Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical construction and materials of the catheter, and the performance studies are non-clinical bench tests. There is no mention of AI, ML, or any software-based analysis or processing of data that would typically involve these technologies.

Therapeutic

No.

The device is indicated for the introduction of interventional devices, not for providing a therapeutic effect itself.

Diagnostic

No

The device is indicated for the introduction of interventional devices, rather than for the purpose of diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with various material components, a marker band, and a coating, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the React™ 71 Catheter is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for the "introduction of interventional devices into the peripheral and neuro vasculature." This describes a device used within the body for a therapeutic or interventional procedure, not for testing samples outside the body to diagnose a condition.
Device Description: The description details a catheter designed for insertion into blood vessels, with features like variable stiffness, a radiopaque marker for visualization under fluoroscopy, and a lubricious coating. These are characteristics of an invasive medical device used in vivo.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The React™ 71 Catheter's function is purely mechanical and procedural within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Product codes

DQY

Device Description

The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and neuro vasculature

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)

Biocompatibility:

Cytotoxicity (Elution Method): The test article extract showed no evidence of causing cell lysis or toxicity and had a Grade 0 (No Reactivity). The ReactTM 71 Catheter is considered non-cytotoxic.
Sensitization (Guinea Pig Maximization Test): The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The ReactTM 71 Catheter does not elicit a sensitization response.
Irritation (Intracutaneous Reactivity): The test article met the requirements of the test. The ReactTM 71 Catheter is considered a non-irritant.
Acute Systemic Toxicity (Systemic Toxicity): There was no mortality or evidence of systemic toxicity from the extracts injected into mice. The ReactTM 71 Catheter does not indicate signs of toxicity.
Hemocompatibility (Hemolysis): The hemolytic index for the test article in direct contact with blood was 0.8%, and for the extract was 0.0%. The ReactTM 71 Catheter is considered non-hemolytic.
Hemocompatibility (Complement Activation): The concentration of SC5b-9 in the test article was not statistically higher than controls. The ReactTM 71 Catheter is not considered to be a potential activator of the complement system.
Hemocompatibility (Thrombogenicity – Canine Model): The test article had a mean score of 1.7 after four hours compared to a control article mean score of 2.0. The ReactTM 71 Catheter demonstrates lower thrombogenic potential in arterial vessels compared to the ACE 68 Reperfusion Catheter.
Pyrogenicity (Material Mediated): No animal showed a temperature rise of 0.5°C or more. The ReactTM 71 Catheter is considered non-pyrogenic.

Performance Data – Bench (Leveraged testing):

Microbial:
- Ethylene Oxide Residual: Met acceptance criteria.
- Ethylene Chlorohydrin Residual: Met acceptance criteria.
- Bioburden Recovery: Met acceptance criteria.
- Bacterial Endotoxin: Met acceptance criteria.
Packaging:
- Visual Inspection: Met acceptance criteria.
- Bubble Leak: Met acceptance criteria.
- Seal Strength: Met acceptance criteria.

Performance Data – Bench (Conducted testing):

Microbial:
- Bioburden: Met acceptance criteria.
Performance:
- Visual Inspection: Met acceptance criteria.
- Dimensional Measurements: Met acceptance criteria.
- Tip Buckling: Met acceptance criteria.
- Kink Resistance: Met acceptance criteria.
- Particulate: Met acceptance criteria.
- Coating Lubricity: Met acceptance criteria.
- Tensile Strength: Met acceptance criteria for the hub and shaft.
- Liquid Leak: Met acceptance criteria.
- Corrosion Resistance: Met acceptance criteria.
- Hub Aspiration Resistance: Met acceptance criteria.
- Radiopacity: Met acceptance criteria.
- Luer Standards: Met acceptance criteria.
- Compatibility: Met acceptance criteria for delivering and retrieving interventional devices.
- Torque to Failure: Was able to withstand torsional forces typical of clinical use.
- Dynamic Pressure: Was able to withstand pressures typical of clinical use.
- Coating Integrity: Remained coated and lubricious.
- Usability: Met acceptance criteria for maneuverability and flexibility.

Performance Data – Animal: Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.

Performance Data – Clinical: Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.

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

Not Found

Predicate Device(s)

K151667, K110055, K180715

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 14, 2018

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

Re: K182097

Trade/Device Name: React™ 71 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 12, 2018 Received: October 15, 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. 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

1

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.html; 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) K182097

Device Name React™ 71 Catheter

Indications for Use (Describe)

The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary: K182097

| 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: (949) 297-5489
Email: ryan.j.kenney@medtronic.com | |
| Date Summary Prepared: | October 12, 2018 | |
| Trade Name of Device: | React™ 71 Catheter | |
| Common Name of Device: | Percutaneous Catheter | |
| Review Panel: | Neurology | |
| Product Code: | DQY | |
| Regulation Number: | 21 CFR 870.1250 | |
| Regulation Name: | Percutaneous Catheter | |
| Device Classification: | Class II | |
| Primary Predicate Device: | AXS Catalyst™ Distal Access Catheter
510(k)#: K151667 | |
| Additional Predicate Devices: | ReFlex™ Guide Catheter
510(k)#: K110055
React™ 68 Catheter
510(k)#: K180715 | |

Device Description:

The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with various durable polymer outer layers. A lubricious, polytetrafluoroethylene liner and Engage™ inner layer is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium marker band which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the Split-Y Introducer Sheath. The proximal end of the React™ 71 Catheter is designed with a green thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is coated with a Surmodics Serene™ Coating.

Indications for Use:

The React™ 71 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

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Device Comparison:
	AXS Catalyst™ Distal
Access Catheter
(K151667)	ReFlex™ Guide
Catheter
(K110055)	React™ 68 Catheter
(K180715)	React™ 71 Catheter
(K182097)
Indication for Use
(IFU) Statement	The AXS Catalyst™
Distal Access Catheter
is indicated for the
insertion and guidance
of appropriately sized
interventional devices
into a selected blood
vessel in the
peripheral and
neurovascular
systems. The AXS
Catalyst™ Distal
Access Catheter is
also indicated for use
as a conduit for
retrieval devices.	The ReFlex™ Guide
Catheter is indicated
for the introduction
of interventional
devices into the
peripheral and neuro
vasculature.	The React™ 68
Catheter is indicated
for the introduction
of interventional
devices into the
peripheral and neuro
vasculature.	The React™ 71
Catheter is indicated
for the introduction
of interventional
devices into the
peripheral and neuro
vasculature.
Materials
Hub	Nylon	Trogamid®	Same as K110055	Same as K110055
Strain Relief	Thermoplastic Rubber	Santoprene™	DynaFlex®	Same as K182097
Inner Layer	PTFE	Same as K151667	Same as K151667	PTFE,
Polyolefin
Reinforcement	Stainless Steel with
Nitinol and Polymer
Fiber	Nitinol	Same as K110055	Same as K110055
Outer Jacket	Pebax®	Polymeric	Grilamid™
Pebax®	Polyamide,
Polyolefin,
Polyurethane
Marker Band	Platinum/
Iridium	Same	Same	Same
	AXS Catalyst™ Distal
Access Catheter
(K151667)	ReFlex™ Guide
Catheter
(K110055)	React™ 68 Catheter
(K180715)	React™ 71 Catheter
(K182097)
Adhesive	Cyanoacrylate	Same	Same	Same
Coating	Hydrophilic	Same	Same	Same
Dimensions
Working Length	132 cm	130 cm	Same as K151667	Same as K151667
Inner Diameter	0.060"	0.072"	0.068"	0.071"
Proximal Outer
Diameter (OD)	0.079"	0.084"	0.083"	0.0855" (Max)
Distal OD	0.071"	0.084"	0.083"	0.0855" (Max)
Packaged Accessories
Peelable Sheath	Yes	Same	Same	Same
Rotating Hemostasis
Valve	Yes	No	Same as K110055	Same as K110055
Packaging
Packaging Card	Polyethylene	Same	Same	Same
Packaging Hoop	Polyethylene	Same	Same	Same
Other
Sterilization	Ethylene Oxide (EO)	Same	Same	Same

Device Comparison:

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Biocompatibility:

Biocompatibility was conducted for the React™ 71 Catheter. The React™ 71 Catheter is categorized as a limited exposure (. | The React™ 71 Catheter met the acceptance criteria for bacterial endotoxin. |
| Packaging | | |
| Visual Inspection | The React™ 71 Catheter was evaluated per ASTM F1886. | The React™ 71 Catheter met the acceptance criteria for visual inspection. |
| Bubble Leak | The React™ 71 Catheter was evaluated per ASTM F2096. | The React™ 71 Catheter met the acceptance criteria for bubble leak. |
| Seal Strength | The React™ 71 Catheter was evaluated per ASTM F88. | The React™ 71 Catheter met the acceptance criteria for seal strength. |

The following non-clinical bench testing was conducted for the React™ 71 Catheter:

Test	Test Method Summary	Results
Microbial
Bioburden	The ReactTM 71 Catheter was
evaluated per ISO 11737-1.	The ReactTM 71 Catheter met
the acceptance criteria for
bioburden.
Performance
Visual Inspection	The ReactTM 71 Catheter was
inspected under x2.5
magnification.	The ReactTM 71 Catheter met
the acceptance criteria for
visual inspection.
Dimensional Measurements	The proximal ID, distal ID,
proximal OD, distal OD, usable
length, total length, coating
length, and distal tip length of
the ReactTM 71 Catheter were
measured.	The ReactTM 71 Catheter met
the acceptance criteria for
dimensional measurements.
Tip Buckling	The ReactTM 71 Catheter was
evaluated for the maximum
compressive force it can
withstand.	The ReactTM 71 Catheter met
the acceptance criteria for tip
buckling.
Kink Resistance	The ReactTM 71 Catheter was
evaluated for the maximum
kink diameter.	The ReactTM 71 Catheter met
the acceptance criteria for kink
resistance.
Particulate	The ReactTM 71 Catheter was
evaluated per USP .	The ReactTM 71 Catheter met
the acceptance criteria for
particulate.
Test	Test Method Summary	Results
Coating Lubricity	The React™ 71 Catheter was evaluated for the average frictional forces.	The React™ 71 Catheter met the acceptance criteria for coating lubricity.
Tensile Strength	The React™ 71 Catheter was evaluated per ISO 10555-1. Annex B.	The React™ 71 Catheter met the acceptance criteria for tensile strength at the hub and shaft.
Liquid Leak	The React™ 71 Catheter was evaluated per ISO 10555-1. Annex C.	The React™ 71 Catheter met the acceptance criteria for liquid leak.
Corrosion Resistance	The React™ 71 Catheter was evaluated per ISO 10555-1. Annex A.	The React™ 71 Catheter met the acceptance criteria for corrosion resistance.
Hub Aspiration Resistance	The React™ 71 Catheter was evaluated per ISO 10555-1. Annex D.	The React™ 71 Catheter met the acceptance criteria for hub air aspiration.
Radiopacity	The markerband length and wall thickness of the React™ 71 Catheter were measured. In addition, radiopacity was confirmed via fluoroscopy.	The React™ 71 Catheter met the acceptance criteria for radiopacity.
Luer Standards	The React™ 71 Catheter was evaluated per ISO 594-1 and ISO 80369-7.	The React™ 71 Catheter met the acceptance criteria for luer standards.
Compatibility	The React™ 71 Catheter was inspected for visual damage of the catheter when delivering and retrieving interventional devices.	The React™ 71 Catheter met the acceptance criteria for delivering and retrieving interventional devices.
Torque to Failure	The React™ 71 Catheter was evaluated for transmission of proximal torque to the distal tip.	The React™ 71 Catheter was able to withstand torsional forces that are typical of clinical use.
Dynamic Pressure	The React™ 71 Catheter was evaluated for the amount of pressure it can withstand.	The React™ 71 Catheter was able to withstand pressures that are typical of clinical use.
Coating Integrity	The React™ 71 Catheter was evaluated for coating coverage and lubricity.	The React™ 71 Catheter remained coated and lubricious.
Usability	The React™ 71 Catheter and predicate device were evaluated for maneuverability and flexibility.	The React™ 71 Catheter met the acceptance criteria for usability.

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Performance Data - Animal:

Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.

Performance Data - Clinical:

Not Applicable. A determination of substantial equivalence is based upon successful completion of non-clinical bench testing as there is no change to the intended use or fundamental scientific technology.

Conclusion:

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

Non-clinical bench testing supports a determination that the subject React™ 71 Catheter is substantially equivalent to the predicate device.