(6 days)
The Imager II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system including the carotid arteries.
The 4F and 5F Imager™ II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90 cm, and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, flush catheters are used to deliver a bolus of contrast to a patient when obtaining an image of a large area (aorta, leg-run off, etc.). Side-holes are added to disperse the contrast. Selective catheters are used to create images of specific areas of interest.
This 510(k) summary (K120893) describes the Imager™ II Angiographic Catheter, a diagnostic intravascular catheter. The submission focuses on demonstrating substantial equivalence to a predicate device (K050863) regarding its packaging configuration after multiple sterilization, climatic conditioning, and distribution simulation. No clinical studies were conducted for this submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for packaging) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Performance after multiple sterilization, climatic conditioning, and distribution simulation is substantially equivalent to the predicate device. | - Visual Inspection performed. |
| - Dye Penetration Testing performed. | |
| - Peel Testing performed. | |
| - Catheter Removal Force Testing performed. |
Note: The document states "Design verification testing as listed below was performed to verify the performance...is substantially equivalent to the predicate device." It does not provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it lists the types of tests conducted to support the claim of substantial equivalence for the packaging.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Design verification testing" but does not detail the number of units tested.
- Data Provenance: The tests are described as "Design verification testing" performed by Boston Scientific Corporation. This implies the data is prospective and generated from internal testing. No country of origin for the data is specified beyond Boston Scientific being based in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission is for a medical device (angiographic catheter) and its packaging. The "ground truth" here relates to the physical and mechanical integrity of the packaging, which is assessed through engineering and quality control tests, not expert interpretation of clinical images or data.
4. Adjudication Method (for the test set)
- Not Applicable. There is no "adjudication" process in the context of package integrity testing like there would be for image interpretation by clinicians. The tests are objective measurements or observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. This was not a clinical or comparative effectiveness study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- No. This device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests on packaging, the "ground truth" would be established by engineering specifications, industry standards, and internal quality control criteria for package integrity. For example, a "Pass/Fail" result for dye penetration would be determined by whether dye was observed past a certain barrier, which is an objective measurement based on defined criteria.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no training set was involved.
§ 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).