(28 days)
The Interlock Fibered IDC Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
The 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System is a product line consisting of 0.018 inch (0.457 mm) system compatible fibered interlocking detachable coils. The Interlock Fibered IDC Occlusion System includes a coil (manufactured from 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 Fibered IDC Occlusion Coil is designed to be delivered under fluoroscopy with a 0.021 inch (0.53 mm) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one or two radiopaque (RO) tip markers. 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) summary for the Interlock™ 018 Fibered IDC™ Occlusion System, a vascular embolization device. The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility assessments, rather than clinical performance studies involving patient data or human readers. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission primarily based on bench and biocompatibility testing for substantial equivalence, the "acceptance criteria" are generally that the new device performs comparably to the predicate device in these tests, and meets established standards for safety (biocompatibility) and functional performance. Specific quantitative acceptance values are not explicitly stated in this summary for each test, but rather the successful completion of these tests.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Tested and completed |
| Sensitization | Tested and completed |
| Intracutaneous Reactivity | Tested and completed |
| Acute Systemic Toxicity | Tested and completed |
| Materials Mediated Pyrogenicity | Tested and completed |
| Hemolysis (Extract Method) | Tested and completed |
| Complement Activation | Tested and completed |
| Implantation | Tested and completed |
| Genotoxicity (Ames Assay and Mouse Lymphoma) | Tested and completed |
| Subacute Toxicity (IP and IV) | Tested and completed |
| USP Physicochemical | Tested and completed |
| Latex | Tested and completed |
| Partial Thromboplastin Time | Tested and completed |
| In-vitro Performance: | |
| Anchorability | Tested and completed |
| Fiber Retention | Tested and completed |
| Microcatheter Compatibility (lumen) | Tested and completed |
| Deliverability/Pushability | Tested and completed |
| Stretch Resistance | Tested and completed |
| Overall (Substantial Equivalence): | "No new safety or performance issues were raised during the testing." |
| "considered substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not specified in terms of number of units tested for each in-vitro or biocompatibility test. These tests typically involve a defined number of samples per test according to relevant standards, but the exact count is not detailed.
- Data Provenance: The tests are described as "bench testing" and "biocompatibility testing," which are laboratory-based studies. There is no patient data or geographical origin specified as it's not a clinical study. It's a prospective evaluation of the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "ground truth" here is determined by the results of the laboratory tests against established scientific and regulatory standards (e.g., ISO standards for biocompatibility). There's no involvement of clinical experts establishing ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set:
- Not applicable. This pertains to clinical studies often involving expert interpretation of images or patient data. Laboratory testing results are generally objective measurements directly from the test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is a clinical study design used to evaluate diagnostic systems involving multiple readers interpreting multiple cases, often with and without AI assistance. This submission relies on bench and biocompatibility testing for a device, not a diagnostic algorithm.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a physical medical device (embolization coil), not an algorithm or AI software. The performance testing is for the device itself, not a separate algorithm. The closest equivalent is the standalone "in-vitro performance tests" and "biocompatibility tests."
7. Type of Ground Truth Used:
- For biocompatibility, the ground truth is established by recognized international standards (e.g., ISO 10993 series) for evaluating biological effects of medical devices.
- For in-vitro performance, the ground truth is established by engineering specifications and functional requirements derived from the device's intended use and comparison to predicate devices, verified through direct physical measurements and observations in a controlled lab setting.
8. Sample Size for the Training Set:
- Not applicable. This submission is for a physical medical device and its manufacturing/material characteristics, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no training set for this type of device submission.
§ 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).