React 68 Catheter

K180715 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · DQY · Jul 4, 2018 · Cardiovascular

Device Facts

• Record ID: K180715
• Device Name: React 68 Catheter
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Device Story

The React 68 Catheter is a single-lumen, variable-stiffness, percutaneous catheter designed for navigating peripheral and neurovascular anatomy. It features a nitinol-reinforced structure, a PTFE liner, and a hydrophilic coating to facilitate tracking. A radiopaque platinum-iridium markerband at the distal tip allows for fluoroscopic visualization. The device is introduced into the vasculature via a split y-introducer sheath. It is operated by a physician in a clinical setting (e.g., interventional suite) to serve as a conduit for delivering interventional devices. The catheter's design balances proximal stiffness for pushability with distal flexibility for navigation. By providing a stable pathway, it enables the delivery of therapeutic devices to target sites, potentially improving procedural outcomes in neurovascular and peripheral interventions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), mechanical performance (ISO 10555-1), and sterility/pyrogenicity testing (ISO 11737-1, ANSI/AAMI ST72).

Technological Characteristics

Single-lumen, variable-stiffness composite catheter. Materials: Nitinol reinforcement, PTFE inner liner, Grilamid/Pebax outer jacket, platinum-iridium markerband, DynaFlex strain relief. Hydrophilic coating. Dimensions: 0.068" ID. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993-1 (biocompatibility), ISO 10555-1 (catheter performance), ISO 594-1/ISO 80369-7 (luer standards), USP <788> (particulates).

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)

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.

July 4, 2018

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

Re: K180715

Trade/Device Name: React 68 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 4, 2018 Received: June 6, 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,

Image /page/1/Picture/6 description: The image shows the name "Xiaolin Zheng" in a large, bold font, followed by a hyphen. Below the name, there is a large, stylized FDA logo in a light gray color. To the left of the logo, there is a large letter "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) K180715

Device Name React 68 Catheter

Indications for Use (Describe)

The React™ 68 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: K180715

| 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<br>Prepared: | June 25, 2018 |
| Trade Name of<br>Device: | React™ 68 Catheter |
| Common Name of<br>Device: | Percutaneous Catheter |
| Review Panel: | Neurology |
| Product Code: | DQY |
| Regulation Number: | 21 CFR 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Predicate Device(s): | AXS Catalyst™ Distal Access Catheter<br>510(k)#: K151667<br>ReFlex™ Guide Catheter<br>510(k)#: K110055 |

### Device Description:

The React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath. The proximal end of the React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The React™ 68 Catheter is designed with a hydrophilic coating.

### Indications for Use:

The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

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| | AXS Catalyst™ Distal<br>Access Catheter<br>(K151667) | ReFlex™ Guide<br>Catheter<br>(K110055) | React™ 68 Catheter |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 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 peripheral<br>and neurovascular<br>systems. The AXS<br>Catalyst™ Distal<br>Access Catheter is also<br>indicated for use as a<br>conduit for retrieval<br>devices. | The ReFlex™ Guide<br>Catheter is indicated<br>for the introduction of<br>interventional devices<br>into the peripheral and<br>neuro vasculature. | Same as K110055 |
| Materials | | | |
| Hub | Nylon | Trogamid® | Same as K110055 |
| Strain Relief | Thermoplastic Rubber | Santoprene | DynaFlex® |
| Inner Layer | PTFE | Same | Same |
| Reinforcement | Stainless Steel with<br>Nitinol and Polymer<br>Fiber | Nitinol | Same as K110055 |
| Outer Jacket | Pebax® | Polymeric | Grilamid™<br>Pebax® |
| Markerband | Platinum/<br>Iridium | Same | Same |
| Adhesive | Cyanoacrylate | Same | Same |
| Coating | Hydrophilic | Same | Same |
| Dimensions | | | |
| Working Length | 132 cm | 130 cm | Same as K151667 |
| Inner Diameter (ID) | 0.060" | 0.072" | 0.068" |
| Proximal Outer<br>Diameter (OD) | 0.079" | 0.084" | 0.083" |
| Distal Outer<br>Diameter (OD) | 0.071" | 0.084" | 0.083" |
| Packaged Accessories | | | |
| Peelable Sheath | Yes | Same | Same |
| Rotating Hemostasis<br>Valve | Yes | No | Same as K110055 |
| Packaging | | | |
| Packaging Card | Polyethylene | Same | Same |
| Packaging Hoop | Polyethylene | Same | Same |
| | AXS Catalyst™ Distal<br>Access Catheter<br>(K151667) | ReFlex™ Guide<br>Catheter<br>(K110055) | React™ 68 Catheter |
| Other | | | |
| Sterilization | Ethylene Oxide (EO) | Same | Same |

# Device Comparison:

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Biocompatibility:

Biocompatibility was conducted for the React™ 68 Catheter. The React™ 68 Catheter is categorized as a limited exposure (< 24 hours), external communicating device contacting circulating blood. The following biocompatibility was conducted for the React™ 68 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 of zero (no reactivity).<br>The test article extract met the<br>requirements of the test since<br>the grade was less than a grade<br>two (mild reactivity). | The ReactTM 68 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 68 Catheter does<br>not elicit a sensitization<br>response. |
| Irritation<br>(Intracutaneous Reactivity) | 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 0.0 for the<br>sodium chloride and sesame<br>oil test article extracts,<br>respectively. | The ReactTM 68 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. All<br>animals were clinically normal<br>throughout the study. | The ReactTM 68 Catheter does<br>not indicate signs of toxicity. |
| Hemocompatibility<br>(Hemolysis) | The hemolytic index for the<br>test article in direct contact<br>with blood was 0.9%, and the<br>hemolytic index for the test<br>article extract was 0.0%. | The ReactTM 68 Catheter is<br>considered non-hemolytic. |
| Hemocompatibility<br>(Complement Activation) | The concentration of SC5b-9<br>in the sponsor provided<br>control sample was not | The control and test article<br>samples are not considered to |

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| Test Description | Results | Conclusions |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| | statistically higher than the<br>activated normal human serum<br>control or the negative control. | be potential activators of the<br>complement system. |
| | The concentration of SC5b-9<br>in the test article sample was<br>not statistically higher than the<br>activated normal human serum<br>control, the negative control or<br>the sponsor provided control. | |
| Hemocompatibility<br>(Thrombogenicity) | The thrombogenic potential of<br>the control article was<br>evaluated in comparison to the<br>test article. Both the control<br>and test articles were<br>determined to have minimal<br>thrombus formation after four<br>(4) hours (±30 minutes)<br>without anticoagulation. | The React™ 68 Catheter<br>demonstrates minimal<br>thrombus formation. |
| 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 temperature during three<br>(3) hours was 0.0°C. | The React™ 68 Catheter is<br>considered non-pyrogenic. |

The React™ 68 Catheter has been evaluated to meet requirements specified in ISO 10993-1.

# Performance Data – Bench:

Non-clinical bench testing was conducted to evaluate the performance of the React™ 68 Catheter. The following non-clinical bench testing was conducted for the React™ 68 Catheter:

| Test | Test Method Summary | Results |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Microbial | | |
| Ethylene Oxide Residual | The React™ 68 Catheter was evaluated per ISO 10993-7. | The React™ 68 Catheter met the acceptance criteria for ethylene oxide residual. |
| Ethylene Chlorohydrin Residual | The React™ 68 Catheter was evaluated per ISO 10993-7. | The React™ 68 Catheter met the acceptance criteria for ethylene chlorohydrin residual. |
| Bioburden | The React™ 68 Catheter was evaluated per ISO 11737-1. | The React™ 68 Catheter met the acceptance criteria for bioburden. |
| Test | Test Method Summary | Results |
| Bacterial Endotoxin | The ReactTM 68 Catheter was<br>evaluated per ANSI/AAMI<br>ST72 and USP <161>. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>bacterial endotoxin. |
| <i>Performance</i> | | |
| Visual Inspection | The ReactTM 68 Catheter was<br>inspected under x2.5<br>magnification. | The ReactTM 68 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 68 Catheter were<br>measured. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>dimensional measurements. |
| Tip Buckling | The ReactTM 68 Catheter was<br>evaluated for the maximum<br>compressive force. | The ReactTM 68 Catheter met<br>the acceptance criteria for tip<br>buckling. |
| Kink Resistance | The ReactTM 68 Catheter was<br>evaluated for the maximum<br>kink diameter. | The ReactTM 68 Catheter met<br>the acceptance criteria for kink<br>resistance. |
| Particulate | The ReactTM 68 Catheter was<br>evaluated per USP <788>. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>particulate evaluation. |
| Coating Lubricity | The ReactTM 68 Catheter was<br>evaluated for the average<br>friction forces. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>coating lubricity. |
| Tensile Strength | The ReactTM 68 Catheter was<br>evaluated per ISO 10555-1.<br>Annex B. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>tensile strength at the hub and<br>shaft. |
| Liquid Leak | The ReactTM 68 Catheter was<br>evaluated per ISO 10555-1.<br>Annex C. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>liquid leak. |
| Corrosion Resistance | The ReactTM 68 Catheter was<br>evaluated per ISO 10555-1.<br>Annex A. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>corrosion resistance. |
| Hub Aspiration Resistance | The ReactTM 68 Catheter was<br>evaluated per ISO 10555-1.<br>Annex D. | The ReactTM 68 Catheter met<br>the acceptance criteria for hub<br>air aspiration. |
| Compatibility | The ReactTM 68 Catheter was<br>inspected for visual damage of<br>the catheter when delivering<br>and retrieving interventional<br>devices | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>delivering and retrieving<br>interventional devices. |
| Test | Test Method Summary | Results |
| Radiopacity | The markerband length and<br>wall thickness of the React™ 68 Catheter were measured. In<br>addition, radiopacity was<br>confirmed via fluoroscopy. | The React™ 68 Catheter met<br>the acceptance criteria for<br>radiopacity. |
| Luer Standards | The React™ 68 Catheter was<br>evaluated per ISO 594-1 and<br>ISO 80369-7. | The React™ 68 Catheter met<br>the acceptance criteria for luer<br>standards. |
| Torque Strength | The React™ 68 Catheter was<br>evaluated for transmission of<br>proximal torque to the distal<br>tip. | The React™ 68 Catheter was<br>able to withstand torsional<br>forces that are typical of<br>clinical use. |
| Dynamic Pressure | The React™ 68 Catheter was<br>evaluated for the amount of<br>pressure it can withstand. | The React™ 68 Catheter was<br>able to withstand pressures that<br>are typical of clinical use. |
| Coating Integrity | The React™ 68 Catheter was<br>evaluated for coating coverage<br>and lubricity. | The React™ 68 Catheter<br>remained coated and lubricous. |
| Usability | The React™ 68 Catheter and<br>predicate device were evaluated<br>for maneuverability and<br>flexibility. | The React™ 68 Catheter met<br>the acceptance criteria for<br>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™ 68 Catheter is substantially equivalent to the predicate device.