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 Description

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

React™ Catheters
Riptide™ Large Bore Aspiration Tubing
Riptide™ Aspiration Pump
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.

AI/ML Overview

The provided text describes the 510(k) clearance for the Riptide™ Aspiration System, a medical device, and its performance data. However, it does not describe a study that proves the device meets acceptance criteria related to an AI/ML component. The document details the device's technical specifications, non-clinical bench testing, and comparison to a predicate device, which are standard for K201689. It is a traditional medical device submission and does not involve AI/ML.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the provided text does not contain such a study or information.

If you have a document describing an AI/ML medical device and its validation study, please provide that, and I would be happy to analyze it according to your requested criteria.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

Prescription Use (Part 21 CFR 801 Subpart D)	true
Over-The-Counter Use (21 CFR 807)	false

|| | 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 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration: 2029214
Contact Person:	Kristy Ann DarlingSenior Regulatory Affairs SpecialistTelephone: (949) 490-3819Email: kristyann.d.darling@medtronic.com

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 System510(k): K172448

Device Description:

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

1. React™ Catheters
1. Riptide™ Large Bore Aspiration Tubing
1. Riptide™ Aspiration Pump
1. 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:

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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:Riptide™ Aspiration System(K172448)	Subject Device:Riptide™AspirationSystem
Indication forUse (IFU)Statement	The Riptide™ Aspiration System is intended for use in therevascularization of patients with acute ischemic strokesecondary to intracranial large vessel occlusive disease (withinthe internal carotid, middle cerebral M1 and M2 segments,basilar, and vertebral arteries) within 8 hours of symptomonset. Patients who are ineligible for intravenous tissueplasminogen activator (IV t-PA) or who fail IV t-PA therapyare candidates for treatment.	Same
IEC 60601-1Compliance	Yes	Same
IEC 60601-1-2Compliance	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™Aspiration System wastested to ensure the devicemeets the productspecification forfunctionality testing.	The subject Riptide™ AspirationSystem met the acceptance criteria forfunctional testing.
Vacuum Pressure	The subject Riptide™Aspiration System wastested to ensure the devicemeets the productspecification for vacuumpressure.	The subject Riptide™ AspirationSystem met the acceptance criteria formaximum vacuum pressure.
Flow Rate	The subject Riptide™Aspiration System wastested to ensure the devicemeets the productspecification for volumetricflow rate.	The subject Riptide™ AspirationSystem met the acceptance criteria forvolumetric flow rate.
Electrical Safety per IEC60601-1	The subject Riptide™Aspiration System was testedto demonstrate it conforms toAAMI/IEC 60601-1:2005 +AMD 1:2012 Medicalelectrical equipment - Part 1:General requirements forbasic safety and essentialperformance.	The subject Riptide™ AspirationSystem met the acceptance criteria fordemonstrating conformance toAAMI/IEC 60601-1:2005 + AMD1:2012.
Electromagnetic Compatibilityper IEC 60601-1-2	The subject RiptideAspiration System wastested to demonstratecompliance to IEC 60601-1-2: 2014 Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance -CollateralStandard: Electromagneticdisturbances - Requirementsand tests.	The subject Riptide™ AspirationSystem met the acceptance criteria.for demonstrating compliance to IEC60601-1-2.
Test	Test Method Summary	Results
Recanalization	The subject Riptide™Aspiration System wastested to ensure it is able toaspirate a clot in theoccluded vessel atrecanalization rates similarto the predicate device.	The subject Riptide™ AspirationSystem met the acceptance criteria forrecanalization for the Riptide™Aspiration System.
Vacuum Pressure	The subject Riptide™Aspiration System wastested to ensure it is capableof accurately translatingvacuum pressure, generatedby the pump, to the tip of thecatheter	The subject Riptide™ AspirationSystem met the acceptance criteriafor vacuum pressure.
Volumetric Flow Rate	The subject Riptide™Aspiration System wastested to ensure it generatessufficient flow through thecatheter to facilitateefficacious withdrawal of theclot from the vasculature.	The subject Riptide™ AspirationSystem met the acceptance criteria forvolumetric 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 predicatedevice.	The subject Riptide™ AspirationSystem met the acceptance criteria forfunctionality, post-durability.
Tip-over Resistance / Degreeof Tilt	Leveraged from predicatedevice.	The subject Riptide™ AspirationSystem met the acceptance criteria fortip-over resistance/degree of tilt.
Usability	Leveraged from predicatedevice.	The subject Riptide™ AspirationSystem met the acceptance criteria forusability.
Clot Engagement andAspiration	Leveraged from predicatedevice.	The subject Riptide™ AspirationSystem met the acceptance criteria forclot 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:

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.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).