Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and mechanical/electrical performance of the coil and detachment system, with no mention of AI or ML.

Therapeutic

Yes
The device is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities to treat conditions such as intracranial aneurysms and arteriovenous malformations, which is a therapeutic intervention.

Diagnostic

No
The Numen™ Coil Embolization System is a therapeutic device designed to obstruct or occlude blood flow in vascular abnormalities, not to diagnose them. It is used for endovascular embolization, which is a treatment.

SaMD (Software as a Medical Device)

No

The device description clearly states it is composed of physical components (introducer sheath, coil system, pusher, coil implant) and a separate handheld device (NumenFR™ Detachment System) with batteries. The performance studies also include extensive testing on physical properties and biological interactions, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the Numen™ Coil Embolization System is for endovascularly obstructing or occluding blood flow in vascular abnormalities. This is a therapeutic intervention performed within the body, not a diagnostic test performed on samples taken from the body.
Device Description: The description details a system for delivering a permanent implant (the coil) to occlude blood flow. This aligns with a therapeutic device, not a diagnostic one.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is a medical device used for a therapeutic procedure (embolization), not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

neurovascular and peripheral vessels, Intracranial, Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, Arterial and venous embolizations in the peripheral vasculature.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use Only

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)

Numen™ Coil Embolization System

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.
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.
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.

NumenFRTM Detachment System

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.
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. Pass.
The device is labeled with two years (2) shelf life, which is supported by accelerated aging shelf-life study. Pass.

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.

K161429, K160096

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.

K151447, K143218, K132952

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

Regulation Number and Section

§ 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).

Summary

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