(61 days)
The SCIMED Impulse Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
The Impulse angiographic catheters and packaging materials are the same as the Impulse catheters currently on the market. The packaging materials for all SCIMED Angiographic catheters have recently been tested to support a 3 year shelf life.
The provided document is a 510(k) notification for SCIMED Impulse Angiographic Catheters, specifically focused on extending the shelf life of the packaging to three years. It is not a study proving the device's clinical performance or a standalone algorithm. Therefore, many of the requested elements (like acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, MRMC studies, and ground truth types) are not applicable to the information presented.
Here's an analysis based on the provided text, focusing on what is available about the shelf-life testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Packaging Shelf Life | Packaging integrity and functionality maintained for 3 years. (Implied from the goal of the submission) | Packaging materials for all SCIMED Angiographic catheters have recently been tested to support a 3-year shelf life. (Specific test results are not provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Standard packaging testing was conducted to support a 3 year package shelf life," but does not detail the number of units tested.
- Data Provenance: Not explicitly stated, but it's internal testing conducted by Boston Scientific SCIMED, Inc. for regulatory approval in the US. It's retrospective as the testing would have been completed prior to this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for packaging shelf life would be determined by laboratory testing results (e.g., burst strength, seal integrity, material degradation over time under accelerated aging conditions), not expert consensus.
4. Adjudication Method for the Test Set
- Not applicable. As above, this is about physical/chemical testing, not human judgment on performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study relates to the clinical interpretation of medical images or diagnostic outputs by human readers, often with and without AI assistance. This document describes a shelf-life extension for catheter packaging, not a clinical diagnostic device or an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This document does not describe an algorithm or AI device.
7. The Type of Ground Truth Used
- For the packaging shelf-life study, the "ground truth" would be laboratory test results (e.g., physical integrity tests, sterility barrier tests, material characterization) conducted on aged packaging materials.
8. The Sample Size for the Training Set
- Not applicable. No AI algorithm or training set is mentioned.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No AI algorithm or training set is mentioned.
Summary of Device and Study Information (Based on provided text):
- Device: SCIMED Impulse Angiographic Catheters (specifically, their packaging for a 3-year shelf life).
- Intended Use: To provide a pathway for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
- Study Purpose: To support a 3-year shelf life for the device's packaging materials.
- Study Type: Non-clinical packaging testing.
- Conclusion (from the submission): "The packaging materials for all SCIMED Angiographic catheters have recently been tested to support a 3 year shelf life." This indicates the testing was successful in meeting the implicit acceptance criteria for a 3-year shelf life, allowing the FDA to clear the device with this extended shelf life.
§ 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).