(268 days)
The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as:
- comminuted open or closed fractures
- polytrauma patient
- damage control orthopedics for fractures with severe soft tissue injuries
- peri-prosthetic or peri-implant fractures
- joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
- intra-operative fracture reduction
- intermediate stabilization in staged surgery
- infected non-union pending second stage treatment bone-loss or other reconstructive procedures.
The Galaxy UNYCO System consists of a series of sterile kits that include clamps, rods, screws and specific application tools. An external fixation system, as the subject device, is modular and so different frame configurations are possible. The Orthofix components in the Galaxy UNYCO System are not intended to replace normal healthy bone or to withstand the stresses of weight bearing. The Galaxy UNYCO System is compatible with Galaxy Fixation System and bicortical screws.
Here's an analysis of the provided text regarding acceptance criteria and studies, organized as requested.
The provided document describes the Galaxy UNYCO System, which is an external fixation device. This device is exempt from the typical AI/machine learning evaluation criteria, as it is a mechanical device, not a diagnostic algorithm. Therefore, many of the requested fields (such as effect size of human readers with AI, standalone performance, training set details, and expert ground truth establishment for AI) are not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, mechanical performance, and biocompatibility, as is typical for traditional 510(k) submissions for mechanical devices.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Galaxy UNYCO System are based on its mechanical performance and biocompatibility, demonstrating that it meets established standards for external skeletal fixation devices and medical-grade materials. The reported performance indicates that the device met or exceeded these requirements.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Description | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Withstanding expected loads without failure, per relevant ASTM standards for external skeletal fixation devices and bone screws. | All testing met or exceeded the requirements established by test protocols and applicable standards. The components are capable of withstanding expected loads without failure. |
| Biocompatibility | Non-pyrogenicity and safety for patient contact, per USP and ANSI/AAMI standards. | Additional tests performed according to USP 38:2014 and ANSI/AAMI ST72:2011 demonstrated non-pyrogenicity (e.g., bacterial endotoxin test). |
| Substantial Equivalence | Demonstrated equivalence in intended use, site of application, patient population, conditions-of-use, mechanical performances, basic design, operating principles, and materials compared to predicate devices. | Documentation provided shows substantial equivalence to legally marketed predicate devices (Synthes Large External Fixation, Orthofix Galaxy Unyco System (K153233)). |
Study Details (Focusing on Mechanical Device Evaluation)
As this is a mechanical device, the "study" primarily refers to bench testing and material characterization, not clinical trials or AI performance evaluations.
- Sample size used for the test set and the data provenance: Not explicitly stated in terms of a "sample size" for a test set as would be for an AI model. The evaluation involved mechanical testing of device components and biocompatibility testing of materials. The data provenance would be laboratory testing conducted by or for Orthofix Srl. No specific country of origin for this testing data is provided, but Orthofix Srl is located in Italy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is established through engineering specifications, material science, and established international standards (e.g., ASTM, ISO), not by expert consensus in diagnosing cases.
- Adjudication method for the test set: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, common in diagnostic imaging studies for AI.
- 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 device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used:
- Mechanical: Engineering specifications and performance defined by international standards (ASTM F1541-02e1, ASTM F899-12b, ASTM F543-13e1).
- Biocompatibility: Standards for non-pyrogenicity and material safety (USP 38:2014, ANSI/AAMI ST72:2011).
- The sample size for the training set: Not applicable. This is not an AI device and does not have a "training set" in the machine learning sense. The design and material choices are based on established engineering principles and prior knowledge.
- How the ground truth for the training set was established: Not applicable.
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Orthofix Srl % Ms. Cheryl Wagoner Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K170146
Trade/Device Name: Galaxy UNYCO System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: September 11, 2017 Received: September 12, 2017
Dear Ms. Wagoner:
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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Casey Hanley -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
510(k) Number (if known) K170146
Device Name Galaxy UNYCO System
Indications for Use (Describe)
The Galaxy UNYCO System is intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
Temporary stabilization of the femur, tibia and ankle in conditions and procedures, such as:
- · comminuted open or closed fractures
- · polytrauma patient
- · damage control orthopedics for fractures with severe soft tissue injuries
- · peri-prosthetic or peri-implant fractures
- · joint dislocations, intra- and extra-articular injuries where spanning fixation is needed
- · intra-operative fracture reduction
- · intermediate stabilization in staged surgery
- · infected non-union pending second stage treatment bone-loss or other reconstructive procedures.
| Type of Use (Select one or both, as applicable) | Reproductive Use (Part 31 CFR 321 Subpart B) One-Time Consumptive Use (31 CFR 321 Subpart C) | Reproductive Use (Part 31 CFR 321 Subpart B) | One-Time Consumptive Use (31 CFR 321 Subpart C) |
|---|---|---|---|
| Reproductive Use (Part 31 CFR 321 Subpart B) | One-Time Consumptive Use (31 CFR 321 Subpart C) |
X | 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/2 description: The image shows the logo for Orthofix, a medical device company. Below the logo, the text "510(k) Summary" is written in a clear, bold font. The logo consists of the word "ORTHOFIX" in bold, black letters, with a blue, abstract shape above it.
(as required by 21 CFR 807.92)
| Submitter | Orthofix Srl |
|---|---|
| Via delle Nazioni, 9 37012 Bussolengo (VR) - Italy | |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca RicadonaQuality & 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 | January 13, 2017 |
| Trade Name | Galaxy UNYCO System |
|---|---|
| Common Name | External Fixation Device and Accessories |
| Panel Code | Orthopedic |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories. |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | KTT |
| Predicate Device Name | 510(k) Number | Manufacturer |
|---|---|---|
| Synthes Large External Fixation, MR Conditional | K082650 | Synthes |
| Galaxy Unyco System | K153233 | Orthofix Srl |
| Description | The Galaxy UNYCO System consists of a series of sterile kits thatinclude clamps, rods, screws and specific application tools. Anexternal fixation system, as the subject device, is modular and sodifferent frame configurations are possible. The Orthofix componentsin the Galaxy UNYCO System are not intended to replace normalhealthy bone or to withstand the stresses of weight bearing. TheGalaxy UNYCO System is compatible with Galaxy Fixation Systemand bicortical screws. |
|---|---|
| Indications andIntended Use | The Galaxy UNYCO System is intended to be used for temporarybone stabilization in trauma and orthopedic procedures of the lowerlimb prior to definitive treatment.Temporary stabilization of the femur, tibia and ankle in conditions andprocedures, such as:• comminuted open or closed fractures• polytrauma patient• damage control orthopedics for fractures with severe soft tissueinjuries• peri-prosthetic or peri-implant fractures |
| joint dislocations, intra- and extra-articular injuries where spanning fixation is needed intra-operative fracture reduction intermediate stabilization in staged surgery infected non-union pending second stage treatment bone-loss or other reconstructive procedures. | |
| TechnologicalCharacteristics andSubstantialEquivalence | Documentation was provided to demonstrate that the Galaxy Unyco System is substantially equivalent to the legally marketed predicates.The devices and accessories included in the Galaxy Unyco System and the predicate devices are all external fracture fixation systems as defined in 21 CFR 888.3030. The Galaxy Unyco System is substantially equivalent to the predicate devices in intended use, site of application, patient population, conditions-of-use, mechanical performances, basic design, operating principles and materials. |
| 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 devices. Clinical data was not needed to support the safety and effectiveness of the Subject Device.Mechanical testing were performed in accordance to the following international standards: ASTM F1541 - 02e1 2011 "Standard Specification and Test Methods for External Skeletal Fixation Devices" ASTM F899 – 12b 2012 "Standard Specification for Stainless Steel for Surgical Instruments" ASTM F543-13e1 2013 "Standard Specification and Test Methods for Metallic Medical Bone Screws" |
| BiocompatibilityData | In order to address non-pyrogenicity of the Subject System, additional tests were performed according to the following standards and Guidance: USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)". USP 38: 2014 < 161 > "Medical devices – bacterial endotoxin and pyrogen tests". ANSI / AAMI ST72: 2011 "Bacterial endotoxins – Test methodologies, routine monitoring and alternative batch testing". "Guidance for Industry - Pyrogen and Endotoxins Testing: Question and Answers", issued by FDA on June 2012 |
| Conclusion | Based on design, materials, intended use, technological characteristics and comparison to the predicates, Galaxy UNYCO femur and knee bridging has been shown to be substantially equivalent to legally marketed predicate devices. |
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Traditional 510(k) Premarket Notification
Galaxy UNYCO System: femur and knee bridging
§ 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.