(111 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.
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 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 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, the Numen™ Coil Embolization System and NumenFR™ Detachment System. The document details the device, its intended use, comparison to a predicate device, and performance testing. However, it does not describe acceptance criteria for a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device.
The "Performance Testing" section (page 6) outlines bench testing conducted to evaluate device changes and demonstrate substantial equivalence to a predicate device. This is typical for traditional (non-AI/ML) medical devices, focusing on physical and functional properties, rather than AI performance metrics like sensitivity, specificity, or reader agreement.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study demonstrating an AI/ML device's performance based on the provided text, as the text pertains to a different type of medical device assessment.
If you can provide a document that discusses the evaluation of an AI/ML medical device, I would be happy to analyze it according to your requested criteria.
{0}------------------------------------------------
January 10, 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
MicroPort NeuroTech (Shanghai) Co., Ltd. % Ivory Chang Regulatory Consultant BioDesign Regulatory Services, LLC 16185 Los Gatos Boulevard, Suite 205 Los Gatos. California 95032
Re: K232955
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: December 13, 2023 Received: December 14, 2023
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,
Naira Muradyan -S
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 Quality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K232955
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
K232955
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, Guangdan Road 222, Pudong New District, Shanghai, China |
|---|---|
| Contact Person | Name: Jiayin SunEmail: JiaYin.Sun@microport.comPhone: +86 13662109935 |
| Date Prepared | December 17, 2023 |
| Trade Name | NumenTM Coil Embolization SystemNumenFRTM 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 | NumenTM Coil Embolization System; NumenFRTM Detachment System (K203625) |
{4}------------------------------------------------
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 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 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
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.
3. Comparison of the Subject Device with the Predicate Device
Comparison for Numen™ Coil Embolization System
| Characteristics | NumenTM Coil Embolization System(Predicate device, K203625) | Numen™ Coil Embolization System(Subject device, K232955) | |
|---|---|---|---|
| Manufacturer | MicroPort NeuroTech (Shanghai) Co.,Ltd. | Same | |
| Device Classification | Class II | Same | |
| Regulation Numberand RegulationDescription | 21 CFR §870.3300, Device, Vascular, forPromoting Embolization21 CFR §882.5950 NeurovascularEmbolization Device | Same | |
| Characteristics | Numen™ Coil Embolization System(Predicate device, K203625) | Numen™ Coil Embolization System(Subject device, K232955) | |
| Classification | KRD | Same | |
| Product Code | HCG | Same | |
| IntendedUse/Indications forUse | Numen™ Coil Embolization System isintended to endovascularly obstruct orocclude blood flow in vascularabnormalities of the neurovascular andperipheral vessels.Numen™ Coil Embolization System isindicated for endovascular embolizationof:• Intracranial aneurysms• Other neurovascular abnormalities suchas arteriovenous malformations andarteriovenous fistulae• Arterial and venous embolizations in | Same | |
| NumenFR™ Detachment System isintended for use with MicroPortNeuroTech Numen™ Coil EmbolizationSystem in the embolization ofintracranial aneurysms and other vascularabnormalities of the neuro and peripheralvasculature. | |||
| 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 | 183.5 cm | 187.8 cm | |
| Material of Coil Embolization System | |||
| Primary Coil Wire | Pt (92%) / W (8%) | Same | |
| Stretch ResistantThread | Polypropylene | Same | |
| Pusher (BodyHypotube) | SS 304 | Same | |
| Introducer Sheath | HDPE | Same | |
| Proximal Rod/Proximal Anchor | Pt/Ir | Stainless steel | |
| Adhesive | Epoxy 353NDEpoxy H20E | Epoxy 353ND | |
| Other | |||
| DetachmentMechanism | Electrolytic | Same | |
| How Supplied | Sterile, for single use only | Same | |
| Sterilization Method | Ethylene Oxide | Same |
{5}------------------------------------------------
croPort NeuroTech
{6}------------------------------------------------
Comparison for NumenFR™ 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 device changes and to demonstrate substantial equivalence of the modified Numen™ Coil Embolization System to the predicate device. The testing was performed on test units representative of final finished devices. The device is labeled with two years (2) shelf life, which is supported by accelerated aging shelf-life study.
| Test | Test Method Summary | Test Results |
|---|---|---|
| VisualInspection ofPusher | Examine the test sample surface under specificmagnification. | Pass |
| DimensionalVerification ofPusher | Pusher diameters and pusher length aremeasured to match the specifications. | Pass |
| Simulated Use | Verify that the coil embolization systemperforms as intended in a representativetortuous anatomical model. | Pass |
| Fatigue Testing | Verify the durability of the coil embolizationsystem by repeating the simulated use sixtimes, including coil retraction into themicrocatheter and re-deployment. | Pass |
| DetachmentTime andDetachmentReliability | Verify the reliability of intentional detachmentas well as reliability of the coil attachment afterfatigue testing of the coil embolization systemin a representative tortuous anatomical model. | Pass |
| Pusher ProximalHypotubeContact TensileStrength | Verify that the tensile strength meets theacceptance criteria. | Pass |
| PusherCorrosionResistance | Corrosion resistance testing per ISO 10555-1Annex A methods for the pusher. | Pass |
| SterilizationValidation | Per ISO 11135, Annex B Overkill Method toensure that the sterilization process achievessterility assurance level of 10-6. | Pass |
| EndotoxinTesting | Bacterial endotoxin assay validation per USP<85> to ensure the endotoxin levels for thedevice are below 2.15 EU/device. | Pass |
| Electrical Safety | Electrical safety testing in accordance with IEC60601-1. | Pass |
{7}------------------------------------------------
Biocompatibility
The design modifications to the proximal portion of the pusher of the Numen™ Coil Embolization System were limited to components that do not contact the patient. Additional biocompatibility assessments were not deemed necessary to support the design change to the pusher of the Numen™ Coil Embolization System.
5. Conclusion
MicroPort NeuroTech has made modifications to the Numen™ Coil Embolization System. The intended use and indications for use of the device remain unchanged, and the modifications do not affect the fundamental scientific technology of the device. A comprehensive risk assessment of the modifications 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 NumenFRTM 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).