FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The current Micros Spherical MicroCoil System (510k # K002056) is available in 10 and 18 system sizes.
The 10 System Spherical MicroCoils are available in diameters ranging from 2 mm to 10 mm and in lengths ranging from 2 cm to 20 cm.
The 18 System Spherical MicroCoils are available in diameters ranging from 2 mm to 19 mm and in lengths ranging from 2 cm to 30 cm.
The proposed longer Spherical MicroCoil, which is the focus of this submission, is designed to provide move aneurysm-framing loops to provide better aneurysm wall and aneurysm neck coverage in aneurysms ranging from 6 to 10 mm in size:
The "Long 10 System Spherical" MicroCoils will be available in diameters ranging from 6 mm to 10 mm and in lengths ranging from 20 cm to 30 cm.
These long Spherical MicroCoils are a line extension of the current regular length Micrus Spherical MicroCoils.
Both the original length and long length Spherical MicroCoil Systems are "framing" coils, to be used interchangeably to frame the inner wall of the aneurysm prior to filling it with Helical MicroCoils. All Micrus MicroCoils are part of the complete Micrus MicroCoil Delivery System, which has three components (sold and provided individually):

Micrus Platinum MicroCoil Systems, Spherical, Straight, and Stretch Resistant configurations, consist of an embolic coil attached to a variable stiffness Device Positioning Unit (DPU). The DPU has a radiopaque marker band located three (3) centimeters from its distal end for compatibility with infusion microcatheters with 2 tip markers.
Detachment Control Boxes (DCB). This device provides the energy to detach the MicroCoil from the DPU at the clinician's command. The DCB is provided NON-STERILE.
Connecting Cable. The Connecting Cable is used to bring the energy from the DCB to the MicroCoil System, and is approximately 5-ft (1.5 m) long.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted to address your specific questions:

Acceptance Criteria and Device Performance

Test	Acceptance Criteria	Reported Device Performance
V0381: Durability	Withstand 6 cycles of deployment and retraction through the tip of the microcatheter in a tortuous anatomy flow model without stretching, knotting, or breaking.	The 10 System long Spherical MicroCoil System demonstrates the durability to withstand 6 cycles of deployment and retraction through the tip of the microcatheter in a tortuous anatomy flow model without stretching, knotting, or breaking.
V0384: Advancement, Retraction, and Framing	Able to advance, retract, frame the aneurysm, and enable packing of the framed aneurysm with helical filler coils.	The long Spherical MicroCoil System is able to advance, retract, frame the aneurysm, and enable packing of the framed aneurysm with helical filler coils.
V0387: Frictional Forces	Frictional forces equal to or less than the currently marketed helically shaped and spherically shaped MicroCoil systems.	The frictional forces of the long Spherical MicroCoil System were equal or less than the currently marketed helically shaped and spherically shaped MicroCoil systems.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document describes non-clinical tests. There is no mention of a human test set, clinical data, or data provenance (country of origin, retrospective/prospective). The tests referenced are in vitro (flow model and frictional force testing).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The tests are non-clinical, mechanical/performance evaluations. Ground truth for clinical data is not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as there is no human test set or clinical data requiring adjudication.
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 tool. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these non-clinical tests would be the pre-defined performance specifications (refer to "Acceptance Criteria" table above) for mechanical properties and functional performance (durability, ability to advance/retract/frame, and frictional forces). These are engineering specifications rather than clinical ground truth like pathology or expert consensus.
The sample size for the training set
- Not applicable. This is not an AI/machine learning device; therefore, there is no training set.
How the ground truth for the training set was established
- Not applicable for the same reason as above.

Summary

Regulation Number and Section

§ 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).