(65 days)
The Sapphire Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable.
The intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use.
Sapphire Detachable Fibered Coil - The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.
The Sapphire Detachable Coil (SDC) is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary helical shape. The coil is welded to a positioning wire, which consist of ground stainless steel core wire with a stainless steel coil laser welded at the distal end and a Teflon outer jacket. The coil is detached by the battery operated power supply (Sapphire Detachment System, SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire. The fibered coil is manufactured with nylon fibers secured into the primary coil. The fibered coils are available in two shapes (Helix and Cyclone) and different sizes.
The Sapphire Detachable Fibered Coil System demonstrates its acceptance criteria and performance through a series of bench, animal, and physician evaluation tests. The device's substantial equivalence to the predicate device, Target GDC fibered coils, is asserted based on similar intended use, operating principles, basic design, and sterilization processes.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria & Reported Performance |
|---|---|---|
| Bench Testing | Coil Strength (Coil Deformation and Softness) | Meet established acceptance criteria |
| Ease of Delivery | Meet established acceptance criteria | |
| Reliability After Fatigue & Premature Detachment | Meet established acceptance criteria | |
| Tensile Strength of Coil & Detachment Zone | Meet established acceptance criteria | |
| Tensile Strength of Delivery Wire | Meet established acceptance criteria | |
| Delivery Wire Flexibility | Meet established acceptance criteria | |
| Detachment Time | Meet established acceptance criteria | |
| Radiopacity | Meet established acceptance criteria | |
| Particulate Generation of Detachment Zone | Meet established acceptance criteria | |
| Aging and Shelf Life (3 year) | Meet established acceptance criteria | |
| Fiber Pull Out | Meet established acceptance criteria | |
| Fiber Endurance | Meet established acceptance criteria | |
| Packaging validation after 3-year accelerated aging | Meet established acceptance criteria | |
| Animal Testing | Coil Per Aneurysm (Avg./S.D.) | Comparable to the Predicate Device |
| Detachment Time (seconds) | Comparable to the Predicate Device | |
| Coil Detachment Reliability (detachment attempts/coil) | The Sapphire demonstrated higher reliability compared to the Predicate Device | |
| Post Embolization Angiographic Assessment | Comparable to the Predicate Device | |
| Angiographic Assessment One-Month Follow-Up | Comparable to the Predicate Device | |
| Angiographic Assessment Three-Month Follow-Up | Comparable to the Predicate Device | |
| Physician Device Evaluation | Ease of Coil Preparation | Comparable to acceptance criteria |
| Ability to move coil within Catheter | Comparable to acceptance criteria | |
| Access | Acceptance Criteria | |
| Ability to Place catheter tip in desired location | Comparable to acceptance criteria | |
| Trackability, Friction of coil through catheter | Comparable to acceptance criteria | |
| Coil Visualization | Acceptance Criteria | |
| Fluoroscopic visibility of Coil | Comparable to acceptance criteria | |
| Fluoroscopic visibility of Detachment Markers | Comparable to acceptance criteria | |
| Coil Delivery Procedure | Acceptance Criteria | |
| Ability to Position Coil in Sac | Comparable to acceptance criteria | |
| Detachment Time | Comparable to acceptance criteria | |
| Ability to Pack Aneurysm Sac | Comparable to acceptance criteria | |
| Ability to Reposition | Comparable to acceptance criteria | |
| Ease of use of the SDS Detachment System | Comparable to acceptance criteria | |
| Coil Positional Stability/Aneurysm Occlusion | Comparable to acceptance criteria | |
| Overall (Ease of Use) | Comparable to acceptance criteria | |
| Overall (Overall performance) | Comparable to acceptance criteria | |
| MRI Compatibility | MRI Compatibility | Compatible with 1.5 Tesla |
2. Sample size used for the Test Set and Data Provenance
The provided document does not explicitly state the sample size for the test set used in the animal testing or physician device evaluation. Similarly, the data provenance (e.g., country of origin, retrospective or prospective nature) for these tests is not specified. The bench testing would likely be performed in a laboratory setting, not involving human or animal subjects in the same way.
3. Number of Experts and their Qualifications for Ground Truth
The document does not specify the number of experts used or their qualifications for establishing ground truth, particularly for the animal testing or physician device evaluation. However, the "Physician Device Evaluation" implies the involvement of medical professionals in assessing the device's practical performance.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The study focuses on comparing the Sapphire Detachable Fibered Coil System against a predicate device through bench, animal, and physician evaluations, rather than assessing human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance
This device is a physical medical device (embolization coil system), not an AI-powered diagnostic or therapeutic algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission.
7. Type of Ground Truth Used
Based on the descriptions:
- Bench Testing: The ground truth for bench testing is inherent in established engineering and physicochemical standards and specifications for material properties, mechanical performance, and device functionality.
- Animal Testing: The ground truth for animal testing would be based on physiological and anatomical observations, angiographic assessments, and potentially histopathological evaluations in the animal models. The comparison is made against the performance of the predicate device in a living system.
- Physician Device Evaluation: The ground truth for physician evaluations is based on the subjective and objective assessments of experienced medical professionals regarding the device's ease of use, handling, visualization, and overall performance in a simulated or real clinical environment (though the nature of the evaluation is not fully detailed to determine if it's purely simulated or involves actual clinical use).
8. Sample Size for the Training Set
Since this is a physical medical device and not an AI/ML algorithm requiring a training set, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set was Established
As mentioned above, this section is not applicable to the Sapphire Detachable Fibered Coil System as it is not an AI/ML device.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).