(94 days)
The Impulse™ and Expo™ 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™ and Expo™ Angiographic Catheters are single lumen catheters offered in Selective, Pigtail and Multi-Purpose models in 5F and 6F. The devices have multiple polymer layers with a stainless steel braid embedded between the layers. The atraumatic tip does not contain braid. The proximal end consist of an insert molded polymer hub and a strain relief.
This document is for an angiographic catheter and describes non-clinical testing. It does not include information about clinical studies or AI/ML device performance. Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI, nor can I answer questions about sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's the information that can be extracted from the provided text regarding the non-clinical testing:
Acceptance Criteria and Device Performance (Non-Clinical)
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance (as stated in the document) |
|---|---|---|
| Mechanical Bench Testing | Shaft Stiffness | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." |
| Tip Bond Tensile Strength | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." | |
| Shaft Integrity: Burst Pressure | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." | |
| Hub Tensile | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." | |
| Radiopacity | "Design verification testing, including mechanical bench testing was performed to verify that the performance of the Impulse™ and Expo™ Angiographic Catheters remain substantially equivalent to both predicate devices." | |
| Biocompatibility Testing | Cytotoxicity | "Biocompatibility...testing were also performed to verify the overall safety and efficacy of the device." |
| Hemolysis | "Biocompatibility...testing were also performed to verify the overall safety and efficacy of the device." | |
| FTIR (Fourier-transform infrared spectroscopy) | "Biocompatibility...testing were also performed to verify the overall safety and efficacy of the device." | |
| Latex | "Biocompatibility...testing were also performed to verify the overall safety and efficacy of the device." | |
| Sterility | Sterility Testing | "Sterility...testing were also performed to verify the overall safety and efficacy of the device." |
| Packaging | Packaging Testing | "Packaging testing were also performed to verify the overall safety and efficacy of the device." |
Key Findings from the Document:
- No Clinical Testing: The document explicitly states, "Clinical Evaluation was not required for these devices." This means there is no clinical study data to report for humans.
- Substantial Equivalence: The primary method for demonstrating safety and efficacy for this device was through substantial equivalence to predicate devices, supported by non-clinical testing. The performance goal for each non-clinical test appears to be demonstrating that the new device remains "substantially equivalent" to its predicates.
- Device Type: This is a diagnostic intravascular guide catheter, which is a physical medical device, not an AI/ML software device. Therefore, questions related to AI/ML specific performance metrics are not applicable.
Answers to Specific Questions (based on the provided text):
- A table of acceptance criteria and the reported device performance: See the table above. The performance reported is that the devices "remain substantially equivalent" to predicate devices for the listed tests.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for non-clinical bench testing. The document does not specify sample sizes for mechanical or biocompatibility tests, nor data provenance in terms of country or retrospective/prospective nature.
- 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 or AI studies does not apply to materials and mechanical bench testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to adjudication of medical opinions, which is not relevant for bench testing.
- 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. Clinical evaluation was not required, and this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm; it is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for bench testing would typically be engineering specifications, material properties, and established laboratory standards that the device must meet or exceed. The document implies compliance to these standards to achieve "substantial equivalence."
- The sample size for the training set: Not applicable. There is no AI model, therefore no training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).