(153 days)
The G-Beam™ Fusion Beaming System is intended to be inserted in the foot and ankle for alignment, stabilization and fixation of various fractures and osteotomies, fusions and reconstructions. It is indicated for fracture and osteotomy fixation, reconstruction procedures, non-unions and fusions of the foot and ankle including metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus. Specific example: medial and lateral column fusions resulting from neuropathic osteoarthropathy (Charcot osteoarthropathy).
Components and instrumentation included in the G-Beam™ Fusion Beaming System and the predicate device are both internal fracture fixation systems, as defined in 21 CFR 888.3040.
The provided text describes Orthofix Srl's G-Beam Fusion Beaming System and its 510(k) submission for FDA clearance. The document focuses on establishing substantial equivalence to predicate devices through technical characteristics and mechanical performance testing rather than clinical studies or AI algorithm evaluation. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-specific metrics is not available in the given text.
However, based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The text indicates that the device met or exceeded requirements established by test protocols and applicable standards. However, specific numerical acceptance criteria and precise performance values (e.g., specific load capacities, fatigue cycles) are not detailed in the provided summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties | Equivalent or better than predicate devices, capable of withstanding expected loads without failure. |
| Non-pyrogenicity | Tests performed according to USP 38: 2014 < 85 >, USP 38: 2014 < 161 >, and ANSI / AAMI ST72: 2011 met requirements. |
2. Sample size used for the test set and the data provenance
The text refers to "mechanical testing" and "tests were performed" but does not specify the sample size of the devices or components used for these tests. Data provenance is not described in terms of country of origin or retrospective/prospective; it's related to laboratory testing results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a physical medical implant, not an AI-powered diagnostic device requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication of expert opinions for ground truth in diagnostic studies, which is not relevant for this device's evaluation.
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. The G-Beam Fusion Beaming System is a physical implant, not an AI system for image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. No AI algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" is defined by the requirements of the standards (e.g., specific load magnitudes, displacement limits, fatigue life) within the scope of the testing protocols. For pyrogenicity, it's the absence of bacterial endotoxins as defined by the USP and ANSI/AAMI standards.
8. The sample size for the training set
Not applicable. There is no AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI model requiring a training set or its associated ground truth establishment.
Summary of the Study performed (Mechanical and Pyrogenicity Testing):
Study Purpose: To demonstrate that the G-Beam Fusion Beaming System is substantially equivalent to legally marketed predicate devices in terms of mechanical performance and non-pyrogenicity.
Methodology:
- Mechanical Performance Testing:
- Standards Used: ASTM F1264-16 "Standard Specification and Test Methods for Intramedullary Fixation Devices" and ASTM F-543-13 "Standard Specification and Test Methods for metallic bone screws".
- Outcome: "A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure."
- Pyrogenicity Testing:
- Standards Used: USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)", USP 38: 2014 < 161 > "Medical devices – bacterial endotoxin and pyrogen tests", and ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Test methodologies, routine monitoring and alternative batch testing".
- Outcome: "tests were performed according to the following international standards" to establish non-pyrogenicity.
Results/Conclusion: All testing met or exceeded the requirements as established by the test protocols and applicable standards. The mechanical properties of the subject device were found to be "equivalent or better than the predicate device." The device was found to be "substantially equivalent to the predicate device" in terms of safety and effectiveness, and "Clinical data was not needed to support the safety and effectiveness of the Subject Device."
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February 7, 2018
Orthofix Srl Gianluca Ricadona Sr. Quality & Regulatory Affairs Manager Via delle Nazioni, 9 37012 Bussolengo (VR) Italy
Re: K172698
Trade/Device Name: G-Beam Fusion Beaming System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: January 5, 2018 Received: January 8, 2018
Dear Gianluca Ricadona:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K172698
Device Name G-Beam™ Fusion Beaming System
Indications for Use (Describe)
The G-Beam™ Fusion Beaming System is intended to be inserted in the foot and ankle for alignment,
stabilization and fixation of various fractures and osteotomies, fusions and reconstructions.
It is indicated for fracture and osteotomy fixation, reconstruction procedures, non-unions and fusions of the foot and ankle including metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus.
Specific example: medial and lateral column fusions resulting from neuropathic osteoarthropathy (Charcot osteoarthropathy).
| 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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Image /page/3/Picture/1 description: The image shows the logo for Orthofix, a medical device company. Below the logo is the text "510(k) Summary" and the text "(as required by 21 CFR 807.92)". The logo consists of the word "ORTHOFIX" in a bold, sans-serif font, with a registered trademark symbol next to it. Above the word is a blue, abstract shape.
| Submitter Name | Orthofix Srl |
|---|---|
| Address | Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca RicadonaSr. Quality & Regulatory Affairs Manager |
|---|---|
| Address | Via delle Nazioni, 937012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| GianlucaRicadona@orthofix.it | |
| Date Prepared | February 5, 2018 |
| Trade Name | G-Beam™ Fusion Beaming System |
|---|---|
| Common Name | Screw, fixation, bone |
| Panel Code | Orthopedic |
| Classification | Smooth or threaded metallic bone fixation fastener |
| Name | |
| Class | Class II |
| Regulation Number | 21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Device Name | 510(k) Number | Manufacturer |
|---|---|---|
| SALVATION™ Beams and BoltsSystem | K140741 | Wright Medical Technology, Inc. |
| Axis Charcot Fixation System | K171018 | Extremity Medical LLC |
| Orthofix External Fixation Screw(Pin) with hydroxyapatite coating(Reference device) | K974186 | Orthofix SRL |
| Orthofix Titanium Nailing Systems(Reference device) | K053261 | Orthofix SRL |
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| procedures, non-unions and fusions of bones of the foot and ankle |
|---|
| including metatarsals, cuneiforms, cuboid, navicular, calcaneus and |
| talus. |
| Specific example: medial and lateral column fusions resulting from |
| neuropathic osteoarthropathy (Charcot osteoarthropathy). |
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| TechnologicalCharacteristics andSubstantialEquivalence | Documentation was provided to demonstrate that the G-Beam™Fusion Beaming System is substantially equivalent to the legallymarketed predicates.Components and instrumentation included in the G-Beam™ FusionBeaming System and the predicate device are both internal fracturefixation systems, as defined in 21 CFR 888.3040.The G-Beam™ Fusion Beaming System is substantially equivalentto the predicate devices in: intended use, site of application, patientpopulation, conditions of use, mechanical performances, operatingprinciples.Mechanical testing show how the mechanical properties of thesubject device are equivalent or better than the predicate device. |
|---|---|
| Performance Data | The potential hazards have been evaluated and controlled througha Risk Management Plan.All testing met or exceeded the requirements as established by thetest protocols and applicable standards. A review of the mechanicaldata indicates that the components of the Subject device arecapable of withstanding expected loads without failure. The Subjectdevice was therefore found to be substantially equivalent to thepredicate device. Clinical data was not needed to support thesafety and effectiveness of the Subject Device.Mechanical testing was performed according to the followingstandards:• ASTM F1264-16 "Standard Specification and Test Methodsfor Intramedullary Fixation Devices".• ASTM F-543-13 "Standard Specification and Test Methodsfor metallic bone screws" |
| Pyrogenicitydata | In order to establish the Subject device non-pyrogenicity, tests wereperformed according to the following international standards:• USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)".• USP 38: 2014 < 161 > "Medical devices – bacterial endotoxinand pyrogen tests".• ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Testmethodologies, routine monitoring and alternative batch testing". |
| Conclusion | Based upon similarities in: intended use, site of application, patientpopulation, conditions of use, mechanical performances, operatingprinciples, and according to the results of mechanical testing, G-Beam™ Fusion Beaming System has been shown to besubstantially equivalent to the legally marketed predicate device andto be as safe and effective as the predicate for its intended use. |
§ 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.