(180 days)
The Contour® Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations.
The FasTracker-325® Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour® Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.
The Contour® Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations.
The FasTracker-325® Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour® Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.
The provided text details the submission of the Contour® Emboli PVA and FasTracker®-325 Infusion Catheter for 510(k) clearance, asserting substantial equivalence to predicate devices. However, the document does not explicitly describe acceptance criteria, nor does it provide a study report detailing specific performance metrics against such criteria. It mentions a prospective clinical study, but no performance data from that study is included within the provided sections.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
What is present in the document is the following:
- Clinical Data Source: Clinical data were collected in a prospective clinical study to support the safety and effectiveness of these devices for treatment of uterine fibroids. This indicates that a clinical study was performed, but the results and details of this study are not within the provided text.
- Biocompatibility Testing: The devices were tested for biocompatibility per ISO 10993, and all data demonstrated biocompatibility for their intended use. This is a form of acceptance criteria (biocompatibility) with a positive outcome, but it's not related to diagnostic or therapeutic efficacy performance.
- Substantial Equivalence: The submission asserts that the devices have been tested and compared to predicate devices, and "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This is the primary "proof" for 510(k) clearance, but it refers to a comparison with existing devices rather than a detailed performance study against specific, pre-defined acceptance criteria for the new device.
§ 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).