(69 days)
Not Found
No
The summary describes a mechanical coil embolization system and detachment system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are bench tests evaluating mechanical properties.
Yes.
The device is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities, such as intracranial aneurysms and arteriovenous malformations, which are conditions requiring therapeutic intervention.
No
The device is an embolization system designed to obstruct or occlude blood flow in vascular abnormalities, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components like an introducer sheath, coil system (pusher and coil implant), and a handheld detachment system with batteries. These are hardware components, not software.
Based on the provided text, the Numen™ Coil Embolization System and NumenFR™ Detachment System are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The text describes a system used to embolize blood vessels within the body (intracranial aneurysms, AVMs, fistulae, etc.). This is an in vivo procedure, not an in vitro (outside the body) diagnostic test.
- The intended use is therapeutic. The purpose of the device is to obstruct or occlude blood flow to treat vascular abnormalities, not to diagnose a condition by analyzing a sample.
- The device description aligns with a medical implant and delivery system. It includes a coil implant and a system for delivering and detaching it within the body.
Therefore, the Numen™ Coil Embolization System and NumenFR™ Detachment System are medical devices used for therapeutic intervention, not IVD devices.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular and peripheral vessels; Intracranial; neuro and peripheral vasculature; Arterial and venous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Visual Inspection of Pusher: Examine the test sample surface under specific magnification.
- Simulated Use: Verify that the coil embolization system performs as intended in a representative tortuous anatomical model.
- Fatigue Testing: Verify the durability of the coil embolization system by repeating the simulated use six times, including coil retraction into microcatheter and re-deployment.
- 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.
- Delivery and Retraction Friction in Introducer Sheath: Measured by max friction force when advancing or retracting the coil system in introducer sheath.
- Delivery, Deployment and Retraction Friction in Microcatheter: Measured by max friction force when advancing, deploying or retracting the coil system through microcatheter in a relevant, tortuous, anatomical model.
- Kink Resistance: Demonstrate that the resistance to kinking of the device meets pre-specified acceptance criteria, and could withstand bending forces that the device may encounter in clinical usage.
- Torque Strength: Verify the torque strength by rotating the proximal end of the device for 8 turns.
- Flexing Test: Per ISO 11070, Annex G Test method for resistance of guidewires to damage by flexing
- Fracture Test: Per ISO 11070, Annex F Test method Test method for fracture of guidewires
All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
September 30, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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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3
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 and
Address | MicroPort NeuroTech (Shanghai) Co., Ltd.
Building 16, Guangdan Road 222, Pudong New District,
Shanghai, China |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Yuying Chen
Email: YuYing.Chen@microport.com
Phone:+86 13311583098 |
| Date Prepared | September 14, 2024 |
| Trade Name | Numen™ Coil Embolization System
NumenFR™ 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 Marketed
Predicate Device | Numen™ Coil Embolization System; NumenFR™
Detachment System (K232955) |
4
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.
5
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 Number
and Regulation
Description | 21 CFR § 870.3300, Device, Vascular,
for Promoting Embolization
21 CFR § 882.5950 Neurovascular
Embolization Device | Same |
| Classification
Product Code | HCG
KRD | Same |
| Intended
Use/Indications for
Use | NumenTM Coil Embolization System is
intended to endovascularly obstruct or
occlude blood flow in vascular
abnormalities of the neurovascular and
peripheral vessels.
NumenTM 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 NumenTM Coil
Embolization System in the
embolization of intracranial aneurysms
and other vascular abnormalities of the
neuro and peripheral vasculature. | Same |
| Types | MicroFrame, MicroFill, MicroFinish | MicroFrame, MicroFill, MicroFinish, SILK |
| No. of Models
Offered | 177 | 224 |
| | Dimension/Shape of Coil Embolization System | |
| Secondary Shape | 3D, Helical | Same |
| Coil Type | Stretch Resistance | Same |
| Coil Secondary
Diameter | 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 Resistant
Thread | Polypropylene | Same |
| Pusher (Body
Hypotube) | SS 304 | Same |
| Introducer Sheath | HDPE | Same |
| Proximal Rod | Stainless Steel | Same |
| Adhesive | Epoxy 353ND. | Same |
| Other | | |
| Detachment
Mechanism | Electrolytic | Same |
| How Supplied | Sterile, for single use only | Same |
| Sterilization Method | Ethylene Oxide | Same |
6
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 Inspection | ||
| of Pusher | Examine the test sample surface under specific magnification. | 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 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 | |
| Delivery and | ||
| Retraction Friction | ||
| in Introducer | ||
| Sheath | Measured by max friction force when advancing or retracting | |
| the coil system in introducer sheath. | Pass |
7
| Test | Test Method Summary | Test
Results |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Delivery,
Deployment and
Retraction Friction
in Microcatheter | Measured by max friction force when advancing, deploying or
retracting the coil system through microcatheter in a relevant,
tortuous, anatomical model. | Pass |
| Kink Resistance | Demonstrate that the resistance to kinking of the device meets
pre-specified acceptance criteria, and could withstand bending
forces that the device may encounter in clinical usage. | Pass |
| Torque Strength | Verify the torque strength by rotating the proximal end of the
device for 8 turns. | Pass |
| Flexing Test | Per ISO 11070, Annex G Test method for resistance of
guidewires to damage by flexing | Pass |
| Fracture Test | Per ISO 11070, Annex F Test method Test method for fracture
of 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,
8
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.