React 71 Catheter

K182097 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · DQY · Nov 14, 2018 · Cardiovascular

Device Facts

• Record ID: K182097
• Device Name: React 71 Catheter
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

React™ 71 Catheter is a single-lumen, flexible, variable-stiffness composite catheter; nitinol-reinforced structure; jacketed with polymer layers; PTFE and Engage™ inner liner; platinum-iridium radiopaque marker band; Surmodics Serene™ hydrophilic coating. Used in peripheral and neurovascular procedures; introduced via Split-Y Introducer Sheath. Operated by physicians under fluoroscopic guidance. Device acts as a conduit for interventional devices; facilitates navigation through vasculature. Benefits include improved maneuverability and flexibility for device delivery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), mechanical performance (tensile strength, kink resistance, torque, pressure, lubricity), and sterilization validation.

Technological Characteristics

Single-lumen composite catheter; nitinol reinforcement; PTFE/Polyolefin inner layer; Polyamide/Polyurethane/Polyolefin outer jacket; platinum-iridium marker band; Surmodics Serene™ hydrophilic coating. Dimensions: 0.071" ID, 0.0855" max OD. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993-1, ISO 10993-7, ISO 11737-1, ISO 10555-1, ISO 594-1, ISO 80369-7, ASTM F1886, ASTM F2096, ASTM F88, USP <788>, USP <161>.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

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

• AXS Catalyst™ Distal Access Catheter (K151667)
• ReFlex™ Guide Catheter (K110055)
• React™ 68 Catheter (K180715)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 14, 2018

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K182097

Trade/Device Name: React™ 71 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 12, 2018 Received: October 15, 2018

Dear Ryan Kenney:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 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) K182097

Device Name React™ 71 Catheter

Indications for Use (Describe)

The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro 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)

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## 510(k) Summary: K182097

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration No.: 2029214 | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Ryan Kenney<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>Email: [e-mail] | |
| Date Summary Prepared: | October 12, 2018 | |
| Trade Name of Device: | React™ 71 Catheter | |
| Common Name of Device: | Percutaneous Catheter | |
| Review Panel: | Neurology | |
| Product Code: | DQY | |
| Regulation Number: | 21 CFR 870.1250 | |
| Regulation Name: | Percutaneous Catheter | |
| Device Classification: | Class II | |
| Primary Predicate Device: | AXS Catalyst™ Distal Access Catheter<br>510(k)#: K151667 | |
| Additional Predicate Devices: | ReFlex™ Guide Catheter<br>510(k)#: K110055<br>React™ 68 Catheter<br>510(k)#: K180715 | |

## Device Description:

The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.

## Indications for Use:

The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

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| Device Comparison: | | | | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| | AXS Catalyst™ Distal<br>Access Catheter<br>(K151667) | ReFlex™ Guide<br>Catheter<br>(K110055) | React™ 68 Catheter<br>(K180715) | React™ 71 Catheter<br>(K182097) |
| Indication for Use<br>(IFU) Statement | The AXS Catalyst™<br>Distal Access Catheter<br>is indicated for the<br>insertion and guidance<br>of appropriately sized<br>interventional devices<br>into a selected blood<br>vessel in the<br>peripheral and<br>neurovascular<br>systems. The AXS<br>Catalyst™ Distal<br>Access Catheter is<br>also indicated for use<br>as a conduit for<br>retrieval devices. | The ReFlex™ Guide<br>Catheter is indicated<br>for the introduction<br>of interventional<br>devices into the<br>peripheral and neuro<br>vasculature. | The React™ 68<br>Catheter is indicated<br>for the introduction<br>of interventional<br>devices into the<br>peripheral and neuro<br>vasculature. | The React™ 71<br>Catheter is indicated<br>for the introduction<br>of interventional<br>devices into the<br>peripheral and neuro<br>vasculature. |
| Materials | | | | |
| Hub | Nylon | Trogamid® | Same as K110055 | Same as K110055 |
| Strain Relief | Thermoplastic Rubber | Santoprene™ | DynaFlex® | Same as K182097 |
| Inner Layer | PTFE | Same as K151667 | Same as K151667 | PTFE,<br>Polyolefin |
| Reinforcement | Stainless Steel with<br>Nitinol and Polymer<br>Fiber | Nitinol | Same as K110055 | Same as K110055 |
| Outer Jacket | Pebax® | Polymeric | Grilamid™<br>Pebax® | Polyamide,<br>Polyolefin,<br>Polyurethane |
| Marker Band | Platinum/<br>Iridium | Same | Same | Same |
| | AXS Catalyst™ Distal<br>Access Catheter<br>(K151667) | ReFlex™ Guide<br>Catheter<br>(K110055) | React™ 68 Catheter<br>(K180715) | React™ 71 Catheter<br>(K182097) |
| Adhesive | Cyanoacrylate | Same | Same | Same |
| Coating | Hydrophilic | Same | Same | Same |
| Dimensions | | | | |
| Working Length | 132 cm | 130 cm | Same as K151667 | Same as K151667 |
| Inner Diameter | 0.060" | 0.072" | 0.068" | 0.071" |
| Proximal Outer<br>Diameter (OD) | 0.079" | 0.084" | 0.083" | 0.0855" (Max) |
| Distal OD | 0.071" | 0.084" | 0.083" | 0.0855" (Max) |
| Packaged Accessories | | | | |
| Peelable Sheath | Yes | Same | Same | Same |
| Rotating Hemostasis<br>Valve | Yes | No | Same as K110055 | Same as K110055 |
| Packaging | | | | |
| Packaging Card | Polyethylene | Same | Same | Same |
| Packaging Hoop | Polyethylene | Same | Same | Same |
| Other | | | | |
| Sterilization | Ethylene Oxide (EO) | Same | Same | Same |

#### Device Comparison:

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## Biocompatibility:

Biocompatibility was conducted for the React™ 71 Catheter. The React™ 71 Catheter is categorized as a limited exposure (< 24 hours), external communicating device contacting circulating blood. The following biocompatibility was conducted for the React™ 71 Catheter:

| Test Description | Results | Conclusions |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Cytotoxicity<br>(Elution Method) | The test article extract showed<br>no evidence of causing cell<br>lysis or toxicity and had a<br>Grade 0 (No Reactivity). The<br>test article extract met the<br>requirements of the test since<br>the grade was < Grade 2<br>(Mild Reactivity). | The ReactTM 71 Catheter is<br>considered non-cytotoxic. |
| Sensitization<br>(Guinea Pig Maximization Test) | The test article extracts<br>showed no evidence of<br>causing delayed dermal<br>contact sensitization in the<br>guinea pig. | The ReactTM 71 Catheter does<br>not elicit a sensitization<br>response. |
| Irritation<br>(Intracutaneous Reactivity) | The test article met the<br>requirements of the test since<br>the difference between each<br>test article extract overall<br>mean score and corresponding<br>control extract overall mean<br>score was 0.0 and 0.2 for the<br>Sodium Chloride and Sesame<br>Oil test article extracts,<br>respectively. | The ReactTM 71 Catheter is<br>considered a non-irritant. |
| Acute Systemic Toxicity<br>(Systemic Toxicity) | There was no mortality or<br>evidence of systemic toxicity<br>from the extracts injected into<br>mice. | The ReactTM 71 Catheter does<br>not indicate signs of toxicity. |

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| Test Description | Results | Conclusions |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Hemocompatibility<br>(Hemolysis) | The hemolytic index for the<br>test article in direct contact<br>with blood was 0.8%, and the<br>hemolytic index for the test<br>article extract was 0.0%. | The ReactTM 71 Catheter is<br>considered non-hemolytic. |
| Hemocompatibility<br>(Complement Activation) | The concentration of SC5b-9<br>in the test article was not<br>statistically higher than the<br>activated normal human serum<br>control or the negative control.<br>The test article was<br>statistically lower than the<br>sponsor provided control<br>article. | The ReactTM 71 Catheter is not<br>considered to be potential<br>activator of the complement<br>system. |
| Hemocompatibility<br>(Thrombogenicity – Canine<br>Model) | The control article was<br>evaluated and determined to<br>have a mean score of 2.0. The<br>test article was evaluated and<br>determined to have a mean<br>score of 1.7 after four (4)<br>hours (±30 minutes) without<br>systemic anticoagulation. | The ReactTM 71 Catheter<br>demonstrates lower<br>thrombogenic potential in<br>arterial vessels compared to<br>the ACE 68 Reperfusion<br>Catheter. |
| Pyrogenicity<br>(Material Mediated) | Not a single animal showed a<br>temperature rise of 0.5°C or<br>more above its baseline<br>temperature. The total rise of<br>the rabbits' temperature during<br>the three (3) hours was 0.0°C. | The ReactTM 71 Catheter is<br>considered non-pyrogenic. |

The React™ 71 Catheter has been evaluated to meet requirements specified in ISO 10993-1.

## Performance Data – Bench:

Non-clinical bench testing was leveraged and conducted to evaluate the performance of the React™ 71 Catheter.

The following non-clinical bench testing was leveraged for the React™ 71 Catheter:

| Test | Test Method Summary | Results |
|--------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------|
| Microbial | | |
| Ethylene Oxide Residual | The React™ 71 Catheter was evaluated per ISO 10993-7. | The React™ 71 Catheter met the acceptance criteria for ethylene oxide residual. |
| Ethylene Chlorohydrin Residual | The React™ 71 Catheter was evaluated per ISO 10993-7. | The React™ 71 Catheter met the acceptance criteria for ethylene chlorohydrin residual. |

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| Test | Test Method Summary | Results |
|---------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Bioburden Recovery | The React™ 71 Catheter was evaluated per ISO 11737-1. | The React™ 71 Catheter met the acceptance criteria for bioburden recovery. |
| Bacterial Endotoxin | The React™ 71 Catheter was evaluated per ANSI/AAMI ST72 and USP <161>. | The React™ 71 Catheter met the acceptance criteria for bacterial endotoxin. |
| Packaging | | |
| Visual Inspection | The React™ 71 Catheter was evaluated per ASTM F1886. | The React™ 71 Catheter met the acceptance criteria for visual inspection. |
| Bubble Leak | The React™ 71 Catheter was evaluated per ASTM F2096. | The React™ 71 Catheter met the acceptance criteria for bubble leak. |
| Seal Strength | The React™ 71 Catheter was evaluated per ASTM F88. | The React™ 71 Catheter met the acceptance criteria for seal strength. |

The following non-clinical bench testing was conducted for the React™ 71 Catheter:

| Test | Test Method Summary | Results |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| <i>Microbial</i><br>Bioburden | The ReactTM 71 Catheter was<br>evaluated per ISO 11737-1. | The ReactTM 71 Catheter met<br>the acceptance criteria for<br>bioburden. |
| <i>Performance</i><br>Visual Inspection | The ReactTM 71 Catheter was<br>inspected under x2.5<br>magnification. | The ReactTM 71 Catheter met<br>the acceptance criteria for<br>visual inspection. |
| Dimensional Measurements | The proximal ID, distal ID,<br>proximal OD, distal OD, usable<br>length, total length, coating<br>length, and distal tip length of<br>the ReactTM 71 Catheter were<br>measured. | The ReactTM 71 Catheter met<br>the acceptance criteria for<br>dimensional measurements. |
| Tip Buckling | The ReactTM 71 Catheter was<br>evaluated for the maximum<br>compressive force it can<br>withstand. | The ReactTM 71 Catheter met<br>the acceptance criteria for tip<br>buckling. |
| Kink Resistance | The ReactTM 71 Catheter was<br>evaluated for the maximum<br>kink diameter. | The ReactTM 71 Catheter met<br>the acceptance criteria for kink<br>resistance. |
| Particulate | The ReactTM 71 Catheter was<br>evaluated per USP <788>. | The ReactTM 71 Catheter met<br>the acceptance criteria for<br>particulate. |
| Test | Test Method Summary | Results |
| Coating Lubricity | The React™ 71 Catheter was evaluated for the average frictional forces. | The React™ 71 Catheter met the acceptance criteria for coating lubricity. |
| Tensile Strength | The React™ 71 Catheter was evaluated per ISO 10555-1. Annex B. | The React™ 71 Catheter met the acceptance criteria for tensile strength at the hub and shaft. |
| Liquid Leak | The React™ 71 Catheter was evaluated per ISO 10555-1. Annex C. | The React™ 71 Catheter met the acceptance criteria for liquid leak. |
| Corrosion Resistance | The React™ 71 Catheter was evaluated per ISO 10555-1. Annex A. | The React™ 71 Catheter met the acceptance criteria for corrosion resistance. |
| Hub Aspiration Resistance | The React™ 71 Catheter was evaluated per ISO 10555-1. Annex D. | The React™ 71 Catheter met the acceptance criteria for hub air aspiration. |
| Radiopacity | The markerband length and wall thickness of the React™ 71 Catheter were measured. In addition, radiopacity was confirmed via fluoroscopy. | The React™ 71 Catheter met the acceptance criteria for radiopacity. |
| Luer Standards | The React™ 71 Catheter was evaluated per ISO 594-1 and ISO 80369-7. | The React™ 71 Catheter met the acceptance criteria for luer standards. |
| Compatibility | The React™ 71 Catheter was inspected for visual damage of the catheter when delivering and retrieving interventional devices. | The React™ 71 Catheter met the acceptance criteria for delivering and retrieving interventional devices. |
| Torque to Failure | The React™ 71 Catheter was evaluated for transmission of proximal torque to the distal tip. | The React™ 71 Catheter was able to withstand torsional forces that are typical of clinical use. |
| Dynamic Pressure | The React™ 71 Catheter was evaluated for the amount of pressure it can withstand. | The React™ 71 Catheter was able to withstand pressures that are typical of clinical use. |
| Coating Integrity | The React™ 71 Catheter was evaluated for coating coverage and lubricity. | The React™ 71 Catheter remained coated and lubricious. |
| Usability | The React™ 71 Catheter and predicate device were evaluated for maneuverability and flexibility. | The React™ 71 Catheter met the acceptance criteria for usability. |

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## Performance Data - Animal:

Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.

## Performance Data - Clinical:

Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.

## Conclusion:

The design modifications incorporated do not alter the intended use or fundamental scientific technology.

Non-clinical bench testing supports a determination that the subject React™ 71 Catheter is substantially equivalent to the predicate device.