It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.

Device Description

The RIST Radial Access Catheter is a flexible, single lumen catheter compatible with 0.038inch quidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature, facilitate introduction of diagnostic agents in the 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. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-the-shelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided text discusses the RIST Radial Access Catheter (K201682) and its substantial equivalence to predicate devices, primarily focusing on performance testing. However, it does not contain information related to an AI/ML device. The document is a 510(k) summary for a physical medical device (catheter) and the performance data presented pertains to physical properties, mechanical tests, and biocompatibility, not AI model performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set data) are specific to the evaluation of AI/ML models, which are not applicable to the RIST Radial Access Catheter described here.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

September 28, 2020

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

Re: K201682

Trade/Device Name: RIST Radial Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQO Dated: August 28, 2020 Received: August 31, 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 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

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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 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,

Naira Muradvan, Ph.D. Assistant 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) K201682

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.

It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510K SUMMARY	K201682
Date Summary Prepared:	September 23, 2020
Submitter:	RIST Neurovascular, Inc.11611 Interchange Circle SouthMiramar, FL 33025
Primary Submission Contact:	Vyoma Upadhya ChikaraDesign Quality & Requlatory AffairsRIST 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
Requlation Number:	21 CFR 870.1250
Device Common orClassification Name:	Percutaneous Catheter
Product Class:	Class II
Product Panel:	Neurovascular
Product Code:	QJP
Secondary Product Code:	DQO
Predicate Devices:	SOFIA 6F Plus/Distal Access Catheter (K150366)RIST Radial Access Catheter (K200417)

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A) Device Description

B) Indications for Use

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

It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.

C) 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 devices, the SOFIA 6F Plus/Distal Access Catheter (K150366), and RIST Radial Access Catheter (K200417). A comparison of the technological characteristics of the subject device, the predicate devices, is summarized in Table c.1 below.

Parameter	Subject DeviceRIST Radial Access Catheter	Predicate DeviceSOFIA 6Fr PLUS/DistalAccess Catheter(K150366)	Predicate DeviceRIST Radial Access Catheter(K200417)
Indications forUse	The RIST Radial AccessCatheter is indicated for theintroduction of interventionaldevices into the peripheral,coronary and neurovasculature.It can be used to facilitateintroduction of diagnosticagents in the neurovasculature. It is not intended tofacilitate introduction ofdiagnostic agents in coronaryor peripheral arteries.	The SOFIA PLUS/DistalAccess Catheters areindicated for generalintravascular use, includingthe neuro and peripheralvasculature. It can be used tofacilitate introduction ofdiagnostic and therapeuticagents. It is not intended foruse in coronary arteries.	RIST Radial Access Catheter isindicated for the introduction ofinterventional devices into theperipheral, coronary, and neurovasculature.
Principles ofoperation	The device is advanced into thevasculature over a guidewire.	Same	Same
Parameter	Subject DeviceRIST Radial Access Catheter	Predicate DeviceSOFIA 6Fr PLUS/DistalAccess Catheter(K150366)	Predicate DeviceRIST Radial Access Catheter(K200417)
	once advanced and placed intothe desired vasculature, theinner lumen is used to deliverdevices or diagnostic agents.
PerformanceTesting	The product performance hasbeen evaluated per ISO10555-1.	Same	Same
Product Code	QJP, DQO	DQY, DQO	QJP, DQY
Classification	Class II	Same	Same
Material	Catheter Body:Outer polymer jacket ofPolyether Block Amide(PEBAX) with BaSO4Inner polymer layer ofPolyether Block Amide(PEBAX) with BaSO4	Catheter Body:Outer polymer jacket ofPolyamide (Grilamid),Polyether Block Amide(PEBAX), and polyurethaneelastomer (Polyblend andPellethane)Inner polymer layer of PTFEand polyolefin elastomer	Same as subject device
	Reinforcement layer:Stainless Steel Braid	Reinforcement layer:Stainless Steel Braid/Coil	Same as subject device
	Strain Relief: Polyolefin Hub:Polycarbonate (Makrolon)	Strain Relief: PolyurethaneHub: Nylon	Same as subject device
Catheter ShaftReinforcementPattern	Braid	Same	Same
HydrophilicCoating	No	Yes	Same as subject device
Visibility underfluoroscopy	Yes	Same	Same
Working Length	120 and 130 cm	115cm - 135cm	Same as subject device
Outer Diameter	5.5Fr	5Fr and 6Fr	Same as subject device
Inner Diameter	0.040 inches	0.055 inches and 0.070inches	Same as subject device
Tip ShapesOffered	Yes	Steam Shapeable by user	Same as subject device
Packaging	Pouch & Carton	Same	Same
Sterilization	Ethylene Oxide	Same	Same
Number of Uses	Single Use	Same	Same

Table c.1 Technological Characteristics comparison

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D) 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 devices. There are no known performance standards for this device, the verification and validation test data, including biocompatibility were leveraged from data that had been generated from testing done on a previously cleared device. The summary of these tests is included in Table d.2.

To support the indication for use for the subject device RIST Radial Access Catheter in diagnostic angiography procedures, the following additional testing was performed: Power Injection testing. A summary of this test is presented in Table d.1.

Test Performed	Test Method / Applicable Standard	Results
Power Injection	Testing was completed per ISO 10555-1 connectingunits to power injector at different flow rates using testfluid.	All units met the power injectionacceptance criteria.

Table d. 1 Summary of Additional testing Conducted

Table d.2 Summary of Testing leveraged from previous cleared device
Test Performed	Test Method / Applicable Standard	Results
Testing Leveraged from RIST RADIAL ACCESS Catheter (K200417)
Tensile Strength	Testing was completed per ISO 10555-1. Using aforce gauge, test samples were pulled until failure.	All units met the Tensile Strengthacceptance criteria.
Torque Strength	The distal end of the unit was held rigid while theproximal end was turned until failure.	All units met the Torque Strengthacceptance criteria.
Particulates	Particulate testing was performed in a tortuousmodel and particulate count was evaluated per USP<788>.	The acceptance criteria forParticulate testing was met.
DimensionalVerification - ID	The ID was measured to ensure the acceptancecriteria was met.	The acceptance criteria for IDDimensional Verification was met.
DimensionalVerification -OD	The OD was measured to ensure the acceptancecriteria was met.	The acceptance criteria for ODDimensional Verification was met.
DimensionalVerification - WorkingLength	The working length was measured to ensure theacceptance criteria were met.	The acceptance criteria for WorkingLength Dimensional Verification wasmet.
DimensionalVerification - TipLength	The tip length was measured to ensure theacceptance criteria were met.	The acceptance criteria for TipLength Dimensional Verification weremet.
Kink Resistance	Test units were wrapped around progressivelysmaller diameter pegs and/or mandrels until a kinkwas observed.	All units met the Kink Resistanceacceptance criteria.
Visual Inspection (TipTaper/Transitions)	Samples were visually inspected to ensure theacceptance criteria were met.	All units met the Tip Taper/TransitionVisual Inspection acceptance criteria
Shape Retention(Catheter Tip Shape)	Samples were individually inspected to ensure thatthe shape met the specified specification.	All units met the Shape RetentionAcceptance criteria.
Radiopacity	Physicians will be shown fluoroscopic images of theRIST Radial Access Catheter and asked to identifythe location of the distal tip, the shape of thecatheter, and the location of each curve along theshape of the catheter.	All acceptance criteria were met.
Test Performed	Test Method / Applicable Standard	Results
Testing Leveraged from RIST RADIAL ACCESS Catheter (K200417)
Burst Test	Testing was completed per ISO 10555-1 byclamping the distal end and pressurizing theassembly was pressurized and peak pressure wasrecorded.	All units met the Catheter Burstacceptance criteria.
Liquid Leak Test	Testing was completed per ISO 10555-1 byconnecting the catheter to test equipment, sealingthe distal end of the catheter, pressurizing thecatheter, holding the pressure, and ensuring therewas no leakage.	All units met the Liquid Leakacceptance criteria.
Air Leak Test	Testing was conducted per ISO 80369-7 to ensureno air leaks into the product assembly.	All units met the Air Leak Testacceptance criteria.
Hub Compatibility	Catheter luers were tested per ISO 594.	All units met the Hub Compatibilityacceptance criteria
Chemical Compatibility	Samples of catheter and accessories were exposedto saline, dextrose, heparin, and radiocontrast andthen inspected for any signs of degradation andensure the ID had no obstruction.	All units met the ChemicalCompatibility acceptance criteria.
Corrosion	Testing was conducted per ISO 10555-1 Annex A.	All units met the Corrosionacceptance criteria.
Packaging - VisualInspection	Packaging was visually inspected to verify theintegrity of the pouch and verify the product was freefrom damage prior to, and when removed from thepackaging.	All units met the Packaging VisualInspection.
Packaging - PouchLeak	Testing was conducted per ASTM F-1929-15. Thepouch was dipped into a dyed solution and visuallyinspected for dye penetration through the seal.	All units met the Pouch Leak test
Packaging - PouchPeel	Testing was conducted per ASTM F-88/F88M-15. ASample from the chevron seal and in-house sealwere cut and pulled using a force gauge until thetwo pieces of pouch material separate.	All units met the Pouch Peel test.
Packaging - SealWidth	The in-house pouch seal width was measured toensure the acceptance criteria were met.	All seals met the acceptance criteriafor Seal Width.
Labeling Legibility -Label	Labeling was inspected to ensure test remainedlegible after transportation and environmentalconditioning.	The acceptance criteria for LabelingLegibility was met.
Barcode	Barcode was scanned on randomly selected cartonand pouch to ensure the scan matches theappropriate information.	The acceptance criteria for Barcodewas met.
Labeling Legibility -IFU	Labeling was inspected to ensure test remainedlegible after transportation and environmentalconditioning.	The acceptance criteria for IFULegibility was met.
Sterilization	Testing was performed per ANSI/AAMI/ISO11135:2014 and AAMI TIR 28:2016	Product was sterile.
Biocompatibility	Cytotoxicity(ISO MEM Elution)	The test article is considered non-cytotoxic under the conditions of thistest. No abnormal events such as pHchange or debris were noted.
	Sensitization(ISO Guinea Pig Maximization Sensitization)	Under the conditions of this protocol,the test article did not elicit asensitization response.
Test Performed	Test Method / Applicable Standard	Results
Testing Leveraged from RIST RADIAL ACCESS Catheter (K200417)
	Irritation(ISO Intracutaneous Irritation)	No significant dermal reactions wereobserved at the injected test andcontrol sites in any of the testsubjects.
	Systemic ToxicityISO Acute Systemic Injection	None of the study subjects wereobserved with abnormal clinical signsindicative of toxicity during the testperiod.
	HemocompatibilityComplement Activation, SC5b-9 Assay	The test article results in the Sc5b-9assay were not statistically significant(p>0.05) when compared to thereference material and comparisonarticle.
	HemocompatibilityASTM Hemolysis - Direct Contact and ExtractMethod	For Direct Contact method andExtract method, the test articlereturned a blank corrected percenthemolysis above the negative controlof 0.0%.
	HemocompatibilityIn Vivo Thromboresistance Evaluation	Implantation of the test and controldevices resulted in no adverse effectsor clinical signs.
	PyrogenicityMaterials Mediated Rabbit Pyrogen	The test article extracts did not causea pyrogenic response and all validitycriteria were met during the assay.
Friction Force	The frictional forces of the RIST Radial AccessCatheter and the predicate device were measuredwhen deployed and retracted in a simulated-useanatomical model.	The RIST Radial Access Catheterhad comparable friction forces to it'spredicate devices.
In vitro Simulated UseStudy - Bench	The Berenstein (BER) and Simmons 2 (SIM2)shapes of the RIST Radial Access Catheter wereprepared per the IFU. A simulated interventionalprocedure was performed by physicians in order toverify the product's performance.Competitive devices were evaluated in order toestablish a baseline for trackability and support	All acceptance criteria were met.
In vitro Simulated UseStudy - Usability	ratings.Evaluators representative of the intended userpopulation evaluated the RIST Radial AccessCatheter as per the Instructions for Use.	All acceptance criteria were met.

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E) Shelf Life Testing

The labeled shelf life for the RIST Radial Access Catheter is 6months. Shelf life testing (product and packaging) and Distribution Shipping Challenge Conditioning and testing results were leveraged from data generated to support the previously cleared predicate device RIST Radial Access Catheter (K200417). All results met established criteria.

F) Conclusion

Review of the test data, as well as comparison of the device classifications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device,

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the RIST Radial Access Catheter, is substantially equivalent to the predicates SOFIA 6F Plus/Distal Access Catheter (K150366) and RIST Radial Access Catheter (K200417). Any differences between the subject and the predicate devices do not raise new 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).