(68 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 5 French SCIMED IMPULSE Angiographic Catheters will be available in 3 models; 0.045" ID Selective curve styles, 0.047" ID Selective curve styles, and the 0.045" ID Pigtail and Multipurpose curve styles whose tip ID tapers from 0.045" to 0.041" distally. Curve styles will be available with optional side holes. The shafts of all 3 models utilize common biocompatible materials and consist of the following three layers: 1) The inner layer provides a smooth surface to allow for dye delivery and ease of guide wire movement. The Selective models utilize Pebax® for the inner layer, while the Pigtail and Multipurpose catheters utilize a Polyurethane/Pebax coextrusion, 2) The middle layer is made of braided stainless steel wire that extends from the shaft to the tip to provide torque control, kink resistance and support, and 3) the outer layer, which is also manufactured from Pebax, provides stiffness and curve retention. Radiopaque materials are utilized in the inner shaft, outer shaft and tip to allow visualization of the catheter during the procedure. The tips of the Selective models are made from polyurethane, while the multipurpose and pigtail tips are composed of Pebax. Both tips are radiopaque to allow visualization during a procedure. The tips are heat fused to the distal end of the shaft. The catheters utilize a polycarbonate hub and Pebax strain relief. The hub is molded to the proximal end of the catheter shaft. The devices will be provided sterile and are intended for one procedure use only.
The provided text describes a 510(k) notification for the SCIMED® 5 F Diagnostic Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical study to establish new performance criteria. Therefore, the information provided does not align with the typical requirements for describing acceptance criteria and study results for a novel medical device as outlined in your request.
Here's why and what information can be extracted:
- No "Acceptance Criteria" in the traditional sense for novel device performance: The document is a 510(k) notification, which aims to show the new device is "substantially equivalent" to an already marketed predicate device. This means the acceptance criteria are generally that the new device performs as well as or similarly to the predicate, in specific functional tests. It's not about achieving a standalone performance threshold for a new indication.
- No "Study" as in a clinical trial with human subjects for efficacy/safety: The text explicitly states "Non-clinical Test Summary" and "results of in-vitro testing and evaluation." This means the performance tests were benchtop (laboratory) studies, not clinical trials.
- No "Device Performance" for metrics like sensitivity/specificity: Since it's a diagnostic catheter, its "performance" is related to its mechanical and material properties (e.g., dye flow, kink resistance) rather than diagnostic accuracy like a screening algorithm.
Based on the provided text, here's what can be answered, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by substantial equivalence) | Reported Device Performance (Summary of In-vitro Testing) |
|---|---|
| Pressure burst performance similar to predicate | Test results verified adequacy for intended use |
| Tip bond tensile strength similar to predicate | Test results verified adequacy for intended use |
| Hub tensile strength similar to predicate | Test results verified adequacy for intended use |
| Dye flow rates similar to predicate | Test results verified adequacy for intended use |
| Maximum dye flow rates similar to predicate | Test results verified adequacy for intended use |
| Tip coefficient of friction similar to predicate | Test results verified adequacy for intended use |
| Force transmitted by the catheter tip similar to predicate | Test results verified adequacy for intended use |
| Device radiopacity similar to predicate | Test results verified adequacy for intended use |
| Pigtail straightener peel-away force similar to predicate | Test results verified adequacy for intended use |
| Biocompatibility | Biocompatibility testing conducted (verified adequacy) |
| Shelf life | Shelf life testing conducted (verified adequacy) |
| Overall performance substantially equivalent to predicate devices (SCIMED® 5 French EXPO™ Angiographic Catheters and Cordis® Corporation 5 F Infiniti™ Angiographic Catheter) | 5 F IMPULSE Angiographic Catheters are considered substantially equivalent based on intended use, design, and results of in-vitro testing and evaluation. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the individual functional tests.
- Data Provenance: Not specified as it's non-clinical test data. It would be manufacturer-generated test data, likely from an in-house lab or contracted lab. Not applicable for retrospective/prospective as it's not human subject data.
3. 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. This device is a diagnostic catheter, not an diagnostic imaging/algorithm device requiring expert interpretation for ground truth. The "ground truth" here is the physical and material properties measured by established engineering test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, there's no expert interpretation or adjudication involved for the functional and material property tests described.
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
- Not Applicable. This is a physical medical device (catheter), not an AI algorithm. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (catheter), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests would be the measured values from standardized engineering and material science test protocols. For example, a pressure burst test result is a direct measurement, not an expert consensus.
8. The sample size for the training set
- Not Applicable. This is a physical medical device (catheter). It does not use machine learning, therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set for this type of device.
§ 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).