Predicate Devices

K 152876

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter sheath, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No
The device is a sheath intended to provide access and a conduit for other interventional devices, not to directly treat a condition.

Diagnostic

No

Explanation: The device is described as an access sheath for introducing interventional devices, and its intended use is to provide a conduit for other intravascular devices, not to diagnose.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical catheter with a reinforced shaft, radiopaque marker band, and accessories like a dilator and hemostasis valve. It is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the RIST Cath Radial Access Long Sheath is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's for the "introduction of interventional devices into the peripheral, coronary, and neuro vasculature." This describes a device used within the body for medical procedures, not a device used to test samples outside the body.
Device Description: The description details a physical catheter designed to be inserted into blood vessels. This is consistent with an in-vivo medical device, not an in-vitro diagnostic.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in-vitro diagnostics.

In-vitro diagnostics are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The RIST Cath is an interventional device used directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DQY

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral, coronary, and neuro vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Design verification and validation were performed to ensure that the RIST Cath meets its performance specifications and demonstrates substantial equivalence to the predicate device. All pre-determined acceptance criteria were met.

Study Type: Design Verification Testing
Sample Size: Not Specified
Key Results: All units met the Tensile Strength acceptance criteria, PTFE Delamination acceptance criteria, Torque Strength acceptance criteria, Hydrophilic Coating acceptance criteria, Particulate testing acceptance criteria, ID Dimensional Verification acceptance criteria, OD Dimensional Verification acceptance criteria, Working Length Dimensional Verification acceptance criteria, Kink Resistance acceptance criteria, Transition and Tip Visual Inspection acceptance criteria, Catheter Burst acceptance criteria, Liquid Leak acceptance criteria, Air Leak Test acceptance criteria, Pouch Peel test, Pouch Leak test, Packaging Visual Inspection acceptance criteria, and Seal Width acceptance criteria.

Study Type: Design Validation Testing (In vitro Simulated Use Study - Bench)
Sample Size: Not Specified
Key Results: All acceptance criteria were met. The performance of the RIST Cath was found to be substantially equivalent to the predicate device.

Study Type: Design Validation Testing (In vitro Simulated Use Study - Usability)
Sample Size: Not Specified
Key Results: All acceptance criteria were met. The usability of the RIST Cath was able to be used as per the Instruction for Use.

Study Type: Biocompatibility Testing
Sample Size: Not Specified
Key Results: The RIST Cath is non-cytotoxic, non-sensitizer, non-irritant, non-pyrogenic, non-hemolytic, and non-thrombogenic. Complement activation assays were similar for test and comparison articles. PTT values for the test article and predicate were "Similar".

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Stryker AXS Infinity # K 152876

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Terumo Glidesheath Slender # K173831

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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

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 (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)
-------------------------------------------------	--

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 S
Miramar, FL 33025
Primary Submission Contact:	Elena Jugo
Regulatory Consultant
Caraballo Consulting
19700 Stirling Road
Southwest Ranches, FL 33332
Telephone: 1-305-510-4398
Facsimile: 1-954-742-5989
E-Mail: Elena@Caraballoconsulting.com
Secondary Submission Contact:	Marianne Grunwaldt
Director, Quality Assurance & Regulatory Affairs
RIST Neurovascular Inc.
19700 Stirling Road
Southwest Ranches, FL 33332
Telephone: 1-305-495-3883
Facsimile: 1-954-742-5989
E-Mail: Marianne@InNeuroCo.com
Trade Name:	RIST Cath Radial Access Long Sheath
Regulation Number:	21 CFR 870.1250
Device Common or
Classification Name:	Percutaneous Catheter
Product Class:	Class II
Product Panel:	Cardiovascular
Product Code:	DQY
Predicate Device:
Reference Predicate:	Stryker AXS Infinity # K 152876
Terumo Glidesheath Slender # K173831

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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.

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

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

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 This
Test Supports a Finding
of Substantial
Equivalence |
|----------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design Verification Testing | | | |
| Tensile Strength | Testing was completed per
ISO 10555-1. Using a force
gauge, test samples were
pulled until failure. | All units met the Tensile
Strength acceptance
criteria. | This test demonstrates
that the RIST Cath is
structurally sound after
passing it through a
model which simulates
actual anatomy.
Simulating actual use
supports the indications
for use which are the
same in the RIST Cath
and in the predicate
device. |
| PTFE Delamination | The liner was inspected for
signs of damage. | All units met the PTFE
Delamination acceptance
criteria. | This test demonstrates
that the inner liner will
remain adhered to the
outer jacket. This test
supports substantial
equivalence because
both the RIST Cath and
the predicate device have
a PTFE liner. |
| Torque Strength | The distal end of the unit
was held rigid while the
proximal end was turned
until failure. | All units met the Torque
Strength acceptance
criteria. | This test demonstrates the
ability of the unit to
function in a clinical
setting and therefore
supports the indications
for use which is the same
in the RIST Cath and in
the predicate device. |
| Hydrophilic Coating | The integrity of the
hydrophilic coating was
inspected before and after | All units met the
Hydrophilic Coating
acceptance criteria. | Both the RIST Cath and
the predicate device
have a hydrophilic |
| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence |
| | simulation, and the length of
the coating was measured. | | coating which aids in
tracking. This test
demonstrates that the
hydrophilic coating is
present after simulated
use.
In simulating actual use,
the test supports the
indications for use
which are the same in
the RIST Cath and in the
predicate device and
helps support
the presence of the
hydrophilic coating. |
| Particulates | Particulate testing was
performed in a tortuous
model. | The acceptance criteria
for Particulate testing was
met. | Both the RIST Cath and
the predicate device have
a hydrophilic coating.
This test quantifies the
number of particles
generated during
simulated use and
demonstrate that the
particle quantities are
within expected
parameters which do not
raise any new questions
of safety and efficacy.
The test supports the
indications for use
which are the same in
the RIST Cath and in the
predicate
device. |
| Dimensional
Verification - ID | The ID was measured to
ensure the acceptance criteria
was met. | The acceptance criteria
for ID Dimensional
Verification was met. | This test verifies
functional characteristics
of the RIST Cath. The
internal diameter of the
RIST Cath and the
predicate are minimally
different, but this does
not affect safety or
efficacy. The test
supports the indications
for use which are the
same in the RIST Cath
and 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
-----------------------------------------------------------------	--

9

| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensional
Verification -OD | The OD was measured to
ensure the acceptance criteria
was met. | The acceptance criteria
for OD Dimensional
Verification was met. | This test verifies
functional characteristics
of the RIST Cath. The
outer diameter of the
RIST Cath and the
predicate are minimally
different, but this does
not affect safety or
efficacy. The test
supports the indications
for use which are the
same in the RIST Cath
and in the predicate
device. |
| Dimensional
Verification - Working
Length | The working length was
measured to ensure the
acceptance criteria was met. | The acceptance criteria
for Working Length
Dimensional Verification
was met. | This test verifies the
functional characteristics
of working length. The
RIST Cath is offered in
similar working lengths
as the predicate device.
The test supports the
indications for use
which are the same in
the RIST
Cath and in the predicate
device. |
| Kink Resistance | Test units were wrapped
around progressively smaller
diameter pegs and/or
mandrels until a kink was
observed. | All units met the Kink
Resistance acceptance
criteria. | This test demonstrates the
ability of the unit to
maintain structural
integrity and therefore
supports the indications
for use which is the same
in the RIST Cath and in
the predicate device. |
| Visual Inspection
(Transitions & Tip) | Samples were visually
inspected to ensure the
acceptance criteria were met. | All units met the
Transition and Tip Visual
Inspection acceptance
criteria | Both the RIST Cath and
the predicate device have
similar functional
characteristics. This test
demonstrates the integrity
of the RIST Cath under
predetermined conditions.
The test supports the
indications for use which
are the same in the RIST
Cath and in the predicate
device. |
| Catheter Burst | Testing was completed per
ISO 10555-1 by clamping the
distal end and pressurizing | All units met the Catheter
Burst acceptance criteria. | Both the RIST and the
predicate device have
similar 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 pressurized
and peak pressure was
recorded.		characteristics. This test
demonstrates the integrity
of the RIST Cath under
predetermined conditions.
The test supports the
indications for use which
are the same in the RIST
Cath and in the predicate
device
	Liquid Leak Test	Testing was completed per
ISO 10555-1 by connecting
the catheter to test
equipment, sealing the distal
end of the catheter,
pressurizing the catheter,
holding the pressure, and
ensuring there was no
leakage.	All units met the Liquid
Leak acceptance criteria.	Both the RIST Cath and
the predicate device have
similar functional
characteristics. This test
demonstrates the
functional integrity of the
RIST Cath under
predetermined conditions.
The test supports the
indications for use which
are the same in the RIST
Cath and in the predicate
device
	Air Leak Test	Testing was conducted per
ISO 80369-7 to ensure no air
leaks into the product
assembly.	All units met the Air Leak
Test acceptance criteria.	Both the RIST Cath and
the predicate device have
similar functional
characteristics. This test
demonstrates the
functional integrity of the
RIST Cath under
predetermined conditions.
The test supports the
indications for use which
are the same in the RIST
Cath and in the predicate
device
	Packaging - Pouch Peel	Testing was conducted per
ASTM F-88/F88M-15. A
Sample from the chevron seal
and in-house seal were cut
and pulled using a force
gauge until the two pieces of
pouch material separate.	All units met the Pouch
Peel test.	The packaging of the
RIST Cath is identical to
the predicate device.
This test verifies the
integrity of the pouch seal
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 - Pouch
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
Test Supports a Finding
of Substantial
Equivalence
	Competitive devices were
evaluated in order to
establish a baseline for
trackability and support
ratings.		and in the predicate
device.
In vitro Simulated Use
Study - Usability	Evaluators representative of
the intended user population
evaluated the RIST Cath
Radial Access Long Sheath
as per the Instructions for
Use.	All acceptance criteria
were met.	The usability of the
RIST Cath was able to
be used as per the
Instruction for Use.
The test supports the
indications for use
which are the same in
the RIST Cath
and in the predicate
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
Test Supports a Finding
of Substantial
Equivalence
Testing Leveraged from SYPHONTRAK IC (formerly known as the InNeuroCo Intermediate Catheter or
IC), 510(k) #K152202, and Zenith, 510(k) #K171672
Chemical Compatibility	Samples of catheter and
accessories were exposed to
saline, dextrose, heparin, and
radiocontrast and then
inspected for any signs of
degradation and ensure the
ID had no obstruction.	All units met the
Chemical Compatibility
acceptance criteria.	The materials of the
predicate device and
accessories are mostly the
same as those of the RIST
Cath and accessories. This
test confirms that the
materials of the RIST
Cath and accessories can
be used with chemicals
typically used in a clinical
setting. The test supports
the indications for use
which are the same in the
RIST Cath and in the
predicate device.
Hub Compatibility	Catheter luers were tested per
ISO 80369.	All units met the Hub
Compatibility acceptance
criteria	This test demonstrates
compatibility of the RIST
Cath luer and accessory
luers with mating luer
surfaces. Both the
predicate device (along
with accessory luers) and
the RIST Cath (along with
accessory 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 This
Test Supports a Finding
of Substantial
Equivalence |
| | | | tapered hubs. The test
supports the indications
for use which are the
same in the RIST Cath
and in the predicate
device. |
| Corrosion | Testing was conducted per
ISO 10555-1 Annex A. | All units met the
Corrosion acceptance
criteria. | device.
This test demonstrates the
ability of the stainless
steel reinforcement to
resist deterioration. This
test supports substantial
equivalence because the
RIST Cath and the
predicate device have
the same stainless steel
reinforcement. |
| Testing Leveraged from SYPHONTRAK SDA, 510(k) #K161262, and SYPHONTRAK IC (formerly known as
the InNeuroCo Intermediate Catheter or IC), 510(k) #K15220 | | | |
| Labeling Legibility -
Label | Labeling was inspected to
ensure test remained legible
after transportation and
environmental conditioning. | The acceptance criteria
for Labeling Legibility
was met. | Both the RIST Cath and
the predicate device have
similar information
contained in the product
label. This test verifies
that the text of the label is
legible. The test supports
the indications for use
which are the same in the
RIST Cath
and in the predicate
device. |
| Labeling Legibility -
IFU | Labeling was inspected to
ensure test remained legible
after transportation and
environmental conditioning. | The acceptance criteria
for IFU Legibility was
met. | Both the RIST Cath and
the predicate device have
similar information
contained in the product
IFU. This test verifies that
the text of the IFU is
legible. The test supports
the indications for use
which are the same in the
RIST Cath
and in the predicate
device. |
| Barcode | Barcode was scanned on
randomly selected carton and
pouch to ensure the scan
matches the appropriate
information. | The acceptance criteria
for Barcode was met. | Both the RIST Cath and
the predicate device have
similar information
contained in the product
barcode. This test verifies
that the barcode is
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
Test Supports a Finding
of Substantial
Equivalence |
| | | | information within is
appropriate. The test
supports the indications
for use which are the
same in the RIST Cath
and in the predicate
device. |
| Testing Leveraged from AXS Infinity LS, 510(k) #K152876 | | | |
| Sterilization | Testing was performed per
ANSI/AAMI/ISO
11135:2014 and AAMI TIR
28:2016 | Product was sterile. | The adoption assessment
documented evidence that
the RIST Cath does not
present a greater
challenge to the
sterilization process.
Therefore, the
sterilization process will
deliver a sterility
assurance level (SAL) of
at least $10^{-6}$ to the
product, which is the
same as the predicate
device. |

13

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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.

15

Table 5 - Summary of Biocompatibility Testing
Test	Results	Conclusion
	reaction than the sites injected with
the control article.
Material Mediated Pyrogenicity	The test article extracts did not cause
a pyrogenic response and all validity
criteria were met during the assay.	The RIST Cath is non-pyrogenic.
Systemic Toxicity	The test article extracts did not cause
acute adverse effects under the
conditions of this assay.	The RIST Cath is non-cytotoxic.
Hemolysis, ASTM Method, indirect
contact (human blood)	The difference between the
hemolytic indexes of the test article
and the negative control is 0.00
Hemolysis, ASTM Method, direct
contact (human blood)	percent; this places the test article in
the non-hemolytic range.	The RIST Cath is non-hemolytic.
Complement Activation, C3a and
SC5b-9	SC5b-9 curve has a correlation
coefficient above 0.95, which
indicates that the results are
acceptable.	The compliment activation of the
C3a and SC5b assays were similar
for test and comparison articles.
Partial Thromboplastin Time (PTT),
Human Plasma	P values of clotting time for the test
article and predicate were "Similar",
hence results are acceptable.	The RIST Cath is considered to be
non-activator.
Dog Thrombogenicity	The test article had an acceptable
interaction with blood under the
conditions tested.	The RIST Cath is non
thrombogenic.

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.