(24 days)
The Bi-Directional Tunneler is indicated for use in creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.
The Bi-Directional Tunneler is a stainless steel device composed of a knurled handle, shafts in different lengths and curvatures, bullet tips from 4mm to 12 mm diameter, and a vein tip with a luer adapter. Each tunneler shaft is manufactured with internal threaded ends and a locking mechanism on each end for interchangeable tip and handle attachment. Each tip is manufactured with an external threaded end for luer adapter and shaft attachment. The Bi-Directional Tunneler is supplied non-sterile to the user in a stainless steel perforated case. The perforations are intended to facilitate steam sterilization.
The provided text describes a 510(k) premarket notification for a medical device called the "Bi-Directional Tunneler." This clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to establish acceptance criteria and performance. Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert involvement, and specific study types is not available in the provided document.
Here's why and what can be extracted:
- 510(k) Premarket Notification: This regulatory pathway primarily relies on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety/effectiveness. It generally does not require extensive new clinical trials with clearly defined acceptance criteria in the same way a Premarket Approval (PMA) application might.
- Focus on Substantial Equivalence: The document explicitly states: "The Bi-Directional Tunneler is substantially equivalent in intended use, design, technology/operating principles, materials and performance to the Kelly-Wick Tunneler. Differences between the two devices do not raise any significant issues of safety or effectiveness." This statement is the core of the submission, implying that the safety and effectiveness profile is considered similar to the predicate, which has already met regulatory requirements.
Information that CAN be extracted:
- Device Name: Bi-Directional Tunneler
- Predicate Device: Kelly-Wick Tunneler
- Intended Use: Creating subcutaneous tunnels for the placement of vascular prostheses or autogenous grafts for arteriovenous access, peripheral vascular and extra-anatomic bypass procedures.
- Technological Characteristics Summary: Made from stainless steel, supplied non-sterile, equivalent in size and configuration to the predicate. The main difference is the "bi-directional feature," which is stated not to affect safety or effectiveness.
- Regulatory Status: Cleared via 510(k) (K991027), classified as Class II, Product Code 74 DSY.
Regarding your specific points:
- A table of acceptance criteria and the reported device performance: Not available. The document asserts substantial equivalence, meaning its performance is considered equivalent to the predicate, without citing specific performance metrics or acceptance criteria for a new study.
- Sample sized used for the test set and the data provenance: Not applicable. No new "test set" or clinical data is presented for this substantial equivalence submission.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. No new ground truth establishment is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable (this is a physical surgical tool, not an algorithm).
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission showing substantial equivalence, not a clinical study outlining specific acceptance criteria or performance metrics derived from new testing.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”