(80 days)
The SCIMED 6 French 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 6 French SCIMED IMPULSE Angiographic Catheters are single lumen catheters which will be available in Selective, Pigtail and Multipurpose models. The shafts of all 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. 2) The middle layer provides torque control, kink resistance and support, and 3) The outer layer provides stiffness and curve retention. Radiopaque materials are utilized in the outer layer to allow visualization of the catheter during the procedure. A Pigtail Straightener is available to aid the physician in straightening the Pigtail curve while being introduced into the introducer sheath.
The medical device, SCIMED® 6 French IMPULSE™ Angiographic Catheters, did not provide acceptance criteria in a structured manner but rather demonstrated substantial equivalence to predicate devices through non-clinical functional testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from Functional Testing) | Reported Device Performance |
|---|---|
| Pressure burst: Catheter withstands internal pressure without bursting. | Verified as adequate for intended use. |
| Tip bond tensile: Strength of the bond between catheter tip and shaft. | Verified as adequate for intended use. |
| Hub tensile: Strength of the bond between catheter hub and shaft. | Verified as adequate for intended use. |
| Dye flow: Ability to deliver contrast media effectively. | Verified as adequate for intended use. |
| Tip coefficient of friction: Low friction at the tip for smooth navigation. | Verified as adequate for intended use. |
| Force transmitted by catheter tip: Ability to transmit force for maneuvering. | Verified as adequate for intended use. |
| Torque response: Ability to transmit rotational force for steering. | Verified as adequate for intended use. |
| Torque to fail: Resistance to twisting force before damage occurs. | Verified as adequate for intended use. |
Study Details:
- Study Type: Non-clinical (in-vitro) functional testing and comparison study for substantial equivalence.
- Device: SCIMED® 6 French IMPULSE™ Angiographic Catheters.
- Predicate Devices: SCIMED® 6 French EXPO™ Angiographic Catheter and SCIMED 5 French IMPULSE™ Angiographic Catheter.
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "functional testing" but does not quantify the number of catheters or tests performed for each criterion.
- Data Provenance: The study was non-clinical (in-vitro) and conducted by SCIMED Life Systems, Inc. The country of origin for the data is not specified beyond being generated by the submitter (SCIMED Life Systems, Inc. in Maple Grove, Minnesota, USA). The study is prospective in the sense that these tests were performed on the new device for regulatory submission.
3. Number of Experts and Qualifications for Ground Truth: Not applicable. This was a non-clinical, in-vitro functional testing study, not a study involving human interpretation or expert consensus for ground truth.
4. Adjudication Method: Not applicable. This was a non-clinical, in-vitro functional testing study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI algorithm or imaging device that would typically involve human readers interpreting cases.
6. Standalone Performance Study:
Yes, a standalone study was done in the sense that the device's functional performance was evaluated independently against engineering specifications and industry standards (implicitly, by demonstrating "adequacy for intended use" and "substantial equivalence"). The "algorithm only" context is not relevant here as it is a physical device.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" was established by pre-defined engineering specifications, performance standards, and the demonstrated performance of predicate devices. For example, a catheter must withstand a certain pressure to pass the pressure burst test.
8. Sample Size for the Training Set: Not applicable. This is not an AI/machine learning study requiring a training set.
9. How Ground Truth for the Training Set was Established: Not applicable. This is not an AI/machine learning study requiring a training set.
§ 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).