(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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 1, 2021
MicroPort NeuroTech (Shanghai) Co., Ltd. % Ivory Chang Regulatory Consultant BioDesign Regulatory Services, LLC 16185 Los Gatos Boulevard, Suite 205 Los Gatos, California 95032
Re: K203625
Trade/Device Name: Numen Coil Embolization System: NumenFR Detachment System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG. KRD Dated: July 30, 2021 Received: August 2, 2021
Dear Ivory Chang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203625
Device Name Numen™ Coil Embolization System NumenFR™ Detachment System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Subject Device:
Numen™ Coil Embolization System
NumenFRTM Detachment System
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.
| Submitter Name andAddress | MicroPort NeuroTech (Shanghai) Co., Ltd.Building #16, 222 Guangdan Road, Pudong New District,201318 Shanghai, China |
|---|---|
| Contact Person | Name: Qiuhua ZouPhone Number: +86-21-38954600 ext. 3959 |
| Date Prepared | August 25, 2021 |
| Trade Name | Numen™ Coil Embolization SystemNumenFR™ Detachment System |
| Common Name | Detachable Coil, Power Supply |
| Classification Name | Neurovascular Embolization Device (HCG);Device, Vascular, for Promoting Embolization (KRD) |
| Regulation Number | 21 CFR 882.5950 (HCG); 21 CFR 870.3300 (KRD) |
| Product Code(s) | HCG, KRD |
| Classification | II |
| Review Panel | Neurology (HCG); Cardiovascular (KRD) |
| Use | Prescription Use Only |
| Legally MarketedPredicate Devices | Predicate devices:Target® Detachable Coils (K161429), InZone DetachmentSystem (K160096)Reference devices:Axium™ Detachable Coil System, K151447Penumbra Smart Coil, K143218Microplex Coil System, K132952 |
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1. Device Description
MicroPort NeuroTech has developed the Numen™ Coil Embolization System and NumenFRTM Detachment System.
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 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 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.
2. Intended Use/ Indications for Use
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
NumenFRTM 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.
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3. Comparison of the Subject Device to the Predicate Devices
Comparison for Numen™ Coil Embolization System
The subject device Numen™ Coil Embolization System is substantially equivalent to the commercially available predicate device, Target® Detachable Coils (K161429) in terms of intended use/indications for use and technical characteristics.
The Numen™ Coil Embolization System has the same intended use/indications for use (endovascular embolization and occlusion of blood flow) as the Target® Detachable Coils.
The following table compares the main characteristics of the subject device NumenTM Coil Embolization System to the predicate device:
| Characteristics | Target® Detachable Coils (K161429),(Predicate device) | Numen™ Coil EmbolizationSystem (K203625),(Subject device) | Similarities/Differences |
|---|---|---|---|
| 510(k) Number | K161429 | K203625 | N/A |
| Manufacturer | Stryker Neurovascular | MicroPort NeuroTech (Shanghai)Co., Ltd. | N/A |
| DeviceClassification | Class II | Class II | Same |
| RegulationNumber andRegulationDescription | 21 CFR § 870.3300Device, Vascular, for PromotingEmbolization21 CFR § 882.5950Neurovascular embolization device | 21 CFR § 870.3300Device, Vascular, for PromotingEmbolization21 CFR § 882.5950Neurovascular embolization device | Same |
| ClassificationProduct Code | KRDHCG | KRDHCG | Same |
| IntendedUse/Indications forUse | Target Detachable Coils are intended toendovascularly obstruct or occlude bloodflow in vascular abnormalities of theneurovascular and peripheral vessels.Target Detachable Coils are indicatedfor endovascular embolization of:• Intracranial aneurysms• Other neurovascular abnormalities suchas arteriovenous malformations andarteriovenous fistulae• Arterial and venous embolizations inthe peripheral vasculature | Numen™ Coil Embolization Systemis intended to endovascularly obstructor occlude blood flow in vascularabnormalities of the neurovascularand peripheral vessels.Numen™ Coil Embolization Systemis indicated for endovascularembolization of:• Intracranial aneurysms• Other neurovascular abnormalitiessuch as arteriovenousmalformations and arteriovenousfistulae• Arterial and venous embolizationsin the peripheral vasculature | Same |
| Dimension/Shape of Coil Embolization System | |||
| Secondary Shape | 3D, Helical | 3D, Helical | Same |
| Coil Type | Stretch Resistance | Stretch Resistance | Same |
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| Characteristics | Target® Detachable Coils (K161429),(Predicate device) | Numen™ Coil EmbolizationSystem (K203625),(Subject device) | Similarities/Differences |
|---|---|---|---|
| Coil SecondaryDiameter | 1-24 mm | 1-24 mm | Same |
| Coil Length | 1-50 cm | 1-70 cm | Longer length |
| Pusher length | 185 cm | 183.5 cm | Similar |
| Material of Coil Embolization System | |||
| Primary Coil wire | Pt (92%) / W (8%) | Pt (92%) / W (8%) | Same |
| Stretch ResistantThread | Polypropylene | Polypropylene | Same |
| Pusher (BodyHypotube) | SS 304 | SS 304 | Same |
| Introducer Sheath | HDPE | HDPE | Same |
| Other | |||
| Detachmentmechanism | Electrolytic | Electrolytic | Same |
| How Supplied | Sterile, for single use only | Sterile, for single use only | Same |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Same |
The reference devices listed below are used in the verification testing of the Numen™ Coil Embolization System.
- K151447 (Axium Detachable Coil System) r
- K143218 (Penumbra Smart Coil) ▼
- K132952 (Microplex Coil System) レ
See the following table for the comparison between the subject device and reference devices:
| Subject device | Reference device #1 | Reference device #2 | Reference device #3 | ||
|---|---|---|---|---|---|
| Characteristics | NumenTM CoilEmbolization System(K203625) | AxiumTM DetachableCoil System (K151447) | Penumbra SmartCoilTM (K143218) | MicroPlex CoilSystem (K132952) | ComparisonResults |
| 510(k) Number | K203625 | K151447 | K143218 | K132952 | N/A |
| Manufacturer | MicroPort NeuroTech(Shanghai) Co., Ltd. | Micro Therapeutics,Inc. d/b/a ev3Neurovascular | Penumbra, Inc. | Microvention, Inc | N/A |
| DeviceClassification | Class II | Class II | Class II | Class II | Same |
| RegulationNumber andRegulationDescription | 21 CFR § 870.3300Device, Vascular, forPromoting Embolization21 CFR § 882.5950Neurovascularembolization device | 21 CFR § 870.3300Device, Vascular, forPromotingEmbolization21 CFR § 882.5950Neurovascularembolization device | 21 CFR § 870.3300Device, Vascular, forPromotingEmbolization21 CFR § 882.5950Neurovascularembolization device | 21 CFR § 870.3300Device, Vascular, forPromotingEmbolization21 CFR § 882.5950Neurovascularembolization device | Same |
| ClassificationProduct Code | KRDHCG | KRDHCG | KRDHCG | KRDHCG | Same |
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| Subject device | Reference device #1 | Reference device #2 | Reference device #3 | ||
|---|---|---|---|---|---|
| Characteristics | Numen™ CoilEmbolization System(K203625) | Axium™ DetachableCoil System (K151447) | Penumbra SmartCoil™ (K143218) | MicroPlex CoilSystem (K132952) | ComparisonResults |
| IntendedUse/Indications for Use | Numen™ CoilEmbolization System isintended toendovascularly obstruct orocclude blood flow invascular abnormalities ofthe neurovascular andperipheral vessels.Numen™ CoilEmbolization System isindicated for endovascularembolization of:• Intracranial aneurysms• Other neurovascularabnormalities such asarteriovenousmalformations andarteriovenous fistulae• Arterial and venousembolizations in theperipheral vasculature | The Axium DetachableCoil System is indicatedfor the endovascularembolization ofintracranial aneurysmsand other neurovascularabnormalities, such asarteriovenousmalformations andarteriovenous fistulae.The Axium DetachableCoils are also indicatedfor arterial and venousembolizations in theperipheral vasculature. | The Penumbra SmartCoil System is indicatedfor the embolization of:· Intracranialaneurysms• Other neurovascularabnormalities such asarteriovenousmalformations andarteriovenous fistulae• Arterial and venousembolizations in theperipheral vasculature | Intended for theendovascularembolization ofintracranial aneurysmsand otherneurovascularabnormalities such asarteriovenousmalformations andarteriovenous fistulae.Also intended forvascular occlusion ofblood vessels withinthe neurovascularsystem to permanentlyobstruct blood flow toan aneurysm or othervascular malformationand for arterial andvenous embolizationsin the peripheralvasculature. | Similar |
| Coil SecondaryDiameter | 1-24 mm | 1-25 mm | 1-18 mm | 1-24 mm | Similar |
| Coil Length | 1-70 cm | 1-50 cm | 1-60 cm | 1-68 cm | Similar |
Comparison for NumenFR™ Detachment System
The subject device NumenFR™ Detachment System is substantially equivalent to the commercially available predicate device, the InZone Detachment System (K160096) in terms of intended use/indications for use, technical characteristics, and functional performance.
The intended use/indications for use of the NumenFRTM Detachment System are the same as that of the InZone Detachment System.
The following table compares the main characteristics of the subject device NumenFRTM Detachment System to the predicate device:
| Characteristics | InZone Detachment System(K160096), (Predicate device) | NumenFR TM Detachment System(K203625), (Subject device) | Similarities/Differences |
|---|---|---|---|
| 510(k) Number | K160096 | K203625 | N/A |
| Manufacturer | Stryker Neurovascular | MicroPort NeuroTech (Shanghai)Co., Ltd. | N/A |
| Characteristics | InZone Detachment System(K160096), (Predicate device) | NumenFRTM Detachment System(K203625), (Subject device) | Similarities/Differences |
| DeviceClassification | Class II | Class II | Same |
| RegulationNumber andRegulationDescription | 21 CFR § 870.3300Device, Vascular, for PromotingEmbolization21 CFR § 882.5950Neurovascular embolization device | 21 CFR § 870.3300Device, Vascular, for PromotingEmbolization21 CFR § 882.5950Neurovascular embolization device | Same |
| ClassificationProduct Code | KRDHCG | KRDHCG | Same |
| IntendedUse/Indications forUse | The InZone Detachment System isintended for use with all versions ofStryker Neurovascular detachable coils inthe embolization of intracranialaneurysms and other vascularmalformations of the neuro and peripheralvasculature. | NumenFRTM Detachment Systemis intended for use with MicroPortNeuroTech NumenTM CoilEmbolization System in theembolization of intracranialaneurysms and other vascularabnormalities of the neuro andperipheral vasculature. | Same |
| Dimension | 140.0 mm x 58.0 mm x 28.0 mm | 140.0 mm × 45.0 mm × 28.0 mm | Similar |
| Weight | 80 g | 65.0g - 75.0g | Similar |
| Key Characteristic | Sterile, hand-held, single-patient-usepowered by pre-loaded alkaline batteries,disposable unit | Sterile, hand-held, single-patient-usepowered by pre-loaded alkalinebatteries, disposable unit | Same |
| Power Source | Two 1.5 V (AAAA) DC alkaline batteries(in series) | Two 1.5 V (AAAA) DC alkalinebatteries (in series) | Same |
| Max VoltageOutput | 28 V DC | 28 V DC | Same |
| Max CurrentOutput | 2.4 mA | 1.8 mA | Similar |
| Max Time ofSingle Cycle | 10 seconds | 10 seconds | Same |
| Number ofDetachments | Minimum of 20 detachments | Minimum of 20 detachments | Same |
| Power Switch | Inserting coil delivery wire turns the uniton. Removing the delivery wire turns theunit off. Unit turns off after 2 minutes ifunit detects no activity. | Inserting coil delivery wire turns theunit on. Removing the delivery wireturns the unit off. Unit turns off after2 minutes if unit detects no activity. | Same |
| To startdetachment | Press Detachment Button | Press Detachment Button | Same |
| Detachmentmechanism | Electrolytic | Electrolytic | Same |
| How Supplied | Sterile, for single use only | Sterile, for single use only | Same |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Same |
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There are some device characteristics that differ as shown in the comparison tables above. Verification and validation testing has been completed and test results show that the subject devices, Numen™ Coil Embolization System and NumenFR™ Detachment System, are substantially equivalent to the predicate devices.
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The differences do not affect the intended use/indications for use of the devices, nor do they alter their fundamental scientific technology compared to the predicate devices.
4. Performance Testing
Numen™ Coil Embolization System
All necessary testing has been performed for the Numen™ Coil Embolization System to demonstrate that the device performs as intended and that it is substantially equivalent to the predicate. The testing was performed on test units representative of final finished devices.
| Test | Test method summary | Test results |
|---|---|---|
| Visual inspection | Examine the test sample surface under specific magnification. | Pass |
| Dimensional verification | Implant coil, pusher and introducer sheath dimensions are measured to match the specifications. | Pass |
| Simulated use | Verify that the coil embolization system performs as intended in a representative tortuous anatomical model. | 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. | 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. | 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. | 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. | Pass |
| Torque strength | Verify the torque strength by rotating the proximal end of the device for 8 turns. | Pass |
| Radiopacity | Qualitatively assess the radiopacity of the device under X-ray to demonstrate the equivalence to the 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. | Pass |
| Coil deformation force | To verify that the coil implants are not too stiff to loop adequately and achieve their intended secondary shape. | Pass |
| Test | Test method summary | Test results |
| Tensile strengthtesting | 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. | Pass |
| CorrosionResistance | Corrosion resistance testing per ASTMF2129 for coil implant, per ISO 11070 for pusher. | Pass |
| MR Compatibility | MR testing performed per ASTM F2119, ASTMF2213, ASTM F2052 and additionalMRA characterization testing. | Testing demonstrated the device isMR conditional. |
| Packaging and ShelfLife | 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 and device testing demonstrate the ability to perform as intended through the labeled 2-year shelf life of the device. |
| SterilizationValidation | Per ISO 11135, Annex B Overkill Method. | Sterilization process achieves sterility assurance level of 10-6. |
| Endotoxin Testing | Bacterial endotoxin assay validation per USP 85. | 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. | Pass |
| Cytotoxicity (coilimplant,pusher and sheath) | Cytotoxicity - MEM Elution per ISO 10993-5. | PassNon-cytotoxic |
| Sensitization (coilimplant,pusher and sheath) | ISO Guinea Pig Maximization Sensitization Test per ISO 10993-10. | PassNon-sensitizer |
| Irritation (coilimplant,pusher and sheath) | ISO Intracutaneous Irritation Test per ISO 10993-10. | PassNon-irritant |
| Acute Toxicity(coil implant, pusherand sheath) | ISO Acute Systemic Injection Test per ISO 10993-11. | PassNon-toxic |
| Pyrogenicity (coilimplant,pusher and sheath) | ISO Material Mediated Rabbit pyrogen per ISO 10993- 11. | PassNon-pyrogenic |
| Hemocompatibility(coil implant,pusher and sheath) | ASTM Hemolysis Study - Direct Contact and Extract method per ISO 10993-4. | PassNon-hemolytic |
| Hemocompatibility(coil implant,pusher and sheath) | Complement Activation SC5b-9 Assay per ISO 10993- 4. | PassNon-activator |
| Hemocompatibility(coil implant, pusherand sheath) | Partial Thromboplastin Time (PTT) per ISO10993-4. | Pass |
| Hemocompatibility(pusher andsheath) | In vivo Thromboresistance Study in Dogs per ISO 10993-4. | Pass |
| Test | Test method summary | Test results |
| Hemocompatibility(pusher and sheath) | In vivo Thromboresistance Study in Dogs, heparinized model per ISO 10993-4. | Pass Thromboresistant |
| Genotoxicity (coilimplant) | Bacterial Mutagenicity Test per ISO 10993-3. | PassNon-genotoxic |
| Genotoxicity (coilimplant) | In vitro Mouse Lymphoma Assay per ISO 10993-3. | PassNon-genotoxic |
| Implantation (coilimplant) | ISO Muscle Implantation Study in Rabbits - 1 week, 4 weeks, 13 weeks per ISO 10993-6. | Pass |
| Subchronic toxicity(coil implant) | ISO Systemic Toxicity Study in Rats Following Subcutaneous Implantation, 13 Weeks per ISO 10993-6 and per ISO 10993-11. | PassNo evidence of systemic toxicity. |
| Carcinogenicity(coil implant) | Toxicological Risk Assessment | Pass |
| Chronic Toxicity(coil implant) | Toxicological Risk Assessment | Pass |
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Biocompatibility
The coil implant of the Numen ™ Coil Embolization System is classified as permanent implant in contact with circulating blood >30 days contact duration.
The delivery system including the pusher and introducer sheath of the Numen ™ Coil Embolization System, is classified as externally communicating device in contact with circulating blood < 24 h contact duration.
Refer to the table above for the biocompatibility testing of the coil system.
NumenFRTM Detachment System
Performance testing of the NumenFRTM Detachment System consisted of the following:
- Functional performance testing to assess proper operation of the NumenFRTM . Detachment System at start-up and during the detachment process when used in combination with MicroPort NeuroTech Numen™ Coil Embolization System.
- . Software verification in accordance with IEC 62304:2015 Ed. 1.1 and risk assessment conducted in accordance with 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.
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- The subject device is sterilized with Ethylene Oxide. The sterility assurance level . (SAL) of at least 10-6 is assured by using a validated sterilization method per ISO 11135:2014.
- . The device is labeled with two years (2) shelf life, which is supported by accelerated aging shelf-life study.
5. Conclusion
Based on the similarities of the intended use/indications for use, technological and functional characteristics and the results of the non-clinical performance testing, the subject devices, the Numen™ Coil Embolization System and NumenFR™ Detachment System, are substantially equivalent to the legally marketed predicate devices.
§ 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).