The RIST Radial Access Catheter is a flexible, single lumen catheter compatible with 0.035 inch and 0.038-inch guidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature and is intended to provide access to the target site via transradial access. The RIST Radial Access Catheter consists of a radiopaque catheter shaft reinforced with stainless steel and has a luer connector at its proximal end for the attachment of accessories and the infusion of fluids. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes, namely Simmons 2 (SIM2) and Berenstein (BER). The catheter has a nominal outer diameter of 0.070 inches and a nominal inner diameter of 0.040 inches. It is available in two working lengths: 120 cm and 130 cm. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-theshelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided text is a 510(k) Summary for the RIST Radial Access Catheter. This document details the engineering and performance tests conducted to demonstrate the device's substantial equivalence to a predicate device, rather than the evaluation of an AI/ML medical device.

Therefore, many of the typical acceptance criteria and study design elements requested in the prompt, such as:

A table of acceptance criteria and reported device performance related to AI/ML metrics (e.g., sensitivity, specificity, AUC)
Sample size for the test set and data provenance (e.g., country, retrospective/prospective) related to clinical data for AI/ML performance
Number of experts and their qualifications for establishing ground truth for AI/ML
Adjudication method for the test set for AI/ML
Multi-Reader Multi-Case (MRMC) comparative effectiveness study for human readers with and without AI
Standalone (algorithm-only) performance
Type of ground truth used (expert consensus, pathology, outcome data) for AI/ML
Sample size for the training set and how ground truth was established for training

cannot be extracted from this document. The document describes a traditional medical device (catheter) and its physical and functional performance testing, not an AI or machine learning algorithm.

The document focuses on establishing substantial equivalence based on:

Indications for Use: Identical to the predicate device.
Technological Characteristics: Comparison of materials, dimensions, and operational principles.
Performance Data: A series of design verification and validation tests, and biocompatibility tests directly on the catheter itself.

However, I can provide the acceptance criteria and reported performance for the physical device based on the available information:

Acceptance Criteria and Device Performance (for a physical catheter; not an AI/ML device)

Acceptance Criteria (Test Performed)	Reported Device Performance (Results)
Design Verification Testing
Tensile Strength	All units met the Tensile Strength acceptance criteria.
Torque Strength	All units met the Torque Strength acceptance criteria.
Particulates (per USP <788>)	The acceptance criteria for Particulate testing was met.
Dimensional Verification - ID	The acceptance criteria for ID Dimensional Verification was met.
Dimensional Verification - OD	The acceptance criteria for OD Dimensional Verification was met.
Dimensional Verification - Working Length	The acceptance criteria for Working Length Dimensional Verification was met.
Dimensional Verification - Tip Length	The acceptance criteria for Tip Length Dimensional Verification were met.
Kink Resistance	All units met the Kink Resistance acceptance criteria.
Visual Inspection (Tip Taper/Transitions)	All units met the Tip Taper/Transition Visual Inspection acceptance criteria.
Shape Retention (Catheter Tip Shape)	All units met the Shape Retention Acceptance criteria.
Burst Test (per ISO 10555-1)	All units met the Catheter Burst acceptance criteria.
Liquid Leak Test (per ISO 10555-1)	All units met the Liquid Leak acceptance criteria.
Air Leak Test (per ISO 80369-7)	All units met the Air Leak Test acceptance criteria.
Chemical Compatibility (with saline, dextrose, heparin, radiocontrast)	All units met the Chemical Compatibility acceptance criteria.
Corrosion (per ISO 10555-1 Annex A)	All units met the Corrosion acceptance criteria.
Packaging - Visual Inspection	All units met the Packaging Visual Inspection.
Packaging - Pouch Leak (per ASTM F-1929-15)	All units met the Pouch Leak test.
Packaging - Pouch Peel (per ASTM F-88/F88M-15)	All units met the Pouch Peel test.
Packaging - Seal Width	All seals met the acceptance criteria for Seal Width.
Comparative Testing
Friction Force (in simulated-use anatomical model)	The RIST Radial Access Catheter and predicate device had comparable friction forces.
Design Validation Testing
In vitro Simulated Use Study - Bench (performance by physicians in simulated procedure, compared to competitive device)	All acceptance criteria were met. The performance was found to be substantially equivalent.
Radiopacity (physician identification of distal tip, shape, curves from fluoroscopic images)	All acceptance criteria were met. The performance was found to be substantially equivalent.
In vitro Simulated Use Study - Usability (evaluators representative of intended user population, per IFU)	All acceptance criteria were met. The catheter was able to be used as per the Instruction for Use.
Leveraged Testing (from previous submissions)
Hub Compatibility (Catheter luers per ISO 594)	All units met the Hub Compatibility acceptance criteria.
Labeling Legibility - Label	The acceptance criteria for Labeling Legibility was met.
Barcode	The acceptance criteria for Barcode was met.
Labeling Legibility - IFU	The acceptance criteria for IFU Legibility was met.
Sterilization (per ANSI/AAMI/ISO 11135:2014 and AAMI TIR 28:2016)	Product was sterile (achieved SAL of at least 10⁻⁶).
Biocompatibility Testing (per EN ISO 10993-1)
Cytotoxicity (ISO MEM Elution)	The test article is considered non-cytotoxic.
Sensitization (ISO Guinea Pig Maximization Sensitization)	The test article did not elicit a sensitization response; classified as non-sensitizer.
Irritation (ISO Intracutaneous Irritation)	No significant dermal reactions observed; non-irritant.
Systemic Toxicity (ISO Acute Systemic Injection)	No abnormal clinical signs indicative of toxicity; non-cytotoxic (conclusion oddly repeats cytotoxicity).
Complement Activation, SC5b-9 Assay	SC5b-9 assay results not statistically significant when compared to reference material and comparison.
Hemocompatibility (ASTM Hemolysis - Direct Contact and Extract Method)	Test article returned a blank corrected percent hemolysis above the negative control of 0.0% (interpreted as non-hemolytic based on conclusion).
Pyrogenicity (Materials Mediated Rabbit Pyrogen)	Test article extracts did not cause a pyrogenic response; non-pyrogenic.

Study Details (for a physical catheter, not AI/ML):

Sample sizes used for the test set and the data provenance: The document generally states "All units" or "Samples" without specifying the exact number of units tested for each criterion. The data provenance is internal RIST Neurovascular testing, leveraging some data from previously cleared devices (K152202, K161262, K152876). The studies are evidently prospective, laboratory/benchtop tests, not clinical studies on human subjects, hence "country of origin of the data" in a clinical sense is not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For the In vitro Simulated Use Study - Bench and Radiopacity tests, "physicians" were used. For the In vitro Simulated Use Study - Usability, "evaluators representative of the intended user population" were used. No specific number or qualifications (e.g., years of experience, specialty) of these experts are provided in the summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and not mentioned, as these are primarily objective engineering performance tests rather than subjective human assessments requiring adjudication. For the tests involving physicians/evaluators, specific adjudication methods are not detailed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done, as this is a physical medical device (catheter), not an AI/ML system being evaluated for diagnostic accuracy improvement.
If a standalone performance was done: Yes, the described performance tests (e.g., tensile strength, torque strength, dimensional verification, kink resistance, burst, leak tests, biocompatibility, sterilization) were performed directly on the RIST Radial Access Catheter in a standalone manner to demonstrate its inherent properties and safety.
The type of ground truth used: For most engineering tests, the ground truth is established by the specified ISO/ASTM standards and internal acceptance criteria (e.g., a specific pressure for burst test, a specific force for tensile strength). For the simulated use and radiopacity tests, the 'ground truth' is the observable, functional performance and perception by the evaluating physicians/users, often compared to the predicate device. Biocompatibility used standard biological test methods.
The sample size for the training set: Not applicable. This is a physical device submission, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for a physical device.

Summary

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May 2, 2020

RIST Neurovascular, Inc. Vyoma Chikara Design Quality/RA 11611 Interchange Circle South Miramar, Florida 33025

Re: K200417

Device Name: RIST Radial Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: OJP, DOY Dated: February 19, 2020 Received: February 20, 2020

Dear Vyoma Chikara:

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

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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,

Xiaolin Zheng, Ph.D., M.S. Director 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) K200417

Device Name RIST Radial Access Catheter

Indications for Use (Describe)

The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, 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

Date Summary Prepared:	April 23, 2020
Submitter:	RIST Neurovascular, Inc.11611 Interchange Circle SMiramar, FL 33025
Primary Submission Contact:	Vyoma Upadhya ChikaraDesign Quality/RARIST Neurovascular Inc.11611 Interchange Circle SouthMiramar, FL 33025Telephone: 1-954-559-1323Facsimile: 1-954-742-5989E-Mail: Vyoma@InNeuroCo.com
Secondary Submission Contact:	Marianne GrunwaldtDirector, Quality Assurance & Regulatory AffairsRIST Neurovascular Inc.11611 Interchange Circle SouthMiramar, FL 33025Telephone: 1-305-495-3883Facsimile: 1-954-742-5989E-Mail: Marianne@InNeuroCo.com
Trade Name:	RIST Radial Access Catheter
Regulation Number:	21 CFR 870.1250
Device Common orClassification Name:	Percutaneous Catheter
Product Class:	Class II
Product Panel:	Cardiovascular
Product Code:	QJP, DQY
Predicate Device:	Penumbra, Inc. Benchmark Intracranial AccessSystem (5F Select Catheter), #K142321
Reference Predicate:	RIST Cath Radial Access Long Sheath, #K191551

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1. Device Description

2. Indications for Use

The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The indication for use for the RIST Radial Access Catheter is identical to the indication for use of the predicate device.

3. Technological Characteristics and Basis for Substantial Equivalence

The RIST Radial Access Catheter, subject of this 510(k) submission, is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, sterilization method and performance to the predicate device, the Penumbra, Inc. 5F Select Catheter that was cleared as part of the Benchmark Intracranial Access System, and the reference predicate device, the RIST Cath Radial Access Long Sheath.

A comparison of the technological characteristics of the subject device, the predicate, and the reference predicate devices, is summarized in Table 1.

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Parameter	Subject DeviceRIST Radial AccessCatheter	Predicate DevicePenumbra BenchmarkAccess System (5F SelectCatheter)510(k) # K142321	Reference Predicate DeviceRIST Cath Radial AccessLong Sheath510(k) #K191551
Indications for Use	The RIST Radial AccessCatheter is indicated for theintroduction of interventionaldevices into the peripheral,coronary, and neurovasculature.	The Benchmark IntracranialAccess System is indicatedfor the introduction ofinterventional devices intothe peripheral, coronary, andneuro vasculature.	The RIST Cath RadialAccess Long Sheath isindicated for the introductionof interventional devices intothe peripheral, coronary, andneuro vasculature.
Product Code	QJP, DQY	DQY	DQY
Regulation No.	21 CFR 870.1250	21 CFR 870.1250	21 CFR 870.1250
Classification	Class II	Class II	Class II
Catheter Material	Polyether Block Amide(PEBAX) with BaSO4	Commonly used medicalgrade plastics	Chronoflex/Polyblend (distalmost section)ChronoflexPolyether Block Amide(PEBAX)Vestamid (proximal mostsection)
Hub Material	Polycarbonate (Makrolon)	Not Available	Polycarbonate (Makrolon)
Catheter ShaftReinforcement	Stainless Steel	Stainless Steel	Stainless Steel Coil(proximal)Nitinol Wire Coil (distal)
Working Length	120, 130 cm	123, 131.5 cm	95, 100 cm
Inner Diameter	0.040 inches Minimum	0.043 inches Maximum	0.079 inches
Outer Diameter	0.070 inches Maximum	0.069 inches Maximum	0.093 inches
Tip Shapes	Simmons 2Berenstein	SimmonsBerensteinHI	N/A
Packaging	Tyvek/Nylon pouch,polyethylene support tube,packaging card, SBS carton	Commonly used medicaldevice packaging materials	Tyvek/Nylon pouch,polyethylene support tube,packaging card, SBS carton
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Pyrogenicity	Nonpyrogenic	Nonpyrogenic	Nonpyrogenic
Number of Uses	Single Use	Single Use	Single Use

Table 1 – Comparison Between the RIST Radial Access Catheter and Predicate Device

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4. Performance Data

Design verification and validation were performed to ensure that the RIST Radial Access Catheter meets its performance specifications and demonstrates substantial equivalence to the predicate device. There are no known performance standards for this device. A list of the performance testing conducted on the RIST Radial Access Catheter is presented in Table 2. Some of the tests were also conducted on the predicate device to help establish substantial equivalence. All predetermined acceptance criteria were met.

In some cases, verification test data were leveraged from data that had been generated from testing done on previously cleared devices. These tests are included in Table 3.

The data demonstrates that the RIST Radial Access Catheter is substantially equivalent to the predicate device.

Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
Design Verification Testing
Tensile Strength	Testing was completed perISO 10555-1. Using a forcegauge, test samples werepulled until failure.	All units met the TensileStrength acceptancecriteria.	This test demonstratesthat the RIST RadialAccess Catheter isstructurally sound afterpassing it through amodel which simulatesactual anatomy.Simulating actual usesupports the indicationsfor use which are thesame in the RIST RadialAccess Catheter and inthe predicate device.
Torque Strength	The distal end of the unit washeld rigid while the proximalend was turned until failure.	All units met the TorqueStrength acceptancecriteria.	This test demonstrates theability of the unit tofunction in a clinicalsetting and thereforesupports the indicationsfor use which is the samein the RIST Radial AccessCatheter and in thepredicate device.
Particulates	Particulate testing wasperformed in a tortuousmodel and particulate countwas evaluated per USP<788>.	The acceptance criteriafor Particulate testing wasmet.	This test quantifies thenumber of particlesgenerated duringsimulated use anddemonstrate that theparticle quantities arewithin expectedparameters which do notraise any new questions
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
			of safety and efficacy.The test supports theindications for usewhich are the same inthe RIST Radial AccessCatheter and in thepredicate device.
DimensionalVerification - ID	The ID was measured toensure the acceptance criteriawas met.	The acceptance criteriafor ID DimensionalVerification was met.	This test verifiesfunctional characteristicsof the RIST RadialAccess Catheter. Theinternal diameter of theRIST Radial AccessCatheter and thepredicate are minimallydifferent, but this doesnot affect safety orefficacy. The testsupports the indicationsfor use which are thesame in the RIST RadialAccess Catheter and inthe predicate device.
DimensionalVerification -OD	The OD was measured toensure the acceptance criteriawas met.	The acceptance criteriafor OD DimensionalVerification was met.	This test verifiesfunctional characteristicsof the RIST RadialAccess Catheter. Theouter diameter of theRIST Radial AccessCatheter and thepredicate are minimallydifferent, but this doesnot affect safety orefficacy. The testsupports the indicationsfor use which are thesame in the RIST RadialAccess Catheter and inthe predicate device.
DimensionalVerification - WorkingLength	The working length wasmeasured to ensure theacceptance criteria were met.	The acceptance criteriafor Working LengthDimensional Verificationwas met.	This test verifies thefunctional characteristicsof working length. TheRIST Radial AccessCatheter is offered insimilar working lengthsas the predicate device.The working length ofthe RIST Radial AccessCatheter and the
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
			predicate are minimallydifferent, but this doesnot affect safety orefficacy. The testsupports the indicationsfor use which are thesame in the RIST RadialAccess Catheter and inthe predicate device.
DimensionalVerification - TipLength	The tip length was measuredto ensure the acceptancecriteria were met.	The acceptance criteriafor Tip LengthDimensional Verificationwere met.	Both the RIST RadialAccess Catheter and thepredicate device havesimilar functionalcharacteristics. This testdemonstrates theintegrity of the RISTRadial Access Catheterunder predeterminedconditions. The testsupports the indicationsfor use which are thesame in the RIST RadialAccess Catheter and inthe predicate device.
Kink Resistance	Test units were wrappedaround progressively smallerdiameter pegs and/ormandrels until a kink wasobserved.	All units met the KinkResistance acceptancecriteria.	This test demonstrates theability of the unit tomaintain structuralintegrity and thereforesupports the indicationsfor use which is the samein the RIST Radial AccessCatheter and in thepredicate device.
Visual Inspection (TipTaper/Transitions)	Samples were visuallyinspected to ensure theacceptance criteria were met.	All units met the TipTaper/Transition VisualInspection acceptancecriteria	Both the RIST RadialAccess Catheter and thepredicate device havesimilar functionalcharacteristics. This testdemonstrates the integrityof the RIST RadialAccess Catheter underpredetermined conditions.The test supports theindications for use whichare the same in the RISTRadial Access Catheterand in the predicatedevice.
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
Shape Retention(Catheter Tip Shape)	Samples were individuallyinspected to ensure that theshape met the specifiedspecification.	All units met the ShapeRetention Acceptancecriteria.	Both the RIST and thepredicate device havesimilar functionalcharacteristics. This testdemonstrates the RISTRadial Access Cathetertip will retain its shape.The test supports theindications for use whichare the same in the RISTRadial Access Catheterand in the predicatedevice.
Burst Test	Testing was completed perISO 10555-1 by clamping thedistal end and pressurizingthe assembly was pressurizedand peak pressure wasrecorded.	All units met the CatheterBurst acceptance criteria.	Both the RIST RadialAccess Catheter and thepredicate device havesimilar functionalcharacteristics. This testdemonstrates the integrityof the RIST RadialAccess Catheter underpredetermined conditions.The test supports theindications for use whichare the same in the RISTRadial Access Catheterand in the predicatedevice.
Liquid Leak Test	Testing was completed perISO 10555-1 by connectingthe catheter to testequipment, sealing the distalend of the catheter,pressurizing the catheter,holding the pressure, andensuring there was noleakage.	All units met the LiquidLeak acceptance criteria.	Both the RIST RadialAccess Catheter and thepredicate device havesimilar functionalcharacteristics. This testdemonstrates thefunctional integrity of theRIST Radial AccessCatheter underpredetermined conditions.The test supports theindications for use whichare the same in the RISTRadial Access Catheterand in the predicatedevice.
Air Leak Test	Testing was conducted perISO 80369-7 to ensure no airleaks into the productassembly.	All units met the Air LeakTest acceptance criteria.	Both the RIST RadialAccess Catheter and thepredicate device havesimilar functionalcharacteristics. This test
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
			demonstrates thefunctional integrity of theRIST Radial AccessCatheter underpredetermined conditions.The test supports theindications for use whichare the same in the RISTRadial Access Catheterand in the predicatedevice.
Chemical Compatibility	Samples of catheter andaccessories were exposed tosaline, dextrose, heparin, andradiocontrast and theninspected for any signs ofdegradation and ensure theID had no obstruction.	All units met theChemical Compatibilityacceptance criteria.	The materials of thepredicate are mostly thesame as those of the RISTRadial Access Catheter.This test confirms that thematerials of the RISTRadial Access Cathetercan be used withchemicals typically usedin a clinical setting. Thetest supports theindications for use whichare the same in the RISTRadial Access Catheterand in the predicatedevice.
Corrosion	Testing was conducted perISO 10555-1 Annex A.	All units met theCorrosion acceptancecriteria.	This test demonstrates theability of the stainless-steel reinforcement toresist deterioration. Thistest supports substantialequivalence because theRIST Radial AccessCatheter and the predicatedevice have the samestainless steelreinforcement.
Packaging - VisualInspection	Packaging was visuallyinspected to verify theintegrity of the pouch andverify the product was freefrom damage prior to, andwhen removed from thepackaging.	All units met thePackaging VisualInspection.	The packaging of theRIST Radial AccessCatheter is identical tothe reference predicatedevice. This test verifiesthe integrity of thepouched unit whichhelps support thepackaging comparison.The test supports theindications for use
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
			which are the same inthe RIST Radial AccessCatheter and in thepredicate device.
Packaging - PouchLeak	Testing was conducted perASTM F-1929-15. Thepouch was dipped into a dyedsolution and visuallyinspected for dye penetrationthrough the seal.	All units met the PouchLeak test	The packaging of theRIST Radial AccessCatheter is identical tothe reference predicatedevice. This testdemonstrates that theseals have no channelswhich would inhibitsterilization which helpssupport the packagingcomparison. The testsupports the indicationsfor use which are thesame in the RISTRadial AccessCatheter and in thepredicate device.
Packaging - Pouch Peel	Testing was conducted perASTM F-88/F88M-15. ASample from the chevron sealand in-house seal were cutand pulled using a forcegauge until the two pieces ofpouch material separate.	All units met the PouchPeel test.	The packaging of theRIST Radial AccessCatheter is identical tothe reference predicatedevice. This test verifiesthe integrity of thepouch seal which helpssupport the packagingcomparison. The testsupports the indicationsfor use which are thesame in the RIST RadialAccess Catheter and inthe predicate device.
Packaging - Seal Width	The in-house pouch sealwidth was measured toensure the acceptance criteriawere met.	All seals met theacceptance criteria forSeal Width.	The packaging of theRIST Radial AccessCatheter is identical tothe reference predicatedevice. This test verifiesthe integrity of thesealed pouch unit whichhelps support thepackaging comparison.The test supports theindications for usewhich are the same inthe RIST Radial AccessCatheter and in thepredicate device.
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
Comparative Testing
Friction Force	The frictional forces of theRIST Radial Access Catheterand the predicate Penumbracatheter were measured whendeployed and retracted in asimulated-use anatomicalmodel.	The RIST Radial AccessCatheter and predicatedevice had comparablefriction forces.	Both the RIST RadialAccess Catheter andthe predicate devicehave comparablefriction forces. The testsupports the indicationsfor use which are thesame in the RISTRadial Access Catheterand in the predicatedevice.
Design Validation Testing
In vitro Simulated UseStudy - Bench	The Berenstein (BER) andSimmons 2 (SIM2) shapes ofthe RIST Radial AccessCatheter were prepared perthe IFU. A simulatedinterventional procedure wasperformed by physicians inorder to verify the product'sperformance.Competitive devices wereevaluated in order toestablish a baseline fortrackability and supportratings. (Note - thecompetitive deviceused for this evaluationwas Penumbra NeuronSelect 5Fr (K082290).This device is identicalto the predicate 5FrSelect catheter, clearedas part of theBenchmarkIntracranial AccessSystem (K142321).	All acceptance criteriawere met.	The performance of theRIST Radial AccessCatheter was found tobe substantiallyequivalent to thepredicate device. Thetest supports theindications for usewhich are the same inthe RIST RadialAccess Catheter and inthe predicate device.
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
Radiopacity	Physicians will be shownfluoroscopic images of theRIST Radial Access Catheterand asked to identify thelocation of the distal tip, theshape of the catheter, and thelocation of each curve along theshape of the catheter.	All acceptance criteria weremet.	The performance of theRIST Radial AccessCatheter was found tobe substantiallyequivalent to thepredicate device. Thetest supports theindications for usewhich are the same inthe RIST RadialAccess Catheter and inthe predicate device.
In vitro Simulated UseStudy - Usability	Evaluators representative ofthe intended user populationevaluated the RIST RadialAccess Catheter as per theInstructions for Use.	All acceptance criteriawere met.	The usability of theRIST Radial AccessCatheter was able to beused as per theInstruction for Use.The test supports theindications for usewhich are the samein the RIST RadialAccess Catheter andin the predicate device.
Test Leveraged	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
Testing Leveraged from SYPHONTRAK IC (formerly known as the InNeuroCo Intermediate Catheter orIC), 510(k) #K152202
Hub Compatibility	Catheter luers were tested perISO 594.	All units met the HubCompatibility acceptancecriteria	This test demonstratescompatibility of the RISTRadial Access Catheterluer with mating luersurfaces. Both thepredicate device and theRIST Radial AccessCatheter have luer taperedhubs. The test supportsthe indications for usewhich are the same in theRIST Radial AccessCatheter and in thepredicate device.
Testing Leveraged from SYPHONTRAK SDA, 510(k) #K161262
Labeling Legibility -Label	Labeling was inspected toensure test remained legibleafter transportation andenvironmental conditioning.	The acceptance criteriafor Labeling Legibilitywas met.	Both the RIST RadialAccess Catheter and thepredicate device havesimilar informationcontained in the productlabel. This test verifiesthat the text of the label islegible. The test supportsthe indications for usewhich are the same in theRIST Radial AccessCatheter and in thepredicate device.
Barcode	Barcode was scanned onrandomly selected carton andpouch to ensure the scanmatches the appropriateinformation.	The acceptance criteriafor Barcode was met.	Both the RIST RadialAccess Catheter and thepredicate device havesimilar informationcontained in the productbarcode. This test verifiesthat the barcode isscannable and theinformation within isappropriate. The testsupports the indicationsfor use which are thesame in the RIST RadialAccess Catheter and inthe predicate device.
Test Leveraged	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
Testing Leveraged from SYPHONTRAK SDA, 510(k) #K161262, and SYPHONTRAK IC (formerly knownas the InNeuroCo Intermediate Catheter or IC), 510(k) #K152202
Labeling Legibility -IFU	Labeling was inspected toensure test remained legibleafter transportation andenvironmental conditioning.	The acceptance criteriafor IFU Legibility wasmet.	Both the RIST RadialAccess Catheter and thepredicate device havesimilar informationcontained in the productIFU. This test verifies thatthe text of the IFU islegible. The test supportsthe indications for usewhich are the same in theRIST Radial AccessCatheter and in thepredicate device.
Testing Leveraged from AXS Infinity LS, 510(k) #K152876
Sterilization	Testing was performed perANSI/AAMI/ISO11135:2014 and AAMI TIR28:2016	Product was sterile.	The adoption assessmentdocumented evidence thatthe RIST Radial AccessCatheter does not presenta greater challenge to thesterilization process.Therefore, thesterilization process willdeliver a sterilityassurance level (SAL) ofat least 10⁻⁶ to theproduct, which is thesame as the predicatedevice.
Biological Effect	Test	Results	Conclusion
Cytotoxicity	ISO MEM Elution	The test article isconsidered non-cytotoxicunder the conditions ofthis test. No abnormalevents such as pHchange or debris werenoted.	The RIST RadialAccess Catheter isnon-cytotoxic.
				Sensitization	ISO Guinea PigMaximizationSensitization	Under the conditions ofthis protocol, the testarticle did not elicit asensitization response.	The RIST RadialAccess Catheter isclassified as a non-sensitizer.
								Irritation	ISO IntracutaneousIrritation	No significant dermalreactions were observedat the injected test andcontrol sites in any of thetest subjects.	The RIST RadialAccess Catheter isnon-irritant.
Systemic Toxicity	ISO Acute SystemicInjection	None of the studysubjects were observedwith abnormal clinicalsigns indicative oftoxicity during the testperiod.	The RIST RadialAccess Catheter isnon-cytotoxic.
					Complement Activation,SC5b-9 Assay	The test article results inthe SC5b-9 assay werenot statisticallysignificant (p>0.05)when compared to thereference material andcomparison article.	The complimentactivation of the SC5bassays were similar fortest and comparisonarticles.
								Hemocompatibility	ASTM Hemolysis -Direct Contact andExtract Method	For Direct Contactmethod and Extractmethod, the test articlereturned a blankcorrected percenthemolysis above thenegative control of 0.0%.	The RIST RadialAccess Catheter isnon-hemolytic.

				Pyrogenicity	Materials MediatedRabbit Pyrogen	The test article extractsdid not cause apyrogenic response andall validity criteria weremet during the assay.	The RIST RadialAccess Catheter isnon-pyrogenic.

Table 2 - Summary of Performance Testing Conducted on RIST Radial Access Catheter

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Table 3 – Summary of Testing Leveraged from Previous Submissions

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5. Biocompatibility Testing

The RIST Radial Access Catheter was assessed for biocompatibility in accordance with EN ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The biological effects tests performed are summarized in Table 4 .

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Table 4 – Summary of Biocompatibility Testing

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The results of the testing demonstrate the biocompatibility of the RIST Radial Access Catheter for its indicated use.

6. Conclusion

Review of the verification and validation test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the RIST Radial Access Catheter, is substantially equivalent to the predicate Penumbra 5F Select Catheter which was cleared as part of the Benchmark Intracranial Access System, K142321, on January 26, 2015. Any differences between the subject and the predicate devices do not raise any issues of safety and effectiveness.

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).