(173 days)
The Solus Gold Embolization Device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
The Solus Gold Embolization Device is a vascular plug device intended to obstruct or reduce the rate of blood flow in the peripheral vasculature. It is comprised of an implant assembly and a delivery system assembly. The delivery system assembly is comprised of a microcatheter and a delivery catheter. A rotating hemostatic valve (RHV) and a 3-way stopcock is provided on the hub of the delivery catheter for injecting fluid to facilitate expansion of the implant. The Solus Gold implant is available in 3 mm – 6 mm diameters. All implant sizes are provided with the same delivery system, and the physician selects the device size based on the treatment plan. The Solus Gold implant assembly consists of a gold implant body, a distal neck subassembly, and an implant mating component. The proximal end of the implant is joined to the delivery catheter through the implant , which is a platinum tubular segment secured to the inside of the gold implant body with adhesive. The distal neck subassembly is comprised of two stacked silicone valves and a platinum (Pt) marker band that are contained within a stainless-steel housing and bonded to the implant with adhesive. The distal neck subassembly of the implant is mounted to the microcatheter over a preparation tool, which is removed by the user after device preparation. The implant is pleated and folded, loaded onto the delivery catheter and microcatheter, and protected with a sheath. The device is provided sterile and is intended for single use only.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the Solus Gold Embolization Device:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary doesn't explicitly present acceptance criteria in a structured table with performance against each. However, we can infer the criteria and reported performance from the various performance data sections.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Sterilization: Sterility Assurance Level (SAL) | Validated to provide a SAL of 10^-6 according to ANSI / AAMI /ISO 11135. |
| Packaging & Shelf-Life: Pouch Seal Strength | Demonstrated at T=0 and accelerated aging T=6 months. |
| Packaging & Shelf-Life: Packaging Integrity | Demonstrated at T=0 and accelerated aging T=6 months. |
| Packaging & Shelf-Life: Unique Device Identification Barcode Quality | Demonstrated at T=0 and accelerated aging T=6 months. |
| Packaging & Shelf-Life: Microbial Barrier | Demonstrated at T=0 and accelerated aging T=6 months. |
| Packaging & Shelf-Life: Product Integrity Following Transit | Demonstrated at T=0. |
| Packaging & Shelf-Life: Device Condition after Transit | Demonstrated at T=0. |
| Packaging & Shelf-Life: Device performs as intended throughout labeled shelf-life | Accelerated aged samples demonstrated the device performs as intended throughout its labeled shelf-life. |
| Biocompatibility: Meet ISO 10993-1 and FDA Guidance Standards | Biological risks addressed by appropriate testing, chemical characterization, literature review, or a combination. The device is categorized for long-term contact with circulating blood (implant) and limited contact with blood (delivery system). |
| Bench Performance (Implant): Tensile Strength | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Implant): Expansion Rate/Characteristics | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Implant): Maximum Pressure | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Implant): Distal Neck Sub-assembly Flow | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Implant): Dimensions | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Implant): Corrosion Resistance | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Implant): MR Compatibility | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Microcatheter Distal Flexibility | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Microcatheter/Delivery Catheter Liquid Leak/Burst | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Catheter Air Leak | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Catheter Kink Resistance | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Catheter Torque Durability | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Catheter Tensile Force | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Inadvertent Implant Detachment | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Luer Hub Compatibility | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Coating Integrity | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Delivery System): Catheter Corrosion Resistance | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Complete Device): Simulated Use Testing | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Complete Device): Microcatheter Retraction Tensile Force | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Complete Device): Implant Detachment Tensile Force | Performed (no specific values provided, but confirmed to meet product specifications). |
| Bench Performance (Complete Device): Particulate | Performed (no specific values provided, but confirmed to meet product specifications). |
| Human Factors: Proper use of device, safe in intended environment, no new risks | Evaluated by 15 users. Demonstrated proper use, risks acceptable, no new risks identified. |
| Animal Study (Acute Embolization Effectiveness): Time to achieve complete target vessel occlusion | Mean time to complete (Grade 0 or 1) occlusion: 0.50 minute for Solus Gold (compared to 1.94 minutes for predicate). |
| Animal Study (Chronic Embolization Effectiveness/Durability): Complete target vessel occlusion at 90 days | 14/14 occurrences for Solus Gold (compared to 2/14 for predicate). |
| Animal Study (Chronic Embolization Effectiveness/Durability): Morphometric percent vessel lumen occlusion at 90 days | Mean (maximal) percent vessel lumen occlusion: 100% for Solus Gold (compared to 79.6% for predicate). |
| Animal Study (Safety): No complications | No complications observed for the Solus Gold Embolization Device. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sterilization Validation: Not specified, but validated to ISO 11135.
- Packaging & Shelf-Life Validation: Samples tested at T=0 and accelerated aging T=6 months. Specific numerical sample sizes are not provided.
- Biocompatibility: No specific sample size as it involves testing, chemical characterization, and literature review.
- Bench Performance Testing: Not specified, but "bench testing" was performed.
- Human Factors Assessment: 15 intended users evaluated the device. The data provenance is a simulated clinical setting.
- Pre-Clinical Animal Performance Testing: Seven (7) canine subjects underwent treatment procedures. Data provenance is a prospective animal study model (canine), conducted under Good Laboratory Practice (GLP) controls, specifically 21 CFR §58, and complied with relevant guidance documents. The study was conducted by Artio Medical, Inc., likely in the US given the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Human Factors Assessment: No "experts" established ground truth in the traditional sense. The ground truth (device usability and safety) was assessed through observation of 15 intended users during simulated use and their knowledge assessments.
- Pre-Clinical Animal Performance Testing: The ground truth for acute and chronic embolization effectiveness, as well as safety, was established by the study investigators through:
- Angiography (Day 0 and Day 28 ± 3 days)
- Histology (morphometric percent vessel lumen occlusion on Day 90)
- Observation for complications.
The specific qualifications of these investigators are not detailed beyond operating under GLP controls and adhering to specific guidance documents for animal studies for cardiovascular devices.
4. Adjudication Method for the Test Set
- Human Factors Assessment: Adjudication method isn't explicitly stated but appears to be based on direct observation of user performance and knowledge assessments, with results compiled and analyzed by the study observers/team.
- Pre-Clinical Animal Performance Testing: Adjudication for angiographic and histological measurements is not explicitly described (e.g., blinded reads by multiple independent experts). However, the study being conducted under GLP controls implies a structured approach to data collection and reporting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done.
- This device is a physical medical device (embolization device), not an Artificial Intelligence (AI) software/algorithm. Therefore, the concept of human readers improving with AI assistance is not applicable. The comparison was between the subject device and a predicate physical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Human Factors Assessment: The ground truth was primarily user performance observation and knowledge assessments related to device usability and safety in a simulated environment.
- Pre-Clinical Animal Performance Testing: The ground truth was based on:
- Angiographic assessments (time to occlusion, degree of occlusion).
- Histology (morphometric percent vessel lumen occlusion).
- Clinical observation of the animals for safety and complications.
This can be categorized as a type of outcomes data (short-term and chronic biological/physiological outcomes) from an animal model.
8. The Sample Size for the Training Set
- Not applicable. This summary does not describe any machine learning or AI components that would require a "training set." The data presented is for device verification and validation of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no described training set for an AI/ML algorithm, this question is irrelevant to the provided document.
§ 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).