HydroCoil Embolic System (HES)

K161367 · MicroVention, Inc. · HCG · Aug 31, 2016 · Neurology

Device Facts

• Record ID: K161367
• Device Name: HydroCoil Embolic System (HES)
• 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

Indications for Use

The HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES 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

HydroCoil Embolic System (HES) consists of platinum alloy implant coils with inner hydrogel core; 3D spherical structure. Coils attach to V-Trak or V-Trak Advanced Delivery Pusher via polyolefin elastomer filament. Pusher is stainless steel hypotube with platinum/stainless steel distal coils. Physician operates device under fluoroscopic guidance in neurovascular/peripheral procedures. Pusher proximal end inserts into handheld, battery-powered V-Grip Detachment Controller. Activation heats filament via electrical current, detaching coil. Hydrogel expands post-hydration to facilitate permanent vascular occlusion. Benefits include effective embolization of aneurysms and vascular malformations.

Clinical Evidence

Bench testing only. Testing included visual inspection, dimensional measurement, simulated use in cerebrovascular benchtop model, reposition time, advancement/retraction force, expanded gel diameter, spring constant, and weld tensile strength. Biocompatibility testing performed per ISO 10993-3, -4, -5, -6, -10, and -11, confirming non-toxic, non-irritant, non-hemolytic, and non-pyrogenic status.

Technological Characteristics

Implant: Platinum/tungsten alloy coil, hydrophilic acrylic copolymer hydrogel core. Delivery: Stainless steel hypotube pusher, platinum/iridium coupler, polyolefin elastomer filament. Detachment: Electrical heating via battery-operated controller. Dimensions: 1-9 mm diameter, 2-36 cm length. Sterilization: Gamma radiation. Connectivity: Standalone. Software: None.

Indications for Use

Indicated for endovascular embolization of intracranial aneurysms, arteriovenous malformations, and arteriovenous fistulae; vascular occlusion of neurovascular blood vessels to obstruct blood flow to aneurysms or malformations; and arterial and venous embolizations in the 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

• HydroFrame 10 (K090357, K100454 and K103758)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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: K161367

Trade/Device Name: HydroCoil® Embolic System (HES) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: July 28, 2016 Received: August 4, 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.

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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

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# Indications for Use

510(k) Number (if known) K161367

Device Name HydroCoil® Embolic System (HES)

#### Indications for Use (Describe)

The HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES 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 yenous embolizations in the peripheral vasculature.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) SUMMARY

This 510(k) summary for the HydroCoil® Embolic System (HES) - HydroFrame® 10 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 16, 2016 |

# DEVICE [807.92(a)(2)]

| Name of Device: | HydroCoil Embolic System (HES) |
|---------------------------|-----------------------------------------------------------------------------------------------|
| Common or Usual Name: | HydroCoils |
| 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)]

HydroFrame® 10 (K090357, K100454 and K103758)

DEVICE DESCRIPTION [807.92(a)(4)]

The HydroFrame coils in the HydroCoil Embolic System (HES) consist of implant coil made of platinum alloy with inner hydrogel core.

The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is Page 1 of 6

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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 HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES 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 HydroFrame coils (K090357, K100454 and K103758) 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 similar construction and material
- Are packaged and sterilized using same material and processes

The line extension of the HydroFrame 10 coils (includes addition of sizes from 1mm to 9 mm secondary wind diameter with lengths from 2 cm to 36 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.

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

| | Existing HydroFrame 10 (Predicate Device,<br>(K090357, K100454 and K103758) ) | HydroFrame 10 Line<br>Extension (Subject<br>Device) |
|--------------|-------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | | |

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| Intended Use<br>Statement | The HydroCoil Embolic System (HES) 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 HES 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 | 0.00150 inch, .00175 inch, .00200 inch,<br>.00225 inch | Same | Coil Implant Diameter | 2 – 12 mm | 1 – 9 mm | Coil Restrained Length | 2 – 43 cm | 2 - 36 cm | Coil Gap | Closed | Same | 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 (K103758) or<br>Polyolefin Elastomer (K090357, K100454) | Same | Hydrogel | Hydrophilic Acrylic Copolymer | Same | 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 |
| | Implantable Embolization Coil | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Coil Shape | 3D - Spherical | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Primary Coil Wire OD | 0.00150 inch, .00175 inch, .00200 inch,<br>.00225 inch | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Coil Implant Diameter | 2 – 12 mm | 1 – 9 mm | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Coil Restrained Length | 2 – 43 cm | 2 - 36 cm | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Coil Gap | Closed | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 (K103758) or<br>Polyolefin Elastomer (K090357, K100454) | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Hydrogel | Hydrophilic Acrylic Copolymer | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| MRI compatibility | Yes | Same |
|-----------------------|----------------------------------------------------------------------------|------|
| Method of Supply | Sterile and single use (Gamma Radiation) | Same |
| Package Configuration | Placed in Introducer Sheath, Dispenser Coil,<br>Pouch, and Shipping Carton | Same |

# 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 HydroFrame Coils<br>per device drawing, PDH-HFRM-ATP. | All test samples passed testing. |
| Dimensional Measurement: Using a microscope, inspect<br>HydroFrame Coil's secondary wire diameter. | All test samples passed testing. |
| Simulated Use: The test simulate the use of HydroFrame coils in-<br>vitro using a cerebrovascular benchtop model. | All test samples passed testing. |
| Reposition Time: The test reposition the device within simulated<br>use bench top model and determine the performance of the gel. | All test samples passed testing. |
| Advancement/Retraction Force: The test measures the maximum<br>force required to advance and retract the coil through the<br>microcatheter after 30 minutes. | All test samples passed testing. |
| Expanded Gel Diameter: The HydroFrame coils are detached from<br>the pusher and the expanded diameter of the hydrogel (post<br>hydration) are measured using a microscope. | 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. |
| Weld Tensile: The coil/coupler weld tensile strength is tested and<br>measured. | All test samples passed testing. |

## Biocompatibility Summary – HydroFrame 10 Implant

| Biocompatibility | Test Standard | Results |
|-------------------------------|---------------|-----------|
| Cytotoxicity | | |
| MEM Elution Test | ISO 10993-5 | Non-toxic |
| ISO Cell Culture Agar Overlay | ISO 10993-5 | Non-toxic |
| Sensitization | | |

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| 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 |
| 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 (IV injection) | ISO 10993-11 | Non-toxic |

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| Rabbit Pyrogen Test (material mediated) | ISO 10993-11 | Non-pyrogenic |
|-----------------------------------------|--------------|---------------|
|-----------------------------------------|--------------|---------------|

# CONCLUSIONS

Based on the 510(k) summary and information provided herein, we conclude the subject device, HydroFrame 10 in the HES, is substantially equivalent in its intended use, design, material, performance, and the underlying fundamental scientific technology used, to the predicate HydroFrame 10, K090357, K100454 and K103758.