(81 days)
The Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
The Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are visually identified by a distal radiopaque tip bonded onto a stainless steel braided catheter shaft. Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are manufactured in lengths of 40. 60. 65. 75. 80. 90. 100. 125. 135 and 150 centimeters and have no distal sideports. Each catheter is manufactured with either a plastic winged hub. mounted on the proximal end of the catheter, indicating the catheter French size and relative endhole diameter, or a translucent hub with a strain relief. The catheters are manufactured with a 4.0, 4.1, 4.5, 5.0, 5.5 or 6.5 French catheter shaft that is designed with an inner lumen tapered to a 0.035 or a 0.038 inch endhole diameter. These catheters. are manufactured in a variety of distal tip configurations.
The provided document is a 510(k) summary for a medical device modification, specifically for the Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data.
Therefore, many of the requested items related to clinical studies (e.g., sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable as this document describes physical performance testing, not a clinical study.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Predetermined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | In conformance with the applicable sections of ISO 10555-1 | The predetermined acceptance criteria were met. Testing shows the tensile strength during proper clinical use should not fracture or rupture the catheter. |
| Leakage | In conformance with the applicable sections of ISO 10555-1 | The predetermined acceptance criteria were met. Testing shows there would be no leakage from the catheter during proper clinical use. |
| Biocompatibility | In conformance with the applicable sections of ISO 10993-1 | The predetermined acceptance criteria were met. Testing shows the device is biocompatible. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this submission type. The document describes physical and biocompatibility testing, not clinical data from a "test set" of patients. The tests mentioned are laboratory-based engineering and biological evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in the context of clinical expert consensus is not relevant for the physical and biocompatibility tests performed. Standards (ISO 10555-1, ISO 10993-1) define the "ground truth" for acceptance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication is relevant for interpreting clinical data, not for the straightforward physical and biocompatibility tests described.
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
- Not applicable. This device is a catheter, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Tensile Strength and Leakage: The ground truth is defined by the technical specifications and performance limits set forth in ISO 10555-1 (Intravascular catheters - Sterile single-use catheters - Part 1: General requirements).
- For Biocompatibility: The ground truth is defined by the toxicological and biological safety requirements outlined in ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).
8. The sample size for the training set
- Not applicable. This document describes physical testing of a medical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or machine learning model is involved.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).