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

Device Description

The RIST Cath Radial Access Long Sheath (RIST Cath) is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft and has a radiopaque marker band on the distal end to aid in visualization. The catheter has a nominal outer diameter of 0.093 inches and a nominal inner diameter of 0.079 inches. It is available in two working lengths: 95 cm and 100 cm. The RIST Cath is intended to provide access to the target site via transradial access and once in place, provides a reinforcing conduit for other intravascular devices. The RIST Cath Radial Access Long Sheath has a PTFE-lined lumen to facilitate movement of other devices passing through its lumen. Accessories included with the device are a radial access dilator and a hemostasis valve. The RIST Cath is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All pre-determined acceptance criteria were met" for all listed tests. However, it does not explicitly state the numerical acceptance criteria for each test. It primarily reports that the device "met the acceptance criteria" for each specific test.

Test Performed	Acceptance Criteria (Not explicitly quantified in the document)	Reported Device Performance
Tensile Strength	Implicit: Structurally sound after simulated use	All units met the Tensile Strength acceptance criteria.
PTFE Delamination	Implicit: Liner remains adhered to outer jacket	All units met the PTFE Delamination acceptance criteria.
Torque Strength	Implicit: Ability to function in a clinical setting	All units met the Torque Strength acceptance criteria.
Hydrophilic Coating	Implicit: Coating integrity after simulation	All units met the Hydrophilic Coating acceptance criteria.
Particulates	Implicit: Particle quantities within expected parameters	The acceptance criteria for Particulate testing was met.
Dimensional Verification - ID	Implicit: ID within specified range	The acceptance criteria for ID Dimensional Verification was met.
Dimensional Verification - OD	Implicit: OD within specified range	The acceptance criteria for OD Dimensional Verification was met.
Dimensional Verification - Working Length	Implicit: Working length within specified range	The acceptance criteria for Working Length Dimensional Verification was met.
Kink Resistance	Implicit: Maintain structural integrity	All units met the Kink Resistance acceptance criteria.
Visual Inspection (Transitions & Tip)	Implicit: Integrity of transitions and tip	All units met the Transition and Tip Visual Inspection acceptance criteria
Catheter Burst	Implicit: Integrity under pressure	All units met the Catheter Burst acceptance criteria.
Liquid Leak Test	Implicit: No leakage under pressure	All units met the Liquid Leak acceptance criteria.
Air Leak Test	Implicit: No air leaks into assembly	All units met the Air Leak Test acceptance criteria.
Packaging - Pouch Peel	Implicit: Pouch seal integrity	All units met the Pouch Peel test.
Packaging - Pouch Leak	Implicit: No dye penetration through seal	All units met the Pouch Leak acceptance criteria.
Packaging - Visual Inspection	Implicit: Integrity of pouch and seals	All units met the Packaging Visual Inspection.
Packaging - Seal Width	Implicit: Seal width within specified range	All seals met the acceptance criteria for Seal Width.
Chemical Compatibility	Implicit: No degradation after exposure to chemicals	All units met the Chemical Compatibility acceptance criteria.
Hub Compatibility	Implicit: Compatibility with mating luer surfaces	All units met the Hub Compatibility acceptance criteria.
Corrosion	Implicit: Stainless steel reinforcement resists deterioration	All units met the Corrosion acceptance criteria.
Labeling Legibility - Label	Implicit: Legible after transportation and conditioning	The acceptance criteria for Labeling Legibility was met.
Labeling Legibility - IFU	Implicit: Legible after transportation and conditioning	The acceptance criteria for IFU Legibility was met.
Barcode	Implicit: Scannable and contains appropriate information	The acceptance criteria for Barcode was met.
Sterilization	Product was sterile.	Product was sterile.
Cytotoxicity	Implicit: Non-cytotoxic	The RIST Cath is non-cytotoxic.
Sensitization	Implicit: Non-sensitizer	The RIST Cath is classified as a non-sensitizer.
Irritation	Implicit: Non-irritant	The RIST Cath is non-irritant.
Material Mediated Pyrogenicity	Implicit: Non-pyrogenic	The RIST Cath is non-pyrogenic.
Systemic Toxicity	Implicit: No acute adverse effects	The RIST Cath is non-cytotoxic.
Hemolysis, ASTM Method (indirect)	Implicit: Non-hemolytic	The difference between hemolytic indexes is 0.00 percent, placing in non-hemolytic range.
Hemolysis, ASTM Method (direct)	Implicit: Non-hemolytic	The RIST Cath is non-hemolytic.
Complement Activation, C3a and SC5b-9	Implicit: Similar to comparison articles	Complement activation of C3a and SC5b assays similar for test and comparison articles.
Partial Thromboplastin Time (PTT)	Implicit: Non-activator	P values of clotting time for test article and predicate were "Similar".
Dog Thrombogenicity	Implicit: Non-thrombogenic	The RIST Cath is non-thrombogenic.
In vitro Simulated Use Study - Bench	Implicit: Performance substantially equivalent to predicate	All acceptance criteria were met. Performance found substantially equivalent to predicate.
In vitro Simulated Use Study - Usability	Implicit: Usable as per Instructions for Use	All acceptance criteria were met. Usability demonstrated as per IFU.

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

The document does not explicitly state the sample size used for the test set (number of devices tested for each performance criterion). However, for test methods like "Tensile Strength" and "PTFE Delamination," it mentions "All units met..." which suggests that a certain number of units were tested. The overall context is a premarket notification (510(k)) for a medical device seeking substantial equivalence, meaning the data is likely derived from retrospective testing performed by the manufacturer. The data provenance (country of origin) is not specified.

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

For the "In vitro Simulated Use Study - Bench," it states that "A simulated interventional procedure was performed by physicians." For the "In vitro Simulated Use Study - Usability," "Evaluators representative of the intended user population evaluated the RIST Cath Radial Access Long Sheath..."

Number of experts: Not explicitly stated (e.g., "3 physicians").
Qualifications of experts: "Physicians" for the bench study and "Evaluators representative of the intended user population" for the usability study. Specific specialties or years of experience are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "Results" column consistently states that "All units met the acceptance criteria" or similar, implying a direct assessment against predefined criteria rather than a consensus among multiple adjudicators for subjective outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study typically assesses the impact of an AI system on human reader performance, which is not relevant for this medical device (a catheter sheath).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device (a catheter sheath), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant. The performance studies are focused on the physical characteristics and functionality of the device itself.

7. Type of Ground Truth Used

The ground truth for the various performance tests is established by:

Engineering specifications and standards: Many tests reference ISO standards (e.g., ISO 10555-1, ISO 80369-7, ISO 11135:2014) or ASTM standards (e.g., ASTM F-88/F88M-15).
Established testing protocols and acceptance criteria: For each test, there were pre-determined acceptance criteria based on the device's design and intended function.
Visual inspection and measurements: For dimensional checks, visual inspections, etc.
Biological testing standards: For biocompatibility tests, standards like EN ISO 10993-1 were followed.
Clinical simulation by physicians: For the in-vitro simulated use study, the performance parameters assessed by physicians against expected clinical performance would serve as the ground truth.

There is no mention of pathology, outcomes data, or expert consensus in the sense of comparing device performance against a gold standard interpretation of a clinical condition (which would be common for diagnostic AI).

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device and does not involve a "training set" in the context of machine learning or AI algorithms.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

December 23, 2019

RIST Neurovascular, Inc. % Elena Jugo Regulatory Consultant Caraballo Consulting 11037 Bitternut Hickory Lane Boynton Beach, Florida 33437

Re: K191551

Device Name: RIST Cath Radial Access Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 27, 2019 Received: November 29, 2019

Dear Elena Jugo:

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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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, PhD, MS 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) K191551

Device Name RIST Cath Radial Access Long Sheath

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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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:	November 22, 2019
Submitter:	RIST Neurovascular, Inc.11611 Interchange Circle SMiramar, FL 33025
Primary Submission Contact:	Elena JugoRegulatory ConsultantCaraballo Consulting19700 Stirling RoadSouthwest Ranches, FL 33332Telephone: 1-305-510-4398Facsimile: 1-954-742-5989E-Mail: Elena@Caraballoconsulting.com
Secondary Submission Contact:	Marianne GrunwaldtDirector, Quality Assurance & Regulatory AffairsRIST Neurovascular Inc.19700 Stirling RoadSouthwest Ranches, FL 33332Telephone: 1-305-495-3883Facsimile: 1-954-742-5989E-Mail: Marianne@InNeuroCo.com
Trade Name:	RIST Cath Radial Access Long Sheath
Regulation Number:	21 CFR 870.1250
Device Common orClassification Name:	Percutaneous Catheter
Product Class:	Class II
Product Panel:	Cardiovascular
Product Code:	DQY
Predicate Device:Reference Predicate:	Stryker AXS Infinity # K 152876Terumo Glidesheath Slender # K173831

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1. Device Description

2. Indications for Use

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

3. Technological Characteristics and Basis for Substantial Equivalence

The RIST Cath, 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 Stryker AXS Infinity LS. The inner and outer diameters of the RIST Cath are within the cleared range of diameters for the predicate reference device, the Terumo Glidesheath Slender.

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 Cath Radial AccessLong Sheath	Predicate DeviceStryker AXS Infinity LS510(k) # K152876	Reference Predicate DeviceTerumo GlidesheathSlender510(k) # K173831
Indications for Use	The RIST Cath RadialAccess Long Sheath isindicated for the introductionof interventional devices intothe peripheral, coronary, andneuro vasculature.	The Long Sheath is indicatedfor the introduction ofinterventional devices intothe peripheral, coronary, andneuro vasculature.	The Glidesheath Slender isindicated to facilitate placinga catheter through the skininto the radial artery.
Product Code	DQY	DQY	DYB
Regulation No.	21CFR870.1250	21CFR870.1250	21 CFR 870.1340
Classification	Class II	Class II	Class II
ComponentsSupplied	Sheath, Vessel Dilator,Hemostasis Valve	Sheath, Vessel Dilator,Hemostasis Valve	Sheath, Vessel dilator, EntryNeedle, Miniguide Wire,Guidewire Inserter
Catheter ShaftMaterial	Chronoflex/Polyblend (distalmost section)ChronoflexPolyether Block Amide(PEBAX)Vestamid (proximal mostsection)	ChronoflexPolyether Block Amide(PEBAX)Vestamid	Ethylene-Tetrafluoroethylene (ETFE)copolymerColorantBarium sulfateDispersantSilicone oil
Inner Liner	PTFE	PTFE	PolypropyleneStainless Steel
Hub Material	Polycarbonate (Makrolon)	Polycarbonate	Sorbitan fatty acid ester
Strain Relief	Polyolefin	Polyolefin	PolycarbonatePolystyrene
Catheter ShaftReinforcement	Stainless Steel Coil(proximal)Nitinol Wire Coil (distal)	Stainless Steel Braid	Polyester-Chlorinatedpolyvinyl chloride
Lubricious Coating	Hydrophilic Coating	Hydrophilic Coating	Hydrophilic Coating
Radiopaque MarkerBand	Platinum/Iridium	Platinum/Iridium	Information not available
Working Length	95, 100cm	70, 80, 90 cm	10, 16 cm
Inner Diameter	0.079 inches	0.088 inches	Body: 0.074, 0.087, 0.100inchesTip: 0.070, 0.083, 0.096inches
Outer Diameter	0.093 inches	0.109 inches	0.084, 0.097, 0.110 inches
Packaging	Tyvek/Nylon pouch,polyethylene support tube,packaging card, SBS carton	Tyvek/Nylon pouch,polyethylene support tube,packaging card, SBS carton	Tyvek, Polyester-polyethylene laminated film,high impact Polystyrene
Parameter	Subject DeviceRIST Cath Radial AccessLong Sheath	Predicate DeviceStryker AXS Infinity LS510(k) # K152876	Reference Predicate DeviceTerumo GlidesheathSlender510(k) # K173831
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Pyrogenicity	Nonpyrogenic	Nonpyrogenic	Information not available
Number of Uses	Single Use	Single Use	Single Use

Table 1 – Comparison Between the RIST Cath Radial Access Long Sheath and Predicate Device

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		Table 1 - Comparison Between the RIST Cath Radial Access Long Sheath and Predicate Device

The minor differences between the subject and predicate devices are listed in Table 2, along with an explanation as to why these differences are not critical to the intended use of the device and do not impact the substantial equivalence of the subject device with the predicate device.

Feature of theDevice	Subject DeviceRIST Cath RadialAccess Long Sheath	Predicate DeviceStryker AXS InfinityLS510(k) # K152876	Reference PredicateDeviceTerumo GlidesheathSlender510(k) # K173831	Discussion /Comment
Catheter ShaftReinforcement	Stainless Steel Coil(proximal)Nitinol Wire Coil(distal)	Stainless Steel Braid	Information notavailable	The purpose of thereinforcement featureof the catheter deviceis to provide structuralsupport along thelength. This support isprovided usingvarious metals andpatterns. Thisreinforcement layer isencapsulated betweenthe inner and outerpolymer layers. Thisslight difference in thepattern and metal useddoes not impact safetyor efficacy, asdemonstrated by testresults.
WorkingLength	95, 100 cm	70, 80, 90 cm	10, 16 cm	Functional testingdemonstrated theslight difference inlength does notimpact safety orefficacy.

Table 2 – Differences Between the RIST Cath Radial Access Long Sheath and Predicate Devices

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4. Performance Data

Design verification and validation were performed to ensure that the RIST Cath 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 Cath Radial Access Long Sheath is presented in Table 3. Some of the tests were also conducted on the predicate device to help establish substantial equivalence. All pre-determined 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 Cath 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 Cath isstructurally sound afterpassing it through amodel which simulatesactual anatomy.Simulating actual usesupports the indicationsfor use which are thesame in the RIST Cathand in the predicatedevice.
PTFE Delamination	The liner was inspected forsigns of damage.	All units met the PTFEDelamination acceptancecriteria.	This test demonstratesthat the inner liner willremain adhered to theouter jacket. This testsupports substantialequivalence becauseboth the RIST Cath andthe predicate device havea PTFE liner.
Torque Strength	The distal end of the unitwas held rigid while theproximal end was turneduntil 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 Cath and inthe predicate device.
Hydrophilic Coating	The integrity of thehydrophilic coating wasinspected before and after	All units met theHydrophilic Coatingacceptance criteria.	Both the RIST Cath andthe predicate devicehave a hydrophilic
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
	simulation, and the length ofthe coating was measured.		coating which aids intracking. This testdemonstrates that thehydrophilic coating ispresent after simulateduse.In simulating actual use,the test supports theindications for usewhich are the same inthe RIST Cath and in thepredicate device andhelps supportthe presence of thehydrophilic coating.
Particulates	Particulate testing wasperformed in a tortuousmodel.	The acceptance criteriafor Particulate testing wasmet.	Both the RIST Cath andthe predicate device havea hydrophilic coating.This test quantifies thenumber of particlesgenerated duringsimulated use anddemonstrate that theparticle quantities arewithin expectedparameters which do notraise any new questionsof safety and efficacy.The test supports theindications for usewhich are the same inthe RIST Cath and in thepredicatedevice.
DimensionalVerification - ID	The ID was measured toensure the acceptance criteriawas met.	The acceptance criteriafor ID DimensionalVerification was met.	This test verifiesfunctional characteristicsof the RIST Cath. Theinternal diameter of theRIST Cath and thepredicate are minimallydifferent, but this doesnot affect safety orefficacy. The testsupports the indicationsfor use which are thesame in the RIST Cathand in the predicate

Table 3 - Summary of Performance Testing Conducted on RIST Cath

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Table 3 - Summary of Performance Testing Conducted on RIST Cath
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Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
DimensionalVerification -OD	The OD was measured toensure the acceptance criteriawas met.	The acceptance criteriafor OD DimensionalVerification was met.	This test verifiesfunctional characteristicsof the RIST Cath. Theouter diameter of theRIST Cath and thepredicate are minimallydifferent, but this doesnot affect safety orefficacy. The testsupports the indicationsfor use which are thesame in the RIST Cathand in the predicatedevice.
DimensionalVerification - WorkingLength	The working length wasmeasured to ensure theacceptance criteria was met.	The acceptance criteriafor Working LengthDimensional Verificationwas met.	This test verifies thefunctional characteristicsof working length. TheRIST Cath is offered insimilar working lengthsas the predicate device.The test supports theindications for usewhich are the same inthe RISTCath and in the predicatedevice.
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 Cath and inthe predicate device.
Visual Inspection(Transitions & Tip)	Samples were visuallyinspected to ensure theacceptance criteria were met.	All units met theTransition and Tip VisualInspection acceptancecriteria	Both the RIST Cath andthe predicate device havesimilar functionalcharacteristics. This testdemonstrates the integrityof the RIST Cath underpredetermined conditions.The test supports theindications for use whichare the same in the RISTCath and in the predicatedevice.
Catheter Burst	Testing was completed perISO 10555-1 by clamping thedistal end and pressurizing	All units met the CatheterBurst acceptance criteria.	Both the RIST and thepredicate device havesimilar functional

Table 3 - Summary of Performance Testing Conducted on RIST Cath

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Test Performed	Test Method	Results	Discussion of How This Test Supports a Finding of Substantial Equivalence
	the assembly was pressurizedand peak pressure wasrecorded.		characteristics. This testdemonstrates the integrityof the RIST Cath underpredetermined conditions.The test supports theindications for use whichare the same in the RISTCath and 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 Cath andthe predicate device havesimilar functionalcharacteristics. This testdemonstrates thefunctional integrity of theRIST Cath underpredetermined conditions.The test supports theindications for use whichare the same in the RISTCath and 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 Cath andthe predicate device havesimilar functionalcharacteristics. This testdemonstrates thefunctional integrity of theRIST Cath underpredetermined conditions.The test supports theindications for use whichare the same in the RISTCath and in the predicatedevice
	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 Cath is identical tothe predicate device.This test verifies theintegrity of the pouch sealwhich helps support thepackaging comparison.The test supports theindications for use whichare the same in the RISTCath and in the predicatedevice.
	Packaging - PouchLeak	Testing was conducted per	All units met the Pouch	The packaging of the
Test Performed	Test Method	Results	Discussion of How This Test Supports a Finding of Substantial Equivalence
Packaging - Visual Inspection	pouch was dipped into a dyed solution and visually inspected for dye penetration through the seal.	All units met the Packaging Visual Inspection.	the predicate device. This test demonstrates that the seals have no channels which would inhibit sterilization which helps support the packaging comparison. The test supports the indications for use which are the same in the RIST Cath and in the predicate device
Packaging was visually inspected to verify the integrity of the pouch and of the seals.	The packaging of the RIST Cath is identical to the predicate device. This test verifies the integrity of the pouched unit which helps support the packaging comparison. The test supports the indications for use which are the same in the RIST Cath and in the predicate device.
	The packaging of the RIST Cath is identical to the predicate device. This test verifies the integrity of the sealed pouch unit which helps support the packaging comparison. The test supports the indications for use which are the same in the RIST Cath and in the predicate device.
Packaging - Seal Width	The in-house pouch seal width was measured to ensure the acceptance criteria were met.	All seals met the acceptance criteria for Seal Width.	The packaging of the RIST Cath is identical to the predicate device. This test verifies the integrity of the sealed pouch unit which helps support the packaging comparison. The test supports the indications for use which are the same in the RIST Cath and in the predicate device.
Design Validation Testing
In vitro Simulated Use Study - Bench	The RIST Cath was prepared per the IFU with all the product accessories including the dilator and hemostasis valve. A simulated interventional procedure was performed by physicians in order to verify the product's	All acceptance criteria were met.	The performance of the RIST Cath was found to be substantially equivalent to the predicate device. The test supports the indications for use which are the same in the RIST Cath
Test Performed	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
	Competitive devices wereevaluated in order toestablish a baseline fortrackability and supportratings.		and in the predicatedevice.
In vitro Simulated UseStudy - Usability	Evaluators representative ofthe intended user populationevaluated the RIST CathRadial Access Long Sheathas per the Instructions forUse.	All acceptance criteriawere met.	The usability of theRIST Cath was able tobe used as per theInstruction for Use.The test supports theindications for usewhich are the same inthe RIST Cathand in the predicatedevice.

Table 3 – Summary of Performance Testing Conducted on RIST Cath

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Table 3 – Summary of Performance Testing Conducted on RIST Cath

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	Table 3 – Summary of Performance Testing Conducted on RIST Cath

Table 4 - Summary of Completed Testing from Previous Submissions used to Support the Subject 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, and Zenith, 510(k) #K171672
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 device andaccessories are mostly thesame as those of the RISTCath and accessories. Thistest confirms that thematerials of the RISTCath and accessories canbe used with chemicalstypically used in a clinicalsetting. The test supportsthe indications for usewhich are the same in theRIST Cath and in thepredicate device.
Hub Compatibility	Catheter luers were tested perISO 80369.	All units met the HubCompatibility acceptancecriteria	This test demonstratescompatibility of the RISTCath luer and accessoryluers with mating luersurfaces. Both thepredicate device (alongwith accessory luers) andthe RIST Cath (along withaccessory luers) have luer
Table 4 - Summary of Completed Testing from Previous Submissions used to Support the Subject Device
Test Leveraged	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
			tapered hubs. The testsupports the indicationsfor use which are thesame in the RIST Cathand in the predicatedevice.
Corrosion	Testing was conducted perISO 10555-1 Annex A.	All units met theCorrosion acceptancecriteria.	device.This test demonstrates theability of the stainlesssteel reinforcement toresist deterioration. Thistest supports substantialequivalence because theRIST Cath and thepredicate device havethe same stainless steelreinforcement.
Testing Leveraged from SYPHONTRAK SDA, 510(k) #K161262, and SYPHONTRAK IC (formerly known asthe InNeuroCo Intermediate Catheter or IC), 510(k) #K15220
Labeling Legibility -Label	Labeling was inspected toensure test remained legibleafter transportation andenvironmental conditioning.	The acceptance criteriafor Labeling Legibilitywas met.	Both the RIST Cath andthe predicate 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 Cathand in the predicatedevice.
Labeling Legibility -IFU	Labeling was inspected toensure test remained legibleafter transportation andenvironmental conditioning.	The acceptance criteriafor IFU Legibility wasmet.	Both the RIST Cath andthe predicate 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 Cathand in the predicatedevice.
Barcode	Barcode was scanned onrandomly selected carton andpouch to ensure the scanmatches the appropriateinformation.	The acceptance criteriafor Barcode was met.	Both the RIST Cath andthe predicate device havesimilar informationcontained in the productbarcode. This test verifiesthat the barcode isscannable and the
Table 4 - Summary of Completed Testing from Previous Submissions used to Support the Subject Device
Test Leveraged	Test Method	Results	Discussion of How ThisTest Supports a Findingof SubstantialEquivalence
			information within isappropriate. The testsupports the indicationsfor use which are thesame in the RIST Cathand in the predicatedevice.
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 Cath does notpresent a greaterchallenge to thesterilization process.Therefore, thesterilization process willdeliver a sterilityassurance level (SAL) ofat least $10^{-6}$ to theproduct, which is thesame as the predicatedevice.

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5. Biocompatibility Testing

The RIST Cath 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 5.

Table 5 – Summary of Biocompatibility Testing
Test	Results	Conclusion
Cytotoxicity	All test method acceptance criteria were met.	The RIST Cath is non-cytotoxic.
Sensitization	The USP 0.9% Sodium Chloride for Injection and Cottonseed Oil extracts of the test article elicited no reaction at the challenge, following an induction phase.	The RIST Cath is classified as a non-sensitizer.
Irritation	The test article sites did not show a significantly greater biological	The RIST Cath is non-irritant.

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Table 5 - Summary of Biocompatibility Testing
Test	Results	Conclusion
	reaction than the sites injected withthe control article.
Material Mediated Pyrogenicity	The test article extracts did not causea pyrogenic response and all validitycriteria were met during the assay.	The RIST Cath is non-pyrogenic.
Systemic Toxicity	The test article extracts did not causeacute adverse effects under theconditions of this assay.	The RIST Cath is non-cytotoxic.
Hemolysis, ASTM Method, indirectcontact (human blood)	The difference between thehemolytic indexes of the test articleand the negative control is 0.00
Hemolysis, ASTM Method, directcontact (human blood)	percent; this places the test article inthe non-hemolytic range.	The RIST Cath is non-hemolytic.
Complement Activation, C3a andSC5b-9	SC5b-9 curve has a correlationcoefficient above 0.95, whichindicates that the results areacceptable.	The compliment activation of theC3a and SC5b assays were similarfor test and comparison articles.
Partial Thromboplastin Time (PTT),Human Plasma	P values of clotting time for the testarticle and predicate were "Similar",hence results are acceptable.	The RIST Cath is considered to benon-activator.
Dog Thrombogenicity	The test article had an acceptableinteraction with blood under theconditions tested.	The RIST Cath is nonthrombogenic.

Tohla 5

The results of the testing demonstrate the biocompatibility of the RIST Cath 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 Cath Radial Access Long Sheath, is substantially equivalent to the predicate Stryker, AXS Infinity LS, K152876, cleared on January 8, 2016. 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).