(242 days)
Not Found
No
The summary describes a mechanical implant system and its associated instrumentation. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is intended for the treatment, stabilization, and reconstruction of various types of fractures or deformities, which aligns with the definition of a therapeutic device.
No
The device is described as a "Fixation System" intended for the "stabilization of various types of fractures or deformities." Its components are "implantable components (nails, end caps and screws) and instrumentation" for insertion into the medullary canal of a femur. This indicates it is a therapeutic device used for treatment, not a diagnostic device used to identify a condition or disease.
No
The device description explicitly states that the system consists of implantable components (nails, end caps, and screws) and instrumentation, which are physical hardware components.
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 clearly states the device is for "insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities." This describes a surgical implant used in vivo (within the body) for structural support and fracture fixation.
- Device Description: The description details implantable components (nails, end caps, screws) and instrumentation used for surgical insertion. This aligns with a surgical device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a physical condition (fractures).
N/A
Intended Use / Indications for Use
The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities.
The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximal to the intercondylar notch. These includes traumatic fractures, re-fractures, non-union, reconstruction, malalignment, pathological fractures and impending pathological fractures.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing System consists of implantable components (nails, end caps and screws) and instrumentation. The proximal part of the nail features a threaded bore to connect the nail to the targeting handle by means of a cannulated bolt. The insertion of the nail into the femur medullary canal is typically performed by some instruments, including: guide wire, awl, reamer and impactor elements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur
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 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 was performed according to the following standards:
• ISO 7206-4 "Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components".
• ISO 12107 "Metallic materials - Fatigue testing - Statistical planning and analysis of data".
• ASTM F384-12 "Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices".
• ASTM F1264-14 "Standard Specification and Test Methods for Intramedullary Fixation Devices".
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 24, 2017
Orthofix Srl % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 28408
Re: K161466
Trade/Device Name: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: December 23, 2016 Received: December 27, 2016
Dear Cheryl 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161466
Device Name
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
Indications for Use (Describe)
The ORTHOFIX CHIMAERA Hip Fracture System – trochanteric nailing system is intended for insertion into the medullary canal of a femur for the alignment, stabilization of various types of fractures or deformities.
The ORTHOFIX CHIMAERA Hip Fracture System - trochanteric nailing system is indicated for treatment of stable and unstable pertrochanteric, intertrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximal to the intercondylar notch. These includes traumatic fractures, re-fractures, non-union, reconstruction, malalignment, pathological fractures and impending pathological fractures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Attachment 7
Image /page/3/Picture/2 description: The image shows the logo for ORTHOFIX, followed by the text "510(k) Summary" and the number K161466. The ORTHOFIX logo is a blue symbol above the company name, which is written in bold, black letters. The text is centered on a white background.
(as required by 21 CFR 807.92)
| 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 | May 26, 2016 |
| Trade Name | ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System |
|---|---|
| Common Name | Rod, fixation, intramedullary and accessories |
| Panel Code | Orthopedic |
| Classification Name | Intramedullary fixation rod. |
| Class | Class II |
| Regulation Number | 21 CFR 888.3020 |
| Product Code | HSB |
| Primary
| Predicate | Predicate Device Name | 510(k) | Manufacturer |
|---|---|---|---|
| √ | Orthofix Titanium Nailing System | ||
| (VeroNail) | K053261 | Orthofix Srl | |
| Gamma3 Nail System | K043431 | Howmedica | |
| Osteonics Corp. |
| Device description | The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric
Nailing System consists of implantable components (nails, end caps
and screws) and instrumentation.
The proximal part of the nail features a threaded bore to connect the
nail to the targeting handle by means of a cannulated bolt. The
insertion of the nail into the femur medullary canal is typically
performed by some instruments, including: guide wire, awl, reamer
and impactor elements. |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and
Indications | The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric
Nailing System is intended for insertion into the medullary canal of a
femur for the alignment, stabilization and fixation of various types of
fractures or deformities.
The ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric |
4
| Nailing System is indicated for treatment of stable and unstable
pertrochanteric, intertrochanteric and subtrochanteric fractures of the
femur alone or when these fractures occur in combination with shaft
fractures, or when these fractures occur in combination with shaft
fractures extending distally to a point approximately 10 cm proximal to
| the intercondylar notch. |
|---|
| These includes traumatic fractures, re-fractures, non-union, |
| reconstruction, malunion, malalignment, pathological fractures and |
| impending pathological fractures. |
| Technological
Characteristics and
Substantial
Equivalence | Documentation was provided to demonstrate that the ORTHOFIX
CHIMAERA Hip Fracture System - Trochanteric Nailing System is
substantially equivalent to the legally marketed predicates.
Components and instrumentation included in the ORTHOFIX
CHIMAERA Hip Fracture System - Trochanteric Nailing System
and the predicate devices are all internal fracture fixation systems,
as defined in 21 CFR 888.3020. The ORTHOFIX CHIMAERA Hip
Fracture System - Trochanteric Nailing System is substantially
equivalent to the predicate devices in: intended use, site of
application, patient population, conditions of use, mechanical
performances, operating principles and materials. The ORTHOFIX
CHIMAERA Hip Fracture System - Trochanteric Nailing System is
comparable to its predicate in dimensions and materials.
Mechanical testing show how the mechanical properties of the
subject device are equivalent or better than the predicate devices. |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 was performed according to the following
standards:
• ISO 7206-4 "Implants for surgery - Partial and total hip joint
prostheses - Part 4: Determination of endurance properties
and performance of stemmed femoral components".
• ISO 12107 "Metallic materials - Fatigue testing - Statistical
planning and analysis of data".
• ASTM F384-12 "Standard Specifications and Test Methods for
Metallic Angled Orthopedic Fracture Fixation Devices".
• ASTM F1264-14 "Standard Specification and Test Methods for
Intramedullary Fixation Devices". |
| Biocompatibility
data | In order to establish non-pyrogenicity of the Subject device,
additional tests were performed according to the following
international standard:
• 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". |
| | • FDA 2012 Q&A "Guidance for Industry Pyrogen and
Endotoxins Testing: Question and Answers". |
| | Here below the tests references list: |
| | • Validation report 16VA00533 |
| | • Test report Cert_2016_7505 |
| | • Test report Cert_2016_7506 |
| | • Test report Cert_2016_7507. |
| Conclusion | Based upon similarities in: intended use, site of application, patient
population, conditions of use, mechanical performances, operating
principles, materials and for the results of mechanical testing,
ORTHOFIX CHIMAERA Hip Fracture System – Trochanteric Nailing
System has been shown to be substantially equivalent to the legally
marketed predicate devices. |
5