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.

AI/ML Overview

The provided document describes the React™ 71 Catheter. Based on the content, here's a breakdown of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests, their methods, and states that the React™ 71 Catheter "met the acceptance criteria" or similar statements for each. Specific quantitative acceptance criteria are generally not provided in this summary, but the results confirm compliance.

Test Description	Test Method Summary	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility
Cytotoxicity (Elution Method)	The test article extract showed no evidence of causing cell lysis or toxicity and had a Grade 0 (No Reactivity).	Grade < 2 (Mild Reactivity)	Met (Grade 0: No Reactivity), 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.	No evidence of sensitization	Met, does not elicit a sensitization response.
Irritation (Intracutaneous Reactivity)	The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.2 for the Sodium Chloride and Sesame Oil test article extracts, respectively.	Difference in mean score ≤ a specified threshold (implied to be low)	Met, considered a non-irritant.
Acute Systemic Toxicity (Systemic Toxicity)	There was no mortality or evidence of systemic toxicity from the extracts injected into mice.	No mortality or systemic toxicity	Met, does not indicate signs of toxicity.
Hemocompatibility (Hemolysis)	The hemolytic index for the test article in direct contact with blood was 0.8%, and the hemolytic index for the test article extract was 0.0%.	Hemolytic index below a specified threshold	Met (0.8% and 0.0%), considered non-hemolytic.
Hemocompatibility (Complement Activation)	The concentration of SC5b-9 in the test article was not statistically higher than the activated normal human serum control or the negative control.	SC5b-9 concentration not statistically higher than controls	Met, not considered a potential activator of the complement system.
Hemocompatibility (Thrombogenicity – Canine Model)	The control article had a mean score of 2.0. The test article had a mean score of 1.7 after four (4) hours (±30 minutes) without systemic anticoagulation.	Lower thrombogenic potential than predicate/control	Met, demonstrates lower thrombogenic potential compared to ACE 68 Reperfusion Catheter.
Pyrogenicity (Material Mediated)	Not a single animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the rabbits' temperature during the three (3) hours was 0.0°C.	Temperature rise < 0.5°C above baseline	Met, considered non-pyrogenic.
Bench Performance (Leveraged Testing)
Ethylene Oxide Residual	Evaluated per ISO 10993-7.	Met acceptance criteria for residuals	Met the acceptance criteria.
Ethylene Chlorohydrin Residual	Evaluated per ISO 10993-7.	Met acceptance criteria for residuals	Met the acceptance criteria.
Bioburden Recovery	Evaluated per ISO 11737-1.	Met acceptance criteria for recovery	Met the acceptance criteria.
Bacterial Endotoxin	Evaluated per ANSI/AAMI ST72 and USP <161>.	Met acceptance criteria for endotoxin levels	Met the acceptance criteria.
Packaging Visual Inspection	Evaluated per ASTM F1886.	Met acceptance criteria for visual integrity	Met the acceptance criteria.
Bubble Leak	Evaluated per ASTM F2096.	Met acceptance criteria for leak integrity	Met the acceptance criteria.
Seal Strength	Evaluated per ASTM F88.	Met acceptance criteria for seal strength	Met the acceptance criteria.
Bench Performance (Conducted Testing)
Bioburden	Evaluated per ISO 11737-1.	Met acceptance criteria for bioburden	Met the acceptance criteria.
Visual Inspection	Inspected under x2.5 magnification.	Met acceptance criteria for visual integrity	Met the acceptance criteria.
Dimensional Measurements	Proximal ID, distal ID, proximal OD, distal OD, usable length, total length, coating length, and distal tip length measured.	Met acceptance criteria for specified dimensions	Met the acceptance criteria.
Tip Buckling	Evaluated for maximum compressive force.	Met acceptance criteria for tip buckling force	Met the acceptance criteria.
Kink Resistance	Evaluated for maximum kink diameter.	Met acceptance criteria for kink diameter	Met the acceptance criteria.
Particulate	Evaluated per USP <788>.	Met acceptance criteria for particulate levels	Met the acceptance criteria.
Coating Lubricity	Evaluated for average frictional forces.	Met acceptance criteria for frictional forces	Met the acceptance criteria.
Tensile Strength	Evaluated per ISO 10555-1. Annex B.	Met acceptance criteria for tensile strength	Met the acceptance criteria.
Liquid Leak	Evaluated per ISO 10555-1. Annex C.	Met acceptance criteria for liquid leak	Met the acceptance criteria.
Corrosion Resistance	Evaluated per ISO 10555-1. Annex A.	Met acceptance criteria for corrosion	Met the acceptance criteria.
Hub Aspiration Resistance	Evaluated per ISO 10555-1. Annex D.	Met acceptance criteria for hub air aspiration	Met the acceptance criteria.
Radiopacity	Markerband length and wall thickness measured; confirmed via fluoroscopy.	Met acceptance criteria for radiopacity	Met the acceptance criteria.
Luer Standards	Evaluated per ISO 594-1 and ISO 80369-7.	Met acceptance criteria for luer standards	Met the acceptance criteria.
Compatibility	Inspected for visual damage when delivering and retrieving interventional devices.	Met acceptance criteria for no visual damage/functionality	Met the acceptance criteria.
Torque to Failure	Evaluated for transmission of proximal torque to the distal tip.	Withstood typical clinical torsional forces	Was able to withstand torsional forces typical of clinical use.
Dynamic Pressure	Evaluated for the amount of pressure it can withstand.	Withstood typical clinical pressures	Was able to withstand pressures typical of clinical use.
Coating Integrity	Evaluated for coating coverage and lubricity.	Remained coated and lubricious	Remained coated and lubricious.
Usability	Evaluated for maneuverability and flexibility against a predicate device.	Met acceptance criteria for maneuverability and flexibility.	Met the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test. For the biocompatibility study on thrombogenicity, it mentions a "Canine Model" with "four (4) hours (±30 minutes) without systemic anticoagulation," and comparing a "control article" to the "test article." This implies a very small comparative animal study, rather than a large test set for AI evaluation.

The provenance of data (e.g., country of origin, retrospective/prospective) is not provided as the tests are primarily bench and animal studies (biocompatibility) conducted in controlled laboratory settings for device performance and safety.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a medical device submission based on product performance and biocompatibility testing, not an AI/software submission requiring expert ground truth for classification or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/software submission involving human interpretation or adjudication for ground truth, this information is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This is a medical device submission for a catheter, not an AI system that would typically undergo MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's physical and biological performance in bench and animal tests.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on established scientific and engineering standards and methods. For example:

Biocompatibility: In vitro and in vivo testing (e.g., cell cultures, guinea pigs, mice, canine model) following ISO 10993 standards.
Performance Data – Bench: Standardized laboratory tests (e.g., ISO, ASTM, USP) for physical, mechanical, and material properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" as understood in AI/machine learning. The device design and manufacturing processes are refined through engineering development, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model. For the device itself, the "ground truth" for its design and performance requirements is established through regulatory standards, predicate device characteristics, and engineering specifications.

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

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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.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 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration No.: 2029214
Contact Person:	Ryan KenneySenior Regulatory Affairs SpecialistTelephone: (949) 297-5489Email: 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 Catheter510(k)#: K151667
Additional Predicate Devices:	ReFlex™ Guide Catheter510(k)#: K110055React™ 68 Catheter510(k)#: K180715

Device Description:

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™ DistalAccess Catheter(K151667)	ReFlex™ GuideCatheter(K110055)	React™ 68 Catheter(K180715)	React™ 71 Catheter(K182097)
Indication for Use(IFU) Statement	The AXS Catalyst™Distal Access Catheteris indicated for theinsertion and guidanceof appropriately sizedinterventional devicesinto a selected bloodvessel in theperipheral andneurovascularsystems. The AXSCatalyst™ DistalAccess Catheter isalso indicated for useas a conduit forretrieval devices.	The ReFlex™ GuideCatheter is indicatedfor the introductionof interventionaldevices into theperipheral and neurovasculature.	The React™ 68Catheter is indicatedfor the introductionof interventionaldevices into theperipheral and neurovasculature.	The React™ 71Catheter is indicatedfor the introductionof interventionaldevices into theperipheral and neurovasculature.
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 withNitinol and PolymerFiber	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™ DistalAccess Catheter(K151667)	ReFlex™ GuideCatheter(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 OuterDiameter (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 HemostasisValve	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 (< 24 hours), external communicating device contacting circulating blood. The following biocompatibility was conducted for the React™ 71 Catheter:

Test Description	Results	Conclusions
Cytotoxicity(Elution Method)	The test article extract showedno evidence of causing celllysis or toxicity and had aGrade 0 (No Reactivity). Thetest article extract met therequirements of the test sincethe grade was < Grade 2(Mild Reactivity).	The ReactTM 71 Catheter isconsidered non-cytotoxic.
Sensitization(Guinea Pig Maximization Test)	The test article extractsshowed no evidence ofcausing delayed dermalcontact sensitization in theguinea pig.	The ReactTM 71 Catheter doesnot elicit a sensitizationresponse.
Irritation(Intracutaneous Reactivity)	The test article met therequirements of the test sincethe difference between eachtest article extract overallmean score and correspondingcontrol extract overall meanscore was 0.0 and 0.2 for theSodium Chloride and SesameOil test article extracts,respectively.	The ReactTM 71 Catheter isconsidered a non-irritant.
Acute Systemic Toxicity(Systemic Toxicity)	There was no mortality orevidence of systemic toxicityfrom the extracts injected intomice.	The ReactTM 71 Catheter doesnot indicate signs of toxicity.

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Test Description	Results	Conclusions
Hemocompatibility(Hemolysis)	The hemolytic index for thetest article in direct contactwith blood was 0.8%, and thehemolytic index for the testarticle extract was 0.0%.	The ReactTM 71 Catheter isconsidered non-hemolytic.
Hemocompatibility(Complement Activation)	The concentration of SC5b-9in the test article was notstatistically higher than theactivated normal human serumcontrol or the negative control.The test article wasstatistically lower than thesponsor provided controlarticle.	The ReactTM 71 Catheter is notconsidered to be potentialactivator of the complementsystem.
Hemocompatibility(Thrombogenicity – CanineModel)	The control article wasevaluated and determined tohave a mean score of 2.0. Thetest article was evaluated anddetermined to have a meanscore of 1.7 after four (4)hours (±30 minutes) withoutsystemic anticoagulation.	The ReactTM 71 Catheterdemonstrates lowerthrombogenic potential inarterial vessels compared tothe ACE 68 ReperfusionCatheter.
Pyrogenicity(Material Mediated)	Not a single animal showed atemperature rise of 0.5°C ormore above its baselinetemperature. The total rise ofthe rabbits' temperature duringthe three (3) hours was 0.0°C.	The ReactTM 71 Catheter isconsidered non-pyrogenic.

The React™ 71 Catheter has been evaluated to meet requirements specified in ISO 10993-1.

Performance Data – Bench:

Non-clinical bench testing was leveraged and conducted to evaluate the performance of the React™ 71 Catheter.

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

Test	Test Method Summary	Results
Microbial
Ethylene Oxide Residual	The React™ 71 Catheter was evaluated per ISO 10993-7.	The React™ 71 Catheter met the acceptance criteria for ethylene oxide residual.
Ethylene Chlorohydrin Residual	The React™ 71 Catheter was evaluated per ISO 10993-7.	The React™ 71 Catheter met the acceptance criteria for ethylene chlorohydrin residual.

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Test	Test Method Summary	Results
Bioburden Recovery	The React™ 71 Catheter was evaluated per ISO 11737-1.	The React™ 71 Catheter met the acceptance criteria for bioburden recovery.
Bacterial Endotoxin	The React™ 71 Catheter was evaluated per ANSI/AAMI ST72 and USP <161>.	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
MicrobialBioburden	The ReactTM 71 Catheter wasevaluated per ISO 11737-1.	The ReactTM 71 Catheter metthe acceptance criteria forbioburden.
PerformanceVisual Inspection	The ReactTM 71 Catheter wasinspected under x2.5magnification.	The ReactTM 71 Catheter metthe acceptance criteria forvisual inspection.
Dimensional Measurements	The proximal ID, distal ID,proximal OD, distal OD, usablelength, total length, coatinglength, and distal tip length ofthe ReactTM 71 Catheter weremeasured.	The ReactTM 71 Catheter metthe acceptance criteria fordimensional measurements.
Tip Buckling	The ReactTM 71 Catheter wasevaluated for the maximumcompressive force it canwithstand.	The ReactTM 71 Catheter metthe acceptance criteria for tipbuckling.
Kink Resistance	The ReactTM 71 Catheter wasevaluated for the maximumkink diameter.	The ReactTM 71 Catheter metthe acceptance criteria for kinkresistance.
Particulate	The ReactTM 71 Catheter wasevaluated per USP <788>.	The ReactTM 71 Catheter metthe acceptance criteria forparticulate.
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:

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.

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).