(54 days)
The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.
The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following:
- 175cm Working Length 0.014" Safe-Cross RF Crossing Wirc Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
- 275cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool)
- Safe-Cross RF System Console with Display and Footswitch .
The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The I he modified Sale-Cross RF Bystein is simmal nt a Y-Site hub that houses the optic proximal end of the RF connector. The optical connector is connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the imput on the console to anow the medical proceed to the RF couput on the digit vessel for havigation purposes. The re-over to provide discrete RF energy to the distal console: - This anoving the wire tip through the occlusion in the vessel.
The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping The Kr Crossing Wire is packaged warate peel pouch. A rorquer is provided the oxide) and non-pyrogenic, and is intended for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Safe-Cross® Radio Frequency Total Occlusion Crossing System:
It's important to note that the provided text is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting full clinical trial results with specific acceptance criteria in the way a PMA (Pre-Market Approval) or novel device application might. Therefore, the information available is focused on comparison to a previously cleared device and internal testing, which may not align with the standard format for reporting clinical study results to establish acceptance criteria for a new, unique claim.
Based on the provided document, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials in modified RF Crossing Wires are safe (as per predicate device's safety profile). | "Biocompatibility testing has been conducted to verify that the materials in the modified RF Crossing Wires are safe." |
| Benchtop Performance | Functional performance characteristics of modified RF Crossing Wires (matching or improving upon predicate device). Satisfy safety and performance requirements of device specifications. | "In vitro bench testing was conducted to evaluate the performance characteristics of the modified RF Crossing Wires. Benchtop performance test results indicate that the modified RF Crossing Wires satisfy safety and performance requirements of the device specifications and do not raise additional safety issues." |
| In Vivo (Animal) Performance | System components function properly together in an intravascular environment. Satisfy intravascular performance requirements. | "In vivo animal studies have shown that the components of the system function properly together and satisfy intravascular performance requirements in an animal model." |
| Software Validation | (Implicit: Software in the combined console functions correctly and safely). | "software validation testing." (No specific details of results provided here, only that testing was conducted). |
| Safety | No additional safety issues compared to the predicate device. | "Benchtop performance test results indicate... do not raise additional safety issues." "On the basis of the testing conducted on the modified Safe-Cross System it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population." |
| Performance (Overall) | Satisfies safety and performance requirements when used as indicated, indicating substantial equivalence to predicate. | "On the basis of the testing conducted on the modified Safe-Cross System it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population. The modified Safe-Cross System is substantially equivalent to the predicate device." |
Important Note on "Acceptance Criteria": In a 510(k), explicit "acceptance criteria" are often internal to the manufacturer's design controls and testing protocols. The public summary typically states that these criteria were met rather than detailing the specific numerical targets. The primary "acceptance criterion" for the FDA in a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device.
Detailed Study Information:
The document describes several types of studies performed, but it focuses on demonstrating substantial equivalence to a predicate device (K032031, also the Safe-Cross Radio Frequency Total Occlusion Crossing System). It does not present a traditional clinical study with explicitly defined acceptance criteria, sample sizes for test sets in human patients, or ground truth established by independent experts for a novel device claim.
Here's a breakdown based on the categories requested:
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set (Human Data): Not applicable for a typical "test set" as understood in machine learning or a de novo clinical trial. This 510(k) relies on non-clinical data and comparison to a predicate device.
- Data Provenance:
- Bench Testing: In vitro, conducted by the manufacturer (IntraLuminal Therapeutics, Inc.).
- Animal Studies: In vivo, conducted by the manufacturer. No country of origin is specified for the animal studies, but the company is US-based.
- Retrospective/Prospective: The testing described (biocompatibility, bench, animal, software validation) would be considered prospective for the purpose of demonstrating substantial equivalence for this modification, but it's not a prospective human clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as the submission does not detail an independent expert review process for a "test set" in the context of human data. The "ground truth" for this submission is based on engineering specifications, biocompatibility standards, and the performance of the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of an adjudication method as there's no "test set" of human cases with independent expert interpretation forming a ground truth.
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
- No. An MRMC study was not performed. This device is a catheter guide wire system aiding in physical navigation, not an AI-powered diagnostic or assistive tool for human readers interpreting medical images.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (catheter guide wire system) that requires human operation; it is not a standalone algorithm. The "software validation testing" mentioned is for the integrated console, not for an independent diagnostic algorithm.
7. The Type of Ground Truth Used
- Engineering Specifications and Performance Standards: For bench and animal testing, the "ground truth" would be successful adherence to predefined engineering specifications, performance targets, and safety criteria relevant to the device's intended function and comparison to the predicate.
- Predicate Device Performance: The overarching ground truth is the established safety and effectiveness profile of the predicate device (Safe-Cross Radio Frequency Total Occlusion Crossing System cleared under K032031). The modified device aims to maintain or improve upon this.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a physical medical device and its modifications, not a machine learning model requiring a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for an algorithm in this context.
§ 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.