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510(k) Data Aggregation
(69 days)
Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen™ Coil Embolization System is indicated for endovascular embolization of:
- . Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- . Arterial and venous embolizations in the peripheral vasculature
NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
The Numen™ Coil Embolization System is composed of two parts as described below:
- An introducer sheath: The function of the introducer sheath is to facilitate introduction . of the coil into the microcatheter.
- . The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
The MicroPort NeuroTech NumenFR™ Detachment System is a sterile, handheld, singlepatient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
The provided text describes a 510(k) premarket notification for a medical device called the "Numen Coil Embolization System" and "NumenFR Detachment System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced performance or efficacy through extensive clinical studies. Therefore, much of the information typically sought in a study proving a device meets acceptance criteria (like MRMC studies, effect sizes, detailed ground truth establishment for AI models, and training set details) will not be present.
Based on the document, here's what can be extracted regarding acceptance criteria and performance:
The acceptance criteria are implicitly defined by the "Pass" result for each non-clinical bench test. The study proving the device meets these criteria is the Performance Testing section (Section 4).
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria Summary (Implicit from Test Method and "Pass" result) | Reported Device Performance |
|---|---|---|
| Visual Inspection of Pusher | Pass visual inspection under specific magnification (e.g., no defects, meeting dimensional/surface quality). | Pass |
| Simulated Use | Perform as intended in a representative tortuous anatomical model (e.g., successful delivery, deployment, and retrieval). | Pass |
| Fatigue Testing | Durability after repeating simulated use six times, including coil retraction and re-deployment (e.g., no breakage, no significant functional degradation). | Pass |
| Detachment Time and Detachment Reliability | Reliable intentional detachment and reliable coil attachment after fatigue testing in a representative tortuous anatomical model (e.g., detaches within specified time, no premature detachment). | Pass |
| Delivery and Retraction Friction in Introducer Sheath | Max friction force when advancing or retracting the coil system in introducer sheath meets pre-specified limits. | Pass |
| Delivery, Deployment and Retraction Friction in Microcatheter | Max friction force when advancing, deploying or retracting the coil system through microcatheter in a relevant, tortuous, anatomical model meets pre-specified limits. | Pass |
| Kink Resistance | Resistance to kinking meets pre-specified acceptance criteria and can withstand bending forces encountered in clinical usage. | Pass |
| Torque Strength | Torque strength meets pre-specified criteria after rotating the proximal end of the device for 8 turns (e.g., no damage, no functional impairment). | Pass |
| Flexing Test (Per ISO 11070, Annex G) | Resistance to damage by flexing meets the requirements of ISO 11070, Annex G. | Pass |
| Fracture Test (Per ISO 11070, Annex F) | Resistance to fracture meets the requirements of ISO 11070, Annex F. | Pass |
Note: The document states "pre-specified acceptance criteria" for some tests, but the specific numerical values or detailed parameters of these criteria are not provided within the scope of this FDA letter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes (e.g., number of coils or devices) used for each bench test. It refers to "test units representative of final finished devices." Given that this is a 510(k) submission primarily relying on bench testing to demonstrate substantial equivalence for a modification (new coil type), detailed clinical test set provenance (country of origin, retrospective/prospective) is not applicable here, as it's not a clinical study.
3. 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. This document describes non-clinical bench testing, not a study involving human experts establishing ground truth for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, this is bench testing, not an expert-adjudicated clinical study.
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 (coil embolization system) and not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed or is 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 physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench tests, the "ground truth" or reference for evaluating performance would be the predefined engineering specifications and performance targets for each test, as derived from relevant standards (e.g., ISO 11070 for Flexing and Fracture Tests) and internal product design requirements.
8. The sample size for the training set
Not applicable. This document describes testing for a physical medical device. The concept of a "training set" is relevant for machine learning models, which are not involved here.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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