SOFIA Plus Aspiration Catheter

K173200 · MicroVention, Inc. · NRY · Jun 11, 2018 · Cardiovascular

Device Facts

• Record ID: K173200
• Device Name: SOFIA Plus Aspiration Catheter
• Applicant: MicroVention, Inc.
• Product Code: NRY · Cardiovascular
• Decision Date: Jun 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.

Device Story

Single-lumen aspiration catheter; designed for neurovascular access over steerable guidewire. Features semi-rigid proximal section and flexible distal tip; radiopaque marker band for fluoroscopic visualization; hydrophilic coating to reduce friction. Used in clinical settings (e.g., neuro-interventional suites) by physicians to remove thrombus/embolus from intracranial vessels. Operates via connection to external aspiration pump (Gomco 405) and tubing. Physician navigates catheter to occlusion site under fluoroscopy; applies vacuum pressure to aspirate clot. Facilitates revascularization in acute ischemic stroke patients; potentially restores blood flow to ischemic brain tissue.

Clinical Evidence

No clinical data. Evidence provided via bench testing and comparative animal study in a swine model. Bench testing included biocompatibility (ISO 10993), simulated use, dimensional/physical attributes, kink resistance, coating durability, tensile strength, burst pressure, and leak testing. All tests passed.

Technological Characteristics

Single-lumen catheter; materials include polyurethane elastomer, Pebax, polyamide, stainless steel/NiTi coil, PTFE, and polyolefin. Hydrophilic coating (Hydak). Radiopaque Pt/Ir marker band. Dimensions: 0.070 in ID, 0.083/0.082 in OD. Sterilized via ethylene oxide. Single-use. Mechanical aspiration principle via external pump.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, M1/M2 middle cerebral, basilar, and vertebral arteries) within 8 hours of symptom onset. Candidates include patients ineligible for or failing IV t-PA therapy.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Penumbra Reperfusion Catheter ACE64 and ACE68 (K152541)

Submission Summary (Full Text)

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June 11, 2018

MicroVention, Inc. Naomi Gong Associate Director, Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780

Re: K173200

Trade/Device Name: SOFIA Plus Aspiration Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 27, 2018 Received: May 1, 2018

Dear Naomi Gong:

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Xiaolin Zheng -S

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) K173200

Device Name SOFIA Plus Aspiration Catheter

#### Indications for Use (Describe)

The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA therapy are candidates for treatment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary - K173200

Pursuant to Section 12, Part (a)(i)(3)(A) of the Safe Medical Devices Act of 1990, MicroVention, Inc. is providing this summary of substantial equivalence for the SOFIA™ Plus Aspiration Catheter (21 CFR 807.92).

#### Applicant Name and Address

MicroVention, Inc. 1311 Valencia Avenue Tustin, California 92780 USA

#### Contact Information

Naomi Gong Associate Director, Regulatory Affairs Tel: [phone] naomi.gong(@microvention.com

## Date of Preparation of the 510(k) Summary

June 5. 2018

## Device Trade or Proprietary Name

SOFIA Plus Aspiration Catheter

#### Device Classification

| Regulatory Class: | II |
|-----------------------|------------------------------------|
| Classification Panel: | Neurology |
| Regulation Name(s): | Percutaneous Catheter |
| Regulation Number(s): | 21 CFR 870.1250 |
| Product Code: | NRY (Catheter, Thrombus Retriever) |

## Predicate Device

Penumbra Reperfusion Catheter ACE64 and ACE68 (K152541)

## Indications for Use

The SOFIA Plus Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVention Tubing Kit is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

## Device Description

The SOFIA Plus Aspiration Catheter is a single lumen catheter designed to be introduced over a steerable guidewire to access the neurovasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. A single radiopaque marker at the distal end facilitates fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to reduce friction during navigation in the vasculature. A luer fitting on the microcatheter hub is used for the attachment of accessories. The strain relief at the hub provides kink resistance for the proximal end. A steam shaping mandrel and introducer sheath are also packaged with the catheter. The SOFIA Plus Aspiration Catheter is used to remove thrombus/embolus from the neurovasculature using aspiration tubing and pump.

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# Technological Characteristics Comparison Table

| | Penumbra Reperfusion Catheter<br>ACE 64/68<br>(K152541 predicate device) | | SOFIA Plus Aspiration Catheter<br>(subject device) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication | The Penumbra System is intended for use<br>in the revascularization of patients with<br>acute ischemic stroke secondary to<br>intracranial large vessel occlusive disease<br>(within the internal carotid, middle<br>cerebral - M1 and M2 segments, basilar,<br>and vertebral arteries) within 8 hours of<br>symptom onset. | | SAME:<br>The SOFIA Plus Aspiration Catheter with the<br>Gomco 405 Aspiration Pump and<br>MicroVention Tubing Kit is intended for use in<br>the revascularization of patients with acute<br>ischemic stroke secondary to intracranial large<br>vessel occlusive disease (within the internal<br>carotid, middle cerebral - M1 and M2<br>segments, basilar, and vertebral arteries) within<br>8 hours of symptom onset. Patients who are<br>ineligible for intravenous tissue plasminogen<br>activator (IV t-PA) or who fail IV t-PA therapy<br>are candidates for treatment. |
| Material | | | |
| Catheter body | Outer layer of polyurethane elastomer<br>(Tecoflex and Pellethane), polyether block<br>amide (Pebax) and polyamide (Vestimid);<br>inner layer of stainless steel and/or NiTi<br>coil | | Outer layer of polyurethane elastomer<br>(Polyblend and Pellethane), polyether block<br>amide (Pebax) and polyamide (Grilamid); inner<br>layer of stainless steel braid/coil, PTFE and<br>polyolefin elastomer |
| Marker band | Pt/Ir | | Pt/Ir |
| Hub | Nylon (Grilamid) | | Nylon |
| Strain relief | Nylon (Grilamid)/SS304 | | Polyurethane |
| Introducer | PTFE | | Pebax |
| Shaping mandrel | Stainless Steel | | Stainless steel |
| ID | ACE64:<br>Prox = 0.068 in. Min<br>Distal = 0.064 in. Min | ACE68:<br>0.068 in. Min | 0.070 in. |
| OD | ACE64:<br>Prox = 0.084 in. Max<br>Distal = 0.080 in. Max | ACE68:<br>0.084 in. Max | Prox: 0.083 in.<br>Distal: 0.082 in. |
| Effective Length | 115 - 132 cm | | 125 - 131 cm |
| Coating | Hydrophilic coating (SRDX Harmony) | | Hydrophilic coating (Hydak®) |
| Tip Configuration | Steam shapeable by user | | Steam shapeable by user |
| Accessories | Peelable sheath, rotating hemostatic valve,<br>shaping mandrel | | Introducer sheath and shaping mandrel |
| Method of Supply | Sterile and single use | | Sterile and single use |
| Sterilization Method | Ethylene oxide | | Ethylene oxide |
| Packaging<br>Configuration | Polyester/polyethylene/Tyvek® pouch,<br>Polyethylene hoop, polyethylene card,<br>paperboard carton. | | Polyester/polyethylene/Tyvek® pouch,<br>Polyethylene tube, polyethylene card, paperboar<br>carton. |
| Components | | | |
| Aspiration Pump | Penumbra Aspiration Pump<br>Vacuum of -25 in Hg | | Gomco 405 Aspiration Pump |
| Aspiration Tubing | 112 inch length<br>Tubing ID = 0.110 inch | | Same |

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## Summary of Pre-Clinical Testing

Included in this section are summary descriptions of the non-clinical testing which substantiates the performance of the subject device, the SOFIA Plus Aspiration Catheter:

| Biocompatibility | Results | Conclusions |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Cytotoxcitiy (ISO 10993-5)<br>- MEM elution assay | Cell culture treated with test article<br>exhibited slight reactivity (Grade 1) | Non-cytotoxic<br>PASSED |
| Sensitization/Irritation (ISO 10993-10)<br>- Guinea pig maximization<br>sensitization | Extracts of the test article elicited no<br>reaction at the challenge (0%<br>sensitization) following the induction<br>phase (Grade 1). | Weak allergic<br>potential or<br>sensitizing<br>capacity<br>PASSED |
| Sensitization/Irritation (ISO 10993-10)<br>- Intracutaneous reactivity | Extracts of the test article did not show a<br>significantly greater biological reaction<br>than the sites injected with the control<br>article | Non-irritant<br>PASSED |
| Hemocompatibility – Rabbit Blood<br>Direct and Indirect Contact (ISO<br>10993-4) | The hemolysis index was 0.13% (direct<br>contact) and 0.0% (indirect contact) | Non-hemolytic<br>PASSED |
| Hemocompatibility – Unactivated<br>Partial Thromboplastin Time Assay<br>Direct Contact (ISO 10993-4) | No statistically significant difference<br>found between the Unactivated Partial<br>Thromboplastin Time (UPTT) of the<br>plasma exposed to the test article and<br>that of the plasma exposed to either the<br>negative control or the untreated control | No effect on<br>coagulation<br>PASSED |
| Hemocompatibility - Complement<br>Activation Assay (ISO 10993-4) | C3a and SC5b-9 levels < negative and<br>untreated controls | No effect on<br>complement<br>activation<br>PASSED |
| Hemocompatibility - Thrombogenicity<br>Study in Dogs (ISO 10993-4) | Minimal thrombosis observed with a<br>Grade 0 in two out of two test sites and<br>two out of two control sites | No significant<br>thrombosis<br>PASSED |
| Systemic Toxicity - Systemic Injection<br>Test (ISO 10993-11) | Extracts of test article did not induce a<br>significantly greater biological reaction<br>than the control extracts when injected<br>in Swiss Albino mice | No toxic effects<br>PASSED |
| Systemic Toxicity - Rabbit Pyrogen<br>Test (ISO 10993-11) | The temperature increases (maximum)<br>was 0.03°C from baseline | Non-pyrogenic<br>PASSED |

# Biocompatibility Testing:

## Verification and Test Summary:

The physical and mechanical properties of the SOFIA Plus Aspiration Catheter device were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:

| Bench Testing | | |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Test | Results | Conclusions |
| Simulated Use | Test articles achieved a rating $\geq$ 3 for<br>preparation/ease of assembly, introducer<br>sheath interaction, introducer peel away,<br>tracking with guidewire/microcatheter,<br>microcatheter/guidewire lockup, lubricity and<br>durability of hydrophilic coating,<br>microcatheter/ guidewire removal, removal/<br>aspiration of clot. | Device performs as intended<br>and demonstrates equivalency<br>to its predicate devices under<br>simulated use conditions |
| Dimensional and Physical<br>Attributes | Test articles met the specified dimensional<br>requirements for catheter OD, catheter ID, | Device met established<br>dimensional and physical |
| Bench Testing<br>Test | Results | Conclusions |
| overall working length, length of distal<br>section, length of distal tip to marker band and<br>total length of hub/strain relief | specifications and is<br>substantially equivalent to the<br>predicate device | |
| Kink Resistance | No kinks when wrapped around 0.030 and<br>0.040-inch pin gauges<br>No kinks noted during simulated use testing | Device resistant to kinking<br>around small radii turns<br>Same as predicate device |
| Durability/Lubricity of<br>Hydrophilic Coating | Test article achieved a rating of $\ge$ 3 during<br>simulated use testing for coating durability<br>and lubricity. | Device tracks easily with no<br>coating cracking or separation |
| Catheter Stiffness | Device stiffness equivalent to predicate and<br>competitive devices | Device tracks in tortuous<br>anatomy while advancing to<br>target site |
| Catheter Flexural Fatigue | No flexural fatigue following repeated<br>bending during simulated use testing and<br>repeated hoop stress following pressure and<br>air aspiration testing | Device integrity suitable for<br>intended clinical use |
| Force at Break (Shaft and hub) | Catheter force at break $\ge$ 15N for shaft section<br>and hub/catheter junction | Tensile strength test results<br>meet acceptance criteria and<br>equivalent to predicate and<br>competitive devices |
| Force at Break (After tip<br>shaping) | Catheter force at break $\ge$ 15N for distal<br>section assessed pre- and post-tip shaping | Device meets acceptance<br>criteria and no difference<br>between pre- and post- force<br>at break |
| Static Burst Pressure | No damage of pressurized catheter at 46 psi | Device integrity suitable for<br>intended clinical use and met<br>requirements of ISO 10555-1 |
| Fluid Leakage at > 46 psi | No liquid leakage from hub and catheter shaft<br>at 46 psi for 30 seconds | Device integrity suitable for<br>intended clinical use and met<br>requirements of ISO 10555-1 |
| Air Leakage | No air leakage at hub into syringe for 15<br>seconds | Device integrity suitable for<br>intended clinical use and met<br>requirements of ISO 10555-1 |
| Dynamic Burst | Test articles did not burst at or below 300 psi | Device met labeled maximum<br>infusion pressure of 300 psi |
| Catheter Collapse | Test articles were pressurized for a duration of<br>6 minutes and no observation of catheter<br>collapse | No observation of device<br>collapse, equivalent to<br>predicate device |
| Vacuum Pressure | Vacuum pressure testing of catheter at distal<br>tip was compared to vacuum pressure of<br>source. No difference detected. | No difference was measured<br>between device and predicate |
| Torque Response | Catheter torque response was assessed in<br>vascular model and met acceptance criteria. | Equivalent or better than<br>predicate |
| Torque Strength | Catheter was torqued and did not break | Met acceptance criteria |
| Advance/Retract | Catheter was subjected to advance/retraction<br>test in a vascular model and was equivalent or<br>better than predicate | Met acceptance criteria |
| Radiopacity | Marker band was detectable under<br>fluoroscopy | Marker band is visible under<br>fluoroscopy |
| Corrosion Resistance | Met ISO 10555-1 | Catheter is corrosion resistant |
| Particulate Testing | Met USP <788> criteria | Catheter does not generate<br>particulate |

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## Animal Study:

The SOFIA Plus Aspiration Catheter was evaluated in a comparative animal study that was conducted to evaluate its aspiration performance and its safe use in a swine model. Histopathological evaluations of the affected vasculature using the device were also performed as part of the study.

#### Summary of Clinical Data:

Not applicable

#### Summary of Substantial Equivalence

The data presented in this submission demonstrate the technological similarity and performance equivalency of the SOFIA Plus Aspiration Catheter when compared with the predicate device, the Penumbra Reperfusion Catheter ACE 64 and ACE 68 (K152541).

The devices:

- . Have the same intended use and indications for use,
- Have the same mode of action,
- Use the same operating principle, ●
- Incorporate the same basic design, materials, dimensional and physical characteristics, and
- Are packaged and sterilized using same methods, with similar shelf-life. .

In summary, the SOFIA Plus Aspiration Catheter described in this substantially equivalent to its predicate device, Penumbra Reperfusion Catheter ACE 64 and ACE 68 (K152541).