(30 days)
The AOS Galileo™ Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.
The AOS Galileo™ Trochanteric Nail System is a single-use, open reduction and internal fixation device, comprised of the Trochanteric Intermedullary Nail, Telescoping Lag Screws, Anti Rotation Screw, Cortical Locking Bone Screws, and their dedicated accessories, and sterilization trays. The trochanteric nail is a side specific cannulated femoral intramedullary nail with a proximal bend that is designed to enter through the greater trochanter, for the treatment of fractures to the femur, including peritrochanteric, intertrochanteric, high subtrochanteric fractures, and combinations thereof. The device is meant to be used as a load sharing device, and it may be removed once the fracture is healed.
This document is a 510(k) summary for the AOS Galileo™ Trochanteric Nail System. It describes the device, its indications for use, and its substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided text in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a tabular format as would typically be seen for AI/software-as-a-medical-device (SaMD) performance. Instead, it describes a comparison to predicate devices for mechanical properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate mechanical properties/strength | "The AOS Galileo™ Trochanteric Nail System was subjected to functional testing and strength comparison analysis. The results demonstrate that the Galileo™ Intramedullary Nails and accessories are substantially equivalent to the predicates." |
| Same intended use, patient population, operating principle, risk profile | "The subject AOS Galileo™ Trochanteric Nail System, the predicates... have the same intended use, patient population, operating principle, and risk profile." |
| Identical manufacturing, packaging, sterilization, and shipping | "They have identical manufacturing, packaging, sterilization parameters, and shipping processes, all of which will be conducted under the same quality management system." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of AI/SaMD performance evaluation. The "testing" mentioned is functional and strength comparison analysis of the physical device. Therefore, a sample size for a test set and data provenance for a clinical study are not applicable or provided here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD that requires human expert ground truth for image interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD.
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 document pertains to a physical orthopedic implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical orthopedic implant.
7. The Type of Ground Truth Used
For the functional and strength testing, the "ground truth" would be the established mechanical standards and performance characteristics of the predicate devices, against which the new device was compared. This is based on engineering principles and material science, not clinical outcomes or expert consensus in the typical sense for AI.
8. The Sample Size for the Training Set
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This document pertains to a physical orthopedic implant, not an AI/SaMD.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document describes "functional testing and strength comparison analysis" as the study performed to demonstrate that the AOS Galileo™ Trochanteric Nail System is substantially equivalent to its predicate devices. The study concluded that the new device's performance is substantially equivalent, implying it meets the mechanical and functional requirements of the predicate. This is a non-clinical study focused on the physical device's characteristics rather than a clinical trial measuring patient outcomes or an AI model's diagnostic accuracy.
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August 28, 2020
Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Advanced Orthopaedic Solutions, Inc. Jolie Krance Senior Regulatory Affairs Specialist 3203 Kashiwa Street Torrance, California 90505
Re: K202099
Trade/Device Name: AOS Galileo™ Trochanteric Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 29, 2020 Received: July 30, 2020
Dear Jolie Krance:
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.
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
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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 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,
Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Special 510(k) Summary
| Date Prepared | August 21, 2020 |
|---|---|
| Submitted by | Advanced Orthopaedic Solutions, Inc3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966 |
| Establishment Registration | 2032480 |
| Owner Operator Number | 9046896 |
| Regulatory Contact | Jolie KranceSenior Regulatory Affairs SpecialistAdvanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505(310) 533-9966jkrance@aosortho.com |
| Device Name | AOS Galileo™ Trochanteric Nail System |
| Common Name | Trochanteric Intermedullary Nail System |
| Classification | Class II, 21 CFR 888.3020 Intramedullary Fixation Rod |
| Device Code | HSB — Rod, Fixation, Intramedullary and Accessories |
| AOS Legally MarketedSubstantially EquivalentDevices | Primary — AOS Galileo™ Trochanteric Nail System - Lag Screw(K120148, Cleared October 2, 2012)Additional — AOS Galileo™ Trochanteric Nail System (K021008,Cleared June 20, 2002), and AOS Galileo™ Trochanteric Nail System -ES Nail (K103533, Cleared January 19, 2011) |
| Device Description | The AOS Galileo™ Trochanteric Nail System is a single-use, openreduction and internal fixation device, comprised of the TrochantericIntermedullary Nail, Telescoping Lag Screws, Anti Rotation Screw,Cortical Locking Bone Screws, and their dedicated accessories, andsterilization trays. The trochanteric nail is a side specific cannulatedfemoral intramedullary nail with a proximal bend that is designed toenter through the greater trochanter, for the treatment of fractures tothe femur, including peritrochanteric, intertrochanteric, highsubtrochanteric fractures, and combinations thereof. The device ismeant to be used as a load sharing device, and it may be removedonce the fracture is healed. |
| Indications for Use | The AOS Galileo™ Trochanteric Nail System is intended to treat stableand unstable proximal fractures of the femur includingperitrochanteric, intertrochanteric and high subtrochanteric fracturesand combinations of these fractures. The long trochanteric nail isadditionally indicated for subtrochanteric fractures, peritrochantericfractures associated with shaft fractures, pathologic fractures(including prophylactic use) in osteoporotic bone of the trochantericand diaphyseal areas, long subtrochanteric fracture, ipsilateral femoralfractures, proximal and distal non-unions and malunions and revisionsprocedures. |
| TechnologicalCharacteristics | The AOS Galileo Trochanteric Nail System subject device has similartechnological charateristics to the identified predicates. The materialand chemical composition, performance requirements, and method ofoperation are identical to the predicate devices. |
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Image /page/4/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" and "O" in blue and the "S" in gray. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
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Image /page/5/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in blue, the "O" in blue, and the "S" in gray. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is aligned to the left.
| Substantial Equivalence | The subject AOS Galileo™ Trochanteric Nail System, the predicatesAOS Galileo™ Lag Screw (K120148) AOS Galileo™ Trochanteric NailSystem (K021008), and the AOS Galileo™ Trochanteric ES Nail(K103533), have the same intended use, patient population, operatingprinciple, and risk profile. They have identical manufacturing,packaging, sterilization parameters, and shipping processes, all ofwhich will be conducted under the same quality management system. |
|---|---|
| Nonclinical Testing | The AOS Galileo™ Trochanteric Nail System was subjected tofunctional testing and strength comparison analysis. The resultsdemonstrate that the Galileo™ Intramedullary Nails and accessoriesare substantially equivalent to the predicates. |
| Conclusion | Since the device has the same intended use and similar technologicalcharacteristics to the identified predicates, the device does not raiseany different questions of safety or effectiveness. The performancetesting and engineering analysis demonstrated that the subject devicehad substantially equivalence performance. Therefore, the premarketnotification demonstrated that the device is substantially equivalent tothe predicate |
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.