SOFIA DISTAL ACCESS CATHETER

K131482 · MicroVention, Inc. · DQY · Nov 22, 2013 · Cardiovascular

Device Facts

• Record ID: K131482
• Device Name: SOFIA DISTAL ACCESS CATHETER
• Applicant: MicroVention, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The SOFIA Distal Access Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate the introduction of diagnostic and therapeutic agents. It is not intended for use in coronary arteries.

Device Story

SOFIA Distal Access Catheter is a single-lumen, flexible catheter with coil and braid reinforcement; features steam-shapeable distal segment and hydrophilic coating for navigation. Radiopaque platinum/iridium marker at distal end allows fluoroscopic visualization. Provided with introducer sheath and shaping mandrel. Used by physicians in clinical settings to facilitate introduction of diagnostic/therapeutic devices into neuro and peripheral vasculature. Device tracks through tortuous anatomy; provides access for delivery of agents. Benefits include improved navigation and access to target sites in neuro/peripheral vasculature.

Clinical Evidence

Bench testing only. Testing included simulated use, dimensional/physical attributes, kink resistance, tip shapeability, radiopacity, hub performance (ISO 594-2), coating durability/lubricity, torque strength, flexural fatigue, flow rate, burst pressure, and particulate testing. Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-irritant, non-hemolytic, non-pyrogenic, and no systemic toxicity.

Technological Characteristics

Single-lumen catheter; outer layer polyurethane elastomer (Polyblend/Pellethane), Pebax, polyamide; inner layer stainless steel braid/coil, PTFE, polyolefin elastomer. Platinum/iridium marker. Hydrophilic coating. Steam-shapeable distal tip. Sterilized via Ethylene Oxide. Compatible with 0.035-inch/0.038-inch guidewires. Meets ISO 594-2 for hub/luer and ISO 10555-1 for pressure/leakage.

Indications for Use

Indicated for general intravascular use in neuro and peripheral vasculature to facilitate introduction of diagnostic and therapeutic agents. Contraindicated for use in coronary arteries.

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

• Chaperon Guiding Catheter (K082385)
• Headway Duo Microcatheter (K120917)

Submission Summary (Full Text)

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# V131482

| 510(k) Summary | |
|-------------------|----------------------------------------------------------------------------|
| Trade Name: | SOFIA™ Distal Access Catheter |
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 (DQY), 21 CFR 870.1200 (DQO) |
| Submitted By: | MicroVention, Inc<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Contact: | Naomi Gong |
| Date: | 2013 November 13 |
| Predicate Device: | Chaperon Guiding Catheter (K082385)<br>Headway Duo Microcatheter (K120917) |

## Device Description:

The SOFIA Distal Access Catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.

### Indications For Use:

The SOFIA Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic devices. It is not intended for use in coronary arteries.

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# Technological Comparison:

| | Chaperon Guiding<br>Catheter | SOFIA Distal Access<br>Catheter | Headway Duo<br>Microcatheter | | Chaperon Guiding<br>Catheter | SOFIA Distal Access<br>Catheter | Headway Duo<br>Microcatheter |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------------------------------------|----------------------------------------|-----------------------------------------|
| Intended Use | Intended for general<br>intravascular use, including<br>the neuro and peripheral<br>vasculature. It can be used<br>to facilitate the introduction<br>of diagnostic and<br>therapeutic agents. It is not<br>intended for use in coronary<br>arteries. | Intended for general<br>intravascular use, including<br>the neuro and peripheral<br>vasculature. It can be used<br>to facilitate the introduction<br>of diagnostic and<br>therapeutic agents. It is not<br>intended for use in coronary<br>arteries. | Intended for general<br>intravascular use, including<br>the peripheral and coronary<br>vasculature for the infusion<br>of diagnostic agents, such<br>as contrast media, and<br>therapeutic agents, such as<br>embolization materials.<br>Intended for neurovascular<br>use for the infusion of<br>diagnostic agents, such as<br>contrast media, and<br>therapeutic agents that have<br>been cleared or approved<br>for use in the<br>neurovasculature and are<br>compatible with the inner<br>diameter of the<br>microcatheter. | Catheter size | 5 F (outer catheter) | રે દ | 1.6 - 2.1 F. |
| Material<br>Catheter Body | Outer layer of polyester<br>elastomer; stainless steel<br>braid; inner layer of PTFE<br>(polytetrafluoroehthylene). | Outer layer of polyurethane<br>elastomer (Polyblend and<br>Pellethane), polyether block<br>amide (Pebax) and<br>polyamide (Grilamid); inner<br>layer of stainless steel<br>braid/coil, PTFE and<br>polyolefin elastomer | Outer layer of polyether<br>block amide (Pebax) and<br>polyamide (Grilamid); inner<br>layer of stainless steel<br>braid/coil and PTFE | ID | 0.059 inch (1.5 mm) | 0.055 inch (1.4 mm) | 0.0165 inch (0.42 mm) |
| Marker | Tungsten | Platinum/Iridium | Platinum/Iridium | OD | 0.068 inch (1.7 mm) | 0.068 inch (1.7 mm) | 0.023 - 0.0275 inch<br>(0.58 - 0.70 mm) |
| Hub | Nylon | Nylon | Nylon | Effective Length | 95 cm (outer)<br>117 cm (inner) | 125 cm | 157 and 168 cm |
| Strain Relief | Polyester elastomer | Polyurethane | Pebax | Coating | Hydrophilic coating (Terumo<br>proprietary coating) | Hydrophilic coating<br>(Hydak® - same) | Hydrophilic coating<br>(Hydak® - same) |
| Introducer | Not applicable | Pebax | Pebax | Tip Configuration | Preshaped | Steam shapeable by user | Steam shapeable by user |
| Shaping Mandrel | Not applicable | Stainless steel | Stainless steel | Guidewire<br>Compatibility | 0.035 inch or 0.038 inch | 0.035 inch or 0.038 inch | 0.014 inch or smaller |
| Accessories | N/A | Introducer sheath and<br>shaping mandre! | Introducer sheath and<br>shaping mandrel . | | | | |
| Method of Supply | Sterile and single use | Sterile and single use | Sterile and single use | | | | |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | | | |
| Packaging<br>Configuration | Catheter placed on<br>packaging card that is<br>inserted into Tyvek® pouch.<br>Pouch and IFU placed in<br>bleached sulfate carton box. | Catheter placed into a HDPE<br>dispenser tube. Dispenser<br>tube, introducer and shaping<br>mandrel placed on a<br>polyethylene packaging card<br>that is inserted into a Tyvek®<br>pouch. Pouch and IFU<br>placed in bleached sulfate<br>carton box. | Catheter placed into a<br>polyethylene dispenser hoop.<br>Introducer and shaping '<br>mandrel placed on<br>polyethylene packaging card.<br>Dispenser hoop and<br>packaging card inserted into<br>Tyvek® pouch. Pouch and<br>IFU placed in bleached<br>sulfate carton box. | | | | |

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# Verification and Test Summary:

| Bench Testing | | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Test | Results | Conclusions |
| Simulated Use | Test articles achieved a rating $\ge$ 3<br>for preparation/ease of assembly,<br>introducer sheath interaction,<br>introducer peel away, tracking<br>with guidewire/microcatheter,<br>microcatheter/guidewire lockup,<br>lubricity and durability of<br>hydrophilic coating, microcatheter/<br>guidewire removal, removal/<br>aspiration of clot, mechanical clot<br>retriever and stent delivery with no<br>particles | Device performs as intended<br>under simulated use conditions |
| Equipment Interface | Test articles compatible with<br>0.035-inch and 0.038-inch<br>guidewires, 6F or larger guide<br>catheter/guiding sheath, common<br>RHVs using insertion tool,<br>stopcocks and $\le$ 0.027-inch<br>microcatheters | Device compatible with<br>recommended accessories<br>commonly used in intravascular<br>procedures |
| Dimensional and Physical Attributes | Test articles met the specified<br>dimensional requirements for<br>catheter OD, catheter ID, overall<br>working length, length of distal<br>section, length of distal tip to<br>marker band and total length of<br>hub/strain relief | Device met established<br>dimensional and physical<br>specifications |
| Kink Resistance | No kinks at 1 cm, 4 cm, 12 cm and<br>25 cm from distal tip when<br>wrapped around 0.025-inch and<br>0.030-inch pin gauges<br>No kinks noted during simulated<br>use testing | Device resistant to kinking<br>around small radii turns |
| Tip Shapeability | Tip angle of test article equivalent<br>to competitive devices after steam<br>shaping using mandrel with an<br>angle of approximately 90° | Shapeability of distal tip after<br>steam shaping equivalent to<br>competitive devices |
| Radio Detectability | Distal marker band visible under<br>fluoroscopy | Device radiopacity equivalent to<br>or better than predicate and<br>competitive devices |
| Bench Testing | | |
| Test | Results | Conclusions |
| Gauging (ISO 594-2) | Gauging pin and hub align in limit<br>planes | Device hub meets the<br>requirements of ISO 594-2 |
| Separation Force (ISO 594-2) | Mating parts separation force<br>greater than 25 N | Device hub meets the<br>requirements of ISO 594-2 |
| Unscrewing Torque (ISO 594-2) | Test article luer remains attached<br>after applying an unscrewing torque<br>not less than 0.02 Nm for a<br>minimum of 10 seconds | Device hub meets the<br>requirements of ISO 594-2 |
| Stress Cracking (ISO 594-2) | No stress cracks on test article hub | Device hub meets the<br>requirements of ISO 594-2 |
| Ease of Assembly (ISO 594-2) | Components fit together securely<br>with no resistance observed between<br>test article luer and reference fitting | Device hub meets the<br>requirements of ISO 594-2 |
| Resistance to Overriding (ISO 594-2) | Test article luer does not override<br>reference fitting threads | Device hub meets the<br>requirements of ISO 594-2 |
| Durability/Lubricity of Hydrophilic<br>Coating | Test article achieved a rating of ≥ 3<br>during simulated use testing for<br>coating durability and lubricity. | Device tracks easily with no<br>coating cracking or separation |
| Catheter Stiffness | Device stiffness equivalent to<br>predicate and competitive devices | Device tracks in tortuous<br>anatomy while advancing to<br>target site |
| Torque Strength | No catheter breakage after 50<br>rotations | Device torque strength same<br>as predicate device |
| Catheter Flexural Fatigue | No flexural fatigue following<br>repeated bending during simulated<br>use testing and repeated hoop stress<br>following pressure and air aspiration<br>testing | Device integrity suitable for<br>intended clinical use |
| Surface Contamination | Test article free from surface<br>contaminants from uncured coating<br>surface particulates > 0.02 mm², embedded particulates | Device integrity suitable for<br>intended clinical use |
| | Distal tip smooth and tapered<br>PTFE inner layer not delaminated | |
| Force at Break (Distal and Hub) | Catheter force at break ≥2.251bf for<br>distal section and hub/catheter<br>junction | Tensile strength test results<br>equivalent to predicate and<br>competitive devices |
| Bench Testing | | |
| Test | Results | Conclusions |
| Flow Rate | Flow rate at 100 psi and 300 psi<br>with diagnostic agents (e.g., saline,<br>contrast media) equivalent to or<br>better than competitive devices | Device meets specified<br>requirements for delivery of<br>diagnostic agents |
| Static Burst Pressure | No damage of pressurized catheter<br>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<br>catheter shaft at 46 psi for 30<br>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<br>for 15 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<br>below 300 psi | Device met labeled maximum<br>infusion pressure of 300 psi |
| Particulate Test | Less than 25 particles greater than<br>10 microns per ml volume and less<br>than 3 particles less than 25 microns<br>per ml volume<br><br>No particles greater than 70 microns | Device met specifications for<br>maximum allowable particles |

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| Biocompatibility | | | |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|--|
| Test | Results | Conclusions | |
| Cytotoxicity - MEM Elution Assay<br>(ISO 10993-5) | Cell culture treated with test article<br>exhibited slight reactivity (Grade 1) | Non-cytotoxic | |
| Sensitization/Irritation - Kligman<br>Maximization Test (ISO 10993-10) | Extracts of the test article elicited no<br>reaction at the challenge (0%<br>sensitization) following the<br>induction phase (Grade 1). | Weak allergic potential or<br>sensitizing capacity | |
| Sensitization/Irritation -<br>Intracutaneous Injection Test (ISO<br>10993-10) | Extracts of the test article did not<br>show a significantly greater<br>biological reaction than the sites<br>injected with the control article | Non-irritant | |
| Hemocompatibility - Rabbit Blood<br>Direct and Indirect Contact (ISO<br>10993-4) | The hemolysis index was 0.13%<br>(direct contact) and 0.0% (indirect<br>contact) | Non-hemolytic | |

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| Biocompatibility | | | |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|--|
| Test | Results | Conclusions | |
| Hemocompatibility - Unactivated<br>Partial Thromboplastin Time Assay<br>Direct Contact (ISO 10993-4) | No statistically significant<br>difference found between the<br>Unactivated Partial Thromboplastin<br>Time (UPTT) of the plasma exposed<br>to the test article and that of the<br>plasma exposed to either the<br>negative control or the untreated<br>control | No effect on coagulation | |
| Hemocompatibility - Complement<br>Activation Assay (ISO 10993-4) | C3a and SC5b-9 levels $ \u2264 $ negative<br>and untreated controls | No effect on complement<br>activation | |
| Hemocompatibility -<br>Thrombogenicity Study in Dogs (ISO<br>10993-4) | Minimal thrombosis observed with<br>a Grade 0 in two out of two test sites<br>and two out of two control sites | No significant thrombosis | |
| Systemic Toxicity - Systemic<br>Injection Test<br>(ISO 10993-11) | Extracts of test article did not<br>induce a significantly greater<br>biological reaction than the control<br>extracts when injected in Swiss<br>Albino mice | No toxic effects | |
| Systemic Toxicity - Rabbit Pyrogen<br>Test (ISO 10993-11) | The temperature increases<br>(maximum) was 0.03°C from<br>baseline | Non-pyrogenic | |

### Summary of Substantial Equivalence:

The data presented in this submission demonstrates the technological similarity and equivalency of the SOFIA Distal Access Catheter when compared with the predicate Chaperon Guiding Catheter (K082385) and the HEADWAY DUO Microcatheter (K120917) devices. The devices:

- Have an equivalent intended use, "
- 트 Use the same operating principle,
- . Incorporate the same basic design,
- . Are packaged and sterilized using the same methods.

In summary, the SOFIA Distal Access Catheter described in this substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of a bird.

#### Public Health Service

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

#### November 22, 2013

Micro Vention. Inc. c/o Ms. Naomi Gong Sr. Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

Re: K131482

Trade/Device Name: SOFIA Distal Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY, DQO Dated: October 22, 2013 Received: October 23, 2013

#### Dear Ms. 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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Naomi Gong

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang-S

for Victor Krauthamer, Ph.D. Acting 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): K131482

Device Name: SOFIA Distal Access Catheter

Indications For Use:

The SOFIA Distal Access Catheter is intended for general intravascular use, including The GOT IA Dicture al vasculature. It can be used to facilitate the introduction of the nours and therapeutic agents. It is not intended for use in coronary arteries.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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