(187 days)
The SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices. They are intended to facilitate the placement of interventional devices into the peripheral and coronary systems and, in addition for the XF models, into the neurovascular system.
The SCHNEIDER GUIDER Softip® Guiding Catheter in this 510(k) is available in four French sizes (6 through 9 Fr) with multiple distal stem configurations and lengths. SCHNEIDER GUIDER Softip® Guiding Catheters are designed for the introduction of interventional devices.
The provided text describes a 510(k) summary for the SCHNEIDER GUIDER Softip® Guiding Catheters. This submission focuses on demonstrating substantial equivalence to predicate devices based on design and indications for use, rather than conducting a detailed performance study with specific acceptance criteria as you would find for a novel device or AI/software.
Therefore, much of the requested information about acceptance criteria, study design, and ground truth is not explicitly present or applicable to this type of regulatory submission. The document emphasizes mechanical testing in simulated environments to ensure the device's functionality, not clinical performance metrics.
Here is an attempt to address your points based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Force needed for insertion is acceptable (in simulated anatomy). | "These have been tested in simulated aortic and carotid anatomy with appropriate interventional devices to test that the force needed for insertion is acceptable." |
| Design (e.g., French sizes, distal stem configurations, lengths) is consistent with predicate. | "The design of the SCHNEIDER GUIDER Softip® Guiding Catheter remains the same as for the previous cleared devices." |
| Indications for Use are substantially equivalent to predicate devices. | "Schneider (USA) Inc has demonstrated that the SCHNEIDER GUIDER Softip® Guiding Catheters are substantially equivalent based on design, test results, and indications for use to the predicate devices." |
Explanation: In a 510(k) for a medical device like this catheter, acceptance criteria are often implied by comparison to a legally marketed predicate device. The primary "study" is a demonstration of substantial equivalence through design comparison and mechanical testing, rather than a clinical trial with performance metrics like sensitivity, specificity, or accuracy.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The description mentions "simulated aortic and carotid anatomy with appropriate interventional devices," but does not explicitly state the number of catheters tested or the number of simulated procedures performed.
- Data Provenance: The origin of the simulated anatomy data is not specified (e.g., country of origin). The testing was an internal evaluation by the manufacturer, not a clinical study on human subjects, so the terms "retrospective" or "prospective" do not directly apply to patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided. Given that the testing was mechanical in simulated anatomy, "experts" in the sense of clinical reviewers establishing ground truth for disease states or outcomes are not applicable. The "ground truth" here would be the physical properties and functionality of the catheter itself, assessed by engineers or technical personnel.
4. Adjudication Method for the Test Set
- Not applicable. There's no indication of independent review or adjudication for the mechanical testing results beyond the manufacturer's own internal reports.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No. This device is a physical medical instrument (guiding catheter), not an AI or software algorithm. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. As stated above, this is not an AI/algorithm device.
7. The Type of Ground Truth Used
- The "ground truth" was based on mechanical performance and design equivalence to predicate devices. Specifically, it involved whether the "force needed for insertion is acceptable" in simulated anatomical models and whether the design features matched the predicate. It did not involve expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of data used to train an algorithm. Any "training" would refer to the historical data and design principles used to develop the catheter, which is not quantified.
9. How the Ground Truth for the Training Set was Established
- Not applicable. Since there's no training set for an AI algorithm, this question doesn't apply.
§ 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).