(69 days)
Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen™ Coil Embolization System is indicated for endovascular embolization of:
- . Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- . Arterial and venous embolizations in the peripheral vasculature
NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
The Numen™ Coil Embolization System is composed of two parts as described below:
- An introducer sheath: The function of the introducer sheath is to facilitate introduction . of the coil into the microcatheter.
- . The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
The MicroPort NeuroTech NumenFR™ Detachment System is a sterile, handheld, singlepatient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
The provided text describes a 510(k) premarket notification for a medical device called the "Numen Coil Embolization System" and "NumenFR Detachment System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced performance or efficacy through extensive clinical studies. Therefore, much of the information typically sought in a study proving a device meets acceptance criteria (like MRMC studies, effect sizes, detailed ground truth establishment for AI models, and training set details) will not be present.
Based on the document, here's what can be extracted regarding acceptance criteria and performance:
The acceptance criteria are implicitly defined by the "Pass" result for each non-clinical bench test. The study proving the device meets these criteria is the Performance Testing section (Section 4).
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria Summary (Implicit from Test Method and "Pass" result) | Reported Device Performance |
|---|---|---|
| Visual Inspection of Pusher | Pass visual inspection under specific magnification (e.g., no defects, meeting dimensional/surface quality). | Pass |
| Simulated Use | Perform as intended in a representative tortuous anatomical model (e.g., successful delivery, deployment, and retrieval). | Pass |
| Fatigue Testing | Durability after repeating simulated use six times, including coil retraction and re-deployment (e.g., no breakage, no significant functional degradation). | Pass |
| Detachment Time and Detachment Reliability | Reliable intentional detachment and reliable coil attachment after fatigue testing in a representative tortuous anatomical model (e.g., detaches within specified time, no premature detachment). | Pass |
| Delivery and Retraction Friction in Introducer Sheath | Max friction force when advancing or retracting the coil system in introducer sheath meets pre-specified limits. | Pass |
| Delivery, Deployment and Retraction Friction in Microcatheter | Max friction force when advancing, deploying or retracting the coil system through microcatheter in a relevant, tortuous, anatomical model meets pre-specified limits. | Pass |
| Kink Resistance | Resistance to kinking meets pre-specified acceptance criteria and can withstand bending forces encountered in clinical usage. | Pass |
| Torque Strength | Torque strength meets pre-specified criteria after rotating the proximal end of the device for 8 turns (e.g., no damage, no functional impairment). | Pass |
| Flexing Test (Per ISO 11070, Annex G) | Resistance to damage by flexing meets the requirements of ISO 11070, Annex G. | Pass |
| Fracture Test (Per ISO 11070, Annex F) | Resistance to fracture meets the requirements of ISO 11070, Annex F. | Pass |
Note: The document states "pre-specified acceptance criteria" for some tests, but the specific numerical values or detailed parameters of these criteria are not provided within the scope of this FDA letter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes (e.g., number of coils or devices) used for each bench test. It refers to "test units representative of final finished devices." Given that this is a 510(k) submission primarily relying on bench testing to demonstrate substantial equivalence for a modification (new coil type), detailed clinical test set provenance (country of origin, retrospective/prospective) is not applicable here, as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes non-clinical bench testing, not a study involving human experts establishing ground truth for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, this is bench testing, not an expert-adjudicated clinical study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (coil embolization system) and not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench tests, the "ground truth" or reference for evaluating performance would be the predefined engineering specifications and performance targets for each test, as derived from relevant standards (e.g., ISO 11070 for Flexing and Fracture Tests) and internal product design requirements.
8. The sample size for the training set
Not applicable. This document describes testing for a physical medical device. The concept of a "training set" is relevant for machine learning models, which are not involved here.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a machine learning model.
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September 30, 2024
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MicroPort NeuroTech (Shanghai) Co., Ltd. % Ivory Chang Regulatory Consultant BioDesign Regulatory Services, LLC. 16185 Los Gatos Blvd, Suite 205 Los Gatos. California 95032
Re: K242154
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 19, 2024 Received: July 23, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Sara S. Thompson -S
Sara S. Thompson, D.V.M. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
K242154
Subject Device:
Numen™ Coil Embolization System
NumenFR™ Detachment System
This 510(k) Summary is being submitted in accordance with the requirements of 21CFR § 807.92.
| Submitter Name andAddress | MicroPort NeuroTech (Shanghai) Co., Ltd.Building 16, Guangdan Road 222, Pudong New District,Shanghai, China |
|---|---|
| Contact Person | Name: Yuying ChenEmail: YuYing.Chen@microport.comPhone:+86 13311583098 |
| Date Prepared | September 14, 2024 |
| Trade Name | Numen™ Coil Embolization SystemNumenFR™ Detachment System |
| Common Name | Detachable Coil |
| 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 Device | Numen™ Coil Embolization System; NumenFR™Detachment System (K232955) |
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MicroPort NeuroTech (Shanghai) Co., Ltd.
1. Device Description
MicroPort NeuroTech has developed the Numen™ Coil Embolization System and NumenFR™ Detachment System. The Numen™ Coil Embolization System is designed to be used in conjunction with the NumenFR™ 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 NumenFR™ Detachment System is a sterile, handheld, singlepatient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
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
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.
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3. Comparison of the Subject Device with the Predicate Device
Comparison for Numen™ Coil Embolization System
| Characteristics | NumenTM Coil Embolization System(Predicate device, K232955) | NumenTM Coil Embolization System(Subject device) |
|---|---|---|
| Manufacturer | MicroPort NeuroTech (Shanghai) Co.,Ltd | Same |
| Device Classification | Class II | Same |
| Regulation Numberand RegulationDescription | 21 CFR § 870.3300, Device, Vascular,for Promoting Embolization21 CFR § 882.5950 NeurovascularEmbolization Device | Same |
| ClassificationProduct Code | HCGKRD | Same |
| IntendedUse/Indications forUse | NumenTM Coil Embolization System isintended to endovascularly obstruct orocclude blood flow in vascularabnormalities of the neurovascular andperipheral vessels.NumenTM Coil Embolization System isindicated for endovascular embolizationof:• Intracranial aneurysms• Other neurovascular abnormalitiessuch as arteriovenous malformationsand arteriovenous fistulae• Arterial and venous embolizations inthe peripheral vasculatureNumenFRTM Detachment System isintended for use with MicroPortNeuroTech NumenTM CoilEmbolization System in theembolization of intracranial aneurysmsand other vascular abnormalities of theneuro and peripheral vasculature. | Same |
| Types | MicroFrame, MicroFill, MicroFinish | MicroFrame, MicroFill, MicroFinish, SILK |
| No. of ModelsOffered | 177 | 224 |
| Dimension/Shape of Coil Embolization System | ||
| Secondary Shape | 3D, Helical | Same |
| Coil Type | Stretch Resistance | Same |
| Coil SecondaryDiameter | 1-24 mm | Same |
| Coil Length | 1-70 cm | Same |
| Pusher Length | 187.8 cm | Same |
| Material of Coil Embolization System | ||
| Primary Coil Wire | Pt (92%) / W (8%) | Same |
| Characteristics | Numen™ Coil Embolization System(Predicate device, K232955) | Numen™ Coil Embolization System(Subject device) |
| Stretch ResistantThread | Polypropylene | Same |
| Pusher (BodyHypotube) | SS 304 | Same |
| Introducer Sheath | HDPE | Same |
| Proximal Rod | Stainless Steel | Same |
| Adhesive | Epoxy 353ND. | Same |
| Other | ||
| DetachmentMechanism | Electrolytic | Same |
| How Supplied | Sterile, for single use only | Same |
| Sterilization Method | Ethylene Oxide | Same |
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MicroPort NeuroTech
Comparison for NumenFRTM Detachment System
There are no changes to the NumenFRTM Detachment System.
4. Performance Testing
The following non-clinical bench testing was performed to evaluate the new SILK type and to demonstrate substantial equivalence of the subject Numen™ Coil Embolization System to the predicate device. The testing was performed on test units representative of final finished devices.
| Test | Test Method Summary | Test Results |
|---|---|---|
| Visual Inspectionof Pusher | Examine the test sample surface under specific magnification. | Pass |
| Simulated Use | Verify that the coil embolization system performs as intendedin a representative tortuous anatomical model. | Pass |
| Fatigue Testing | Verify the durability of the coil embolization system byrepeating the simulated use six times, including coil retractioninto microcatheter and re-deployment | Pass |
| Detachment Timeand DetachmentReliability | Verify the reliability of intentional detachment as well asreliability of the coil attachment after fatigue testing of the coilembolization system in a representative tortuous anatomicalmodel. | Pass |
| Delivery andRetraction Frictionin IntroducerSheath | Measured by max friction force when advancing or retractingthe coil system in introducer sheath. | Pass |
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| Test | Test Method Summary | TestResults |
|---|---|---|
| Delivery,Deployment andRetraction Frictionin Microcatheter | Measured by max friction force when advancing, deploying orretracting the coil system through microcatheter in a relevant,tortuous, anatomical model. | Pass |
| Kink Resistance | Demonstrate that the resistance to kinking of the device meetspre-specified acceptance criteria, and could withstand bendingforces that the device may encounter in clinical usage. | Pass |
| Torque Strength | Verify the torque strength by rotating the proximal end of thedevice for 8 turns. | Pass |
| Flexing Test | Per ISO 11070, Annex G Test method for resistance ofguidewires to damage by flexing | Pass |
| Fracture Test | Per ISO 11070, Annex F Test method Test method for fractureof guidewires | Pass |
5. Shelf-life
The subject device is constructed using the same materials, packaging, and manufacturing process as the predicate device. The storage and transport conditions for both devices are also the same. There is no increased risk of device failure due to material degradation. The shelf-life testing previously conducted for the predicate devices is also applicable to the subject device, and the shelf-life claims of two (2) years for the subject device are the same as for the predicate device.
6. Biocompatibility
The materials and processing methods of the newly added SILK type are the same as those of the predicate device. The biocompatibility data for the subject device could be adopted from the predicate device. From the evaluation conducted, the biocompatibility testing previously performed for the predicate devices is applicable for the subject device.
7. Conclusion
MicroPort NeuroTech has made modifications to the Numen™ Coil Embolization System, forty-seven (47) new models, named SILK, are added to Numen™ Coil Embolization System. The new SILK type is based on the existing MicroFinish type, but with a modified pusher design. The intended use and indications for use of the device remain unchanged,
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and the modification does not affect the fundamental scientific technology of the predicate device. A comprehensive risk assessment of the modification and successful verification testing have been performed, which did not raise any new questions regarding safety and effectiveness. Based on these evaluations, MicroPort NeuroTech has concluded that the modified Numen™ Coil Embolization System and the NumenFR™ Detachment System are substantially equivalent to the 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).