Riptide Aspiration System

K201689 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · NRY · Jul 21, 2020 · Cardiovascular

Device Facts

• Record ID: K201689
• Device Name: Riptide Aspiration System
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: NRY · Cardiovascular
• Decision Date: Jul 21, 2020
• Decision: SESE
• Submission Type: Special
• 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

Riptide Aspiration System facilitates revascularization in acute ischemic stroke patients. System components include React catheters, large bore aspiration tubing, collection canister, and aspiration pump. Pump generates vacuum pressure (20-25 inHg) to aspirate thrombi from intracranial vessels. Operated by clinicians in clinical settings; vacuum level controlled via manual valve. Output is mechanical suction at catheter tip to withdraw clots. Benefits include restoration of blood flow in occluded vessels. Device is non-sterile, reusable, and used outside the sterile field.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including functionality, vacuum pressure, flow rate, recanalization performance, and electrical safety/EMC compliance. Previous data for catheters and tubing were leveraged from predicate submissions.

Technological Characteristics

System includes catheters, tubing, collection canister, and vacuum pump. Pump operates at 220-240 Vac (50/60 Hz). Complies with AAMI/IEC 60601-1 (General safety) and IEC 60601-1-2 (EMC). Non-sterile, reusable pump. Vacuum range 20-25 inHg.

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

• Riptide™ Aspiration System (K172448)

Reference Devices

• Riptide™ Aspiration System (K183185)

Submission Summary (Full Text)

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July 21, 2020

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Kristy Ann Darling, RAC Senior Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618

Re: K201689

Trade/Device Name: Riptide Aspiration System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: June 19, 2020 Received: June 22, 2020

Dear Kristy Ann Darling:

We have reviewed vour 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201689

Device Name Riptide™ Aspiration System

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 2em; color:green;"><b> true </b></span> |
|----------------------------------------------|--------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 807) | <span style="font-size: 2em; color:green;"><b> false </b></span> |

|| | Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary:

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration: 2029214 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristy Ann Darling<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>Email: [e-mail] |

| Date Summary Prepared: | July 20, 2020 |
|------------------------|-----------------------------------------------|
| Trade Name of Device: | Riptide™ Aspiration System |
| Common Name of 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: | Riptide™ Aspiration System<br>510(k): K172448 |

## Device Description:

The Riptide™ Aspiration System is composed of the following components:

- 1. React™ Catheters
- 2. Riptide™ Large Bore Aspiration Tubing
- 3. Riptide™ Aspiration Pump
- 4. RiptideTM Collection Canister with Intermediate Tubing

No changes were made to the catheters, tubing or collection canister with intermediate tubing cleared in the predicate system under K172448 and, most recently, under K183185.

The Riptide™ Aspiration Pump is designed to generate vacuum for the Riptide Aspiration System. The vacuum pressure of the Riptide Aspiration Pump is set by turning the vacuum control valve until the vacuum gauge reads a minimum of 20inHg but not exceeding 25inHg. The Riptide Aspiration Pump is reusable, non-sterile, and intended to be utilized outside of the sterile environment.

#### Indication for Use Statement:

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

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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.

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# Device Comparison:

| Attribute | Predicate Device:<br>Riptide™ Aspiration System<br>(K172448) | Subject Device:<br>Riptide™<br>Aspiration<br>System |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indication for<br>Use (IFU)<br>Statement | The Riptide™ Aspiration System is intended for use in the<br>revascularization of patients with acute ischemic stroke<br>secondary to intracranial large vessel occlusive disease (within<br>the internal carotid, middle cerebral M1 and M2 segments,<br>basilar, and vertebral arteries) within 8 hours of symptom<br>onset. Patients who are ineligible for intravenous tissue<br>plasminogen activator (IV t-PA) or who fail IV t-PA therapy<br>are candidates for treatment. | Same |
| IEC 60601-1<br>Compliance | Yes | Same |
| IEC 60601-1-2<br>Compliance | Yes | Same |
| Voltage | 110-115 Vac | 220-240 Vac |
| Frequency | 60 Hz | 50/60 Hz |
| Sterilization | Non-sterile | Same |

The following non-clinical bench testing was performed for the Riptide™ Aspiration System:

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| Test | Test Method Summary | Results |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Functionality | The subject Riptide™<br>Aspiration System was<br>tested to ensure the device<br>meets the product<br>specification for<br>functionality testing. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>functional testing. |
| Vacuum Pressure | The subject Riptide™<br>Aspiration System was<br>tested to ensure the device<br>meets the product<br>specification for vacuum<br>pressure. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>maximum vacuum pressure. |
| Flow Rate | The subject Riptide™<br>Aspiration System was<br>tested to ensure the device<br>meets the product<br>specification for volumetric<br>flow rate. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>volumetric flow rate. |
| Electrical Safety per IEC<br>60601-1 | The subject Riptide™<br>Aspiration System was tested<br>to demonstrate it conforms to<br>AAMI/IEC 60601-1:2005 +<br>AMD 1:2012 Medical<br>electrical equipment - Part 1:<br>General requirements for<br>basic safety and essential<br>performance. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>demonstrating conformance to<br>AAMI/IEC 60601-1:2005 + AMD<br>1:2012. |
| Electromagnetic Compatibility<br>per IEC 60601-1-2 | The subject Riptide<br>Aspiration System was<br>tested to demonstrate<br>compliance to IEC 60601-1-<br>2: 2014 Medical electrical<br>equipment - Part 1-2:<br>General requirements for<br>basic safety and essential<br>performance -Collateral<br>Standard: Electromagnetic<br>disturbances - Requirements<br>and tests. | The subject Riptide™ Aspiration<br>System met the acceptance criteria.<br>for demonstrating compliance to IEC<br>60601-1-2. |
| Test | Test Method Summary | Results |
| Recanalization | The subject Riptide™<br>Aspiration System was<br>tested to ensure it is able to<br>aspirate a clot in the<br>occluded vessel at<br>recanalization rates similar<br>to the predicate device. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>recanalization for the Riptide™<br>Aspiration System. |
| Vacuum Pressure | The subject Riptide™<br>Aspiration System was<br>tested to ensure it is capable<br>of accurately translating<br>vacuum pressure, generated<br>by the pump, to the tip of the<br>catheter | The subject Riptide™ Aspiration<br>System met the acceptance criteria<br>for vacuum pressure. |
| Volumetric Flow Rate | The subject Riptide™<br>Aspiration System was<br>tested to ensure it generates<br>sufficient flow through the<br>catheter to facilitate<br>efficacious withdrawal of the<br>clot from the vasculature. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>volumetric flow rate. |

The following non-clinical bench testing was also performed for the Riptide™ Aspiration System:

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| Test | Test Method Summary | Results |
|-----------------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Functionality, Post-Durability | Leveraged from predicate<br>device. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>functionality, post-durability. |
| Tip-over Resistance / Degree<br>of Tilt | Leveraged from predicate<br>device. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>tip-over resistance/degree of tilt. |
| Usability | Leveraged from predicate<br>device. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>usability. |
| Clot Engagement and<br>Aspiration | Leveraged from predicate<br>device. | The subject Riptide™ Aspiration<br>System met the acceptance criteria for<br>clot engagement and aspiration. |

The following non-clinical bench testing was leveraged from the predicate Riptide™ System:

### Performance Data - Animal:

There is no change to the Indication for Use (IFU) Statement of the subject Riptide™ Aspiration System in comparison to the legally marketed predicate device. The difference in technological characteristics do not raise questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.

#### Performance Data - Clinical:

There is no change to the Indication for Use (IFU) Statement of the subject Riptide™ Aspiration System in comparison to the legally marketed predicate device. The difference in technological characteristics do not raise questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.

#### Conclusion:

There is no change to the Indication for Use (IFU) Statement of the subject Riptide™ Aspiration System in comparison to the legally marketed predicate device. In addition, the subject Riptide™ System is equivalent in terms of fundamental scientific technology in comparison to the legally marketed predicate device. The difference in technological characteristics does not raise new questions on the safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods. Therefore, the subject Riptide™ Aspiration System does not raise new questions of safety or efficacy based on comparison to the legally marketed predicate device. In conclusion, the results of the nonclinical testing performed and leveraged for the subject device support a determination of substantial equivalence by demonstrating that the device is at least as safe and effective as the legally marketed predicate device.