(137 days)
The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.
The CoLink® Sfx Implant system is a system of implantable k-wires with tip protectors (caps) used to provide temporary fixation and stabilization of fractured bones of the extremities. The k-wire is made from stainless steel (ASTM F138) and the tip protectors are made from polyethylene. The tip protectors are not implantable and are for protection for protruding ends of wires. These subject devices are part of the overarching CoLink® Plating System.
The provided text is a 510(k) summary for the D CoLink® Sfx Implant System, a medical device used for temporary fixation and stabilization of bone fractures. It describes "performance testing" but explicitly states that no additional mechanical testing was required. This means the FDA cleared the device based on an "engineering analysis comparing the subject implants to legally marketed predicates" and not on specific acceptance criteria for performance met by a study of the device itself.
Therefore, many of the requested details cannot be extracted from this document, as they pertain to a performance study that was not conducted for this specific device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The submission states: "No additional mechanical testing was required for the CoLink® Sfx Implant System as the subject wires are not considered a worst case based on engineering analysis comparing the subject implants to legally marketed predicates." This implies that the acceptance criteria for performance were met by the predicate devices, and the subject device was deemed substantially equivalent without direct performance testing against specific criteria.
2. Sample size used for the test set and the data provenance
This information is not available. No mechanical performance study was conducted for this device. The assessment was based on an engineering analysis comparing it to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available. No performance study requiring expert ground truth was conducted.
4. Adjudication method for the test set
This information is not available. No performance study requiring adjudication was conducted.
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
This information is not applicable. This device is a bone fixation implant system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a bone fixation implant system, not an algorithm.
7. The type of ground truth used
This information is not available. No performance study requiring ground truth was conducted. The clearance was based on substantial equivalence to predicate devices, supported by an engineering analysis and non-mechanical validations.
8. The sample size for the training set
This information is not applicable. This device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. This device is a physical implant, not an AI model requiring a training set.
Summary of what was reported regarding "Performance Testing":
The "Performance Testing" section primarily discusses non-mechanical validations and refers to an "engineering analysis" instead of direct performance testing for the subject device's mechanical properties.
- Validations and risk assessments were conducted for:
- Sterilization (ISO 11137-2)
- Biocompatibility (ISO 10993-1)
- Packaging and shelf life (ISO 111607-1)
- Pyrogenicity (ANSI-AAMI ST72)
- Bacterial endotoxin testing (LAL) is performed on each lot.
It's important to note that these are essential validations for medical devices but do not represent performance testing in the sense of functional mechanical performance criteria typically seen for AI/diagnostic devices or even some other classes of implants where specific performance benchmarks must be met by the device itself in a study. In this case, the decision was made on substantial equivalence, relying on the performance of the predicate devices and an engineering comparison.
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In2Bones USA, LLC Ms. Christine Scifert VP, QA & RA 6000 Poplar Ave, Suite 115 Memphis, Tennessee 381 19
Re: K203698
Trade/Device Name: CoLink® Sfx Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 6, 2021 Received: April 7, 2021
Dear Ms. Scifert:
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 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for
May 4, 2021
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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 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/cdrl-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.
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K203698
Device Name CoLink® Sfx Implant System
Indications for Use (Describe)
The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.
| 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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510(k) Summary
CoLink® Sfx Implant System April 2, 2021
| Company: | In2Bones USA, LLC6000 Poplar Ave, Suite 115Memphis, TN 38119901-260-7931 |
|---|---|
| Primary Contact: | Christine Scifert |
| Trade Name: | CoLink® Sfx Implant System |
| Common Name: | Pin, Fixation, Smooth |
| Classification: | II |
| Regulation Number: | 888.3040 – Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HTY |
Device Description: The CoLink® Sfx Implant system is a system of implantable k-wires with tip protectors (caps) used to provide temporary fixation and stabilization of fractured bones of the extremities. The k-wire is made from stainless steel (ASTM F138) and the tip protectors are made from polyethylene. The tip protectors are not implantable and are for protection for protruding ends of wires. These subject devices are part of the overarching CoLink® Plating System.
The In2Bones USA CoLink® Sfx Implant System is a system of implantable K-Indications for Use: wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
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Primary Predicate
- K153204 – In2Bones Kirschner Wire
Additional Predicates
Reference Device
- o K163293 - CoLink® Plating System
Similar to the primary predicate device (K153204), the subject CoLink® Sfx Implant System is made of Stainless and provided sterile. The CoLink® Sfx Implant System has similar indications to the New Deal K Wire and K-Fix® (K022599 & K022597) and Wright Medical WMT Implantable K-wires (K132895). This submission is adding k-wires and protective caps to the CoLink® family. The subject k-wires and caps have been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.
Performance Testing: No additional mechanical testing was required for the CoLink® Sfx Implant System as the subject wires are not considered a worst case based on engineering analysis comparing the subject implants to legally marketed predicates. The protector caps do not require mechanical testing as they will not see any mechanical loading. Validations and risk assessments were conducted for the CoLink® Sfx Implant System for sterilization (ISO 11137-2), biocompatibility (ISO 10993-1), packaging and shelf life (ISO 111607-1) and pyrogenicity (ANSI-AAMI ST72). Bacterial endotoxin testing (LAL) is performed on each lot.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.
§ 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.