Riptide Aspiration System React 68 Catheter

K180705 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · NRY · Jul 4, 2018 · Cardiovascular

Device Facts

• Record ID: K180705
• Device Name: Riptide Aspiration System React 68 Catheter
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: NRY · Cardiovascular
• Decision Date: Jul 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Riptide™ Aspiration System 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 Story

Single-lumen, variable-stiffness composite catheter; nitinol-reinforced structure with polymer jacket and PTFE liner; platinum-iridium radiopaque markerband for fluoroscopic visualization. Used in neurovascular procedures to revascularize occluded intracranial vessels. Physician navigates catheter through vasculature to site of occlusion; applies aspiration to remove thrombus. Device provides proximal stiffness for pushability and distal flexibility for navigation. Benefits include restoration of blood flow in acute ischemic stroke patients. Used in clinical settings (e.g., interventional suite) by trained physicians.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing (biocompatibility per ISO 10993-1, mechanical performance per ISO 10555-1, vacuum/flow rate, recanalization) and GLP-compliant porcine animal studies comparing safety, efficacy, and usability against the predicate.

Technological Characteristics

Single-lumen catheter; nitinol braid/coil reinforcement; PTFE liner; Trogamid hub; DynaFlex strain relief; Pebax/Grilamid extrusions; Surmodics Serene hydrophilic coating. Radiopaque platinum-iridium markerband. Sterilized via Ethylene Oxide (EO). Dimensions: 0.068" ID, 0.083" max OD. Single-use, disposable.

Indications for Use

Indicated for patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (internal carotid, middle cerebral M1/M2, basilar, vertebral arteries) within 8 hours of symptom onset. Candidates include those 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 System® ACE 68 Reperfusion Catheter (K161064)

Reference Devices

• Riptide™ Aspiration System (K172448)
• Arc™ Intracranial Support Catheter (K150107)

Submission Summary (Full Text)

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July 4, 2018

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

Re: K180705

Trade/Device Name: Riptide Aspiration System (React 68 Catheter) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY 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 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) K180705

Device Name Riptide Aspiration System (React 68 Catheter)

#### Indications for Use (Describe)

The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary: K180705

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
|---------------------------|------------------------------------------------------------------------------------------------------------|
| | 9775 Toledo Way |
| | Irvine, CA 92618 |
| | Establishment Registration No.: 2029214 |
| Contact Person: | Ryan Kenney |
| | Senior Regulatory Affairs Specialist |
| | Telephone: [phone] |
| | Email: [e-mail] |
| Date Summary<br>Prepared: | June 25, 2018 |
| Trade Name of<br>Device: | RiptideTM Aspiration System (React 68 Catheter) |
| Common Name of<br>Device: | Catheter, Thrombus Retriever |
| Review Panel: | Neurology |
| Product Code: | NRY |
| Regulation Number: | 21 CFR 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Device Classification: | Class II |
| Predicate Device(s): | Penumbra System® ACE 68 Reperfusion Catheter<br>510(k)#: K161064 |
| Reference Device(s): | RiptideTM Aspiration System<br>510(k)#: K172448<br>ArcTM Intracranial Support Catheter<br>510(k)#: K150107 |

## Device Description:

The Riptide™ Aspiration System 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 Riptide™ Aspiration System React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath.

The proximal end of the Riptide™ Aspiration System React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The Riptide™ Aspiration System React™ 68 Catheter is designed with a hydrophilic coating. The Riptide™ Aspiration System React™ 68 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.

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## Indications for Use:

The Riptide™ Aspiration System 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.

| | Penumbra System® ACE 68<br>Reperfusion Catheter | React™ 68 Catheter |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use (IFU)<br>Statement | The Penumbra System® is<br>intended for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary<br>to intracranial large vessel<br>occlusive disease (within the<br>internal carotid, middle cerebral –<br>M1 and M2 segments, basilar,<br>and vertebral arteries) within 8<br>hours of symptom onset. | The Riptide™ Aspiration System<br>is intended for use in the<br>revascularization of patients with<br>acute ischemic stroke secondary<br>to intracranial large vessel<br>occlusive disease (within the<br>internal carotid, middle cerebral –<br>M1 and M2 segments, basilar,<br>and vertebral arteries) within 8<br>hours of symptom onset. Patients<br>who are ineligible for intravenous<br>tissue plasminogen activator (IV<br>t-PA) or who fail IV t-PA therapy<br>are candidates for treatment. |
| Materials | | |
| Proximal Hub | Grilamid™ | Trogamid® |
| Strain Relief<br>(Hub Sleeve) | Grilamid™ | DynaFlex® |
| Strain Relief | 304 Stainless Steel | N/A |
| Inner Diameter Band | Polyolefin, PET Yellow<br>(Black Ink) | N/A |
| Liner | PTFE | Same |
| Braid Reinforcement | N/A | Nitinol |
| Coil Reinforcement | 304V Stainless Steel<br>Nickel (55%)/Titanium (45%) | Nitinol |
| Proximal Extrusions | Vestamid®<br>Pebax® 72D | Grilamid™<br>Pebax® 45D<br>Pebax® 55D<br>Pebax® 63D<br>Pebax® 72D |
| Distal Extrusions | Pebax® 35D<br>Pebax® 40D<br>Pebax® 55D<br>Pebax® 63D<br>Pellathane® 80A<br>Tecoflex® 80A | Pebax® 25D<br>Pebax® 35D |
| | Penumbra System® ACE 68<br>Reperfusion Catheter | React™ 68 Catheter |
| Extrusion Colorants | Clear/Natural or Purple | Clear/Natural or Green |
| Markerband | Platinum (90%)/<br>Iridium (10%) | Same |
| Coating | SRDX Harmony | Surmodics Serene® |
| Working Length | 132 cm | Same |
| Proximal Inner Diameter<br>(ID) | 0.068" (Min.) | 0.068" (Min.) |
| Proximal Outer Diameter<br>(OD) | 0.084" (Max.) | 0.083" (Max.) |
| Distal Inner Diameter (ID) | 0.068" (Min.) | 0.068" (Min.) |
| Distal Outer Diameter<br>(OD) | 0.084" (Max.) | 0.083" (Max.) |
| Coating Length | 30cm | 40cm |
| Tip Shape | Straight | Same |
| Accessories | | |
| Peelable Sheath | PTFE | Same |
| Rotating Hemostasis Valve | Polycarbonate Silicone O-Ring | N/A |
| Shaping Mandrel | 0.038" OD Stainless Steel | N/A |
| Packaging | | |
| Carton | SBS Paperboard | Same |
| Packaging Card | Polyethylene | Same |
| Packaging Hoop | Polyethylene | Same |
| Packaging Tray | Polyethylene<br>Terephthalate<br>Polystrene | N/A |
| Pouch | Polyester<br>Polyethylene<br>Tyvek® | Nylon<br>Tyvek® |
| Other | | |
| Shelf Life | 8 Months | 3 Months |
| Sterilization | Ethylene Oxide (EO) | Same |
| Use | Single Use, Disposable | 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). | The React TM 68 Catheter is<br>considered non-cytotoxic. |
| Test Description | Results | Conclusions |
| Sensitization<br>(Guinea Pig Maximization Test) | 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 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<br>statistically higher than the<br>activated normal human serum<br>control or the negative control.<br><br>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. | The control and test article<br>samples are not considered to<br>be potential activators of the<br>complement system. |
| 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 | The ReactTM 68 Catheter<br>demonstrates minimal<br>thrombus formation. |
| Test Description | Results | Conclusions |
| | determined to have minimal<br>thrombus formation after four<br>(4) hours (±30 minutes)<br>without anticoagulation. | |
| 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. |

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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 ReactTM 68 Catheter was<br>evaluated per ISO 10993-7. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>ethylene oxide residual. |
| Ethylene Chlorohydrin<br>Residual | The ReactTM 68 Catheter was<br>evaluated per ISO 10993-7. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>ethylene chlorohydrin residual. |
| Bioburden | The ReactTM 68 Catheter was<br>evaluated per ISO 11737-1. | The ReactTM 68 Catheter met<br>the acceptance criteria for<br>bioburden. |
| 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. |
| Performance | | |
| 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 |
| Test | Test Method Summary | Results |
| Kink Resistance | The ReactTM 68 Catheter was evaluated for the maximum kink diameter. | The ReactTM 68 Catheter met the acceptance criteria for kink resistance. |
| Particulate | The ReactTM 68 Catheter was evaluated per USP <788>. | The ReactTM 68 Catheter met the acceptance criteria for particulate evaluation. |
| Coating Lubricity | The ReactTM 68 Catheter was evaluated for the average friction forces. | The ReactTM 68 Catheter met the acceptance criteria for coating lubricity. |
| Tensile Strength | The ReactTM 68 Catheter was evaluated per ISO 10555-1. Annex B. | The ReactTM 68 Catheter met the acceptance criteria for tensile strength at the hub and shaft. |
| Liquid Leak | The ReactTM 68 Catheter was evaluated per ISO 10555-1. Annex C. | The ReactTM 68 Catheter met the acceptance criteria for liquid leak. |
| Corrosion Resistance | The ReactTM 68 Catheter was evaluated per ISO 10555-1. Annex A. | The ReactTM 68 Catheter met the acceptance criteria for corrosion resistance. |
| Hub Aspiration Resistance | The ReactTM 68 Catheter was evaluated per ISO 10555-1. Annex D. | The ReactTM 68 Catheter met the acceptance criteria for hub air aspiration. |
| Radiopacity | The markerband length and wall thickness of the ReactTM 68 Catheter were measured. In addition, radiopacity was confirmed via fluoroscopy. | The ReactTM 68 Catheter met the acceptance criteria for radiopacity. |
| Luer Standards | The ReactTM 68 Catheter was evaluated per ISO 594-1 and ISO 80369-7. | The ReactTM 68 Catheter met the acceptance criteria for luer standards. |
| Torque Strength | The ReactTM 68 Catheter was evaluated for transmission of proximal torque to the distal tip. | The ReactTM 68 Catheter was able to withstand torsional forces that are typical of clinical use. |
| Dynamic Pressure | The ReactTM 68 Catheter was evaluated for the amount of pressure it can withstand. | The ReactTM 68 Catheter was able to withstand pressures that are typical of clinical use. |
| Coating Integrity | The ReactTM 68 Catheter was evaluated for coating coverage and lubricity. | The ReactTM 68 Catheter remained coated and lubricous. |
| Test | Test Method Summary | Results |
| Recanalization | The Riptide™ Aspiration<br>System React™ 68 Catheter<br>was evaluated for<br>recanalization. | The Riptide™ Aspiration<br>System React™ 68 Catheter<br>met the acceptance criteria for<br>recanalization. |
| Vacuum Pressure | The Riptide™ Aspiration<br>System React™ 68 Catheter<br>was evaluated for vacuum<br>pressure. | The Riptide™ Aspiration<br>System React™ 68 Catheter<br>met the acceptance criteria for<br>vacuum pressure. |
| Suction Flow Rate | The Riptide™ Aspiration<br>System React™ 68 Catheter<br>was evaluated for suction flow<br>rate. | The Riptide™ Aspiration<br>System React™ 68 Catheter<br>met the acceptance criteria for<br>suction flow rate. |
| Usability | The Riptide™ Aspiration<br>System React™ 68 Catheter<br>and the Penumbra System®<br>ACE 68 Reperfusion Catheter<br>were evaluated for<br>maneuverability, flexibility, the<br>ability to engage and apply<br>aspiration, and the ability to<br>safely retrieve clot. | The Riptide™ Aspiration<br>System React™ 68 Catheter<br>met the acceptance criteria for<br>usability. |

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Note: Packaging for the React™ 68 Catheter was leveraged from the Riptide™ Aspiration Tubing.

In addition, the following non-clinical bench testing was conducted to evaluate the performance of the Riptide™ Aspiration System React™ 68 Catheter:

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# Performance Data - Animal:

Non-clinical animal testing was conducted to evaluate the safety, efficacy, and usability of the Riptide™ Aspiration System React™ 68 Catheter in comparison to the Penumbra System® ACE 68 Reperfusion Catheter at acute and chronic time points in a porcine model, both in the presence and absence of simulated clot. Non-clinical animal testing was conducted in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies.

## Performance Data - Clinical:

Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench and animal testing.

#### Conclusion:

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

Non-clinical bench and animal testing supports a determination that the subject Riptide™ Aspiration System React™ 68 Catheter is substantially equivalent to the predicate Penumbra System® ACE 68 Reperfusion Catheter.