(81 days)
The Safe-Cross® Deflecting Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. It may be used to facilitate placement of guide wires and other interventional devices. 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 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 Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross® Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guide wires.
The Safe-Cross® Deflecting Catheter is packaged in a Tyvek® covered custom PETG trav 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.
This document is a 510(k) summary for a medical device called the Safe-Cross® Deflecting Catheter. It focuses on establishing substantial equivalence to a predicate device, not on AI/ML-driven performance or standalone algorithm efficacy. Therefore, much of the requested information regarding AI device evaluation is not applicable.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device Performance) | Reported Device Performance (Safe-Cross® Deflecting Catheter) |
|---|---|---|
| Biocompatibility | Meets established biocompatibility standards for intravascular devices. | "Biocompatibility test results indicate that the device materials are biocompatible." |
| Functional Performance | Satisfies functional requirements (e.g., guide wire access, exchange, delivery of solutions). | "Performance test results indicate that the device satisfies functional performance requirements when used as indicated." |
| Material/Design Similarity | Similar basic materials, design, construction to predicate. | "The Safe-Cross® Deflecting Catheter is similar in basic materials, design, construction and mechanical performance to the predicate device." |
| Physical Dimensions | Effective length, OD, ID comparable to predicate/clinically acceptable. | "The effective length of the Safe-Cross® Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip...is a nominal 0.016" and...accommodate commercially available 0.014" guide wires." |
| Sterility | Sterilized and non-pyrogenic. | "The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic"." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of AI/ML evaluation. The document refers to "Biocompatibility testing and bench studies," but the number of devices or iterations tested is not provided.
- Data Provenance: Not applicable in the context of AI/ML data provenance (e.g., country of origin for images). These are bench tests and biocompatibility studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a traditional medical device submission, not an AI/ML device. Ground truth as typically defined for AI models (e.g., expert labels on medical images) is not relevant here.
4. Adjudication method for the test set
- Not applicable. This is a traditional medical device submission, not an AI/ML device.
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. This document describes a traditional medical device (catheter), not an AI/ML-powered device. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This document describes a traditional medical device (catheter), not an AI/ML-powered device with a standalone algorithm.
7. The type of ground truth used
- For biocompatibility: Adherence to recognized biological safety standards (e.g., ISO 10993).
- For performance: Engineering specifications and functional requirements as determined by the manufacturer and assessed through bench testing (e.g., ability to accommodate guide wires, withstand pressure).
- For substantial equivalence: Comparison against the characteristics of the legally marketed predicate device (IntraLuminal Therapeutics, Inc. ILT Deflecting Catheter cleared under 510(k) K010531).
8. The sample size for the training set
- Not applicable. This is a traditional medical device submission, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a traditional medical device submission, not an AI/ML 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).