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510(k) Data Aggregation
(21 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.
This 510(k) submission describes the Interlock™-35 Fibered IDC™ Occlusion System, which is a vascular embolization device. The submission is for a revision to the Directions for Use (DFU) to include results of non-clinical MRI testing, demonstrating the device's MR Conditional status. It's important to note that this submission is not for a new device but for an updated label based on non-clinical testing. Therefore, the traditional acceptance criteria and study design focused on clinical performance metrics (like sensitivity, specificity, accuracy) are not applicable here.
Instead, the acceptance criteria relate to the device's compatibility with MRI environments, and the study in question is a non-clinical (i.e., benchtop) evaluation.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Device will not present additional risk to a patient during a MRI procedure due to gravitational or daily activities. | "Non-clinical testing demonstrates that the Interlock-35 Fibered IDC Occlusion System will not present additional risk to a patient during a MRI procedure in comparison to risks imposed by gravitational, and other normal daily activities..." (Implied: Device movement/dislodgement is acceptable) |
| Device will not cause a temperature rise in a MRI procedure that exceeds a feverish condition. | "...or a temperature rise that is experienced during a feverish condition." (Implied: Device heating is acceptable within specified limits) |
| Device is MR Conditional under specific static magnetic field strengths. | "The results of testing conducted under methods described by ASTM F2182-02a, ASTM F2052-06e1, ASTM F2213-06 and ASTM F2119-07 have demonstrated that the Coils are MR Conditional and can be scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla." (Explicitly states MR Conditional status at 1.5T and 3.0T). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of devices tested. The studies were non-clinical, so "sample size" would refer to the number of devices or coils subjected to MRI testing. The document refers to "the Coils."
- Data Provenance: The studies were non-clinical benchtop testing, not involving human or animal subjects. Therefore, there's no country of origin or retrospective/prospective nature in the typical sense. The testing was performed in a laboratory setting according to specified ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was a non-clinical safety evaluation for MRI compatibility, not a diagnostic or performance study requiring expert interpretation of results to establish ground truth. The "ground truth" was determined by adherence to established ASTM standards and measurement of physical parameters (e.g., temperature rise, magnetic susceptibility artifacts, force).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As this was a non-clinical, objective assessment based on ASTM standards, there was no subjective interpretation or adjudication process involving multiple experts.
5. 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 submission describes a medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective measurements based on recognized ASTM standards. The "ground truth" for MRI compatibility is defined by the parameters and limits stipulated in the following ASTM standards:
- ASTM F2182-02a (Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging)
- ASTM F2052-06e1 (Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2213-06 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)
- ASTM F2119-07 (Standard Test Method for Quantitative Measurement and Assessment of Magnetically Induced Distortion of an MR Image by a Medical Device)
8. The sample size for the training set
- Not applicable. There is no "training set" as this is a non-clinical evaluation of a physical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" or "ground truth" for a training set in this context.
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