(166 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 Sapphire™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
The Sapphire Detachable Coil (SDC) is manufactured from a platinum alloy attached to a positioning wire. The coil is detached by the Sapphire Detachment System (SDS) power supply, which dissolves a small detachment element between the emboliozation coil and the positioning wire. This occurs after desired placement of the coil in the anatomy. The Sapphire coils are manufactured from platinum/iridium alloy wire that is first wound into the primary coil, and then formed into a secondary (spherical or helical) shape. The Sapphire Detachment Coils are manufactured in different shapes and sizes. These coils are available in spherically shaped configurations, as well as, helically shaped configurations of various diameters and lengths.
The Sapphire Detachable Coil System underwent various tests to demonstrate its performance and substantial equivalence to the predicate device. The Acceptance Criteria and reported performance are summarized below, though specific numerical acceptance criteria were not provided in the document for all tests. The document states that "All performance characteristics met the acceptance criteria" and "All testing demonstrated compliance with the appropriate standard and/or met the acceptance criteria," indicating successful completion of the tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Coil Strength (force required to deform coil shape) | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Ease of Delivery (friction during advancement/retraction) | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Detachment Time | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Reliability after Fatigue (10 cycles) | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Coil, Detachment Zone & Coil Weld Tensile Strength | Met unspecified acceptance criteria | Measured, evaluated, and met acceptance criteria |
| Delivery Wire Flexibility | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Radiopacity | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Particulate Generation | Met unspecified acceptance criteria | Measured, evaluated, and met acceptance criteria |
| Material Compatibility | ||
| MRI Compatibility | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Packaging & Sterility | ||
| Packaging | Met unspecified acceptance criteria | Tested, evaluated, and met acceptance criteria |
| Sterile Integrity & Sterility Validation | Met unspecified acceptance criteria | Tested, evaluated, and met acceptance criteria |
| Detachment System Performance (SDS) | ||
| Conductance of Current | Met product specifications | Tested, evaluated, and met acceptance criteria |
| Compliance with Product Specifications | Met product specifications | Tested, evaluated, and met acceptance criteria |
| Detachment Reliability (in-vitro and in-vivo) | Met unspecified acceptance criteria | Tested, evaluated, and met acceptance criteria |
| Electrical Safety | Compliant with appropriate standard | Tested, evaluated, and demonstrated compliance |
| Radiated Emission | Compliant with appropriate standard | Tested, evaluated, and demonstrated compliance |
| Radio Disturbance | Compliant with appropriate standard | Tested, evaluated, and demonstrated compliance |
| Electro-Static Discharge Immunity | Compliant with appropriate standard | Tested, evaluated, and demonstrated compliance |
| SDS Firmware (expression of modes and states) | Conforms to Design Specifications | Tested, evaluated, and demonstrated compliance |
2. Sample Size for Test Set and Data Provenance
The document describes "animal studies" for the Sapphire Detachable Coil series. However, the specific sample size (number of animals) used for these studies is not provided. The data provenance is described as prospective animal studies. The country of origin of the data is not specified.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not include information on the number of experts used to establish ground truth or their qualifications. The animal studies would rely on observations and measurements from the researchers and veterinarians involved.
4. Adjudication Method
The provided text does not include information on any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a medical implant and not an imaging or diagnostic AI device that would typically involve human readers. The studies focused on the physical and functional performance of the coil and its detachment system.
6. Standalone (Algorithm Only) Performance Study
While the Sapphire Detachment System (SDS) includes firmware, the "standalone" performance described is not in the context of an AI algorithm producing a standalone diagnostic output. Instead, it refers to the functional performance of the SDS, including electrical safety, emission, disturbance, ESD immunity, and firmware compliance with design specifications. The performance of the coil itself is also assessed in a standalone context in the sense that its physical properties are measured independently.
7. Type of Ground Truth Used
The ground truth used in the studies includes:
- Physical Measurements and Standards: For tests like coil strength, tensile strength, flexibility, radiopacity, particulate generation, and electrical properties, ground truth is established by objective measurements against predefined engineering specifications and relevant industry standards.
- In-vitro Performance Assessment: For aspects like ease of delivery, detachment time (in-vitro), and detachment reliability (in-vitro), the ground truth is based on the devices' performance in controlled laboratory settings and simulations.
- Animal Outcomes/Observations: For the animal studies, the ground truth relates to observed physiological responses and device function within a living system, such as fluoroscopic visibility, ability to position and pack the aneurysm sac, coil reposition-ability, ease of use of the detachment system, coil detachment reliability, and coil stability.
8. Sample Size for the Training Set
The concept of a "training set" is typically applicable to machine learning algorithms. Since the Sapphire Detachable Coil System is a physical medical device and not an AI algorithm in the context of its development as described, there is no mention of a training set in the provided information.
9. How the Ground Truth for the Training Set Was Established
As there is no training set discussed, information on how its ground truth was established is not applicable/provided.
§ 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).