(30 days)
The Interlock-35 Fibered IDC Occlusion System is indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
The Interlock-35 Fibered IDC Occlusion System includes a coil manufactured from a platinum-tungsten alloy that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock-35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Diagnostic Catheter (e.g. Imager™ II Diagnostic Catheter). The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.
The provided text describes a 510(k) submission for the "Interlock™-35 Fibered IDC™ Occlusion System," a vascular embolization device. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.
Therefore, the information you requested about acceptance criteria and associated studies is not directly applicable to this type of device submission as it is typically presented for AI/ML device clearances.
Here's why and what can be extracted:
- No "Acceptance Criteria" for Clinical Performance: This submission is for a modified device, not a new one requiring extensive clinical trials to establish its own performance metrics. The goal is to show it's as safe and effective as its predicate.
- No "Device Performance" Metrics in the AI/ML Sense: The device is a physical medical implant (an embolization coil), not a diagnostic or therapeutic AI algorithm. Therefore, "device performance" here refers to mechanical and material properties, not accuracy, sensitivity, or specificity.
- No "Study that Proves the Device Meets Acceptance Criteria" in the AI/ML Sense: The "study" is a collection of non-clinical, bench-top tests designed to demonstrate that the modifications to the device do not negatively impact its safety and performance compared to the predicate.
Given this context, I will address your points by extracting the relevant information about the non-clinical performance data and explaining why other points are not present.
Acceptance Criteria and Device Performance (Non-Clinical)
Since this is a physical medical device and not an AI/ML diagnostic, the "acceptance criteria" relate to engineering and material specifications, and "device performance" refers to the results of non-clinical tests. The text indicates that all testing performed and data demonstrate passing results according to executed verification protocols. This implies that the acceptance criteria for each test were met.
| Acceptance Criterion (Implicit: "Passing Results per verification protocols") | Reported Device Performance (Summary) |
|---|---|
| Coil Geometry | Demonstrated passing results per executed verification protocols. |
| Stretch Resistance | Demonstrated passing results per executed verification protocols. |
| Deployment | Demonstrated passing results per executed verification protocols. |
| Atraumatic Embolic Coil Tip | Demonstrated passing results per executed verification protocols. |
| Fiber Retention | Demonstrated passing results per executed verification protocols. |
| Interlocking Arm to Embolic Coil Tensile Strength | Demonstrated passing results per executed verification protocols. |
| Embolic Coil Corrosion Resistance | Demonstrated passing results per executed verification protocols. |
| Radial Force | Demonstrated passing results per executed verification protocols. |
| Atraumatic Delivery Wire Tip | Demonstrated passing results per executed verification protocols. |
| Interlocking Arm to Delivery Wire Tensile Strength | Demonstrated passing results per executed verification protocols. |
| Corrosion Resistance | Demonstrated passing results per executed verification protocols. |
| Delivery Wire Coating Fracture | Demonstrated passing results per executed verification protocols. |
| Delivery Wire Coating Flexure | Demonstrated passing results per executed verification protocols. |
| Delivery Wire OD | Demonstrated passing results per executed verification protocols. |
| Delivery Wire Length | Demonstrated passing results per executed verification protocols. |
| Introducer Sheath Interface | Demonstrated passing results per executed verification protocols. |
| Introducer Sheath Deliverability | Demonstrated passing results per executed verification protocols. |
| Delivery Catheter Compatibility | Demonstrated passing results per executed verification protocols. |
| Rotating Hemostatic Valve (RHV) Compatibility | Demonstrated passing results per executed verification protocols. |
Information Not Applicable/Provided for This Type of Submission:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for non-clinical bench testing of a physical device. There isn't an "image test set." The tests are performed on manufactured device samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is based on engineering specifications and validated test methods, not expert consensus on images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to non-clinical bench testing.
- 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 not an AI-enabled device nor one requiring evaluation of human reader performance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is defined by established engineering and material science standards, measurement techniques, and specifications. Not clinical outcomes or pathology.
- The sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).