Who is the manufacturer of Numen Coil Embolization System; NumenFR Detachment System?

MicroPort NeuroTech (Shanghai) Co., Ltd. filed the 510(k) submission for Numen Coil Embolization System; NumenFR Detachment System (K203625).

What is the FDA product code for Numen Coil Embolization System; NumenFR Detachment System?

HCG. It is classified under 21 CFR 882.5950 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Numen Coil Embolization System; NumenFR Detachment System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Numen Coil Embolization System; NumenFR Detachment System?

Target® Detachable Coils (K161429); InZone Detachment System (K160096).

Who can help prepare an FDA 510(k) submission like Numen Coil Embolization System; NumenFR Detachment System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Numen Coil Embolization System; NumenFR Detachment System

K203625 · MicroPort NeuroTech (Shanghai) Co., Ltd. · HCG · Sep 1, 2021 · Neurology

Device Facts

Record ID	K203625
Device Name	Numen Coil Embolization System; NumenFR Detachment System
Applicant	MicroPort NeuroTech (Shanghai) Co., Ltd.
Product Code	HCG · Neurology
Decision Date	Sep 1, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5950
Device Class	Class 2
Attributes	Therapeutic

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 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.

Device Story

Numen Coil Embolization System consists of introducer sheath, pusher, and coil implant; used for endovascular occlusion of vascular abnormalities. NumenFR Detachment System is a sterile, handheld, battery-powered device used to trigger electrolytic detachment of the coil implant. Operated by physician in clinical setting. Coil delivery involves advancing pusher through microcatheter to target lesion; once positioned, NumenFR unit is connected to pusher; pressing detachment button initiates electrolytic process to release coil. System provides permanent occlusion of blood flow to treat aneurysms/malformations. Benefits include minimally invasive treatment of neurovascular/peripheral vascular abnormalities.

Clinical Evidence

No clinical data. Evidence consists of bench testing (visual inspection, dimensional verification, simulated use, fatigue, detachment reliability, friction force, kink resistance, torque strength, radiopacity, particulate testing, coil deformation, tensile strength, corrosion resistance per ASTM F2129, MR compatibility per ASTM F2119/F2213/F2052), sterilization validation, and GLP animal study (canine model) to evaluate in vivo performance. Biocompatibility testing per ISO 10993 series (cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, hemocompatibility, genotoxicity, implantation, subchronic toxicity).

Technological Characteristics

Coil: Pt (92%)/W (8%) wire, polypropylene stretch-resistant thread. Pusher: SS 304 hypotube. Introducer: HDPE. Detachment: Electrolytic, powered by two 1.5V AAAA alkaline batteries. Max output 28V DC, 1.8mA. Sterile, single-use, EtO sterilized. MR conditional.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities (arteriovenous malformations, arteriovenous fistulae), and arterial/venous embolizations in peripheral vasculature.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Target® Detachable Coils (K161429)
InZone Detachment System (K160096)

Reference Devices

Axium™ Detachable Coil System (K151447)
Penumbra Smart Coil (K143218)
Microplex Coil System (K132952)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 and Address | MicroPort NeuroTech (Shanghai) Co., Ltd. Building #16, 222 Guangdan Road, Pudong New District, 201318 Shanghai, China | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Name: Qiuhua Zou Phone Number: +86-21-38954600 ext. 3959 | | Date Prepared | August 25, 2021 | | Trade Name | Numen™ Coil Embolization System NumenFR™ 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 Marketed Predicate Devices | Predicate devices: Target® Detachable Coils (K161429), InZone Detachment System (K160096) Reference devices: Axium™ Detachable Coil System, K151447 Penumbra Smart Coil, K143218 Microplex Coil System, K132952 | {4}------------------------------------------------ ### 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. {5}------------------------------------------------ #### 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 Embolization System (K203625), (Subject device) | Similarities/ Differences | |-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | 510(k) Number | K161429 | K203625 | N/A | | Manufacturer | Stryker Neurovascular | MicroPort NeuroTech (Shanghai) Co., Ltd. | N/A | | Device Classification | Class II | Class II | Same | | Regulation Number and Regulation Description | 21 CFR § 870.3300 Device, Vascular, for Promoting Embolization 21 CFR § 882.5950 Neurovascular embolization device | 21 CFR § 870.3300 Device, Vascular, for Promoting Embolization 21 CFR § 882.5950 Neurovascular embolization device | Same | | Classification Product Code | KRD HCG | KRD HCG | Same | | Intended Use/Indications for Use | Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Target Detachable Coils are 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 | 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 | Same | | | Dimension/Shape of Coil Embolization System | | | | Secondary Shape | 3D, Helical | 3D, Helical | Same | | Coil Type | Stretch Resistance | Stretch Resistance | Same | {6}------------------------------------------------ | Characteristics | Target® Detachable Coils (K161429), (Predicate device) | Numen™ Coil Embolization System (K203625), (Subject device) | Similarities/ Differences | |--------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------|------------------------------| | Coil Secondary Diameter | 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 Resistant Thread | Polypropylene | Polypropylene | Same | | Pusher (Body Hypotube) | SS 304 | SS 304 | Same | | Introducer Sheath | HDPE | HDPE | Same | | Other | | | | | Detachment mechanism | Electrolytic | Electrolytic | Same | | How Supplied | Sterile, for single use only | Sterile, for single use only | Same | | Sterilization Method | 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 Coil Embolization System (K203625) | AxiumTM Detachable Coil System (K151447) | Penumbra Smart CoilTM (K143218) | MicroPlex Coil System (K132952) | Comparison Results | | 510(k) Number | K203625 | K151447 | K143218 | K132952 | N/A | | Manufacturer | MicroPort NeuroTech (Shanghai) Co., Ltd. | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Penumbra, Inc. | Microvention, Inc | N/A | | Device Classification | Class II | Class II | Class II | Class II | Same | | Regulation Number and Regulation Description | 21 CFR § 870.3300 Device, Vascular, for Promoting Embolization 21 CFR § 882.5950 Neurovascular embolization device | 21 CFR § 870.3300 Device, Vascular, for Promoting Embolization 21 CFR § 882.5950 Neurovascular embolization device | 21 CFR § 870.3300 Device, Vascular, for Promoting Embolization 21 CFR § 882.5950 Neurovascular embolization device | 21 CFR § 870.3300 Device, Vascular, for Promoting Embolization 21 CFR § 882.5950 Neurovascular embolization device | Same | | Classification Product Code | KRD HCG | KRD HCG | KRD HCG | KRD HCG | Same | {7}------------------------------------------------ | | Subject device | Reference device #1 | Reference device #2 | Reference device #3 | | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Characteristics | Numen™ Coil Embolization System (K203625) | Axium™ Detachable Coil System (K151447) | Penumbra Smart Coil™ (K143218) | MicroPlex Coil System (K132952) | Comparison Results | | Intended Use/Indication s 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 | The Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature. | The Penumbra Smart Coil System is indicated for the embolization of: · Intracranial aneurysms • Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae • Arterial and venous embolizations in the peripheral vasculature | Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. Also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. | Similar | | Coil Secondary Diameter | 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 | | Device Classification | Class II | Class II | Same | | Regulation Number and Regulation Description | 21 CFR § 870.3300 Device, Vascular, for Promoting Embolization 21 CFR § 882.5950 Neurovascular embolization device | 21 CFR § 870.3300 Device, Vascular, for Promoting Embolization 21 CFR § 882.5950 Neurovascular embolization device | Same | | Classification Product Code | KRD HCG | KRD HCG | Same | | Intended Use/Indications for Use | The InZone Detachment System is intended for use with all versions of Stryker Neurovascular detachable coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature. | NumenFRTM Detachment System is intended for use with MicroPort NeuroTech NumenTM Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral 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-use powered by pre-loaded alkaline batteries, disposable unit | Sterile, hand-held, single-patient-use powered by pre-loaded alkaline batteries, disposable unit | Same | | Power Source | Two 1.5 V (AAAA) DC alkaline batteries (in series) | Two 1.5 V (AAAA) DC alkaline batteries (in series) | Same | | Max Voltage Output | 28 V DC | 28 V DC | Same | | Max Current Output | 2.4 mA | 1.8 mA | Similar | | Max Time of Single Cycle | 10 seconds | 10 seconds | Same | | Number of Detachments | Minimum of 20 detachments | Minimum of 20 detachments | Same | | Power Switch | Inserting coil delivery wire turns the unit on. Removing the delivery wire turns the unit off. Unit turns off after 2 minutes if unit detects no activity. | Inserting coil delivery wire turns the unit on. Removing the delivery wire turns the unit off. Unit turns off after 2 minutes if unit detects no activity. | Same | | To start detachment | Press Detachment Button | Press Detachment Button | Same | | Detachment mechanism | Electrolytic | Electrolytic | Same | | How Supplied | Sterile, for single use only | Sterile, for single use only | Same | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same | {8}------------------------------------------------ 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. {9}------------------------------------------------ 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 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. | Pass | | Corrosion Resistance | Corrosion resistance testing per ASTM F2129 for coil implant, per ISO 11070 for pusher. | Pass | | MR Compatibility | MR testing performed per ASTM F2119, ASTM F2213, ASTM F2052 and additional MRA characterization testing. | 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 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. | 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 (coil implant, pusher and sheath) | Cytotoxicity - MEM Elution per ISO 10993-5. | Pass Non-cytotoxic | | Sensitization (coil implant, pusher and sheath) | ISO Guinea Pig Maximization Sensitization Test per ISO 10993-10. | Pass Non-sensitizer | | Irritation (coil implant, pusher and sheath) | ISO Intracutaneous Irritation Test per ISO 10993-10. | Pass Non-irritant | | Acute Toxicity (coil implant, pusher and sheath) | ISO Acute Systemic Injection Test per ISO 10993-11. | Pass Non-toxic | | Pyrogenicity (coil implant, pusher and sheath) | ISO Material Mediated Rabbit pyrogen per ISO 10993- 11. | Pass Non-pyrogenic | | Hemocompatibility (coil implant, pusher and sheath) | ASTM Hemolysis Study - Direct Contact and Extract method per ISO 10993-4. | Pass Non-hemolytic | | Hemocompatibility (coil implant, pusher and sheath) | Complement Activation SC5b-9 Assay per ISO 10993- 4. | Pass Non-activator | | Hemocompatibility (coil implant, pusher and sheath) | Partial Thromboplastin Time (PTT) per ISO10993-4. | Pass | | Hemocompatibility (pusher and sheath) | 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 (coil implant) | Bacterial Mutagenicity Test per ISO 10993-3. | Pass Non-genotoxic | | Genotoxicity (coil implant) | In vitro Mouse Lymphoma Assay per ISO 10993-3. | Pass Non-genotoxic | | Implantation (coil implant) | 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. | Pass No evidence of systemic toxicity. | | Carcinogenicity (coil implant) | Toxicological Risk Assessment | Pass | | Chronic Toxicity (coil implant) | Toxicological Risk Assessment | Pass | {10}------------------------------------------------ {11}------------------------------------------------ #### 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. {12}------------------------------------------------ - 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.

Numen Coil Embolization System; NumenFR Detachment System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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Numen Coil Embolization System; NumenFR Detachment System

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Device Story

Clinical Evidence

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Reference Devices

Submission Summary (Full Text)

Panel 1

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