Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of aspiration tubing and its connection to a pump, with no mention of AI or ML technologies.

Therapeutic

Yes
The device is intended for use in the revascularization of patients with acute ischemic stroke, which directly treats a disease.

Diagnostic

No.
The Riptide™ Aspiration System is intended for use in the revascularization of patients and serves as a conduit for vacuum aspiration, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like tubing, a canister, and a pump, indicating it is a hardware-based system, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly describes a system for revascularization in patients with acute ischemic stroke due to large vessel occlusion. This is a therapeutic intervention performed directly on the patient's vascular system.
Device Description: The device description details tubing and a pump used to apply vacuum for aspiration within the body. This is a mechanical device used for a medical procedure.
Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health status. IVDs are designed for testing samples in a laboratory or point-of-care setting.

The device is a medical device used for a therapeutic procedure, not for diagnostic testing of samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NRY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intracranial large vessel occlusive disease (within the internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical bench testing was leveraged and conducted to evaluate the performance of the Riptide™ Large Bore Aspiration Tubing. All tested criteria were met.
The following non-clinical bench testing was leveraged for the Riptide™ Large Bore Aspiration Tubing:

Compatibility
Ethylene Oxide (EO) Residual
Ethylene Chlorohydrin (ECH) Residual
Bioburden Recovery
Bioburden
Bacterial Endotoxin
Packaging Aseptic Presentation
Seal Width
Dye Leak
Visual Inspection
Bubble Leak
Legibility
Foreign Material
Seal Strength
Recanalization
Vacuum Pressure
Volumetric Flow Rate
Usability

The following non-clinical bench testing was conducted:

Dimensional Inspection
Identification (ON/OFF Heat Shrink Bands)
Identification (Flow Switch)
Joint Tensile Strength
Leak
Degree of Collapse

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K172448

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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)

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)
☑ 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 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration: 2029214 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nancy Drew
Senior Regulatory Affairs Specialist
Telephone: (949) 297-9563
Email: nancy.k.drew@medtronic.com |
| Date Summary
Prepared: | December 13, 2018 |
| Trade Name of
Device: | Riptide™ Aspiration System
(Riptide™ Large Bore Aspiration Tubing) |
| 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 |

510(k): K172448

Device Description:

Predicate Device:

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.

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 Bore
Aspiration Tubing met the
acceptance criteria for
compatibility with the Arc™
Catheter, React™ 68 Catheter,
React™ 71 Catheter, and
Riptide™ 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.
Packaging
Aseptic 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 predicate
device	The Riptide™ Large Bore
Aspiration Tubing met the
acceptance criteria for seal
strength.

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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:

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.

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.