(171 days)
The Intramed SBO System is intended for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The angioscope within the Introducer Catheter is intended to be used for vessel visualization, specifically to visualize the lumen of the saphenous vein during the in situ procedures.
The Intramed SBO System, like the CRI Occlusion System, was developed for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The system includes (1) a Coil Delivery Catheter, which is preloaded with an occlusion coil, and (2) an Introducer Catheter, which is used to visualize the side branches and mechanically direct the Coil Delivery Catheter into the side branch for occlusion.
The Coil Delivery Catheter consists of a flexible catheter shaft with an occlusion coil positioned in the distal portion of the catheter lumen. A guide wire is contained within the inner shaft immediately proximal to the occlusion coil. At the proximal end of the catheter, this guide wire connects to a plunger mechanism. When the plunger is depressed. the quide wire pushes the coil out of the catheter and into the side branch for occlusion.
The occlusion coil provided with the Intramed SBO System is purchased from Cook Incorporated. This product is a preamendment device that has been commercially distributed for vessel occlusion/embolizations. The use of this coil in the Intramed SBO System is within the intended use of the occlusion coils as marketed by Cook Incorporated.
The Introducer Catheter has a composite shaft with two lumens. One lumen contains a miniature diameter angioscope with self-contained optics for visualization during the procedure. The other lumen is used to pass the Coil Delivery Catheter to the site of the side branch to be occluded. The catheter has an actuator handle to advance or retract the angioscope by a small amount to provide visualization of the vessel when the angioscope is in the extended position and visualization of the tributary when in the retracted position. The proximal end of the catheter consists of a coil catheter receiver as well as an eyepiece and light source connector for the angioscope.
The provided text describes the Intramed Side Branch Occlusion System and its substantial equivalence to predicate devices, but it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.
The document discusses non-clinical testing (biocompatibility, functional/bench, cadaver testing) and a summary of clinical testing, but it does not provide:
- A table of specific acceptance criteria with quantifiable metrics.
- Reported device performance against those specific criteria.
- Details about sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for clinical studies.
- Information regarding MRMC studies or effect sizes.
- Information about standalone algorithm performance (as this is a medical device, not an AI algorithm).
- Details about training sets or how their ground truth was established.
However, I can extract the information that is present in the document about the testing performed, even if it doesn't meet all your requested categories.
Here's a summary of the available information:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided 510(k) notification for the Intramed Side Branch Occlusion System does not explicitly list quantifiable acceptance criteria in a table format, nor does it present a detailed study with specific metrics to demonstrate the device meets such criteria.
Instead, it relies on demonstrating substantial equivalence to predicate devices and describes various non-clinical and clinical evaluations performed to ensure safety and effectiveness. The "acceptance criteria" are implied by the successful completion of these tests and their findings of biocompatibility, proper function, and comparable performance to predicate devices.
Summary of Reported Testing and Findings:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| 1. Biocompatibility | Catheters and their materials were found to be biocompatible and nontoxic and acceptable for their intended use, in accordance with ISO 10993 standard for Transient Contact Duration, Blood Path Direct, Externally Communicating Devices. |
| 2. Functional/Bench Performance | Testing demonstrated that the product meets its performance requirements (specific requirements are not detailed). |
| 3. Performance in Saphenous Veins (Cadaver Study) | Studies demonstrated that the Intramed SBO System visualizes and identifies side branches and can place coils in appropriate side branches. |
| 4. Clinical Safety and Effectiveness (vs. Predicate) | Clinical evaluation showed that the Intramed SBO System is as safe and effective as the CRI system for the delivery of occlusion coils during in situ saphenous vein bypass surgery. |
| 5. Substantial Equivalence to Predicate Devices | The device was determined substantially equivalent to the CRI Vessel Occlusion System/CRI Occlusion Coil (K914523) and the Intramed™ .7 mm Passive Angioscope (K894459) based on components, mode of operation, intended use, and technological characteristics, despite some differences in materials and mechanics (e.g., coil types, mechanical vs. steerable catheter, mechanical vs. hydraulic ejection, integral angioscope). The differences were deemed not to affect intended use or overall operation. (This is a regulatory "acceptance criterion" rather than a direct performance metric). |
Details Not Provided in the Document:
- Sample size used for the test set and the data provenance: Not specified for any of the described tests (biocompatibility, functional, cadaver, or clinical evaluation).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and/or not specified for the type of testing described (which largely focuses on device function and clinical equivalence rather than diagnostic performance assessed by multiple readers).
- 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, as this is a medical device for intervention, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI algorithm.
- The type of ground truth used:
- For biocompatibility: Standardized testing protocols against ISO 10993.
- For functional/bench testing: Device specifications/requirements.
- For cadaver testing: Direct observation of visualization, identification, and coil placement.
- For clinical evaluation: "Safe and effective as the CRI system" implies direct comparison and clinical outcomes relative to the predicate, but the specific metrics for "safety" and "effectiveness" (e.g., complication rates, successful occlusion rates) and how they constituted ground truth are not detailed. It's likely based on established clinical practice and comparison to the predicate device's known performance.
- The sample size for the training set: Not applicable, as this is a medical device, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable, as this is a medical device, not an AI algorithm.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).