MicroPlex Coil System (MCS) - HyperSoft 3D

K161452 · MicroVention, Inc. · HCG · Aug 31, 2016 · Neurology

Device Facts

• Record ID: K161452
• Device Name: MicroPlex Coil System (MCS) - HyperSoft 3D
• Applicant: MicroVention, Inc.
• Product Code: HCG · Neurology
• Decision Date: Aug 31, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroPlex Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS are 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.

Device Story

MicroPlex Coil System (MCS) consists of platinum alloy implant coils in 3D spherical structures. Coils attach to a V-Trak or V-Trak Advanced Delivery Pusher via a polyolefin elastomer filament. The delivery pusher is a variable stiffness stainless steel hypotube. During procedure, physician inserts the pusher into a handheld, battery-powered V-Grip Detachment Controller. Activation of the controller delivers electrical current to heat the filament, causing detachment of the coil into the target vessel or aneurysm. Used in clinical settings for permanent obstruction of blood flow to neurovascular or peripheral vascular abnormalities. Benefits include minimally invasive endovascular treatment of aneurysms and malformations.

Clinical Evidence

Bench testing only. Verification and validation included visual inspection, dimensional measurement, advancement/retraction force testing, simulated use in a cerebrovascular benchtop model, and spring constant testing. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, irritation, hemocompatibility, systemic toxicity, genetic toxicology, and intramuscular implantation) confirmed the device is non-toxic, non-irritant, and non-hemolytic.

Technological Characteristics

Implant: Platinum/Tungsten alloy coil (92/8). Coupler: Platinum/Iridium (90/10). Adhesive: Ultraviolet curing. Stretch-resistant member: Polyethylene Terephthalate or Polyolefin Elastomer (Engage™). Delivery: Stainless steel hypotube pusher. Detachment: Electrical current via battery-powered controller. Sterilization: E-beam. MRI compatible. Dimensions: 1-6 mm diameter, 6-20 cm length. Connectivity: None.

Indications for Use

Indicated for patients requiring endovascular embolization of intracranial aneurysms, arteriovenous malformations, arteriovenous fistulae, and vascular occlusion of blood vessels within the neurovascular system or peripheral vasculature.

Regulatory Classification

Identification

A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

Predicate Devices

• MicroPlex Coil System (MCS) - HyperSoft® 3D (K131948, K153594)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 31, 2016

MicroVention, Inc. Ms. Sapna Singh, MS. RAC Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, California 92780

Re: K161452

Trade/Device Name: MicroPlex Coil System (MCS) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: August 1, 2016 Received: August 2, 2016

Dear Ms. Singh:

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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J.Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K161452

Device Name MicroPlex Coil System (MCS)

#### Indications for Use (Describe)

The MicroPlex Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS are 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size: 10pt;"> <b> </b> </span> <span style="font-size: 10pt;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> |
| | <span> <span style="font-size: 10pt;"> <b> </b> </span> <span style="font-size: 10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |

#### 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 [e-mail]

"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

This 510(k) summary for the MicroPlex Coil System (MCS) – HyperSoft® 3D is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendations outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], dated 28 July, 2014.

#### SUBMITTER [807.92(a)(1)]

MicroVention, Inc. 1311 Valencia Avenue Tustin, California U.S.A.

| Telephone: | [phone] |
|------------|----------------|
| Fax: | [phone] |

| Contact Person: | Sapna Singh |
|-----------------|------------------------------|
| Email: | [e-mail] |
| Date Prepared: | May 25, 2016 |

#### DEVICE [807.92(a)(2)]

| Name of Device: | MicroPlex Coil System (MCS) |
|---------------------------|-----------------------------------------------------------------------------------------------|
| Common or Usual Name: | MicroPlex Platinum Coils |
| Classification Name: | Neurovascular Embolization Device |
| Product Code: | HCG, KRD |
| Regulatory Class: | Class II |
| Submission Type: | Special 510(K) |
| Regulation Number: | 21 CFR 882.5950 |
| Reviewing Product Branch: | Division of Neurological and Physical Medicine Devices<br>(Office of Device Evaluation, CDRH) |

### PREDICATE DEVICE [807.92(a)(3)]

MicroPlex Coil System (MCS) - HyperSoft® 3D (K131948, K153594)

### DEVICE DESCRIPTION [807.92(a)(4)]

HyperSoft® 3D in the MicroPlex Coil System (MCS) consist of an implant coil made of platinum alloy.

{4}------------------------------------------------

The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament. resulting in detachment of the implant segment.

# INDICATIONS FOR USE [807.92(a)(5)]

The MicroPlex Coil System (MCS) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS are 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.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]

The Table I compares the technological characteristics of the existing HyperSoft® 3D coils (K131948, K153594) with the additional models presented in this 510(k) submission. The devices.

- Have the same intended use ●
- Use the same operating principle ●
- Incorporate the same basic coil design ●
- Use same construction and material
- Are packaged and sterilized using same material and processes .

The line extension of the HyperSoft® 3D coils (includes addition of sizes from 1mm to 6 mm secondary wind diameter with lengths from 6 cm to 20 cm) and change in the Stretch Resistance Member Material from Polyethylene Terephthalate (PET) to PET or Polyolefin Elastomer (Engage™) does not change the indications for use of the coils and is not a change to the fundamental scientific technology.

The performance data below shows the device will perform as well as the previously marketed device.

{5}------------------------------------------------

| | Existing HyperSoft® 3D (Predicate Device,<br>(K131948, K153594) | HyperSoft® 3D Line<br>Extension (Subject<br>Device |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Intended Use | | |
| Intended Use<br>Statement | The MicroPlex Coil System (MCS) are<br>intended for the endovascular embolization of<br>intracranial aneurysms and other<br>neurovascular abnormalities such as<br>arteriovenous malformations and<br>arteriovenous fistulae. The MCS are also<br>intended for vascular occlusion of blood<br>vessels within the neurovascular system to<br>permanently obstruct blood flow to an<br>aneurysm or other vascular malformation and<br>for arterial and venous embolizations in the<br>peripheral vasculature. | Same |
| Performance | | |
| Function | The coils are used for the endovascular<br>embolization of aneurysms, other<br>neurovascular abnormalities such as<br>arteriovenous malformations, arteriovenous<br>fistulae and arterial and venous embolizations<br>in the peripheral neurovasculature. | Same |
| Anatomical Location | General intravascular use, including the neuro<br>and peripheral vasculature. | Same |
| Implantable Embolization Coil | | |
| Coil Shape | 3D - Spherical | Same |
| Primary Coil Wire OD | 0.00125 inch | 0.00125 inch and 0.0015<br>inch |
| Coil Implant Diameter | 1 - 5 mm | 1 - 6 mm |
| Coil Restrained Length | 2 - 15 cm | 6 - 20 cm |
| Coil Gap | Closed | Closed |
| Delivery pusher length | 195 cm | Same |
| Material | | |
| Main Coil Wire | Platinum/Tungsten Alloy (Pt/W: 92/8) | Same |
| Coil-to-Pusher Coupler | Platinum/Iridium (Pt/Ir: 90/10) | Same |
| Adhesive | Ultraviolet Curing Adhesive | Same |
| Implant to Pusher<br>Filament | Polyolefin Elastomer | Same |
| Stretch resistant (SR) | Polyethylene Terephthalate (K131948) | Polyethylene<br>Terephthalate or<br>Polyolefin Elastomer<br>(Engage™) |
| Other Attributes | | |
| Detachment System | Detachment Controller; stand alone, hand<br>held battery operated unit detaches the coil<br>implant | Same |
| Catheter compatibility | Compatible with 10-system microcatheters<br>(minimum ID of 0.0165") | Same |
| MRI compatibility | Yes | Same |
| Method of Supply | Sterile and single use (e-beam) | Same |
| Package Configuration | Placed in Introducer Sheath, Dispenser Coil,<br>Pouch, and Shipping Carton | Same |

#### Table I: Predicate Device vs Subject Device Comparison Table

{6}------------------------------------------------

## PERFORMANCE DATA [807.92(b)]

Results of the verification and validation testing (Table II) indicate that the product meets established performance requirements, and is substantially equivalent for its intended use.

| Table II: Design Verification and Validation Test Summary | | |
|-----------------------------------------------------------|--|--|
|-----------------------------------------------------------|--|--|

| Bench Testing | Result |
|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Visual Inspection: Using a microscope, inspect HyperSoft® 3D per<br>device drawing, PDM-ATP. | All test samples passed testing. |
| Dimensional Measurement: Using a microscope, inspect<br>HyperSoft® 3D Coil's secondary wire diameter. | All test samples passed testing. |
| Advancement/Retraction Force: The test represents the maximum<br>force required to advance and retract the coil through the<br>microcatheter. | All test samples passed testing. |
| Simulated Use: The test simulate the use of HyperSoft® 3D coils in-<br>vitro using a cerebrovascular benchtop model. | All test samples passed testing. |
| Spring Constant: The spring constant force (determination of<br>maximum force to break monofilament) of the coil is measured. | All test samples passed testing. |

#### Biocompatibility Summary – HyperSoft® 3D Implant

| Biocompatibility | Test Standard | Results |
|--------------------------------------------|---------------|------------------------|
| Cytotoxity | | |
| MEM Elution Test | ISO 10993-5 | Non-toxic |
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Non-toxic |
| Sensitization | | |
| Sensitization-Guinea Pig Maximization Test | ISO 10993-10 | No sensitizer response |
| Irritation | | |

{7}------------------------------------------------

| ISO Intracutaneous Reactivity Evaluation<br>Test | ISO 10993-10 | Non-irritant | | |
|--------------------------------------------------|--------------|---------------------------------------|--|--|
| Hemocompatibility | | | | |
| Hemolysis | ISO 10993-4 | Non-hemolytic | | |
| Prothrombin Time Assay - ISO | ISO 10993-4 | No adverse effect on coagulation time | | |
| Systemic Toxicity | | | | |
| Systemic toxicity<br>(IV injection) | ISO 10993-11 | Non-toxic | | |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Non-pyrogenic | | |
| Genetic Toxicology | | | | |
| Bacteria Reverse Mutation Assay (Ames<br>Test) | ISO 10993-3 | Negative response for mutagenicity | | |
| Intramuscular Implantation | | | | |
| 7-day Muscle Implantation | ISO 10993-6 | Non-irritant | | |
| 13-week Intramuscular Implantation Test | ISO 10993-6 | Non-irritant | | |
| 26-week Intramuscular Implantation Test | ISO 10993-6 | Non-irritant | | |

## Biocompatibility Summary – V-Trak™ or V-Trak™ Advanced Delivery Pusher

| Biocompatibility | Test Standard | Results |
|--------------------------------------------------|---------------|---------------------------------------|
| Cytotoxity | | |
| MEM Elution Test | ISO 10993-5 | Non-toxic |
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Non-toxic |
| Sensitization | | |
| Sensitization-Guinea Pig Maximization Test | ISO 10993-10 | No sensitizer response |
| Irritation | | |
| ISO Intracutaneous Reactivity Evaluation<br>Test | ISO 10993-10 | Non-irritant |
| Hemocompatibility | | |
| Hemolysis | ISO 10993-4 | Non-hemolytic |
| Prothrombin Time Assay - ISO | ISO 10993-4 | No adverse effect on coagulation time |
| Systemic Toxicity | | |
| Systemic toxicity<br>(IV injection) | ISO 10993-11 | Non-toxic |
| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Non-pyrogenic |

{8}------------------------------------------------

#### CONCLUSIONS

Based on the 510(k) summary and information provided herein, we conclude the subject device, HyperSoft® 3D in the MCS, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the predicate HyperSoft® 3D, K131948, K153594.