(107 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the intramedullary nail system, with no mention of AI or ML.
Yes.
The device is an intramedullary nail system for internal fixation and stabilization of bone conditions and procedures, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is an intramedullary nail system intended for internal bone fixation and stabilization of various foot instabilities and reconstructions, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly details physical components such as intramedullary nails, endcaps, and instrumentation, all made of titanium alloy. It also mentions the use of existing bone screws and Class I exempt devices, indicating a hardware-based system for internal bone fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for internal bone fixation during surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as an intramedullary nail system, implants, and instrumentation used for stabilizing bones. This aligns with a surgical implant and its associated tools, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) from the human body to provide diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The T2 ICF System is indicated for internal bone fixation of the following conditions and procedures:
- · Neuropathic osteoarthropathy (Charcot)
- · Fracture fixation
- · Osteotomies
- · Non-unions
- · Mal-unions
- · Fusions
Product codes
HWC
Device Description
This Traditional 510(k) premarket notification is being supplied to the U.S. FDA to gain clearance to market the T2 ICF System. The T2 ICF System is a cannulated intramedullary nail system intended for internal fixation and stabilization of various foot instabilities and reconstructions. The T2 ICF system includes sterile packed implants (intramedullary nails and endcaps) available in various diameters and lengths to better accommodate patient anatomy as well as non-sterile instrumentation (targeting devices). The intramedullary nails are assembled with a pre-loaded compression screw, which allows for the nail to compress the bony fragments. The sterile packed intramedullary nails (including the preloaded compression screw) and endcaps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.
Additionally, the T2 ICF System will be used with an existing subset of VariAx 2 bone screws (previously cleared under K191412) to achieve fixation of the nail. The use of this subset of the VariAx 2 bone screws with the T2 ICF System does not alter the intended use, indications for use, or overall function of the VariAx 2 bone screws.
Lastly, the T2 ICF System will be used with several existing Class I 510(k) exempt devices for various orthopedic purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot
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
The following bench testing was conducted to determine substantial equivalence between the subject device and the primary predicate Synthes (USA) 6.5mm Midfoot device:
- Biocompatibility evaluation per ISO 10993-1 and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing per ISO 10993-5, ISO 10993-12, ISO 10993-18.
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72 was used for pyrogenicity testing to achieve an Endotoxin limit of
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
March 20, 2020
Image /page/0/Picture/1 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 with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
Stryker GmbH Cindy Leon Staff Specialist, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K193366
Trade/Device Name: T2 ICF Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: February 19, 2020 Received: February 20, 2020
Dear Cindy Leon:
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
1
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) 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 (OS) 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 mediation-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,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193366
Device Name T2 ICF System
Indications for Use (Describe)
The T2 ICF System is indicated for internal bone fixation of the following conditions and procedures:
- · Neuropathic osteoarthropathy (Charcot)
- · Fracture fixation
- · Osteotomies
- · Non-unions
- · Mal-unions
- · Fusions
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)
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| Proprietary Name: | T2 ICF System |
|---|---|
| Common Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| (21 CFR 888.3040) | |
| Regulation Description: | Smooth or Threaded Metallic Bone Fixation Fastener |
| (21 CFR 888.3040) | |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HWC |
| Device Class: | Class II |
| Sponsor: | Stryker GMBH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Cindy Leon |
| Staff Specialist, Regulatory Affairs | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: 201-831-5374 | |
| Fax: 201-831-6500 | |
| Date Prepared: | December 03, 2019 |
| Primary Predicate: | Synthes (USA) 6.5mm Midfoot Fusion Bolt: K081071 |
| Additional Predicate: | Wright Medical Technology, Inc. SALVATION Midfoot Nail: |
| K180024 |
510(k) Summary
Description
This Traditional 510(k) premarket notification is being supplied to the U.S. FDA to gain clearance to market the T2 ICF System. The T2 ICF System is a cannulated intramedullary nail system intended for internal fixation and stabilization of various foot instabilities and reconstructions. The T2 ICF system includes sterile packed implants (intramedullary nails and endcaps) available in various diameters and lengths to better accommodate patient anatomy as well as non-sterile instrumentation (targeting devices). The intramedullary nails are assembled with a pre-loaded compression screw, which allows for the nail to compress the bony fragments. The sterile packed intramedullary nails (including the preloaded compression screw) and endcaps are made of titanium alloy (Ti6Al4V ELI) as per ASTM F136.
Additionally, the T2 ICF System will be used with an existing subset of VariAx 2 bone screws (previously cleared under K191412) to achieve fixation of the nail. The use of this subset of the
4
VariAx 2 bone screws with the T2 ICF System does not alter the intended use, indications for use, or overall function of the VariAx 2 bone screws.
Lastly, the T2 ICF System will be used with several existing Class I 510(k) exempt devices for various orthopedic purposes.
Intended Use
The T2 ICF System is intended for internal bone fixation.
Indications for Use
The T2 ICF System is indicated for internal bone fixation of the following conditions and procedures:
- · Neuropathic osteoarthropathy (Charcot)
- · Fracture fixation
- · Osteotomies
- · Non-unions
- Mal-unions
- Fusions
Summary of Technologies
A comparison of the systems demonstrated that the subject T2 ICF System is substantially equivalent to the previously cleared predicate Synthes (USA) 6.5mm Midfoot Fusion Bolt (K081071) and the Wright Medical Technology, Inc. SALVATION Midfoot Nail (K180024) regarding their intended use, indications for use, technological characteristics (design features, material and performance), as well as underlying operational principles.
Overall, the subject device and the predicate devices share many of the same technological characteristics including:
- Intramedullary nailing system intended to provide fracture fixation and alignment of the foot
- Nail design (available in various size configurations) and material "(titanium alloy – Ti6Al4V ELI per ASTM F136)
-
- Synthes (USA) 6.5mm Midfoot Fusion Bolt offered in both titanium alloy and stainless steel variants
The following technological differences do exist between the subject and predicate devices:
- . Fixation technology
- Nail diameter size offerings
These differences have been addressed through performance testing, which demonstrates that the subject device is as safe and effective as the predicate devices.
Non-Clinical Testing
The following bench testing was conducted to determine substantial equivalence between the subject device and the primary predicate Synthes (USA) 6.5mm Midfoot device:
5
- l . Biocompatibility evaluation per ISO 10993-1 and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing per ISO 10993-5, ISO 10993-12, ISO 10993-18.
-
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72 was used for pyrogenicity testing to achieve an Endotoxin limit of