(14 days)
Roll-X Coronary Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during intended to faoilitate the procedures. The Guidewire is not to be used in the cerebral blood vessels.
Roll-X™ Guidewire is a steerable guide wire constructed of a stainless steel core wire and a colled wire design at the distal end. The core wire is PTFE coated. The Roll-X Guidewire has a unique distal end design to enhance torque response and control. The distal end of the guidewire is shapeable and is radiopaque. The guide wire is provided sterile and non-pyrogenic.
The provided document describes the St. Jude Medical Roll-X™ Guidewire and its 510(k) premarket notification. This submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than a standalone clinical study with acceptance criteria and device performance metrics against those criteria.
Therefore, many of the requested elements (1, 2, 3, 4, 5, 6, 7, 8, 9) are not applicable or not extractable from this type of regulatory document.
However, I can extract information related to the overall regulatory strategy and non-clinical testing.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided: The document does not present specific acceptance criteria or quantitative performance metrics in a study-like format. Instead, it relies on demonstrating that the new device's technological characteristics are substantially equivalent to predicate devices. The "Summary of Non-Clinical Testing" broadly states that "Results of the testing demonstrate that the guidewire design meets product specifications and intended uses," but no specific criteria or performance data are listed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This document details non-clinical bench testing and animal evaluations, not human clinical trials. Therefore, a "test set" in the context of human data or origin is not relevant here. The non-clinical tests would have involved various samples of the guidewire itself, but the specific numbers are not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As this is a 510(k) submission based on substantial equivalence and non-clinical testing, there is no mention of experts establishing ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical test set requiring adjudication is described.
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
- Not Applicable / Not Provided: This document describes a medical device (guidewire), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a guidewire, a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: For a medical device like a guidewire in a 510(k) submission, "ground truth" in the clinical sense is typically not established through these methods. Instead, the "truth" is established through engineering and performance testing against design specifications, recognized standards, and comparison to predicate devices, ensuring it performs as intended and safely.
8. The sample size for the training set
- Not Applicable / Not Provided: No mention of a training set as this is not a machine learning model.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No mention of a training set.
Summary of the Study and Regulatory Strategy Presented in the Document:
The St. Jude Medical Roll-X™ Guidewire received 510(k) clearance based on demonstrating substantial equivalence to two predicate devices:
- ASAHI Prowater PTCA Coronary Guidewire (K052339)
- Hi-Torque Balanced Middleweight Universal Guidewire (K013833)
The "study" or evidence provided to meet this regulatory pathway consisted of:
- Non-clinical testing: This included in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life and package testing, and sterilization evaluation.
- Conclusion: The results of these non-clinical tests demonstrated that the guidewire design meets product specifications and intended uses, and that its intended use, design, material types, technology, and performance are equivalent to the predicate devices.
- Absence of New Safety/Effectiveness Issues: The submission concluded that there were "no differences between devices which would raise issues of safety or effectiveness."
This type of submission focuses on proving that a new device is "as safe and effective" as a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive standalone clinical trials with predefined acceptance criteria.
§ 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.