Search Results

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.

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.

Ask a specific question about this device

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.

Ask a specific question about this device