(126 days)
The SoloPath® Re-Collapsible Access System is indicated for percutaneous insertion into the femoral artery over a guidewire and, once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery. The device may also be used to expand femoroiliac artery lesions to facilitate its use as an Access System.
The SoloPath Re-Collapsible Access System is a sterile, single-use device that consists of a flexible, reinforced polymer sheath and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve.
The SoloPath assembly is inserted percutaneously over a guidewire, with the deflated Expander in place. Once positioned into the vasculature and inflated with liquid, the Expander balloon exerts a controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement.
The SoloPath Re-Collapsible Access System features an integrated external collapsible outer jacket which is pressurized with liquid under low pressure prior to removal, collapsing the outer sheath diameter for ease of removal. The Sheath is designed: 1) as a guide for catheters and/or devices introduced into the femoral artery and 2) to dilate stenosed femoro-iliac vessels as an adjunct to its primary function.
The principles of operation for the subject SoloPath Re-Collapsible Access System are identical to those of the currently cleared SoloPath Re-Collapsible Access System (K121404). There are no changes to the insertion, deployment, or removal of the device as a result of this secondary indication.
This submission is a 510(k) for the SoloPath Re-Collapsible Access System, which is an intravascular catheter. The 510(k) is for the addition of a secondary indication for use. Therefore, the information provided focuses on non-clinical performance and substantial equivalence to a predicate device, rather than a traditional study with strict acceptance criteria for AI model performance.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a medical device and not an AI/ML product, the "acceptance criteria" are tied to demonstrating substantial equivalence to a predicate device and adherence to relevant ISO standards, rather than metrics like sensitivity or specificity. The "reported device performance" refers to the successful completion of specified tests.
| Acceptance Criteria (related to ISO Standards and Predicate Equivalence) | Reported Device Performance |
|---|---|
| Radio-detectability: Conform to ISO 10555-4, Section 4.2 | Successfully completed. |
| Designation of nominal size: Conform to ISO 10555-4, Section 4.3 | Successfully completed. |
| Balloon rated burst pressure (RBP): Conform to ISO 10555-4, Section 4.4.1, Annex A | Successfully completed. |
| Balloon fatigue; freedom from leakage and damage on inflation: Conform to ISO 10555-4, Section 4.4.2, Annex B | Successfully completed. |
| Balloon deflation time: Conform to ISO 10555-4, Section 4.4.3, Annex C | Successfully completed. |
| Biocompatibility: No changes from original testing (K121404) in accordance with ISO 10993. | Original testing reviewed under K121404 remains valid as no changes to materials, sterilization, or packaging. |
| Sterilization: No changes from original process (K121404) in accordance with ISO 11135-1:2007 to achieve SAL of 10-6. | Original sterilization process and procedure remain valid as no changes have been made. |
| Risk Analysis: Conducted in accordance with ISO 14971, with new risks adequately captured and mitigated. | Completed, new risks assessed and mitigated. |
| Substantial Equivalence: Demonstrate equivalence in intended use, technology/principal of operation, materials, and performance to predicate device (K121404). | Document claims substantial equivalence due to no significant differences raising new safety/effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of patients or cases for "testing." Instead, it refers to a series of non-clinical performance tests on the physical device. The number of devices or components tested for each specific bench test (e.g., RBP, fatigue) is not explicitly stated, but it's implied that sufficient numbers were tested to meet the requirements of the ISO standard.
- Data Provenance: The data provenance is from non-clinical bench testing of the SoloPath Re-Collapsible Access System itself. It is not human subject data, so concepts of country of origin or retrospective/prospective do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This is not applicable as the "ground truth" for non-clinical bench testing is defined by the physical properties of the device and adherence to engineering standards. No human experts were used to establish a "ground truth" for a test set in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
- Not applicable for non-clinical bench testing. Performance is evaluated against objective engineering specifications and standard test methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This is a 510(k) for a physical medical device (catheter introducer) and not an AI/ML product. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included in this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is for a physical medical device. There is no algorithm or AI component involved.
7. The Type of Ground Truth Used
- The "ground truth" used for this device's performance testing is based on objective engineering and material specifications, and compliance with recognized industry standards (ISO 10555-4:2013). For example, for "Balloon rated burst pressure," the ground truth is the specified pressure that the balloon must withstand. For "Biocompatibility," the ground truth is compliance with ISO 10993.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" for a physical medical device like this in the context of AI/ML. The device itself is manufactured based on design specifications; it does not "learn" from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set or ground truth established for a training set.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).