(22 days)
The ILT Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guide wire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The 0.018" Safe-Cross Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guide wires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The effective length of the 0.018" Safe-Cross Deflecting Catheter is 135cm. The shaft deflecting segment maximum outside diameter is 4.3Fr at a use pressure of 10atm. The I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.022" and the inside diameter will accommodate commercially available 0.018" guidewires.
The 0.018" Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.
The provided text is a 510(k) summary for a medical device (Safe-Cross® Deflecting Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with precise acceptance criteria and performance metrics. Therefore, many of the requested data points (e.g., sample sizes for test and training sets, expert qualifications, specific performance metrics against acceptance criteria, MRMC studies, standalone algorithm performance) are not included within this type of regulatory submission.
However, based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the device performs similarly to the predicate device and meets established safety and performance requirements for its intended use. Specific quantitative performance targets are not explicitly stated for parameters like sensitivity, specificity, or reader improvement, as would be common for AI/diagnostic software. Instead, the focus is on the device's physical and functional characteristics.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate and Device Specifications) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Meets established standards for patient safety in contact with blood/tissue. | "Biocompatibility... indicate that the 0.018" Safe-Cross Deflecting Catheter satisfies safety... requirements..." |
| Mechanical Performance | Similar tensile strength, flexibility, lubricity, burst pressure, and other physical characteristics to the predicate device, specifically adapted for the 0.018" guidewire. Ability to accommodate 0.018" guidewires. Ability to deflect. | "...mechanical performance to the predicate device." |
| "I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.022" and the inside diameter will accommodate commercially available 0.018" guidewires." | ||
| Material Composition | Similar materials to the predicate device, including the hydrophilic coating. | "...similar in basic materials, design, construction..." |
| "coated with a Biocoat Hydak® hydrophilic coating..." | ||
| Sterility | Sterility assurance level (SAL) achieved (e.g., 10^-6). Non-pyrogenic. | "The device is provided 'STERILE', 'Non-Pyrogenic'..." |
| Intended Use Compatibility | Effectively functions in accessing peripheral vasculature, facilitating guidewire exchange, and delivering saline/contrast. | "performance testing indicate that the 0.018" Safe-Cross Deflecting Catheter satisfies... performance requirements of the device specifications..." |
2. Sample Sizes and Data Provenance for Test Set
- Sample Size: Not specified. The document mentions "Biocompatibility and performance testing," but does not detail the number of units tested or whether human subjects were involved (unlikely for this type of 510(k) for a catheter enhancement). These tests are typically benchtop or in vitro, and sometimes an in vivo animal study, but the specifics are not provided.
- Data Provenance: Not specified. Given the nature of a 510(k) for mechanical changes to a catheter, the data would primarily be from internal laboratory/bench testing. It is not clinical data from patients or countries of origin in the way typical of AI models. It is entirely retrospective on the device itself.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts/Qualifications: Not applicable in the context of this device. Ground truth for a physical medical device like a catheter is established through validated engineering specifications, material science, and performance testing against industry standards, not through expert consensus on images or clinical outcomes.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. There is no concept of "adjudication" in the sense of reconciling expert opinions for establishing ground truth for a physical device's specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is a physical medical device (catheter), not an AI algorithm or diagnostic imaging tool that would involve human readers interpreting cases with or without AI assistance.
6. Standalone Performance Study
- Standalone Performance: Yes, in an engineering and functional sense. The "performance testing" described in the document is a standalone evaluation of the device's physical and functional characteristics (e.g., integrity, flow capacity, deflection mechanism, guidewire compatibility) according to its design specifications. It is not an "algorithm-only" performance in the context of AI.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is based on engineering specifications and established industry standards for catheters (e.g., material strength, dimensions, coating integrity, sterility validation) and comparison to the performance of the predicate device. It is not pathology, expert consensus on imaging, or patient outcomes data directly.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set" of data.
9. How Ground Truth for Training Set was Established
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).