(47 days)
Roll-X Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wires are also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures. The guidewires are not to be used in cerebral blood vessels.
Roll-X™ Guidewires are steerable guidewires constructed of a stainless steel core wire with a coiled wire spring design at the distal end. The core wire is PTFE coated. Roll-X™ Guidewires have a unique distal end design to enhance torque response and control. The distal end of the guidewire is shapeable and is radiopague. The guidewires are provided sterile and non-pyrogenic.
This St. Jude Medical 510(k) summary (K100710) describes the Roll-X™ Interventional Guidewire Portfolio. The document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and technological characteristics, as well as non-clinical testing. It does not contain information related to software algorithms, AI, or human reader performance.
Here's a breakdown of the requested information based on the provided text, and where specific details are not available, it's noted:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted but does not provide specific acceptance criteria values or detailed reported performance data in a tabular format. The summary states that "Results of the testing demonstrate that the quidewire design meets product specifications and intended uses," but the actual "specifications" or "results" are not enumerated.
| Item | Tests Performed | Reported Device Performance (as stated in document) |
|---|---|---|
| Device Performance | • Tensile Strength | |
| • Torque Strength | ||
| • Torqueability | ||
| • Tip Flexibility | ||
| • Catheter Compatibility | ||
| • Coating Adherence/Integrity | ||
| • Flexing Test | ||
| • Fracture Test | ||
| • Corrosion Resistance | ||
| • Radiopacity | ||
| • Steering Response | ||
| • Tip Load Test | "Results... demonstrate that the guidewire design meets product specifications and intended uses." (No specific values provided) | |
| Biocompatibility | • Cytotoxicity | |
| • Sensitization | ||
| • Irritation | ||
| • Acute Systemic Toxicity | ||
| • Hemolysis | ||
| • Partial Thromboplastin Time | ||
| • Complement Activation | ||
| • In vivo Thromboresistance | "Results... demonstrate that the guidewire design meets product specifications and intended uses." (Implied satisfactory results) | |
| Sterilization/Microbiology | • Ethylene Oxide Sterilization Evaluation | |
| • Bioburden | ||
| • EO residuals | ||
| • Endotoxin | "Results... demonstrate that the guidewire design meets product specifications and intended uses." (Implied satisfactory results) | |
| Packaging | • Pouch Peel Test | |
| • Visual Inspection | ||
| • Pouch Seal Integrity | "Results... demonstrate that the guidewire design meets product specifications and intended uses." (Implied satisfactory results) | |
| Shelf Life | • Same as device performance and packaging tests | "Results... demonstrate that the guidewire design meets product specifications and intended uses." (Implied satisfactory results) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the non-clinical tests. The document lists the types of tests but does not provide the number of units tested.
- Data Provenance: All testing appears to be conducted by St. Jude Medical as part of their premarket notification. It describes "bench and animal testing." No information is provided regarding the country of origin for the data (beyond being part of a US regulatory submission) or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The tests performed are engineering and biological tests on the device itself (e.g., tensile strength, biocompatibility), not diagnostic tests requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the types of tests described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. This type of study is not mentioned or relevant for a guidewire device submission, which focuses on physical and biological performance rather than diagnostic accuracy or human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device is a medical guidewire, not a software algorithm or AI system. Therefore, standalone performance of an algorithm is not applicable.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" would be the established scientific and engineering standards for device performance (e.g., specific tensile strength values, accepted biocompatibility limits, sterility requirements). The document states that results "demonstrate that the quidewire design meets product specifications and intended uses," implying adherence to these standards.
- For Animal Testing, the document mentions:
- Study #1 – assess performance as compared to currently marketed guidewire. This implies a comparative animal model where the performance of the new device is compared against a known, marketed predicate.
- Study #2 – development of hydrophilic coating scheme. This likely involved assessing the performance and characteristics of different coating schemes in an animal model.
8. The Sample Size for the Training Set
This information is not applicable. There is no software algorithm or AI model requiring a training set for this device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a software algorithm/AI model.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.