RIST Radial Access Catheter

K200417 · Rist Neurovascular, Inc. · QJP · May 2, 2020 · Cardiovascular

Device Facts

• Record ID: K200417
• Device Name: RIST Radial Access Catheter
• Applicant: Rist Neurovascular, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: May 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

Flexible, single-lumen percutaneous catheter; 0.070" OD, 0.040" ID; 120/130 cm lengths. Features radiopaque shaft reinforced with stainless steel; luer connector at proximal end; Simmons 2 or Berenstein distal tip shapes. Used for transradial access to deliver interventional devices to target sites in peripheral, coronary, and neuro vasculature. Operated by physicians in clinical settings. Input: guidewires (0.035"/0.038"). Output: conduit for interventional devices and fluid infusion. Benefits: provides access to target vasculature for diagnostic or therapeutic procedures.

Clinical Evidence

Bench testing only. Includes design verification (tensile, torque, kink, burst, leak, particulate, dimensional) and validation (simulated-use study, radiopacity, usability). Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, pyrogenicity). All acceptance criteria met.

Technological Characteristics

Materials: Polyether Block Amide (PEBAX) with BaSO4, Polycarbonate (Makrolon) hub, stainless steel shaft reinforcement. Dimensions: 0.070" OD, 0.040" ID, 120/130 cm length. Sterilization: Ethylene Oxide. Single-use, non-pyrogenic.

Indications for Use

Indicated for introduction of interventional devices into peripheral, coronary, and neuro vasculature. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• Penumbra, Inc. Benchmark Intracranial Access System (5F Select Catheter) (K142321)

Reference Devices

• RIST Cath Radial Access Long Sheath (K191551)
• Penumbra Neuron Select 5Fr (K082290)
• SYPHONTRAK IC (K152202)
• SYPHONTRAK SDA (K161262)
• AXS Infinity LS (K152876)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>11611 Interchange Circle S<br>Miramar, FL 33025 |
| Primary Submission Contact: | Vyoma Upadhya Chikara<br>Design Quality/RA<br>RIST Neurovascular Inc.<br>11611 Interchange Circle South<br>Miramar, FL 33025<br>Telephone: [phone]<br>Facsimile: 1-954-742-5989<br>E-Mail: [e-mail] |
| Secondary Submission Contact: | Marianne Grunwaldt<br>Director, Quality Assurance & Regulatory Affairs<br>RIST Neurovascular Inc.<br>11611 Interchange Circle South<br>Miramar, FL 33025<br>Telephone: [phone]<br>Facsimile: 1-954-742-5989<br>E-Mail: [e-mail] |
| Trade Name: | RIST Radial Access Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Device Common or<br>Classification Name: | Percutaneous Catheter |
| Product Class: | Class II |
| Product Panel: | Cardiovascular |
| Product Code: | QJP, DQY |
| Predicate Device: | Penumbra, Inc. Benchmark Intracranial Access<br>System (5F Select Catheter), #K142321 |
| Reference Predicate: | RIST Cath Radial Access Long Sheath, #K191551 |

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#### 1. Device Description

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.

#### 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 Device<br>RIST Radial Access<br>Catheter | Predicate Device<br>Penumbra Benchmark<br>Access System (5F Select<br>Catheter)<br>510(k) # K142321 | Reference Predicate Device<br>RIST Cath Radial Access<br>Long Sheath<br>510(k) #K191551 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The RIST Radial Access<br>Catheter is indicated for the<br>introduction of interventional<br>devices into the peripheral,<br>coronary, and neuro<br>vasculature. | The Benchmark Intracranial<br>Access System is indicated<br>for the introduction of<br>interventional devices into<br>the peripheral, coronary, and<br>neuro vasculature. | The RIST Cath Radial<br>Access Long Sheath is<br>indicated for the introduction<br>of interventional devices into<br>the peripheral, coronary, and<br>neuro 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<br>(PEBAX) with BaSO4 | Commonly used medical<br>grade plastics | Chronoflex/Polyblend (distal<br>most section)<br>Chronoflex<br>Polyether Block Amide<br>(PEBAX)<br>Vestamid (proximal most<br>section) |
| Hub Material | Polycarbonate (Makrolon) | Not Available | Polycarbonate (Makrolon) |
| Catheter Shaft<br>Reinforcement | Stainless Steel | Stainless Steel | Stainless Steel Coil<br>(proximal)<br>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 2<br>Berenstein | Simmons<br>Berenstein<br>HI | N/A |
| Packaging | Tyvek/Nylon pouch,<br>polyethylene support tube,<br>packaging card, SBS carton | Commonly used medical<br>device packaging materials | Tyvek/Nylon pouch,<br>polyethylene support tube,<br>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 This<br>Test Supports a Finding<br>of Substantial<br>Equivalence | | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Design Verification Testing | | | | | | | | | | | |
| Tensile Strength | Testing was completed per<br>ISO 10555-1. Using a force<br>gauge, test samples were<br>pulled until failure. | All units met the Tensile<br>Strength acceptance<br>criteria. | This test demonstrates<br>that the RIST Radial<br>Access Catheter is<br>structurally sound after<br>passing it through a<br>model which simulates<br>actual anatomy.<br>Simulating actual use<br>supports the indications<br>for use which are the<br>same in the RIST Radial<br>Access Catheter and in<br>the predicate device. | | | | | | | | |
| Torque Strength | The distal end of the unit was<br>held rigid while the proximal<br>end was turned until failure. | All units met the Torque<br>Strength acceptance<br>criteria. | This test demonstrates the<br>ability of the unit to<br>function in a clinical<br>setting and therefore<br>supports the indications<br>for use which is the same<br>in the RIST Radial Access<br>Catheter and in the<br>predicate device. | | | | | | | | |
| Particulates | Particulate testing was<br>performed in a tortuous<br>model and particulate count<br>was evaluated per USP<br><788>. | The acceptance criteria<br>for Particulate testing was<br>met. | This test quantifies the<br>number of particles<br>generated during<br>simulated use and<br>demonstrate that the<br>particle quantities are<br>within expected<br>parameters which do not<br>raise any new questions | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This<br>Test Supports a Finding<br>of Substantial<br>Equivalence | | | | | | | | |
| | | | of safety and efficacy.<br>The test supports the<br>indications for use<br>which are the same in<br>the RIST Radial Access<br>Catheter and in the<br>predicate device. | | | | | | | | |
| Dimensional<br>Verification - ID | The ID was measured to<br>ensure the acceptance criteria<br>was met. | The acceptance criteria<br>for ID Dimensional<br>Verification was met. | This test verifies<br>functional characteristics<br>of the RIST Radial<br>Access Catheter. The<br>internal diameter of the<br>RIST Radial Access<br>Catheter and the<br>predicate are minimally<br>different, but this does<br>not affect safety or<br>efficacy. The test<br>supports the indications<br>for use which are the<br>same in the RIST Radial<br>Access Catheter and in<br>the predicate device. | | | | | | | | |
| Dimensional<br>Verification -OD | The OD was measured to<br>ensure the acceptance criteria<br>was met. | The acceptance criteria<br>for OD Dimensional<br>Verification was met. | This test verifies<br>functional characteristics<br>of the RIST Radial<br>Access Catheter. The<br>outer diameter of the<br>RIST Radial Access<br>Catheter and the<br>predicate are minimally<br>different, but this does<br>not affect safety or<br>efficacy. The test<br>supports the indications<br>for use which are the<br>same in the RIST Radial<br>Access Catheter and in<br>the predicate device. | | | | | | | | |
| Dimensional<br>Verification - Working<br>Length | The working length was<br>measured to ensure the<br>acceptance criteria were met. | The acceptance criteria<br>for Working Length<br>Dimensional Verification<br>was met. | This test verifies the<br>functional characteristics<br>of working length. The<br>RIST Radial Access<br>Catheter is offered in<br>similar working lengths<br>as the predicate device.<br>The working length of<br>the RIST Radial Access<br>Catheter and the | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This<br>Test Supports a Finding<br>of Substantial<br>Equivalence | | | | | | | | |
| | | | predicate are minimally<br>different, but this does<br>not affect safety or<br>efficacy. The test<br>supports the indications<br>for use which are the<br>same in the RIST Radial<br>Access Catheter and in<br>the predicate device. | | | | | | | | |
| Dimensional<br>Verification - Tip<br>Length | The tip length was measured<br>to ensure the acceptance<br>criteria were met. | The acceptance criteria<br>for Tip Length<br>Dimensional Verification<br>were met. | Both the RIST Radial<br>Access Catheter and the<br>predicate device have<br>similar functional<br>characteristics. This test<br>demonstrates the<br>integrity of the RIST<br>Radial Access Catheter<br>under predetermined<br>conditions. The test<br>supports the indications<br>for use which are the<br>same in the RIST Radial<br>Access Catheter and in<br>the predicate device. | | | | | | | | |
| Kink Resistance | Test units were wrapped<br>around progressively smaller<br>diameter pegs and/or<br>mandrels until a kink was<br>observed. | All units met the Kink<br>Resistance acceptance<br>criteria. | This test demonstrates the<br>ability of the unit to<br>maintain structural<br>integrity and therefore<br>supports the indications<br>for use which is the same<br>in the RIST Radial Access<br>Catheter and in the<br>predicate device. | | | | | | | | |
| Visual Inspection (Tip<br>Taper/Transitions) | Samples were visually<br>inspected to ensure the<br>acceptance criteria were met. | All units met the Tip<br>Taper/Transition Visual<br>Inspection acceptance<br>criteria | Both the RIST Radial<br>Access Catheter and the<br>predicate device have<br>similar functional<br>characteristics. This test<br>demonstrates the integrity<br>of the RIST Radial<br>Access Catheter under<br>predetermined conditions.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Radial Access Catheter<br>and in the predicate<br>device. | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This<br>Test Supports a Finding<br>of Substantial<br>Equivalence | | | | | | | | |
| Shape Retention<br>(Catheter Tip Shape) | Samples were individually<br>inspected to ensure that the<br>shape met the specified<br>specification. | All units met the Shape<br>Retention Acceptance<br>criteria. | Both the RIST and the<br>predicate device have<br>similar functional<br>characteristics. This test<br>demonstrates the RIST<br>Radial Access Catheter<br>tip will retain its shape.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Radial Access Catheter<br>and in the predicate<br>device. | | | | | | | | |
| Burst Test | Testing was completed per<br>ISO 10555-1 by clamping the<br>distal end and pressurizing<br>the assembly was pressurized<br>and peak pressure was<br>recorded. | All units met the Catheter<br>Burst acceptance criteria. | Both the RIST Radial<br>Access Catheter and the<br>predicate device have<br>similar functional<br>characteristics. This test<br>demonstrates the integrity<br>of the RIST Radial<br>Access Catheter under<br>predetermined conditions.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Radial Access Catheter<br>and in the predicate<br>device. | | | | | | | | |
| Liquid Leak Test | Testing was completed per<br>ISO 10555-1 by connecting<br>the catheter to test<br>equipment, sealing the distal<br>end of the catheter,<br>pressurizing the catheter,<br>holding the pressure, and<br>ensuring there was no<br>leakage. | All units met the Liquid<br>Leak acceptance criteria. | Both the RIST Radial<br>Access Catheter and the<br>predicate device have<br>similar functional<br>characteristics. This test<br>demonstrates the<br>functional integrity of the<br>RIST Radial Access<br>Catheter under<br>predetermined conditions.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Radial Access Catheter<br>and in the predicate<br>device. | | | | | | | | |
| Air Leak Test | Testing was conducted per<br>ISO 80369-7 to ensure no air<br>leaks into the product<br>assembly. | All units met the Air Leak<br>Test acceptance criteria. | Both the RIST Radial<br>Access Catheter and the<br>predicate device have<br>similar functional<br>characteristics. This test | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This<br>Test Supports a Finding<br>of Substantial<br>Equivalence | | | | | | | | |
| | | | demonstrates the<br>functional integrity of the<br>RIST Radial Access<br>Catheter under<br>predetermined conditions.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Radial Access Catheter<br>and in the predicate<br>device. | | | | | | | | |
| Chemical Compatibility | Samples of catheter and<br>accessories were exposed to<br>saline, dextrose, heparin, and<br>radiocontrast and then<br>inspected for any signs of<br>degradation and ensure the<br>ID had no obstruction. | All units met the<br>Chemical Compatibility<br>acceptance criteria. | The materials of the<br>predicate are mostly the<br>same as those of the RIST<br>Radial Access Catheter.<br>This test confirms that the<br>materials of the RIST<br>Radial Access Catheter<br>can be used with<br>chemicals typically used<br>in a clinical setting. The<br>test supports the<br>indications for use which<br>are the same in the RIST<br>Radial Access Catheter<br>and in the predicate<br>device. | | | | | | | | |
| Corrosion | Testing was conducted per<br>ISO 10555-1 Annex A. | All units met the<br>Corrosion acceptance<br>criteria. | This test demonstrates the<br>ability of the stainless-<br>steel reinforcement to<br>resist deterioration. This<br>test supports substantial<br>equivalence because the<br>RIST Radial Access<br>Catheter and the predicate<br>device have the same<br>stainless steel<br>reinforcement. | | | | | | | | |
| Packaging - Visual<br>Inspection | Packaging was visually<br>inspected to verify the<br>integrity of the pouch and<br>verify the product was free<br>from damage prior to, and<br>when removed from the<br>packaging. | All units met the<br>Packaging Visual<br>Inspection. | The packaging of the<br>RIST Radial Access<br>Catheter is identical to<br>the reference predicate<br>device. This test verifies<br>the integrity of the<br>pouched unit which<br>helps support the<br>packaging comparison.<br>The test supports the<br>indications for use | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This<br>Test Supports a Finding<br>of Substantial<br>Equivalence | | | | | | | | |
| | | | which are the same in<br>the RIST Radial Access<br>Catheter and in the<br>predicate device. | | | | | | | | |
| Packaging - Pouch<br>Leak | Testing was conducted per<br>ASTM F-1929-15. The<br>pouch was dipped into a dyed<br>solution and visually<br>inspected for dye penetration<br>through the seal. | All units met the Pouch<br>Leak test | The packaging of the<br>RIST Radial Access<br>Catheter is identical to<br>the reference predicate<br>device.…