(71 days)
The Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe-Cross® 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 guidewires 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, guidewires 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" guidewires.
The 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 describes a 510(k) premarket notification for a medical device called the "ILT Safe-Cross® Deflecting Catheter." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with extensive performance studies against pre-defined acceptance criteria for efficacy or diagnostic performance. Instead, the "acceptance criteria" here refer to the functional performance requirements of the device and its biocompatibility, which are typically met through bench testing and standard biocompatibility assessments.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantitative, tabular format as one might find for a diagnostic or AI-based device's performance. Instead, it discusses the device's functional characteristics and how its performance was evaluated against these.
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials must be biocompatible (to ensure safety when in contact with body tissues). (Implicit) | "Biocompatibility test results indicate that the device materials are biocompatible." |
| Functional Performance | Device must satisfy functional performance requirements for its intended use (e.g., ability to facilitate guidewire access and exchange, suitable for delivering saline/contrast). (Implicit) | "Performance test results indicate that the device satisfies functional performance requirements when used as indicated." |
| Specific dimensions are provided as characteristics, implying they meet design specifications: |
- Effective length: 135-140 cm
- Shaft nominal O.D.: 2.5 F (0.033")
- Max O.D. of deflecting segment: 3.5 F (0.045") at 10 atm
- I.D. at tip: 0.016"
- Accommodates 0.014" guidewires |
| Sterility | Device must be sterile. (Implicit) | "The packaged units are sterilized with ethylene oxide gas. The device is provided 'STERILE'." |
| Pyrogenicity | Device must be non-pyrogenic. (Implicit) | "'Non-Pyrogenic'" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench studies" and "biocompatibility testing." These types of studies typically involve a set number of manufactured devices tested against engineering specifications and biological safety standards. However, the exact sample sizes for these tests are not specified in the provided text. The data provenance is also not specified, though it would originate from the manufacturer's testing facilities. These were likely prospective tests performed on newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a medical catheter, not a diagnostic device relying on expert interpretation of data or images to establish ground truth for performance. The "ground truth" for this device's performance would be objective measurements against engineering specifications and standard biocompatibility assay results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3. Adjudication methods are typically used in studies involving human interpretation of medical data where there's a need to resolve discrepancies between multiple readers.
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
An MRMC study was not done. This device is a physical catheter, not an AI or imaging-based diagnostic system. Therefore, there's no concept of human readers or AI assistance in its direct use or evaluation in the context of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on:
- Engineering Specifications: Measurements of physical dimensions, flexibility, pushability, torqueability, and other mechanical properties against pre-defined design criteria.
- Standard Biocompatibility Test Results: Objective results from assays (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) performed according to international standards (e.g., ISO 10993).
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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).