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.

Device Description

The Riptide™ Large Bore Aspiration Tubing is provided sterile and intended for single-use. The Riptide™ Large Bore Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the catheter. The Riptide™ Large Bore Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Large Bore Aspiration Tubing is connected to the Riptide™ Canister (outside of the sterile environment) while the distal end of the Riptide™ Large Bore Aspiration Tubing is connected to the catheter (inside the sterile environment). The Riptide™ Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing. The Riptide™ Large Bore Aspiration Tubing is designed to allow the user to control the application via an in-line flow switch.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for the FDA. These summaries typically focus on demonstrating substantial equivalence to a predicate device, often by leveraging data from the predicate or conducting limited bench testing. They are not necessarily full-fledged clinical trials for a new device's efficacy. This document describes a component of a system (Large Bore Aspiration Tubing) and mostly relies on prior testing of the overall system and predicate device. Therefore, many of the typical AI/medical device study questions (like effect size, reader improvements, ground truth establishment for a training set) aren't directly applicable or answered in this context.

1. A table of acceptance criteria and the reported device performance

The document lists several tests, and for most, the acceptance criterion is implied by the "met the acceptance criteria" statement. Specific numerical criteria are not detailed in this summary.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Compatibility	Compatible with specified catheters and collection canister	Met acceptance criteria
Ethylene Oxide (EO) Residual	Within acceptable limits for EO residual	Met acceptance criteria
Ethylene Chlorohydrin (ECH) Residual	Within acceptable limits for ECH residual	Met acceptance criteria
Bioburden Recovery	Met acceptance criteria	Met acceptance criteria
Bioburden	Met acceptance criteria	Met acceptance criteria
Bacterial Endotoxin	Within acceptable limits for bacterial endotoxin	Met acceptance criteria
Packaging Aseptic Presentation	Maintained aseptic presentation	Met acceptance criteria
Seal Width	Within specified seal width range	Met acceptance criteria
Dye Leak	No dye leakage detected	Met acceptance criteria
Visual Inspection	Passed visual inspection	Met acceptance criteria
Bubble Leak	No bubble leakage detected	Met acceptance criteria
Legibility	Labeling was legible	Met acceptance criteria
Foreign Material	No foreign material detected	Met acceptance criteria
Seal Strength	Within specified seal strength limits	Met acceptance criteria
Dimensional Inspection	Dimensions (length, inner/outer diameter) within specifications	Met acceptance criteria
Identification (ON/OFF Heat Shrink Bands)	Heat shrink bands correctly identified	Met acceptance criteria
Identification (Flow Switch)	Flow switch correctly identified	Met acceptance criteria
Joint Tensile Strength	Withstood specified tensile force without failure	Met acceptance criteria
Leak (Vacuum Decay)	Maintained specified vacuum pressure without significant decay	Met acceptance criteria
Degree of Collapse	Met requirements of ISO 10079-3 for degree of collapse	Met acceptance criteria
Recanalization (System)	Met acceptance criteria for recanalization (leveraged)	Met acceptance criteria
Vacuum Pressure (System)	Met acceptance criteria for vacuum pressure (leveraged)	Met acceptance criteria
Volumetric Flow Rate (System)	Met acceptance criteria for volumetric flow rate (leveraged)	Met acceptance criteria
Usability (System)	Met acceptance criteria for usability (leveraged)	Met acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for specific tests. The tests mentioned are primarily bench tests on the device itself or leveraged from a predicate device. So, it refers to the number of units tested.
Data Provenance: The tests are non-clinical bench tests. It doesn't involve human patient data or geographic origin in the way clinical studies do. The data is generated in a lab setting. It is essentially prospective in the sense that these tests were performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/diagnostic device that establishes a "ground truth" based on expert interpretation. The tests are engineering and performance evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/diagnostic device requiring expert adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (aspiration tubing), not an AI diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench tests would be the established engineering/performance specifications and standards (e.g., ISO, ASTM, internal specifications) against which the device's performance is measured. For example, a leak test's "ground truth" is that there should be no detectable leak under specified pressure/vacuum.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 18, 2018

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

Re: K183185

Trade/Device Name: Riptide™ Aspiration System (Riptide™ Large Bore Aspiration Tubing) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: November 16, 2018 Received: November 19, 2018

Dear Nancy Drew, PhD:

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.htm); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K183185

Device Name

Riptide™ Aspiration System (Riptide™ Large Bore Aspiration Tubing)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: K183185

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration: 2029214
Contact Person:	Nancy DrewSenior Regulatory Affairs SpecialistTelephone: (949) 297-9563Email: nancy.k.drew@medtronic.com
Date SummaryPrepared:	December 13, 2018
Trade Name ofDevice:	Riptide™ Aspiration System(Riptide™ Large Bore Aspiration Tubing)
Common Name ofDevice:	Catheter, Thrombus Retriever
Review Panel:	Neurology
Product Code:	NRY
Regulation Number:	21 CFR 870.1250
Regulation Name:	Percutaneous Catheter
Device Classification	Class II

510(k): K172448

Device Description:

Predicate Device:

Riptide™ Aspiration System (Riptide™ Aspiration Tubing)

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 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:	Predicate: Riptide™ Aspiration Tubing (K172448)	Subject: Riptide™ Large Bore Aspiration Tubing
Indication for Use (IFU) 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 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	Same
Materials	Biocompatible, commonly utilized for interventional devices.	Same
Dimensions
Usable Length	112.0"	Same
Distal Length	7.0"	Same
Inner Diameter	0.088"	0.110"
Outer Diameter	0.188"	Same
Sterilization
Method	Ethylene Oxide (EO)	Same
Packaging
Shelf Life	36 Months	Same

Biocompatibility:

Biocompatibility was leveraged for the Riptide™ Large Bore Aspiration Tubing from the predicate device.

Performance Data – Bench:

Non-clinical bench testing was leveraged and conducted to evaluate the performance of the Riptide™ Large Bore Aspiration Tubing.

The following non-clinical bench testing was leveraged for the Riptide™ Large Bore Aspiration Tubing:

Test	Test Method Summary	Results
Performance
Compatibility	Leveraged from predicate device	The Riptide™ Large BoreAspiration Tubing met theacceptance criteria forcompatibility with the Arc™Catheter, React™ 68 Catheter,React™ 71 Catheter, andRiptide™ Collection Canister
Microbial
Test	Test Method Summary	Results
Ethylene Oxide (EO) Residual	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for ethylene oxide residual.
Ethylene Chlorohydrin (ECH) Residual	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for ethylene chlorohydrin residual.
Bioburden Recovery	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for bioburden recovery.
Bioburden	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for bioburden.
Bacterial Endotoxin	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for bacterial endotoxin.
PackagingAseptic Presentation	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for aseptic presentation.
Seal Width	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for seal width.
Dye Leak	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for dye leak.
Visual Inspection	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for visual inspection.
Bubble Leak	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for bubble leak.
Legibility	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for labeling legibility.
Foreign Material	Leveraged from predicate device	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for foreign material.
Test	Test Method Summary	Results
Seal Strength	Leveraged from predicatedevice	The Riptide™ Large BoreAspiration Tubing met theacceptance criteria for sealstrength.

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The following non-clinical bench testing was conducted:

Test	Test Method Summary	Results
Dimensional Inspection	The overall and distal length, proximal and distal inner and outer diameter of the Riptide™ Large Bore Aspiration Tubing is measured.	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for dimensional inspection.
Identification (ON/OFF Heat Shrink Bands)	The heat shrink bands of the Riptide™ Large Bore Aspiration Tubing is visually inspected.	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for identification of the heat shrink bands.
Identification (Flow Switch)	The flow switch of the Riptide™ Large Bore Aspiration Tubing is visually inspected.	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for identification of the flow switch.
Joint Tensile Strength	The Riptide™ Large Bore Aspiration Tubing is affixed to upper and lower grips of the tensile test fixture and stretched. The maximum value before failure is recorded.	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for joint tensile strength.
Leak	The Riptide™ Large Bore Aspiration Tubing is pressurized to specified vacuum pressure and any decay in pressure is recorded.	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for leak (vacuum decay).
Degree of Collapse	Degree of Collapse for the Riptide™ Large Bore Aspiration Tubing is performed per ISO 10079-3	The Riptide™ Large Bore Aspiration Tubing met the acceptance criteria for degree of collapse

In addition, the following non-clinical bench testing was leveraged to evaluate the performance of Riptide™ Aspiration System (Riptide™ Large Bore Aspiration Tubing):

Test	Test Method Summary	Results
Recanalization	Leveraged from predicate device	The Riptide™ Aspiration System (Riptide™ Large Bore Aspiration Tubing) met the acceptance criteria for recanalization.

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Test	Test Method Summary	Results
Vacuum Pressure	Leveraged from predicate device	The Riptide™ Aspiration System (Riptide™ Large Bore Aspiration Tubing) met the acceptance criteria for vacuum pressure.
Volumetric Flow Rate	Leveraged from predicate device	The Riptide™ Aspiration System (Riptide™ Large Bore Aspiration Tubing) met the acceptance criteria for volumetric flow rate.
Usability	Leveraged from predicate device	The Riptide™ Aspiration System (Riptide™ Large Bore Aspiration Tubing) met the acceptance criteria for usability.

Performance Data - Animal:

A determination of substantial equivalence is based upon non-clinical bench testing as there is no change to the indication for use statement, fundamental scientific technology, or materials of construction.

Performance Data - Clinical:

Conclusion:

The design modification incorporated into the Riptide™ Large Bore Aspiration Tubing do not alter the indication for use statement, fundamental scientific technology, or materials of construction. In addition, the design modification does not raise new questions on the safety and effectiveness of the device. Therefore, the Riptide™ Large Bore Aspiration Tubing is substantially equivalent to the 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).