(99 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.
Additionally, the 5F Selective Imager II Angiographic Catheters without sideholes can be used for the controlled and selective delivery of the Boston Scientific Interlock™ 35 Detachable Coils into the peripheral vasculature.
The 5F Selective Imager II Angiographic catheters without sideholes are sterile, single use diagnostic intravascular catheters. These catheters are available in a variety of shapes and lengths depending on the catheter model. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Clinically, selective catheters are used to create images of specific areas of interest. The Imager II 5F Selective Catheter without side-holes can also be used to deliver embolic materials.
The provided text describes a 510(k) summary for the Boston Scientific Imager™ II 5F Selective Angiographic Catheter. This is a medical device submission, not a study evaluating an AI device or algorithm. Therefore, many of the requested fields regarding acceptance criteria for AI performance, clinical study details, ground truth, and training data are not applicable.
The submission focuses on establishing substantial equivalence to previously cleared predicate devices through non-clinical design verification testing.
Here's an analysis based on the provided text, highlighting where information is not available due to the nature of the device and submission:
Acceptance Criteria and Reported Device Performance
As this is a traditional medical device (angiographic catheter) and not an AI or algorithm-based device, the "acceptance criteria" and "reported device performance" are primarily focused on physical and functional characteristics, not diagnostic or predictive metrics like sensitivity/specificity. The submission details design verification tests, which implicitly have internal acceptance criteria to demonstrate safety and effectiveness for substantial equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Embolic Coil Deployment (successful delivery and detachment) | "Design verification testing ... was performed to verify the performance and usability... and to show substantial equivalence." (Implies successful deployment) |
| Catheter Compatibility with 0.035" Embolic Coils | "Design verification testing ... was performed to verify the performance and usability... and to show substantial equivalence." (Implies compatibility) |
| Embolic Coil Stretch Resistance | "Design verification testing ... was performed to verify the performance and usability... and to show substantial equivalence." (Implies adequate resistance) |
| Introducer Sheath Interface (proper fit and function) | "Design verification testing ... was performed to verify the performance and usability... and to show substantial equivalence." (Implies proper interface) |
| Overall Substantial Equivalence to Predicate Devices | Formally found "substantially equivalent" by FDA. |
Study Information (Not Applicable to AI for this Device)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This submission is for a physical medical device (angiographic catheter), not an AI algorithm. The "test set" would refer to physical devices tested during non-clinical verification. No data provenance in the context of clinical images or patient data is provided or relevant here.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical expert consensus for AI, is not relevant here. The "ground truth" for non-clinical testing would be whether the device physically performs as intended (e.g., coil deploys correctly, catheter doesn't break). This is typically assessed by engineers and technicians against design specifications.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This method applies to resolving disagreements among experts for ground truth in clinical evaluations, which is not part of this device submission.
-
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 study is explicitly for evaluating the impact of AI on human reader performance. This device is an angiographic catheter, not an AI system. The submission explicitly states: "Summary of Clinical Testing: Clinical Evaluation was not required for these devices."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable / Engineering Specifications. For non-clinical device testing, the "ground truth" is adherence to predefined engineering specifications and functional performance metrics (e.g., successful deployment of coils, material strength, compatibility with other devices).
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML algorithm.
§ 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).