(27 days)
The Safe Cross® Support Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe Cross Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The Safe Cross® Support Catheter is a single-lumen intravascular catheter intended for percutaneous use. It is designed to use in conjunction with a .014" and .018" quide wire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, quide wires may be exchanged within the catheter. The Safe Cross® Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The effective length of the Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 2.8 French (0.037"). The distal region incorporates a radiopaque material to aid in visualization under fluoroscopy. The inside diameter of the Support Catheter shaft will accommodate a commercially available .014" and .018" quide wire.
The Safe Cross® Support Catheter is packaged in a Tyvek® covered tray and heat-sealed to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The Safe Cross Coated Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
The provided text is related to a 510(k) Premarket Notification for a medical device called the "ILT Safe Cross® Support Catheter". This document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study that would typically establish detailed acceptance criteria and performance against those criteria through extensive clinical trials.
Therefore, the information required to populate the requested table and answer the specific study-related questions (sample size, experts, adjudication, MRMC, standalone performance, ground truth details) is not present in the provided document. The 510(k) summary explicitly states that the device modification was evaluated through "Biocompatibility testing and in vitro bench studies" to demonstrate substantial equivalence, not a clinical study involving human patients, ground truth establishment by experts, or AI performance metrics.
Here's an explanation and an attempt to address the relevant points based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a table of explicit acceptance criteria or specific quantitative performance metrics beyond general statements of "biocompatible" and "satisfies functional performance requirements." This is typical for a 510(k) submission demonstrating substantial equivalence based on bench testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Device materials are biocompatible (concluded from testing). |
| Functional Performance | Device satisfies functional performance requirements when used as indicated (concluded from in vitro bench studies). |
| Substantial Equivalence | Modifications are substantially equivalent to the predicate device and capable of safely and accurately performing the stated intended use (conclusion from overall testing). |
| Accommodates Guide Wires | Accommodates commercially available .014" and .018" guide wires (design specification). |
| Radiopacity | Distal region incorporates a radiopaque material to aid in visualization under fluoroscopy (design specification). |
| Sterility & Non-pyrogenic | Provided "STERILE" and "Non-pyrogenic" (packaging and sterilization claim). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "Biocompatibility testing and in vitro bench studies" but does not detail the number of samples or test runs.
- Data Provenance: Not specified, but generally, bench testing and biocompatibility studies are conducted in a controlled lab environment. There is no mention of country of origin for data or whether it's retrospective or prospective, as it's not a clinical study in that sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical catheter, and its performance evaluation for this 510(k) was based on engineering bench tests and biocompatibility assessments, not on subjective expert interpretation or ground truth establishment relevant to AI/diagnostic performance.
4. Adjudication method for the test set:
- Not Applicable. As mentioned above, there was no expert-based adjudication in the context of this 510(k) submission.
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 is a physical medical device (catheter), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used:
- Bench Testing Standards/Specifications & Biocompatibility Standards: The "ground truth" for this type of device evaluation would be established engineering specifications, industry standards for catheter performance (e.g., burst pressure, tensile strength, pushability, trackability), and recognized standards for biocompatibility (e.g., ISO 10993 series). The document states that "Performance test results indicate that the device satisfies functional performance requirements."
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI algorithm, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI algorithm.
§ 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).