(358 days)
The SoloPath® Re-Collapsible Access System is intended to be inserted percutaneously 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 SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use. Onset Medical Corporation's SoloPath® Re-Collapsible Access System is a sterile, single use device. It consists of a flexible, reinforced polymer sheath with an external collapsible outer jacket 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 folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath Assembly is inserted percutaneously into the femoral artery, over a guidewire, with the deflated Expander in place. Once positioned into the artery, the Expander balloon, when inflated with liquid, exerts 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 large 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 Sheath is designed as a guide for catheters and/or devices introduced into the femoral artery. Prior to removal, the outer jacket is activated with liquid unde pressure, collapsing the outer sheath diameter for ease of removal. The sheath is capable of expanding and actively collapsing.
The SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Functional Verification | Bend | Not explicitly stated, but implied proper function. | Acceptance criteria met. |
| Coating integrity | Not explicitly stated, but implied proper function. | Acceptance criteria met. | |
| Coating particulate | Not explicitly stated, but implied proper function. | Acceptance criteria met. | |
| Collapsation | Demonstrated ability to actively collapse. | Acceptance criteria met. | |
| Dilator burst | Not explicitly stated, but implied structural integrity. | Acceptance criteria met. | |
| Dilator cycle | Not explicitly stated, but implied durability. | Acceptance criteria met. | |
| Expansion | Demonstrated ability to expand. | Acceptance criteria met. | |
| Hemostasis valve leakage | Not explicitly stated, but implied prevention of blood loss. | Acceptance criteria met. | |
| Sheath jacket burst | Not explicitly stated, but implied structural integrity. | Acceptance criteria met. | |
| Sheath jacket cycle | Not explicitly stated, but implied durability. | Acceptance criteria met. | |
| Tensile | Not explicitly stated, but implied strength. | Acceptance criteria met. | |
| Torque | Not explicitly stated, but implied rotational integrity. | Acceptance criteria met. | |
| Trackability | Not explicitly stated, but implied ease of navigation. | Acceptance criteria met. | |
| Biocompatibility | Cytotoxicity | Conformance to ISO 10993-1 requirements. | Acceptance criteria met. |
| Complement Activation | Conformance to ISO 10993-1 requirements. | Acceptance criteria met. | |
| Partial Thromboplastin Time (PTT) | Conformance to ISO 10993-1 requirements. | Acceptance criteria met. | |
| Sensitization | Conformance to ISO 10993-1 requirements. | Acceptance criteria met. | |
| Intracutaneous Reactivity | Conformance to ISO 10993-1 requirements. | Acceptance criteria met. | |
| Acute Systemic Toxicity | Conformance to ISO 10993-1 requirements. | Acceptance criteria met. | |
| Pyrogenicity | Conformance to ISO 10993-1 requirements. | Acceptance criteria met. | |
| Hemolysis | Conformance to ISO 10993-1 requirements. | Acceptance criteria met. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions that "both the 19Fx35 cm and 24Fx35cm the SoloPath® Re-Collapsible Access System" were tested. This implies testing was conducted on at least two distinct configurations of the device. However, the exact number of units tested for each specific test (e.g., how many sheaths for a burst test) is not provided.
- Data Provenance: The study was conducted as in vitro bench studies. There is no mention of human or animal studies, or clinical data. Therefore, there is no country of origin for patient data, and it is entirely retrospective in the sense of being laboratory-based testing, not involving ongoing patient recruitment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable as the studies conducted were in vitro bench studies and biocompatibility testing. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The ground truth was based on pre-defined engineering and biological standards and criteria.
4. Adjudication Method for the Test Set:
- This information is not applicable for the same reasons as above. No adjudication method was necessary as these were objective measurements against pre-defined engineering and biological acceptance criteria.
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, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. The SoloPath® Re-Collapsible Access System is a physical medical device, and its performance is evaluated through bench testing and biocompatibility.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The SoloPath® Re-Collapsible Access System is a physical medical device, not an algorithm or software-only device. Its performance is inherent to its physical properties and design, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the bench studies and biocompatibility testing was based on pre-defined engineering specifications, performance standards, and established international biocompatibility standards (ISO 10993-1). It was not derived from expert consensus, pathology, or patient outcomes data.
8. The sample size for the training set:
- Not applicable. There was no "training set" for this device. This concept is relevant for machine learning or AI algorithms, which are not involved in the SoloPath® Re-Collapsible Access System's evaluation as described.
9. How the ground truth for the training set was established:
- Not applicable. As there was no training set, there was no ground truth for a training set to be established.
§ 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).