(153 days)
No
The 510(k) summary describes a mechanical internal fixation system and does not mention any AI or ML components or functionalities.
No
The device is described as an internal fracture fixation system for alignment, stabilization and fixation of fractures and osteotomies, fusions and reconstructions, which are considered mechanical treatments rather than therapeutic.
No
Explanation: The device is described as an internal fracture fixation system for alignment, stabilization, and fixation of fractures and osteotomies. It is not used for diagnosing medical conditions.
No
The device description explicitly states it is an "internal fracture fixation system" and mentions components and instrumentation, indicating it is a physical medical device, not software only.
Based on the provided information, the G-Beam™ Fusion Beaming System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to be inserted in the foot and ankle for alignment, stabilization and fixation of various fractures and osteotomies, fusions and reconstructions." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The device is described as an "internal fracture fixation system," which is a type of medical device used surgically.
- 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.
IVD devices are used in vitro (outside the body) to analyze biological samples. The G-Beam™ Fusion Beaming System is an in vivo surgical implant.
N/A
Intended Use / Indications for Use
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).
Product codes
HWC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle including metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The potential hazards have been evaluated and controlled through a Risk Management Plan. All testing met or exceeded the requirements as established by the test protocols and applicable standards. A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure. The Subject device was therefore found to be substantially equivalent to the predicate device. Clinical data was not needed to support the safety and effectiveness of the Subject Device. Mechanical testing was performed according to the following standards: ASTM F1264-16 "Standard Specification and Test Methods for Intramedullary Fixation Devices". ASTM F-543-13 "Standard Specification and Test Methods for metallic bone screws".
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 Ricadona
Sr. Quality & Regulatory Affairs Manager |
|----------------|---------------------------------------------------------------|
| Address | Via delle Nazioni, 9
37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| email | 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 Bolts | ||
| System | 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 |
4
| 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). |
5
| Technological
Characteristics and
Substantial
Equivalence | Documentation was provided to demonstrate that the G-Beam™
Fusion Beaming System is substantially equivalent to the legally
marketed predicates.
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 G-Beam™ Fusion Beaming System is substantially equivalent
to the predicate devices in: intended use, site of application, patient
population, conditions of use, mechanical performances, operating
principles.
Mechanical testing show how the mechanical properties of the
subject device are equivalent or better than the predicate device. |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | The potential hazards have been evaluated and controlled through
a Risk Management Plan.
All testing met or exceeded the requirements as established by the
test protocols and applicable standards. A review of the mechanical
data indicates that the components of the Subject device are
capable of withstanding expected loads without failure. The Subject
device was therefore found to be substantially equivalent to the
predicate device. Clinical data was not needed to support the
safety and effectiveness of the Subject Device.
Mechanical testing was performed according to the following
standards:
• ASTM F1264-16 "Standard Specification and Test Methods
for Intramedullary Fixation Devices".
• ASTM F-543-13 "Standard Specification and Test Methods
for metallic bone screws" |
| Pyrogenicity
data | In order to establish the Subject device non-pyrogenicity, tests were
performed according to the following international standards:
• USP 38: 2014 "Bacterial endotoxin test (LAL)".
• USP 38: 2014 "Medical devices – bacterial endotoxin
and pyrogen tests".
• ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Test
methodologies, routine monitoring and alternative batch testing". |
| Conclusion | Based upon similarities in: intended use, site of application, patient
population, conditions of use, mechanical performances, operating
principles, and according to the results of mechanical testing, G-Beam™ Fusion Beaming System has been shown to be
substantially equivalent to the legally marketed predicate device and
to be as safe and effective as the predicate for its intended use. |