(30 days)
Not Found
No
The summary describes a mechanical implant for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an internal fixation device intended to treat fractures, which is a therapeutic purpose, but it is not commonly referred to as a "therapeutic device" in the same vein as devices that administer therapy (e.g., drug delivery systems, pain relief devices). It is a surgical implant designed to stabilize and aid in the healing of fractures.
No
Explanation: The device is described as an "open reduction and internal fixation device" used for treating fractures of the femur. Its function is to stabilize bone fragments, not to diagnose a condition or disease.
No
The device description clearly states it is comprised of physical components like nails, screws, and trays, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to treat bone fractures in the femur. This is a surgical intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as an "open reduction and internal fixation device" comprised of nails, screws, and accessories. These are implants used to stabilize bone fractures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the AOS Galileo™ Trochanteric Nail System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AOS Galileo™ Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric 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.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, trochanteric and diaphyseal areas
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
3
Special 510(k) Summary
| Date Prepared | August 21, 2020 |
|---|---|
| Submitted by | Advanced Orthopaedic Solutions, Inc |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| Establishment Registration | 2032480 |
| Owner Operator Number | 9046896 |
| Regulatory Contact | Jolie Krance |
| Senior Regulatory Affairs Specialist | |
| Advanced Orthopaedic Solutions, Inc. | |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| (310) 533-9966 | |
| jkrance@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 Marketed | |
| Substantially Equivalent | |
| Devices | 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, 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. |
| Indications for Use | The AOS Galileo™ Trochanteric Nail System is intended to treat stable
and unstable proximal fractures of the femur including
peritrochanteric, intertrochanteric and high subtrochanteric fractures
and combinations of these fractures. The long trochanteric nail is
additionally indicated for subtrochanteric fractures, peritrochanteric
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. |
| Technological
Characteristics | The AOS Galileo Trochanteric Nail System subject device has similar
technological charateristics to the identified predicates. The material
and chemical composition, performance requirements, and method of
operation are identical to the predicate devices. |
4
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.
5
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 predicates
AOS Galileo™ Lag Screw (K120148) AOS Galileo™ Trochanteric Nail
System (K021008), and the AOS Galileo™ Trochanteric ES Nail
(K103533), have the same intended use, patient population, operating
principle, and risk profile. They have identical manufacturing,
packaging, sterilization parameters, and shipping processes, all of
which will be conducted under the same quality management system. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nonclinical Testing | 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. |
| Conclusion | Since the device has the same intended use and similar technological
characteristics to the identified predicates, the device does not raise
any different questions of safety or effectiveness. The performance
testing and engineering analysis demonstrated that the subject device
had substantially equivalence performance. Therefore, the premarket
notification demonstrated that the device is substantially equivalent to
the predicate |