(57 days)
The Avanti Orthopaedics 2.2mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixatures, fusions, osteotomies, non-unions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Avanti Orthopaedics Cannulated Compression Screw System are metallic bone screws manufactured from Stainless Steel (ASTM F138). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The Avanti Orthopaedics Cannulated screws are cannulated for use with guidewires for precise placement in bone.
The provided text describes a 510(k) premarket notification for Avanti Orthopaedics 2.2mm, 2.7mm, 3.2mm, and 4.0mm Cannulated Screws. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing of the device hardware itself, rather than the performance of an AI/ML powered medical device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (referring to aspects like sample size, ground truth, expert consensus, MRMC studies, etc.) is not present in the provided document.
The document entirely pertains to the physical characteristics and performance of orthopedic screws.
Here's what can be extracted about the non-clinical performance testing of these orthopedic screws:
Summary of Acceptance Criteria and Device Performance for Orthopedic Screws
The provided document describes the acceptance criteria and performance for physical orthopedic devices, specifically Avanti Orthopaedics 2.2mm, 2.7mm, 3.2mm, and 4.0mm Cannulated Screws. The testing is focused on the mechanical properties and safety of the screws, not on an AI/ML algorithm's performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by) | Reported Device Performance |
|---|---|
| Predetermined acceptance criteria as defined in the FDA guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway". | The device met all predetermined acceptance criteria as defined in the referenced FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states that "Testing was performed per ASTM F543-17."
- Sample Size: Not explicitly stated in the document. ASTM F543-17 (Standard Specification and Test Method for Metallic Bone Screws) would specify the required number of samples for each mechanical test (e.g., torsion, bending, dynamic fatigue).
- Data Provenance: Not applicable in the context of clinical data/images. This testing pertains to the physical device. The testing was non-clinical (laboratory testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth in this context refers to the physical properties and performance of the screw under specific test conditions, as defined by engineering standards (ASTM F543-17) and FDA guidance. No human expert interpretation of data is involved in establishing "ground truth" for mechanical testing.
4. Adjudication Method for the Test Set:
- Not applicable. This is mechanical testing against defined specifications, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a physical medical device (orthopedic screw), not an AI/ML software device. MRMC studies are used for evaluating diagnostic or treatment planning software performance with human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used:
- Engineering Standards and Specifications: The "ground truth" for the device's performance is established by the specified mechanical properties and performance requirements outlined in ASTM F543-17 and the FDA guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway". This is objective, measurable data.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary, the provided FDA document is a 510(k) submission for conventional orthopedic screws, not an AI/ML device. Therefore, the detailed questions about AI/ML device performance (like training sets, ground truth establishment by experts, MRMC studies, etc.) are outside the scope of this document.
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November 23, 2022
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Avanti Orthopaedics, Inc. % Linda Braddon, CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K222967
Trade/Device Name: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 26, 2022 Received: September 27, 2022
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 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 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.
Shumava Ali -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws
Indications for Use (Describe)
The Avanti Orthopaedics 2.2mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
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) |
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Indications for Use
510(k) Number (if known)
Device Name
Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws
Indications for Use (Describe)
The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixatures, fusions, osteotomies, non-unions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
| 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."
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510(k) SUMMARY:
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
| Date Prepared | November 18, 2022 | ||
|---|---|---|---|
| Sponsor | Avanti Orthopaedics, Inc1814 Gilpin AvenueWilmington, DE 19806Phone 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 Orthopaedics 2.2mm and 2.7mm Cannulated ScrewsAvanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws | ||
| Common Name | Prosthetic Device | ||
| Code –Classification | Product Code: HWCRegulation: 21 CFR 888.3040Device Class: II | ||
| Subject Device | Primary Predicate | ||
| Primary Predicate | Avanti Orthopaedics 2.2mm and2.7mm Cannulated CompressionScrews | K161616 DePuy Synthes 2.4 mmCannulated Screws | |
| Avanti Orthopaedics 3.2mm and4.0mm Cannulated CompressionScrews | K161616 DePuy Synthes 3.5 mm and4.0 mm Cannulated Screws | ||
| Subject Device | Additional Predicate(s) | ||
| Additional Predicate | Avanti Orthopaedics 2.2mm and2.7mm Cannulated CompressionScrews | K180541 DePuy Synthes 2.0 mmQuick Insertion Screws | |
| Avanti Orthopaedics 3.2mm and4.0mm Cannulated CompressionScrews | K162825 CAPTIVATE™Compression Screws | ||
| Subject Device | Reference Device(s) | ||
| Reference Device | Avanti Orthopaedics 2.2mm and2.7mm Cannulated CompressionScrews | K191118 Avanti Distal Radius andForearm System | |
| Avanti Orthopaedics 3.2mm and4.0mm Cannulated CompressionScrews | K191118 Avanti Distal Radius andForearm System |
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| Device Description | The Avanti Orthopaedics Cannulated Compression Screw System are metallic bone screws manufactured from Stainless Steel (ASTM F138). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The Avanti Orthopaedics Cannulated screws are cannulated for use with guidewires for precise placement in bone. |
|---|---|
| Indications for Use Statement | Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws:The Avanti Orthopedics 2.2 mm and 2.7mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Compression Screws:The Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. |
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Comparison of Technological Characteristics: Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Compression Screws
| Characteristic | Subject DeviceAvanti Orthopaedics 2.2mm and2.7mm Cannulated Compression Screws | Primary PredicateSynthes USA Products, LLC DePuySynthes 2.4 mm Cannulated ScrewsK161616 |
|---|---|---|
| DeviceClassification | Class II | Class II |
| Product Code | HWC | HWC |
| Purpose | Subject device | Same indications |
| Diameter (mm) | 2.2 – 2.7mm | 2.4mm |
| Lengths (mm) | 14 – 60mm | 10 – 50mm |
| Partially / FullyThreaded | Partially ThreadedFully Threaded | Partially ThreadedFully Threaded |
| Head Type | Headless | Low-Profile |
| Driver Shape | Star | Star |
| Cannulated | Yes | Yes |
| Self-Tapping | Yes | Yes |
| Sterility | End-User Sterilized, SteamSterilizationCycle: Pre-VacuumTemperature: 132°C (270°F)Exposure Time: 4 minutesDrying Time: 60 minutes | End-User Sterilized, SteamSterilization |
| Material | Stainless Steel per ASTM F138 | Stainless Steel per ASTM F138 |
| Manufacturing | Subtractive manufacturing | Subtractive manufacturing |
| Biocompatibility | Implant: Permanent Duration -Implant for Tissue / Bone (>30 days)Instrument: Limited Duration -Implant for Tissue / Bone (< 24 hours) | Implant: Permanent Duration -Implant for Tissue / Bone (>30 days)Instrument: Limited Duration -Implant for Tissue / Bone (< 24 hours) |
| Indicated PatientPopulation | Adults and children (2-12 years) andadolescents (12-21 years) in whichgrowth plates have fused or in whichgrowth plates will not be crossed byscrew fixation | Adults and children (2-12 years) andadolescents (12-21 years) in whichgrowth plates have fused or in whichgrowth plates will not be crossed byscrew fixation |
| Characteristic | Subject DeviceAvanti Orthopaedics 3.2mmand 4.0mm CannulatedCompression Screws | Primary PredicateSynthes USA Products, LLCDePuy Synthes 3.5 mm and4.0 mm Cannulated ScrewsK161616 |
| Device Classification | Class II | Class II |
| Product Code | HWC | HWC |
| Purpose | Subject device | Same indications |
| Diameter (mm) | 3.2 - 4.0mm | 3.5 - 4.0mm |
| Lengths (mm) | 14 - 60mm | 10 - 50mm |
| Partially / Fully Threaded | Partially ThreadedFully Threaded | Partially ThreadedFully Threaded |
| Head Type | Headless | Low-Profile |
| Driver Shape | Star | Hex |
| Cannulated | Yes | Yes |
| Self-Tapping | Yes | Yes |
| Sterility | End-User Sterilized, SteamSterilizationCycle: Pre-VacuumTemperature: 132°C (270°F)Exposure Time: 4 minutesDrying Time: 60 minutes | Terminally Sterilized, GammaIrradiation |
| Material | Stainless Steel per ASTM F138 | Stainless Steel per ASTM F138 |
| Manufacturing | Subtractive manufacturing | Subtractive manufacturing |
| Biocompatibility | Implant: Permanent Duration -Implant for Tissue / Bone (>30days)Instrument: Limited Duration -Implant for Tissue / Bone (< 24hours) | Implant: Permanent Duration -Implant for Tissue / Bone (>30days)Instrument: Limited Duration -Implant for Tissue / Bone (< 24hours) |
| Indicated Patient Population | Adults and children (2-12 years)and adolescents (12-21 years) inwhich growth plates have fusedor in which growth plates willnot be crossed by screwfixation. | Adults and children (2-12 years)and adolescents (12-21 years) inwhich growth plates have fusedor in which growth plates willnot be crossed by screwfixation. |
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Comparison of Technological Characteristics: Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Compression Screws
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Technological Characteristics
There are no significant technological differences between the subject and predicate devices. The subject device uses the same material as the additional predicate and reference device and all devices are manufactured using subtractive techniques. Any differences in available sizes between the subject and predicate devices were addressed via the additional predicates (K180541, K162825).
Non-Clinical Performance Testing Summary
Testing was performed per ASTM F543-17 and the device met all predetermined acceptance criteria as defined in the FDA guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway".
Conclusions
Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.