(79 days)
The Sapphire Detachable Fibered 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 Fibered Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
The Sapphire Detachable Fibered Coil System 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 provided text is a 510(k) summary for a medical device (Sapphire Detachable Fibered Coil System) and does not contain detailed information about acceptance criteria or a study proving its performance against such criteria in the way a clinical trial report would.
However, I can extract information related to the device's claims and the basis for its clearance, which is primarily substantial equivalence to a predicate device.
Here's an attempt to answer your questions based only on the provided text, acknowledging that much of the requested information, particularly regarding specific "acceptance criteria" and detailed "study" results, is not present.
Acceptance Criteria and Study for Sapphire Detachable Fibered Coil System (K03372)
The provided submission (K03372) is a Premarket Notification (510(k)) seeking clearance for an expanded indication for use for the Sapphire Detachable Fibered Coil System, specifically for the endovascular embolization of intracranial aneurysms. The original device (cleared under K031852) was cleared for embolization of neurovascular abnormalities (AVMs and arteriovenous fistulae) and peripheral vasculature.
The basis for this new clearance is primarily substantial equivalence to a predicate device (Cook, Inc. Hilal embolization Microcoil) and supported by "in-vivo, in-vitro studies," as well as technological comparison. The text does not outline specific, quantitative acceptance criteria for device performance (e.g., a specific success rate for aneurysm occlusion or a predefined safety threshold) for the new indication, nor does it present detailed results of a study designed to meet such criteria.
The 510(k) process relies heavily on demonstrating similar safety and effectiveness to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence and Indication) | Reported Device Performance (from text) |
|---|---|
| Safety and Effectiveness for Endovascular Embolization of Intracranial Aneurysms (new indication) | |
| (Implied: Device functions as intended without undue risk, similar to predicate for its indicated uses) | Substantial Equivalence to Predicate Device: |
- Intended Use: Similar (though the current submission expands the indication for fibered coils to aneurysms, a use for which the predicate was presumably already cleared or for which this technology is considered similar).
- Technological Characteristics: Listed as "Same" or "Various but similar" for: Microcoil system supplied as, Coil length and diameter, Radiopacity, MRI Compatibility, Main Coil Material, Detachment Element.
- Coil Shapes: Different (Predicate: Straight and Curled; Sapphire: Helix and Cyclone).
- Catheter Compatibility: Different (Predicate: 18"; Sapphire: 10" and 18").
- Fiber Material: Different (Predicate: Synthetic fiber; Sapphire: Nylon 6-6).
Supporting Data:
- "in-vivo, in-vitro studies" (no details provided on methodology, results, or specific performance metrics).
- "technological comparison to the predicate device." |
| Embolization of Neurovascular Abnormalities (AVMs and Arteriovenous Fistulae) (original indication) | The device was previously cleared for this indication (K031852). The current submission focuses on expanding to aneurysms. No specific performance metrics for AVM/AVF embolization are provided in this document. |
Detailed Study Information (Based only on the provided text):
As noted, the document is a 510(k) summary and not a detailed clinical study report. Therefore, much of the requested information regarding a specific "study" proving acceptance criteria is not explicitly stated.
2. Sample size used for the test set and the data provenance:
* Sample Size: Not specified. The document mentions "in-vivo, in-vitro studies" but does not provide details of their design, sample size, or results.
* Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified. There is no mention of a "test set" in the context of expert-adjudicated images or data in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not specified. No adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. This is a medical device for embolization, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated for the "in-vivo, in-vitro studies." For a device like this, ground truth would typically relate to successful coil deployment, aneurysm occlusion, absence of complications, and mechanical performance characteristics demonstrated in bench testing and animal models (for "in-vivo" studies). The document does not elaborate.
8. The sample size for the training set:
* Not applicable/Not specified. No "training set" is mentioned in the context of an algorithm or AI.
9. How the ground truth for the training set was established:
* Not applicable/Not specified. No "training set" for an algorithm is mentioned.
Summary of what can be gleaned from the K03372 document:
The 510(k) is for an expanded indication of an existing device (Sapphire Detachable Fibered Coil System) to include intracranial aneurysms. The primary argument for clearance is substantial equivalence to the predicate device (Cook, Inc. Hilal Embolization Microcoil) based on similar intended use and technological characteristics. This claim is vaguely supported by "in-vivo, in-vitro studies" and a "technological comparison," but specific performance data, detailed methodologies, or quantitative acceptance criteria are not provided in this summary document. The document essentially states that the new indication is supported by these general types of studies and the similarity to the predicate.
§ 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).