(182 days)
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils consists of an implantable coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire. Both the delivery catheter and guidewire are not included in the system.
Here's an analysis of the provided text regarding the HydroCoil Embolic System (HES) to extract the requested information about acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information (especially quantitative performance data, sample sizes for test/training sets, expert details, and MRMC studies) is not present in this type of regulatory submission. The answers below will reflect the information available.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
Based on the 510(k) summary, the acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to predicate devices rather than meeting specific quantitative performance targets. The "reported device performance" is a general statement about equivalence.
| Acceptance Criteria Category | Acceptance Criteria (Implicit from 510(k)) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Device is substantially equivalent in operating principle, method of application, design, materials, packaging, and sterilization to predicate devices. | "The HydroCoil® Embolic System (HES)... is substantially equivalent in operating principle, method of application, indications for use, design, materials, packaging and sterilization to the predicate devices." |
| Performance (Safety & Effectiveness) | Device is equivalent in performance to the predicate devices, ensuring similar safety and effectiveness. | "Performance testing has demonstrated that the HydroCoil® Embolic System (HES)... is equivalent in performance to the predicate devices." |
| Indications for Use Consistency | Indications for Use are consistent with those of the predicate devices. | The stated Indications for Use are similar to common uses for embolization coils, implying consistency with predicates. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the 510(k) summary. The document mentions "Performance testing" but does not detail the number of samples or cases used.
- Data Provenance: Not specified. This type of submission relies heavily on non-clinical (bench and in-vitro) testing to establish substantial equivalence for embolization coils, rather than extensive clinical data. If any clinical data was used, its origin (country, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not specified. The 510(k) summary does not describe a process involving expert ground truth establishment for a test set, as it's not a diagnostic AI device or a study involving human interpretation of images.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. This information is not relevant for a device of this type or the nature of testing described in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. An MRMC study is typically performed for diagnostic imaging devices where human readers interpret medical images. This device is an embolization system, not a diagnostic tool requiring such a study.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study or AI assistance for human readers is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical device (embolization coil), not a software algorithm. Therefore, "standalone performance" in the context of AI algorithms does not apply. The performance testing refers to the physical and functional properties of the coil.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the conventional sense of diagnostic performance. For physical devices like embolization coils, "ground truth" would relate to successful deployment, mechanical stability, embolic efficacy in an in-vitro or animal model, and biocompatibility. The regulatory submission relies on performance testing (e.g., mechanical properties, fluid dynamics in simulated vessels, biocompatibility tests) against pre-defined engineering and safety specifications, and comparison to predicate device characteristics. Pathology or outcomes data aren't the primary ground truth for the device itself in this context, although they would be for the clinical effectiveness of the embolization procedure.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As this is not an AI algorithm, there is no "training set" or "ground truth" establishment in that context.
§ 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).