RIST Cath Radial Access Long Sheath

K191551 · Rist Neurovascular, Inc. · DQY · Dec 23, 2019 · Cardiovascular

Device Facts

• Record ID: K191551
• Device Name: RIST Cath Radial Access Long Sheath
• Applicant: Rist Neurovascular, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

Single lumen, variable stiffness catheter; stainless steel and nitinol reinforced shaft; radiopaque marker band for visualization. Provides reinforcing conduit for intravascular devices via transradial access. Used in clinical settings by physicians. Facilitates movement of interventional devices through PTFE-lined lumen. Supplied sterile, single-use. Benefits patient by enabling minimally invasive access to target vasculature.

Clinical Evidence

Bench testing only. Includes design verification (tensile strength, torque, kink resistance, burst, leak tests), biocompatibility (ISO 10993-1), and in vitro simulated use studies. All acceptance criteria met.

Technological Characteristics

Materials: Chronoflex, PEBAX, Vestamid, PTFE liner, stainless steel/nitinol wire coil reinforcement, platinum/iridium marker band. Hydrophilic coating. Dimensions: 0.093" OD, 0.079" ID, 95/100 cm lengths. Sterilization: Ethylene Oxide. Single-use.

Indications for Use

Indicated for introduction of interventional devices into peripheral, coronary, and neuro vasculature in patients requiring such access.

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

• Stryker AXS Infinity LS (K152876)

Reference Devices

• Terumo Glidesheath Slender (K173831)
• SYPHONTRAK IC (K152202)
• Zenith (K171672)
• SYPHONTRAK SDA (K161262)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

| 510(k) Summary | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared: | November 22, 2019 |
| Submitter: | RIST Neurovascular, Inc.<br>11611 Interchange Circle S<br>Miramar, FL 33025 |
| Primary Submission Contact: | Elena Jugo<br>Regulatory Consultant<br>Caraballo Consulting<br>19700 Stirling Road<br>Southwest Ranches, FL 33332<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>19700 Stirling Road<br>Southwest Ranches, FL 33332<br>Telephone: [phone]<br>Facsimile: 1-954-742-5989<br>E-Mail: [e-mail] |
| Trade Name: | RIST Cath Radial Access Long Sheath |
| Regulation Number: | 21 CFR 870.1250 |
| Device Common or<br>Classification Name: | Percutaneous Catheter |
| Product Class: | Class II |
| Product Panel: | Cardiovascular |
| Product Code: | DQY |
| Predicate Device:<br>Reference Predicate: | Stryker AXS Infinity # K 152876<br>Terumo Glidesheath Slender # K173831 |

{4}------------------------------------------------

## 1. 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.

#### 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.

{5}------------------------------------------------

| Parameter | Subject Device<br>RIST Cath Radial Access<br>Long Sheath | Predicate Device<br>Stryker AXS Infinity LS<br>510(k) # K152876 | Reference Predicate Device<br>Terumo Glidesheath<br>Slender<br>510(k) # K173831 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | The Long Sheath is indicated<br>for the introduction of<br>interventional devices into<br>the peripheral, coronary, and<br>neuro vasculature. | The Glidesheath Slender is<br>indicated to facilitate placing<br>a catheter through the skin<br>into 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 |
| Components<br>Supplied | Sheath, Vessel Dilator,<br>Hemostasis Valve | Sheath, Vessel Dilator,<br>Hemostasis Valve | Sheath, Vessel dilator, Entry<br>Needle, Miniguide Wire,<br>Guidewire Inserter |
| Catheter Shaft<br>Material | Chronoflex/Polyblend (distal<br>most section)<br>Chronoflex<br>Polyether Block Amide<br>(PEBAX)<br>Vestamid (proximal most<br>section) | Chronoflex<br>Polyether Block Amide<br>(PEBAX)<br>Vestamid | Ethylene-<br>Tetrafluoroethylene (ETFE)<br>copolymer<br>Colorant<br>Barium sulfate<br>Dispersant<br>Silicone oil |
| Inner Liner | PTFE | PTFE | Polypropylene<br>Stainless Steel |
| Hub Material | Polycarbonate (Makrolon) | Polycarbonate | Sorbitan fatty acid ester |
| Strain Relief | Polyolefin | Polyolefin | Polycarbonate<br>Polystyrene |
| Catheter Shaft<br>Reinforcement | Stainless Steel Coil<br>(proximal)<br>Nitinol Wire Coil (distal) | Stainless Steel Braid | Polyester-Chlorinated<br>polyvinyl chloride |
| Lubricious Coating | Hydrophilic Coating | Hydrophilic Coating | Hydrophilic Coating |
| Radiopaque Marker<br>Band | 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, 0.100<br>inches<br>Tip: 0.070, 0.083, 0.096<br>inches |
| Outer Diameter | 0.093 inches | 0.109 inches | 0.084, 0.097, 0.110 inches |
| Packaging | Tyvek/Nylon pouch,<br>polyethylene support tube,<br>packaging card, SBS carton | Tyvek/Nylon pouch,<br>polyethylene support tube,<br>packaging card, SBS carton | Tyvek, Polyester-<br>polyethylene laminated film,<br>high impact Polystyrene |
| Parameter | Subject Device<br>RIST Cath Radial Access<br>Long Sheath | Predicate Device<br>Stryker AXS Infinity LS<br>510(k) # K152876 | Reference Predicate Device<br>Terumo Glidesheath<br>Slender<br>510(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

{6}------------------------------------------------

| | | 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 the<br>Device | Subject Device<br>RIST Cath Radial<br>Access Long Sheath | Predicate Device<br>Stryker AXS Infinity<br>LS<br>510(k) # K152876 | Reference Predicate<br>Device<br>Terumo Glidesheath<br>Slender<br>510(k) # K173831 | Discussion /<br>Comment |
|---------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter Shaft<br>Reinforcement | Stainless Steel Coil<br>(proximal)<br>Nitinol Wire Coil<br>(distal) | Stainless Steel Braid | Information not<br>available | The purpose of the<br>reinforcement feature<br>of the catheter device<br>is to provide structural<br>support along the<br>length. This support is<br>provided using<br>various metals and<br>patterns. This<br>reinforcement layer is<br>encapsulated between<br>the inner and outer<br>polymer layers. This<br>slight difference in the<br>pattern and metal used<br>does not impact safety<br>or efficacy, as<br>demonstrated by test<br>results. |
| Working<br>Length | 95, 100 cm | 70, 80, 90 cm | 10, 16 cm | Functional testing<br>demonstrated the<br>slight difference in<br>length does not<br>impact safety or<br>efficacy. |

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

{7}------------------------------------------------

### 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 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 Cath 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 Cath<br>and in the predicate<br>device. |
| PTFE Delamination | The liner was inspected for<br>signs of damage. | All units met the PTFE<br>Delamination acceptance<br>criteria. | This test demonstrates<br>that the inner liner will<br>remain adhered to the<br>outer jacket. This test<br>supports substantial<br>equivalence because<br>both the RIST Cath and<br>the predicate device have<br>a PTFE liner. |
| Torque Strength | The distal end of the unit<br>was held rigid while the<br>proximal end was turned<br>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 Cath and in<br>the predicate device. |
| Hydrophilic Coating | The integrity of the<br>hydrophilic coating was<br>inspected before and after | All units met the<br>Hydrophilic Coating<br>acceptance criteria. | Both the RIST Cath and<br>the predicate device<br>have a hydrophilic |
| Test Performed | Test Method | Results | Discussion of How This<br>Test Supports a Finding<br>of Substantial<br>Equivalence |
| | simulation, and the length of<br>the coating was measured. | | coating which aids in<br>tracking. This test<br>demonstrates that the<br>hydrophilic coating is<br>present after simulated<br>use.<br>In simulating actual use,<br>the test supports the<br>indications for use<br>which are the same in<br>the RIST Cath and in the<br>predicate device and<br>helps support<br>the presence of the<br>hydrophilic coating. |
| Particulates | Particulate testing was<br>performed in a tortuous<br>model. | The acceptance criteria<br>for Particulate testing was<br>met. | Both the RIST Cath and<br>the predicate device have<br>a hydrophilic coating.<br>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<br>of safety and efficacy.<br>The test supports the<br>indications for use<br>which are the same in<br>the RIST Cath and in the<br>predicate<br>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 Cath. The<br>internal diameter of the<br>RIST Cath 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 Cath<br>and in the predicate<br> |

Table 3 - Summary of Performance Testing Conducted on RIST Cath

{8}------------------------------------------------

| Table 3 - Summary of Performance Testing Conducted on RIST Cath | |
|-----------------------------------------------------------------|--|
|-----------------------------------------------------------------|--|

{9}------------------------------------------------

| Test Performed | Test Method | Results | Discussion of How This<br>Test Supports a Finding<br>of Substantial<br>Equivalence |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Cath. The<br>outer diameter of the<br>RIST Cath 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 Cath<br>and in the predicate<br>device. |
| Dimensional<br>Verification - Working<br>Length | The working length was<br>measured to ensure the<br>acceptance criteria was 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 Cath is offered in<br>similar working lengths<br>as the predicate device.<br>The test supports the<br>indications for use<br>which are the same in<br>the RIST<br>Cath and in the predicate<br>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 Cath and in<br>the predicate device. |
| Visual Inspection<br>(Transitions & Tip) | Samples were visually<br>inspected to ensure the<br>acceptance criteria were met. | All units met the<br>Transition and Tip Visual<br>Inspection acceptance<br>criteria | Both the RIST Cath and<br>the predicate device have<br>similar functional<br>characteristics. This test<br>demonstrates the integrity<br>of the RIST Cath under<br>predetermined conditions.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Cath and in the predicate<br>device. |
| Catheter Burst | Testing was completed per<br>ISO 10555-1 by clamping the<br>distal end and pressurizing | All units met the Catheter<br>Burst acceptance criteria. | Both the RIST and the<br>predicate device have<br>similar functional |

| Table 3 - Summary of Performance Testing Conducted on RIST Cath | | |
|-----------------------------------------------------------------|--|--|
| | | |

{10}------------------------------------------------

| Test Performed | Test Method | Results | Discussion of How This Test Supports a Finding of Substantial Equivalence | |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | the assembly was pressurized<br>and peak pressure was<br>recorded. | | characteristics. This test<br>demonstrates the integrity<br>of the RIST Cath under<br>predetermined conditions.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Cath 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 Cath and<br>the predicate device have<br>similar functional<br>characteristics. This test<br>demonstrates the<br>functional integrity of the<br>RIST Cath under<br>predetermined conditions.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Cath 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 Cath and<br>the predicate device have<br>similar functional<br>characteristics. This test<br>demonstrates the<br>functional integrity of the<br>RIST Cath under<br>predetermined conditions.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Cath and in the predicate<br>device |
| | Packaging - Pouch Peel | Testing was conducted per<br>ASTM F-88/F88M-15. A<br>Sample from the chevron seal<br>and in-house seal were cut<br>and pulled using a force<br>gauge until the two pieces of<br>pouch material separate. | All units met the Pouch<br>Peel test. | The packaging of the<br>RIST Cath is identical to<br>the predicate device.<br>This test verifies the<br>integrity of the pouch seal<br>which helps support the<br>packaging comparison.<br>The test supports the<br>indications for use which<br>are the same in the RIST<br>Cath and in the predicate<br>device. |
| | Packaging - Pouch<br>Leak | 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 This<br>Test Supports a Finding<br>of Substantial<br>Equivalence | |
| | Competitive devices were<br>evaluated in order to<br>establish a baseline for<br>trackability and support<br>ratings. | | and in the predicate<br>device. | |
| In vitro Simulated Use<br>Study - Usability | Evaluators representative of<br>the intended user population<br>evaluated the RIST Cath<br>Radial Access Long Sheath<br>as per the Instructions for<br>Use. | All acceptance criteria<br>were met. | The usability of the<br>RIST Cath was able to<br>be used as per the<br>Instruction for Use.<br>The test supports the<br>indications for use<br>which are the same in<br>the RIST Cath<br>and in the predicate<br>device. | |

Table 3 – Summary of Performance Testing Conducted on RIST Cath

{11}------------------------------------------------

Table 3 – Summary of Performance Testing Conducted on RIST Cath

{12}------------------------------------------------

| | 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 This<br>Test Supports a Finding<br>of Substantial<br>Equivalence |
| Testing Leveraged from SYPHONTRAK IC (formerly known as the InNeuroCo Intermediate Catheter or<br>IC), 510(k) #K152202, and Zenith, 510(k) #K171672 | | | |
| 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 device and<br>accessories are mostly the<br>same as those of the RIST<br>Cath and accessories. This<br>test confirms that the<br>materials of the RIST<br>Cath and accessories can<br>be used with chemicals<br>typically used in a clinical<br>setting. The test supports<br>the indications for use<br>which are the same in the<br>RIST Cath and in the<br>predicate device. |
| Hub Compatibility | Catheter luers were tested per<br>ISO 80369. | All units met the Hub<br>Compatibility acceptance<br>criteria | This test demonstrates<br>compatibility of the RIST<br>Cath luer and accessory<br>luers with mating luer<br>surfaces. Both the<br>predicate device (along<br>with accessory luers) and<br>the RIST Cath (along with<br>accessory luers) have luer<br> |
| Table 4 - Summary of Completed Testing from Previous Submissions used to Support the Subject Device | | | |
| Test Leveraged | Test Method | Results | Discussion of How This<br>Test Supports a Finding<br>of Substantial<br>Equivalence |
| | | | tapered hubs. The test<br>supports the indications<br>for use which are the<br>same in the RIST Cath<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. | device.<br>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 Cath and the<br>predicate device have<br>the same stainless steel<br>reinforcement. |
| Testing Leveraged from SYPHONTRAK SDA, 510(k) #K161262, and SYPHONTRAK IC (formerly known as<br>the InNeuroCo Intermediate Catheter or IC), 510(k) #K15220 | | | |
| Labeling Legibility -<br>Label | Labeling was inspected to<br>ensure test remained legible<br>after transportation and<br>environmental conditioning. | The acceptance criteria<br>for Labeling Legibility<br>was met. | Both the RIST Cath and<br>the predicate device have<br>similar information<br>contained in the product<br>label. This test verifies<br>that the text of the label is<br>legible. The test supports<br>the indications for use<br>which are the same in the<br>RIST Cath<br>and in the predicate<br>device. |
| Labeling Legibility -<br>IFU | Labeling was inspected to<br>ensure test remained legible<br>after transportation and<br>environmental conditioning. | The acceptance criteria<br>for IFU Legibility was<br>met. | Both the RIST Cath and<br>the predicate device have<br>similar information<br>contained in the product<br>IFU. This test verifies that<br>the text of the IFU is<br>legible. The test supports<br>the indications for use<br>which are the same in the<br>RIST Cath<br>and in the predicate<br>device. |
| Barcode | Barcode was scanned on<br>randomly selected carton and<br>pouch to ensure the scan<br>matches the appropriate<br>information. | The acceptance criteria<br>for Barcode was met. | Both the RIST Cath and<br>the predicate device have<br>similar information<br>contained in the product<br>barcode. This test verifies<br>that the barcode is<br>scannable 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 This<br>Test Supports a Finding<br>of Substantial<br>Equivalence |
| | | | information within is<br>appropriate. The test<br>supports the indications<br>for use which are the<br>same in the RIST Cath<br>and in the predicate<br>device. |
| Testing Leveraged from AXS Infinity LS, 510(k) #K152876 | | | |
| Sterilization | Testing was performed per<br>ANSI/AAMI/ISO<br>11135:2014 and AAMI TIR<br>28:2016 | Product was sterile. | The adoption assessment<br>documented evidence that<br>the RIST Cath does not<br>present a greater<br>challenge to the<br>sterilization process.<br>Therefore, the<br>sterilization process will<br>deliver a sterility<br>assurance level (SAL) of<br>at least $10^{-6}$ to the<br>product, which is the<br>same as the predicate<br>device. |

{13}------------------------------------------------

{14}------------------------------------------------

# 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. |

{15}------------------------------------------------

| Table 5 - Summary of Biocompatibility Testing | | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Test | Results | Conclusion |
| | reaction than the sites injected with<br>the control article. | |
| Material Mediated Pyrogenicity | The test article extracts did not cause<br>a pyrogenic response and all validity<br>criteria were met during the assay. | The RIST Cath is non-pyrogenic. |
| Systemic Toxicity | The test article extracts did not cau…