalence Summary | The Avanti Distal Radius and Forearm System has been shown to be substantially equivalent to legally marketed predicate devices. (This is the overarching "performance" claim). |
2. Sample size used for the test set and the data provenance:
Not applicable. This is not a study involving human or image-based test sets. The "test set" here refers to physical devices or components used in mechanical bench testing. The summary does not specify the number of devices or components tested for each non-clinical test, nor their provenance in the context of "data provenance."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome.
4. Adjudication method for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not a standalone algorithm.
7. The type of ground truth used:
Not applicable in the context of diagnostic performance. For the described non-clinical testing, the "ground truth" implicitly refers to established material properties and mechanical performance standards (ASTM standards) that the device must meet to be considered equivalent to its predicates.
8. The sample size for the training set:
Not applicable. There is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided document is a regulatory submission for a physical medical device, not a software or AI product. The "study" referenced is non-clinical bench testing to demonstrate mechanical performance and substantial equivalence to existing devices, not a study of diagnostic accuracy or reader performance. Therefore, most of the questions are not relevant to this document.
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Image /page/0/Picture/0 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2019
Avanti Orthopaedics, Inc. % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K191118
Trade/Device Name: Avanti Distal Radius and Forearm 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: November 13, 2019 Received: November 14, 2019
Dear Linda Braddon:
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 (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.
Shumaya Ali 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Avanti Distal Radius and Forearm System
Indications for Use (Describe)
The system intended for fixation of fractures, osteotomies, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.
Type of Use (Select one or both, as applicable) □ Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D)
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."
FORM FDA 3881 (7/17)
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K191118 Page 1/2
Image /page/3/Picture/1 description: The image shows the logo for Avanti Orthopaedics. The logo is in blue and features a stylized letter "A" with a swooping line extending from the bottom of the "A" to underline the rest of the word "vanti". Below the word "Avanti" is the word "ORTHOPAEDICS" in smaller, sans-serif font.
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Avanti Distal Radius and Forearm System is provided below.
| Date SummaryPrepared | November 13, 2019 |
|---|---|
| Submitter | Avanti Orthopaedics, Inc4606 Simon RoadWilmington, DE 19803Phone 302-530-6369Fax 302-351-4896 |
| 510(k) Contact | Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com |
| Trade Name | Avanti Distal Radius and Forearm System |
| Common Name | Single/Multiple component metallic bone fixation appliances and accessories |
| Code -Classification | HRS, 21 CFR 888.3030: Class II |
| Primary Predicate | K132704 Biomet Distal Radius Volar Rim (DVR) Plating System |
| AdditionalPredicates | K042355 Synthes LCP Wrist Fusion PlatesK951304 Synthes 2.7 MM Cannulated Screw and Threaded WasherK000684 Synthes Small Fragment Dynamic Compression Locking (DCL) SystemK160995 In2Bones SAS Neoview Plate |
| Device Description | The Avanti Distal Radius and Forearm System includes volar plates, wrist fusionplates, spanning plates, forearm plates, ulnar plates, and cannulated screws,with screw and peg fasteners, for the fixation of fractures, malunions, andosteotomies. Distal radius and forearm fixation plates may be placed on thevolar or dorsal surface of the radius and along the shaft of the radius and ulnaon the carpal bones. Features of the system include pre-contoured plates to fitthe anatomy of the distal radius, a low-profile design to minimize soft tissueirritation, low contact design to optimize blood supply, and bi-planar angulatedscrew holes for ease of drilling and to optimize fixation and subchrondralsupport.All plates are manufactured from medical grade stainless steel per ASTM F138or ASTM F139 and are electropolished per ASTM F-86. The Volar PEEK Plate hasa polyetheretherkeytone that is preassembled to the plate and is sourced fromInvibio, LTD. The PEEK insert allows insertion of both locking and non-lockingfasteners with an infinite variable angle up to 11 degrees using the drill guide |
| provided in the system. All plates include low-profile geometry to minimize softtissue irritation and the option of compression or locking cortical screws.The Avanti Distal Radius and Forearm System includes self-tapping screws, listedbelow, that are manufactured from medical grade stainless steel per ASTMF138, electropolished per ASTM F-86, and are compatible with all Avanti plateconfigurations. All fasteners but the Cannulated Screw are intended to be usedwith the plates. The cannulated screws can be used for fracture fixation that isappropriately sized for the device which is determined through surgeondiscretion. | |
| Intended Use | The system intended for fixation of fractures, osteotomies, malunions, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusionplates may be used for wrist arthrodesis. |
| TechnologicalCharacteristics | The subject Avanti Distal Radius and Forearm System is technological similar toother similarly intended devices in that it has the same technologicalcharacteristics to its predicate devices through comparison in areas includingdesign, intended use, material composition, function, and range of sizes. Thesubject system differences technologically in that the volar plate comes with apre-assembled PEEK insert. The PEEK insert allows insertion of both locking andnon-locking fasteners with variable angle up to 11 degrees using the drill guideprovided in the system. |
| Non-ClinicalPerformanceTesting Conclusion | Non-clinical testing was performed to demonstrate the Avanti Distal Radius andForearm System is substantially equivalent to other predicate devices. Thefollowing tests were performed:Static and dynamic plate loading per ASTM F382 Screw pullout strength via ASTM F543 Locking Mechanism Push-Out Testing |
| SubstantialEquivalenceSummary | The Avanti Distal Radius and Forearm System has been shown to be substantiallyequivalent to legally marketed predicate devices. |
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Image /page/4/Picture/1 description: The image shows the logo for Avanti Orthopaedics. The logo is blue and features the word "Avanti" in a stylized font. Below "Avanti" is the word "ORTHOPAEDICS" in a smaller, sans-serif font. The logo is simple and professional.
§ 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.