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510(k) Data Aggregation
(264 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 designed to be used in conjunction with the NumenFRTM Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen™ Coil Embolization System is composed of an introducer sheath and the coil system (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 NumenFRTM Detachment System is a sterile, handheld, single-patient use device designed for use with MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
The provided text describes a 510(k) summary for the Numen™ Coil Embolization System and NumenFR™ Detachment System submitted to the FDA. This document focuses on demonstrating substantial equivalence to predicate devices through various performance tests and comparisons. It is not an AI/ML device, and thus does not include information typically found in studies for AI/ML devices. Therefore, a direct answer to the request based solely on the provided text, especially regarding AI/ML-specific acceptance criteria, ground truth, and human reader studies, is not possible.
However, I can extract the general acceptance criteria and performance results as described for this medical device (a coil embolization system), even though they are not related to AI/ML. The provided document details a series of non-clinical performance tests and biocompatibility assessments to establish substantial equivalence.
Here's an attempt to answer based on the provided text, indicating where information is present and where it is not applicable or unavailable given the nature of the device and the document:
Acceptance Criteria and Device Performance for Numen™ Coil Embolization System and NumenFR™ Detachment System (Non-AI/ML Medical Device)
This document describes the validation of a neurovascular embolization device, not an AI/ML system. Therefore, many of the requested criteria related to AI/ML performance metrics, ground truth establishment by experts, and human reader studies are not applicable. The information provided focuses on the physical and functional performance of a medical device (coils and a detachment system).
1. Table of Acceptance Criteria and Reported Device Performance
For the Numen™ Coil Embolization System, the acceptance criteria are generally qualitative ("Pass") indicating that the device performed as intended and met pre-specified requirements. The performance results consistently show "Pass" for all tests.
| Test | Test Method Summary | Acceptance Criteria (Implicit: "Pass") | Reported Device Performance |
|---|---|---|---|
| Visual inspection | Examine the test sample surface under specific magnification. | Visual inspection confirms material quality and absence of defects. | Pass |
| Dimensional verification | Implant coil, pusher and introducer sheath dimensions are measured to match the specifications. | Dimensions meet specifications. | Pass |
| Simulated use | Verify that the coil embolization system performs as intended in a representative tortuous anatomical model. | Device performs as intended in simulated use. | Pass |
| Fatigue testing | Verify the durability of the coil embolization system by repeating the simulated use for six times, including coil retraction into microcatheter and re-deployment. | Device durable after repeated simulated use. | Pass |
| Detachment time and detachment reliability | Verify the reliability of intentional detachment as well as reliability of the coil attachment after fatigue testing of the coil embolization system in a representative tortuous anatomical model. | Reliable and timely detachment. | Pass |
| Ease of delivery | Measured by max friction force when advancing, deploying or retracting the coil system through the introducer sheath and microcatheter in a relevant tortuous anatomical model. | Ease of delivery within acceptable force limits. | Pass |
| Kink resistance | Demonstrate that kink resistance of the device meets pre-specified acceptance criteria, and could withstand bending forces that the device may encounter during clinical use. | Device withstands bending forces without kinking. | Pass |
| Torque strength | Verify the torque strength by rotating the proximal end of the device for 8 turns. | Device maintains integrity under specified torque. | Pass |
| Radiopacity | Qualitatively assess the radiopacity of the device under X-ray to demonstrate the equivalence to the control device. | Radiopacity comparable to control device. | Pass |
| Particulate testing | Verify that the quantity and size of particulates generated during simulated use in a clinically relevant tortuous anatomical model with all recommended ancillary devices meet the acceptance criteria based on the comparison with the predicate. | Particulate generation within acceptable limits compared to predicate. | Pass |
| Coil deformation force | To verify that the coil implants are not too stiff to loop adequately and achieve their intended secondary shape. | Coils deform adequately to achieve intended shape. | Pass |
| Tensile strength testing | Verify that detachment zone tensile strength, stretch resistance tensile strength, pusher joints tensile strength, and introducer sheath tensile strength meet the acceptance criteria based on a control device. | Tensile strengths meet acceptance criteria compared to control. | Pass |
| Corrosion Resistance | Corrosion resistance testing per ASTM F2129 for coil implant, per ISO 11070 for pusher. | Device resists corrosion. | Pass |
| MR Compatibility | MR testing performed per ASTM F2119, ASTM F2213, ASTM F2052 and additional MRA characterization testing. | Device is MR conditional. | Testing demonstrated the device is MR conditional. |
| Packaging and Shelf Life | Package verification and shelf-life testing performed to demonstrate the integrity of the sterile barrier packaging throughout the proposed shelf life and its ability to protect the packaged devices from damage and maintain sterility during transport and storage conditions. | Packaging integrity and sterility maintained for proposed shelf life. | Packaging and device testing demonstrate the ability to perform as intended through the labeled 2-year shelf life of the device. |
| Sterilization Validation | Per ISO 11135, Annex B Overkill Method. | Sterility assurance level of 10-6 achieved. | Sterilization process achieves sterility assurance level of 10-6. |
| Endotoxin Testing | Bacterial endotoxin assay validation per USP 85. | Endotoxin levels below 2.15 EU/device. | The endotoxin levels for the device are below 2.15 EU/device. |
| GLP animal study | Animal testing to evaluate the in vivo performance of the device in a canine model, reporting both acute and chronic time points. | In vivo performance is acceptable. | Pass |
| Cytotoxicity | MEM Elution per ISO 10993-5 (coil implant, pusher and sheath). | Non-cytotoxic. | Pass (Non-cytotoxic) |
| Sensitization | ISO Guinea Pig Maximization Sensitization Test per ISO 10993-10 (coil implant, pusher and sheath). | Non-sensitizer. | Pass (Non-sensitizer) |
| Irritation | ISO Intracutaneous Irritation Test per ISO 10993-10 (coil implant, pusher and sheath). | Non-irritant. | Pass (Non-irritant) |
| Acute Toxicity | ISO Acute Systemic Injection Test per ISO 10993-11 (coil implant, pusher and sheath). | Non-toxic. | Pass (Non-toxic) |
| Pyrogenicity | ISO Material Mediated Rabbit pyrogen per ISO 10993-11 (coil implant, pusher and sheath). | Non-pyrogenic. | Pass (Non-pyrogenic) |
| Hemocompatibility (Hemolysis) | ASTM Hemolysis Study - Direct Contact and Extract method per ISO 10993-4 (coil implant, pusher and sheath). | Non-hemolytic. | Pass (Non-hemolytic) |
| Hemocompatibility (Complement Activation) | Complement Activation SC5b-9 Assay per ISO 10993- 4 (coil implant, pusher and sheath). | Non-activator. | Pass (Non-activator) |
| Hemocompatibility (PTT) | Partial Thromboplastin Time (PTT) per ISO10993-4 (coil implant, pusher and sheath). | Acceptable PTT. | Pass |
| Hemocompatibility (Thromboresistance) | In vivo Thromboresistance Study in Dogs per ISO 10993-4 (pusher and sheath). | Thromboresistant. | Pass |
| Hemocompatibility (Thromboresistance, heparinized) | In vivo Thromboresistance Study in Dogs, heparinized model per ISO 10993-4 (pusher and sheath). | Thromboresistant in heparinized model. | Pass Thromboresistant |
| Genotoxicity (Bacterial Mutagenicity) | Bacterial Mutagenicity Test per ISO 10993-3 (coil implant). | Non-genotoxic. | Pass (Non-genotoxic) |
| Genotoxicity (Mouse Lymphoma Assay) | In vitro Mouse Lymphoma Assay per ISO 10993-3 (coil implant). | Non-genotoxic. | Pass (Non-genotoxic) |
| Implantation | ISO Muscle Implantation Study in Rabbits - 1 week, 4 weeks, 13 weeks per ISO 10993-6 (coil implant). | Acceptable tissue response. | Pass |
| Subchronic toxicity | ISO Systemic Toxicity Study in Rats Following Subcutaneous Implantation, 13 Weeks per ISO 10993-6 and per ISO 10993-11 (coil implant). | No evidence of systemic toxicity. | Pass (No evidence of systemic toxicity.) |
| Carcinogenicity | Toxicological Risk Assessment (coil implant). | Acceptable carcinogenic risk. | Pass |
| Chronic Toxicity | Toxicological Risk Assessment (coil implant). | Acceptable chronic toxicity risk. | Pass |
For the NumenFR™ Detachment System, performance testing included:
- Functional performance testing to assess proper operation.
- Software verification in accordance with IEC 62304:2015 Ed. 1.1 and risk assessment per ISO 14971:2007/(R) 2010.
- Electrical Safety Testing and EMC Testing in accordance with AAMI/ANSI ES 60601-1:2005, IEC 60601-1-2:2014 Ed. 4 and IEC 60601-1-6 Ed.3.1.
- Sterilization validation per ISO 11135:2014 (SAL of at least 10^-6).
- Accelerated aging shelf-life study supporting a 2-year shelf life.
All these tests are reported to have "Pass" results, indicating the device meets its established criteria for safety and performance compared to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., number of coils tested for fatigue). It generally refers to "test units representative of final finished devices." For the animal study, it mentions "a canine model" but not the number of animals.
- Data Provenance: The studies are non-clinical (bench testing, in vitro, and in vivo animal studies). There's no mention of human clinical data or geographical origin of such data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes a traditional medical device, not an AI/ML system. Ground truth in this context refers to established engineering specifications, biocompatibility standards (e.g., ISO and ASTM standards), and observed physical/biological performance rather than expert interpretation of medical images or data.
4. Adjudication Method for the Test Set
Not Applicable. As this is not an AI/ML diagnostic device involving human interpretation, there is no mention of adjudication methods for a test set. Acceptance is based on meeting predefined engineering and biological performance metrics.
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 physical medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device. There is no algorithm to test in a standalone manner.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance validation is based on:
- Established engineering specifications: Pre-defined dimensional, material, and functional criteria.
- International Standards: Compliance with ISO (e.g., 10993 series for biocompatibility, 11135 for sterilization) and ASTM (e.g., F2129 for corrosion, F2119 for MR compatibility) standards.
- Predicate Device Performance: Benchmarking against legally marketed predicate devices to demonstrate "substantial equivalence."
- In-vivo animal model outcomes: Evaluating device performance in a canine model for acute and chronic time points.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided documentation.
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