(147 days)
The Matrix™ Detachable Coils have the same indications for use as the predicate GDC" coils.
Matrix™ Detachable Coils are intended for embolization of those 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) inoperable,
and for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
The Matrix™ Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
The Matrix™ Detachable Coil system consists of the following, each of which is sold seperately:
- · GDCTM SynerGTM Power Supply
- · Matrix™ Detachable Coil attached to a delivery wire
- · Set of GDCTM SynerGTM connecting cables
- Patient return electrode
- · Two 9-volt batteries
The coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
Matrix™ Detachable Coils are manufactured from platinum wire, which is first wound into a primary coil and then formed into a secondary helical shape. Coating the platinum coil is a proprietary biocompatible absorbable polymer mixture.
Coils are attached to a delivery wire, which consists of a ground stainless-steel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is identical to that employed for the predicate GDCTM Coils cleared under K001083.
The GDCTM SynerGTM power supply is a battery-operated, selfcontained unit designed to initiate and control the electrolytic detachment of a GDC™ Coil or Matrix™ Detachable Coil inside an aneurysm.
The GDC™ SynerG™ Power Supply is designed to apply a constant current through the GDC™ System and to detect when coil detachment has occurred. It maintains a constant current by:
-
sensing the amount of resistance to current flow through the Matrix™ Detachable Coil, and
-
adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the Matrix™ Detachable Coil and to recognize those changes, which indicate detachment.
Once those patterns are identified, the GDCTM SynerGTM power supply signals detachment and stops the flow of current through the Matrix™ Detachable Coil.
The provided document is a 510(k) Premarket Notification for the Matrix™ Detachable Coils, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the information typically requested for a software algorithm/AI device, such as detailed acceptance criteria with specific performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, blinding protocols, and expert ground truth establishment, is largely absent or not applicable in this context.
However, based on the information provided, I can infer and extract the relevant details as much as possible for a device of this nature.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are predominantly demonstrated by showing that the Matrix™ Detachable Coils are substantially equivalent to the Guglielmi Detachable Coil (GDC™) and GDC™ Power Supply (K001083), the predicate device. The performance is assessed against criteria established for the predicate device, indicating no degradation in safety or effectiveness with the modifications made (addition of a biocompatible absorbable polymer and ultraviolet curing adhesive).
| Test or Point of Comparison | Acceptance Criteria (established for predicate device) | Reported Device Performance (Matrix™ Detachable Coils) |
|---|---|---|
| Friction | Meets acceptance criteria | Meets acceptance criteria established for predicate device. |
| Catheter / Coil Compatibility | Meets acceptance criteria | Meets acceptance criteria established for predicate device. |
| Main Coil Tensile Strength | No change made which would affect this test | No change made which would affect this test. |
| Main Coil Junction Strength | Meets acceptance criteria | Meets acceptance criteria established for predicate device. |
| Coil Stiffness Test | Meets acceptance criteria | Meets acceptance criteria established for predicate device. |
| Coil Stability in Aneurysm Test | Meets acceptance criteria | Meets acceptance criteria established for predicate device. |
| Polymer Mass Loss Tests | Meets acceptance criteria | Meets acceptance criteria established for device. |
| Deployment / Retraction Test | Meets acceptance criteria | Meets acceptance criteria established for device. |
| Polymer to Platinum Bond Integrity Testing | Meets acceptance criteria | Meets acceptance criteria established for device. |
| Polymer Integrity Tensile Strength Test | Meets acceptance criteria | Meets acceptance criteria established for device. |
| Compatibility with Saline Test | Meets acceptance criteria | Meets acceptance criteria established for device. |
| Detachment Time | No change made which would affect this test | No change made which would affect this test. |
| Heating Effect of Electrolysis | No change made which would affect this test | No change made which would affect this test. |
| Heating Effect of MRI | No change made which would affect this test | No change made which would affect this test. |
| Electrostatic Discharge | No change made which would affect this test | No change made which would affect this test. |
| Electromagnetic Compatibility - Radiated Susceptibility | No change made which would affect this test | No change made which would affect this test. |
| Electromagnetic Compatibility - Radiated Emissions Class B | No change made which would affect this test | No change made which would affect this test. |
| Electromagnetic Compatibility - Magnetic Immunity | No change made which would affect this test | No change made which would affect this test. |
| Operating System Test (Assembly Source Code) | Meets acceptance criteria | Meets acceptance criteria established for predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of diagnostic performance involving patient data or images (as would be common for AI/software devices). Instead, the "tests" refer to engineering and biocompatibility evaluations on the physical device components and system. The sample sizes for these specific engineering tests are not described in this summary. The data provenance is associated with the device manufacturing and testing process by Boston Scientific Target. This is a premarket notification, not a clinical trial report, so concepts like "country of origin of the data" are not directly applicable to an AI device's test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical medical implant (embolization coil) and associated power supply, not an AI/software diagnostic device that requires expert-established ground truth from images or patient data for performance evaluation. The "ground truth" for these engineering tests would be the established specifications and performance parameters for medical devices of this type, ensuring manufacturing quality and safety.
4. Adjudication method for the test set
Not applicable. There is no "adjudication method" in the traditional sense of resolving discrepancies among experts for diagnostic interpretation, as this is not an AI/software diagnostic device. The "tests" described are physical and electrical engineering evaluations.
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 document pertains to a physical medical device (embolization coil) and its power supply. It is not an AI/software device intended to assist human readers (e.g., radiologists) in diagnostic tasks, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. Its function is to physically embolize aneurysms and vascular malformations, with human intervention for placement and detachment control.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed on the Matrix™ Detachable Coils is based on established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and performance metrics defined for the predicate device (GDC™ Coils). For example, "Friction" would have a specified acceptable range of frictional force, and "Polymer Mass Loss Tests" would have a maximum allowable mass loss over a given period. The overall "ground truth" for the submission is demonstrating substantial equivalence to a device already deemed safe and effective.
8. The sample size for the training set
Not applicable. As this is not an AI/software device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/software device, there is no "training set" or corresponding ground truth to establish in that context.
§ 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).