(120 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of traditional orthopedic implants and instruments, with no mention of AI/ML.
Yes
The device is described as a "fracture fixation system" and is intended for the "fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures" among other fracture-related indications, which are therapeutic actions.
No
The device is described as an internal fixation device used for fracture fixation and stabilization, not for identifying a disease or condition.
No
The device description clearly states that the submission encompasses multiple systems including sterile implants (intramedullary nails, screws, end caps) and non-sterile instruments (targeting devices), which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description clearly states that this system is for internal fixation of bone fractures in the femur. It involves implants (nails, screws) and instruments for surgical implantation. This is a surgical device used within the body, not a test performed on samples outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes related to disease or condition identification through laboratory testing.
Therefore, this device falls under the category of a surgical implant and associated instruments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
T2 Alpha Femur Antegrade GT/PF Nailing System:
The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
The indications for use of these internal fixation devices include:
- Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
- Femoral fixation required as a result of pathological disease
- Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Nonunions and malunions
- Fractures involving osteopenic and osteoporotic bone
IMN Screws System:
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
IMN Instruments System:
The IMN Instruments System is intended to enable the implantation and extraction of intramedullary nail and screw.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HWC
Device Description
T2 Alpha Femur Antegrade GT/PF Nailing System: The T2 Alpha Femur Antegrade GT/PF Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The set screws are manufactured from titanium alloy (Ti6Al4V ELI) as per ASTM F136 and PEEK.
Additionally, the T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the existing locking screws previously cleared in K003018 (Titan Tibial Nail System), the T2 Lag Screw Recon previously cleared in K032898 (T2 Recon Nail System) as well as existing instruments previously cleared in K123401 (Gamma 3 and T2 Recon Targeting Devices), K131365 (T2 Tibial Nailing System) and 510(k) exempt devices. The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for use with IMN Screws System and IMN Instruments System.
IMN Screws System: The IMN Screws System includes locking screws that are inserted through the intramedullary nail to stabilize the nail-bone construct. The locking screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Instruments System.
IMN Instruments System: The IMN Instruments System includes instruments that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Screws System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral shaft, femoral neck, supracondylar regions of the femur, long bone
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)
T2 Alpha Femur Antegrade GT/PF Nailing System:
Non-clinical testing was performed for the T2 Alpha Femur Antegrade GT/PF Nailing System under worst case scenario to determine substantial equivalence.
The following bench testing was conducted:
- Fatigue strength testing
- Testing of mechanical properties as per ASTM F1264
- Cut-out testing
Testing demonstrated that the T2 Alpha Femur Antegrade GT/PF Nailing System is equivalent in mechanical performance to the predicate devices (K102992, K101438, and K083497).
Non-clinical testing has demonstrated that the T2 Alpha Femur Antegrade GT/PF Nailing System is MR Conditional.
Biocompatibility testing was performed to evaluate the biological safety of the T2 Alpha Femur Antegrade GT/PF Nailing System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. Testing demonstrated that the T2 Alpha Femur Antegrade GT/PF Nailing System is biocompatible.
The Bacterial Endotoxin Testing demonstrated that the sterile implants of T2 Alpha Femur Antegrade GT/PF Nailing System meet the specified endotoxin limit.
IMN Screws System:
Non-clinical testing was performed for the IMN Screws System. The following bench testing was conducted:
- Testing of mechanical properties as per ASTM F543
Testing demonstrated that the IMN Screws System is equivalent in mechanical performance to the predicate device (K003018).
Non-clinical testing has demonstrated that the IMN Screws System is MR Conditional.
Biocompatibility assessment was performed according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. It has been demonstrated that the IMN Screws System is biocompatible.
The Bacterial Endotoxin Testing demonstrated that the IMN Screws System meets the specified endotoxin limit.
IMN Instruments System:
Biocompatibility testing was performed to evaluate the biological safety of the IMN Instruments System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. Testing demonstrated that the IMN Instruments System is biocompatible.
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.
T2 Recon Nail System (K102992), T2 Greater Trochanter Nail (GTN) (K101438), Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails (K083497), Titan Tibial Nail (K003018), Gamma3 and T2 Recon Target Devices (K123401)
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.
T2 Recon Nail System (K102992)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration" with "Administration" written on the second line.
January 12, 2018
Stryker Trauma GmbH Heike Gustke Staff Regulatory Affairs Specialist Prof-Kuentscher-Str. 1-5 24232 Schoenkirchen GERMANY
Re: K172774
Trade/Device Name: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: December 8, 2017 Received: December 12, 2017
Dear Heike Gustke:
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
1
manufacturing practice requirements as set forth in 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.
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
T2 Alpha Femur Antegrade GT/PF Nailing System
Indications for Use (Describe)
The indications for use of these internal fixation devices include:
-
Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
-
Femoral fixation required as a result of pathological disease
-
Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
-
Open and closed femoral fractures
-
Pseudoarthrosis and correction osteotomy
-
Pathologic fractures, impending pathologic fractures and tumor resections
-
Ipsilateral femur fractures
-
Fractures proximal to a total knee arthroplasty
-
Nonunions and malunions
-
Fractures involving osteopenic and osteoporotic bone
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)
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."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
3
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name IMN Screws System
Indications for Use (Describe)
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
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."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name IMN Instruments System
Indications for Use (Describe)
The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.
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)
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."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
5
Section 9: 510(k) Summary
I. SUBMITTER
| I. SUBMITTER | ||
|---|---|---|
| Sponsor: | Stryker Trauma GmbH | |
| Prof.-Kuentscher-Str. 1-5 | ||
| 24232 Schoenkirchen / Germany | ||
| Contact Person: | Dr. Heike Gustke | |
| Staff Regulatory Affairs Specialist | ||
| Prof.-Kuentscher-Str. 1-5 | ||
| 24232 Schoenkirchen / Germany | ||
| heike.gustke@stryker.com | ||
| Phone: +49 4348 702 637 | ||
| Fax: +49 4348 702 8637 | ||
| Date Prepared: | November 30, 2017 | |
| II. DEVICE | ||
| Name of Device: | T2 Alpha Femur Antegrade GT/PF Nailing System | |
| IMN Screws System | ||
| IMN Instruments System | ||
| Common Name: | T2 Alpha Femur Antegrade GT/PF Nailing System | |
| Rod, fixation, intramedullary and accessories | ||
| IMN Screws System | ||
| Screw, fixation, bone | ||
| IMN Instruments System | ||
| Rod, fixation, intramedullary and accessories | ||
| Regulation Number / Name: | T2 Alpha Femur Antegrade GT/PF Nailing System | |
| 21CFR 888.3020 (Intramedullary fixation rod) | ||
| IMN Screws System | ||
| 21CFR 888.3040 (Smooth or threaded metallic bone fixation | ||
| fastener) | ||
| IMN Instruments System | ||
| 21CFR 888.3020 (Intramedullary fixation rod) | ||
| Product Code: | T2 Alpha Femur Antegrade GT/PF Nailing System | |
| HSB (Rod, fixation, intramedullary and accessories) | ||
| IMN Screws System | ||
| HWC (Screw, fixation, bone) | ||
| IMN Instruments System | ||
| HSB (Rod, fixation, intramedullary and accessories) | ||
| Regulatory Class: | Class II |
6
III. PREDICATE DEVICE
| T2 Alpha Femur Antegrade GT/PF Nailing System | ||
|---|---|---|
| Primary predicate: | T2 Recon Nail System (K102992) | |
| Additional predicate: | T2 Greater Trochanter Nail (GTN) (K101438) | |
| Zimmer Natural Nail System Piriformis Fossa and Greater | ||
| Trochanter Antegrade Femoral Nails (K083497) | ||
| IMN Screws System | ||
| Primary predicate: | Titan Tibial Nail (K003018) | |
| IMN Instruments System | ||
| Primary predicate: | Gamma3 and T2 Recon Target Devices (K123401) | |
| Reference device: | T2 Recon Nail System (K102992) |
IV. DEVICE DESCRIPTION
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, and IMN
7
Instruments System. This submission encompasses multiple systems that have similar intended use and will be used together during the surgical procedure.
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The set screws are manufactured from titanium alloy (Ti6Al4V ELI) as per ASTM F136 and PEEK.
Additionally, the T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the existing locking screws previously cleared in K003018 (Titan Tibial Nail System), the T2 Lag Screw Recon previously cleared in K032898 (T2 Recon Nail System) as well as existing instruments previously cleared in K123401 (Gamma 3 and T2 Recon Targeting Devices), K131365 (T2 Tibial Nailing System) and 510(k) exempt devices. The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for use with IMN Screws System and IMN Instruments System.
IMN Screws System
The IMN Screws System includes locking screws that are inserted through the intramedullary nail to stabilize the nail-bone construct. The locking screws are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Instruments System.
IMN Instruments System
The IMN Instruments System includes instruments that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Screws System.
8
V. INTENDED USE
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
IMN Screws System
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
IMN Instruments System
The IMN Instruments System is intended to enable the implantation and extraction of intramedullary nail and screw.
VI. INDICATION FOR USE
T2 Alpha Femur Antegrade GT/PF Nailing System
The indications for use of these internal fixation devices include:
- Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal . femoral shaft fractures
- o Femoral fixation required as a result of pathological disease
- Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to ● the supracondylar regions of the femur
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections ●
- Ipsilateral femur fractures ●
- . Fractures proximal to a total knee arthroplasty
- o Nonunions and malunions
- Fractures involving osteopenic and osteoporotic bone ●
9
IMN Screws System
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
IMN Instruments System
The IMN Instruments System is intended to enable the implantation and extraction of intramedullary nail and screw.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
T2 Alpha Femur Antegrade GT/PF Nailing System
Device comparison demonstrated that the T2 Alpha Femur Antegrade GT/PF Nailing System is substantially equivalent to the previously cleared T2 Recon Nail System (K102992), T2 GTN System (K101438) and Zimmer Natural Nail System (K083497) in regards to intended use, indications for use, technological characteristics (design features, material and performance) as well as operating principle.
At a high level, the subject device and predicate devices are based on the following same technological elements:
- . Intramedullary nailing systems to provide a fracture fixation of the long bone
- Nail and screw design (length, diameter, and shape)
- Nails, compression screw and end caps manufactured from titanium alloy (Ti6Al4V ELI) . as per ASTM F136
- Set screws are manufactured from titanium alloy (Ti6A14V ELI) as per ASTM F136 and . PEEK.
The following technological differences exist between the subject and predicate devices:
- . Hole configurations in proximal and distal part of nail
- . Locking configurations.
The differences have been addressed through performance testing which demonstrates that the subject device is as safe and effective as the predicate devices.
IMN Screws System
10
Device comparison demonstrated that the IMN Screws System is substantially equivalent to the locking screws previously cleared in Titan Tibial Nail System (K003018) in regards to intended use, technological characteristics (design features, material and performance) as well as operating principle.
At a high level, the subject device and predicate devices are based on the following same technological elements:
- Stabilization of intramedullary nail-bone construct .
- Used for proximally and distally locking of nail-bone construct ●
- o Screw design (length, diameter, and thread design)
- Manufactured from titanium alloy (Ti6Al4V ELI) as per ASTM F136. .
IMN Instruments System
Device comparison demonstrated that the IMN Instruments System is substantially equivalent to the previously cleared Gamma3 and T2 Recon Target Devices (K123401) in regards to intended use, technological characteristics (design features, material and performance) as well as operating principle.
At a high level, the subject device and predicate devices are based on the following same technological elements:
- Used for guided distal locking of nails .
- Design consisting of distal targeting arm and adjusting device o
- . Manufactured from Stainless Steel, PEEK unreinforced as well as PEEK with carbon fibers.
The following technological differences exist between the subject and predicate devices:
- A single adjusting device to cover all potential locking options. .
The difference has been addressed through performance testing which demonstrates that the subject device is as safe and effective as the predicate devices.
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
T2 Alpha Femur Antegrade GT/PF Nailing System
11
Non-clinical testing was performed for the T2 Alpha Femur Antegrade GT/PF Nailing System under worst case scenario to determine substantial equivalence.
The following bench testing was conducted:
- Fatigue strength testing .
- Testing of mechanical properties as per ASTM F1264 .
- Cut-out testing .
Testing demonstrated that the T2 Alpha Femur Antegrade GT/PF Nailing System is equivalent in mechanical performance to the predicate devices (K102992, K101438, and K083497).
Non-clinical testing has demonstrated that the T2 Alpha Femur Antegrade GT/PF Nailing System is MR Conditional.
Biocompatibility testing was performed to evaluate the biological safety of the T2 Alpha Femur Antegrade GT/PF Nailing System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. Testing demonstrated that the T2 Alpha Femur Antegrade GT/PF Nailing System is biocompatible.
The Bacterial Endotoxin Testing demonstrated that the sterile implants of T2 Alpha Femur Antegrade GT/PF Nailing System meet the specified endotoxin limit.
IMN Screws System
Non-clinical testing was performed for the IMN Screws System. The following bench testing was conducted:
- Testing of mechanical properties as per ASTM F543 ●
Testing demonstrated that the IMN Screws System is equivalent in mechanical performance to the predicate device (K003018).
Non-clinical testing has demonstrated that the IMN Screws System is MR Conditional.
Biocompatibility assessment was performed according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. It has been demonstrated that the IMN Screws System is biocompatible.
The Bacterial Endotoxin Testing demonstrated that the IMN Screws System meets the specified endotoxin limit.
12
IMN Instruments System
Biocompatibility testing was performed to evaluate the biological safety of the IMN Instruments System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. Testing demonstrated that the IMN Instruments System is biocompatible.
IX. CLINICAL TESTING
T2 Alpha Femur Antegrade GT/PF Nailing System
No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted.
IMN Screws System
No clinical testing of the IMN Screws System has been conducted.
IMN Instruments System
No clinical testing of the IMN Instruments System has been conducted.
X. CONCLUSION
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System is substantially equivalent to the predicate devices (K102992, K101438, and K083497) identified in this premarket notification.
IMN Screws System
The IMN Screws System is substantially equivalent to the predicate device (K003018) identified in this premarket notification.
IMN Instruments System
The IMN Instruments System is substantially equivalent to the predicate device (K123401) identified in this premarket notification.