(72 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities.
No
This device is an access catheter designed to deliver interventional devices and provide access to target sites, rather than treating a disease or condition itself.
No
The device is an access catheter used to introduce interventional devices, not to diagnose conditions.
No
The device description clearly details a physical catheter made of materials like stainless steel, with specific dimensions and shapes, indicating it is a hardware device.
Based on the provided information, the RIST Radial Access Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. This is a direct medical intervention within the body.
- Device Description: The description details a physical catheter designed for accessing blood vessels. It's a tool used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The RIST Radial Access Catheter is a device used within the body for a procedural purpose.
N/A
Intended Use / Indications for Use
The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes
OJP, DQY
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-the-shelf accessories. The RIST Radial Access Catheter 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 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.
Performance tests conducted on the RIST Radial Access Catheter:
- Tensile Strength: All units met the Tensile Strength acceptance criteria.
- Torque Strength: All units met the Torque Strength acceptance criteria.
- Particulates: The acceptance criteria for Particulate testing was met.
- Dimensional Verification - ID: The acceptance criteria for ID Dimensional Verification was met.
- Dimensional Verification - OD: The acceptance criteria for OD Dimensional Verification was met.
- Dimensional Verification - Working Length: The acceptance criteria for Working Length Dimensional Verification was met.
- Dimensional Verification - Tip Length: The acceptance criteria for Tip Length Dimensional Verification were met.
- Kink Resistance: All units met the Kink Resistance acceptance criteria.
- Visual Inspection (Tip Taper/Transitions): All units met the Tip Taper/Transition Visual Inspection acceptance criteria.
- Shape Retention (Catheter Tip Shape): All units met the Shape Retention Acceptance criteria.
- Burst Test: All units met the Catheter Burst acceptance criteria.
- Liquid Leak Test: All units met the Liquid Leak acceptance criteria.
- Air Leak Test: All units met the Air Leak Test acceptance criteria.
- Chemical Compatibility: All units met the Chemical Compatibility acceptance criteria.
- Corrosion: All units met the Corrosion acceptance criteria.
- Packaging - Visual Inspection: All units met the Packaging Visual Inspection.
- Packaging - Pouch Leak: All units met the Pouch Leak test.
- Packaging - Pouch Peel: All units met the Pouch Peel test.
- Packaging - Seal Width: All seals met the acceptance criteria for Seal Width.
- Friction Force (Comparative Testing with predicate): The RIST Radial Access Catheter and predicate device had comparable friction forces.
- In vitro Simulated Use Study - Bench: All acceptance criteria were met. The performance of the RIST Radial Access Catheter was found to be substantially equivalent to the predicate device.
- Radiopacity: All acceptance criteria were met. The performance of the RIST Radial Access Catheter was found to be substantially equivalent to the predicate device.
- In vitro Simulated Use Study - Usability: All acceptance criteria were met.
Tests leveraged from previous submissions (SYPHONTRAK IC (K152202), SYPHONTRAK SDA (K161262), AXS Infinity LS (K152876)):
- Hub Compatibility: All units met the Hub Compatibility acceptance criteria.
- Labeling Legibility - Label: The acceptance criteria for Labeling Legibility was met.
- Barcode: The acceptance criteria for Barcode was met.
- Labeling Legibility - IFU: The acceptance criteria for IFU Legibility was met.
- Sterilization: Product was sterile.
Biocompatibility Testing:
- Cytotoxicity (ISO MEM Elution): The test article is considered non-cytotoxic under the conditions of this test. No abnormal events such as pH change or debris were noted.
- Sensitization (ISO Guinea Pig Maximization Sensitization): Under the conditions of this protocol, the test article did not elicit a sensitization response.
- Irritation (ISO Intracutaneous Irritation): No significant dermal reactions were observed at the injected test and control sites in any of the test subjects.
- Systemic Toxicity (ISO Acute Systemic Injection): None of the study subjects were observed with abnormal clinical signs indicative of toxicity during the test period.
- Complement Activation, SC5b-9 Assay: The test article results in the SC5b-9 assay were not statistically significant (p>0.05) when compared to the reference material and comparison article.
- Hemocompatibility (ASTM Hemolysis - Direct Contact and Extract Method): For Direct Contact method and Extract method, the test article returned a blank corrected percent hemolysis above the negative control of 0.0%.
- Pyrogenicity (Materials Mediated Rabbit Pyrogen): The test article extracts did not cause a pyrogenic response and all validity criteria were met during the assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Penumbra, Inc. Benchmark Intracranial Access System (5F Select Catheter), #K142321
Reference Device(s)
RIST Cath Radial Access Long Sheath, #K191551
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
510(k) Summary
| Date Summary Prepared: | April 23, 2020 |
|---|---|
| Submitter: | RIST Neurovascular, Inc. |
| 11611 Interchange Circle S | |
| Miramar, FL 33025 | |
| Primary Submission Contact: | Vyoma Upadhya Chikara |
| Design Quality/RA | |
| RIST Neurovascular Inc. | |
| 11611 Interchange Circle South | |
| Miramar, FL 33025 | |
| Telephone: 1-954-559-1323 | |
| Facsimile: 1-954-742-5989 | |
| E-Mail: Vyoma@InNeuroCo.com | |
| Secondary Submission Contact: | Marianne Grunwaldt |
| Director, Quality Assurance & Regulatory Affairs | |
| RIST Neurovascular Inc. | |
| 11611 Interchange Circle South | |
| Miramar, FL 33025 | |
| Telephone: 1-305-495-3883 | |
| Facsimile: 1-954-742-5989 | |
| E-Mail: Marianne@InNeuroCo.com | |
| Trade Name: | RIST Radial Access Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Device Common or | |
| Classification Name: | Percutaneous Catheter |
| Product Class: | Class II |
| Product Panel: | Cardiovascular |
| Product Code: | QJP, DQY |
| Predicate Device: | Penumbra, Inc. Benchmark Intracranial Access |
| System (5F Select Catheter), #K142321 | |
| Reference Predicate: | RIST Cath Radial Access Long Sheath, #K191551 |
4
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.
5
| Parameter | Subject Device
RIST Radial Access
Catheter | Predicate Device
Penumbra Benchmark
Access System (5F Select
Catheter)
510(k) # K142321 | Reference Predicate Device
RIST Cath Radial Access
Long Sheath
510(k) #K191551 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The RIST Radial Access
Catheter is indicated for the
introduction of interventional
devices into the peripheral,
coronary, and neuro
vasculature. | The Benchmark Intracranial
Access System is indicated
for the introduction of
interventional devices into
the peripheral, coronary, and
neuro vasculature. | The RIST Cath Radial
Access Long Sheath is
indicated for the introduction
of interventional devices into
the peripheral, coronary, and
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
(PEBAX) with BaSO4 | Commonly used medical
grade plastics | Chronoflex/Polyblend (distal
most section)
Chronoflex
Polyether Block Amide
(PEBAX)
Vestamid (proximal most
section) |
| Hub Material | Polycarbonate (Makrolon) | Not Available | Polycarbonate (Makrolon) |
| Catheter Shaft
Reinforcement | Stainless Steel | Stainless Steel | Stainless Steel Coil
(proximal)
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
Berenstein | Simmons
Berenstein
HI | N/A |
| Packaging | Tyvek/Nylon pouch,
polyethylene support tube,
packaging card, SBS carton | Commonly used medical
device packaging materials | Tyvek/Nylon pouch,
polyethylene support tube,
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
6
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
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 Radial
Access Catheter 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 Radial
Access Catheter and in
the predicate device. | | | | | | | | |
| 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 Radial Access
Catheter and in the
predicate device. | | | | | | | | |
| Particulates | Particulate testing was
performed in a tortuous
model and particulate count
was evaluated per USP
. | The acceptance criteria
for Particulate testing was
met. | 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 | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence | | | | | | | | |
| | | | of safety and efficacy.
The test supports the
indications for use
which are the same in
the RIST Radial Access
Catheter 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 Radial
Access Catheter. The
internal diameter of the
RIST Radial Access
Catheter 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 Radial
Access Catheter and in
the predicate device. | | | | | | | | |
| 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 Radial
Access Catheter. The
outer diameter of the
RIST Radial Access
Catheter 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 Radial
Access Catheter and in
the predicate device. | | | | | | | | |
| Dimensional
Verification - Working
Length | The working length was
measured to ensure the
acceptance criteria were met. | The acceptance criteria
for Working Length
Dimensional Verification
was met. | This test verifies the
functional characteristics
of working length. The
RIST Radial Access
Catheter is offered in
similar working lengths
as the predicate device.
The working length of
the RIST Radial Access
Catheter and the | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence | | | | | | | | |
| | | | 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 Radial
Access Catheter and in
the predicate device. | | | | | | | | |
| Dimensional
Verification - Tip
Length | The tip length was measured
to ensure the acceptance
criteria were met. | The acceptance criteria
for Tip Length
Dimensional Verification
were met. | Both the RIST Radial
Access Catheter and the
predicate device have
similar functional
characteristics. This test
demonstrates the
integrity of the RIST
Radial Access Catheter
under predetermined
conditions. The test
supports the indications
for use which are the
same in the RIST Radial
Access Catheter 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 Radial Access
Catheter and in the
predicate device. | | | | | | | | |
| Visual Inspection (Tip
Taper/Transitions) | Samples were visually
inspected to ensure the
acceptance criteria were met. | All units met the Tip
Taper/Transition Visual
Inspection acceptance
criteria | Both the RIST Radial
Access Catheter and the
predicate device have
similar functional
characteristics. This test
demonstrates the integrity
of the RIST Radial
Access Catheter under
predetermined conditions.
The test supports the
indications for use which
are the same in the RIST
Radial Access Catheter
and in the predicate
device. | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence | | | | | | | | |
| Shape Retention
(Catheter Tip Shape) | Samples were individually
inspected to ensure that the
shape met the specified
specification. | All units met the Shape
Retention Acceptance
criteria. | Both the RIST and the
predicate device have
similar functional
characteristics. This test
demonstrates the RIST
Radial Access Catheter
tip will retain its shape.
The test supports the
indications for use which
are the same in the RIST
Radial Access Catheter
and in the predicate
device. | | | | | | | | |
| Burst Test | Testing was completed per
ISO 10555-1 by clamping the
distal end and pressurizing
the assembly was pressurized
and peak pressure was
recorded. | All units met the Catheter
Burst acceptance criteria. | Both the RIST Radial
Access Catheter and the
predicate device have
similar functional
characteristics. This test
demonstrates the integrity
of the RIST Radial
Access Catheter under
predetermined conditions.
The test supports the
indications for use which
are the same in the RIST
Radial Access Catheter
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 Radial
Access Catheter and the
predicate device have
similar functional
characteristics. This test
demonstrates the
functional integrity of the
RIST Radial Access
Catheter under
predetermined conditions.
The test supports the
indications for use which
are the same in the RIST
Radial Access Catheter
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 Radial
Access Catheter and the
predicate device have
similar functional
characteristics. This test | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence | | | | | | | | |
| | | | demonstrates the
functional integrity of the
RIST Radial Access
Catheter under
predetermined conditions.
The test supports the
indications for use which
are the same in the RIST
Radial Access Catheter
and in the predicate
device. | | | | | | | | |
| 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 are mostly the
same as those of the RIST
Radial Access Catheter.
This test confirms that the
materials of the RIST
Radial Access Catheter
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
Radial Access Catheter
and in the predicate
device. | | | | | | | | |
| Corrosion | Testing was conducted per
ISO 10555-1 Annex A. | All units met the
Corrosion acceptance
criteria. | This test demonstrates the
ability of the stainless-
steel reinforcement to
resist deterioration. This
test supports substantial
equivalence because the
RIST Radial Access
Catheter and the predicate
device have the same
stainless steel
reinforcement. | | | | | | | | |
| Packaging - Visual
Inspection | Packaging was visually
inspected to verify the
integrity of the pouch and
verify the product was free
from damage prior to, and
when removed from the
packaging. | All units met the
Packaging Visual
Inspection. | The packaging of the
RIST Radial Access
Catheter is identical to
the reference predicate
device. This test verifies
the integrity of the
pouched unit which
helps support the
packaging comparison.
The test supports the
indications for use | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence | | | | | | | | |
| | | | which are the same in
the RIST Radial Access
Catheter and in the
predicate device. | | | | | | | | |
| Packaging - Pouch
Leak | Testing was conducted per
ASTM F-1929-15. The
pouch was dipped into a dyed
solution and visually
inspected for dye penetration
through the seal. | All units met the Pouch
Leak test | The packaging of the
RIST Radial Access
Catheter is identical to
the reference 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
Radial Access
Catheter 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 Radial Access
Catheter is identical to
the reference 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 Radial
Access Catheter 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 Radial Access
Catheter is identical to
the reference 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 Radial Access
Catheter and in the
predicate device. | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence | | | | | | | | |
| Comparative Testing | | | | | | | | | | | |
| Friction Force | The frictional forces of the
RIST Radial Access Catheter
and the predicate Penumbra
catheter were measured when
deployed and retracted in a
simulated-use anatomical
model. | The RIST Radial Access
Catheter and predicate
device had comparable
friction forces. | Both the RIST Radial
Access Catheter and
the predicate device
have comparable
friction forces. The test
supports the indications
for use which are the
same in the RIST
Radial Access Catheter
and in the predicate
device. | | | | | | | | |
| Design Validation Testing | | | | | | | | | | | |
| In vitro Simulated Use
Study - Bench | The Berenstein (BER) and
Simmons 2 (SIM2) shapes of
the RIST Radial Access
Catheter were prepared per
the IFU. A simulated
interventional procedure was
performed by physicians in
order to verify the product's
performance.
Competitive devices were
evaluated in order to
establish a baseline for
trackability and support
ratings. (Note - the
competitive device
used for this evaluation
was Penumbra Neuron
Select 5Fr (K082290).
This device is identical
to the predicate 5Fr
Select catheter, cleared
as part of the
Benchmark
Intracranial Access
System (K142321). | All acceptance criteria
were met. | The performance of the
RIST Radial Access
Catheter was found to
be substantially
equivalent to the
predicate device. The
test supports the
indications for use
which are the same in
the RIST Radial
Access Catheter and in
the predicate device. | | | | | | | | |
| Test Performed | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence | | | | | | | | |
| Radiopacity | Physicians will be shown
fluoroscopic images of the
RIST Radial Access Catheter
and asked to identify the
location of the distal tip, the
shape of the catheter, and the
location of each curve along the
shape of the catheter. | All acceptance criteria were
met. | The performance of the
RIST Radial Access
Catheter was found to
be substantially
equivalent to the
predicate device. The
test supports the
indications for use
which are the same in
the RIST Radial
Access Catheter and in
the predicate device. | | | | | | | | |
| In vitro Simulated Use
Study - Usability | Evaluators representative of
the intended user population
evaluated the RIST Radial
Access Catheter as per the
Instructions for Use. | All acceptance criteria
were met. | The usability of the
RIST Radial Access
Catheter 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 Radial
Access Catheter and
in the predicate 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 | | | | | | | | | | | |
| Hub Compatibility | Catheter luers were tested per
ISO 594. | All units met the Hub
Compatibility acceptance
criteria | This test demonstrates
compatibility of the RIST
Radial Access Catheter
luer with mating luer
surfaces. Both the
predicate device and the
RIST Radial Access
Catheter have luer tapered
hubs. The test supports
the indications for use
which are the same in the
RIST Radial Access
Catheter and in the
predicate device. | | | | | | | | |
| Testing Leveraged from SYPHONTRAK SDA, 510(k) #K161262 | | | | | | | | | | | |
| 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 Radial
Access Catheter 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 Radial Access
Catheter 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 Radial
Access Catheter and the
predicate device have
similar information
contained in the product
barcode. This test verifies
that the barcode is
scannable and the
information within is
appropriate. The test
supports the indications
for use which are the
same in the RIST Radial
Access Catheter and in
the predicate device. | | | | | | | | |
| Test Leveraged | Test Method | Results | Discussion of How This
Test Supports a Finding
of Substantial
Equivalence | | | | | | | | |
| Testing Leveraged from SYPHONTRAK SDA, 510(k) #K161262, and SYPHONTRAK IC (formerly known
as the InNeuroCo Intermediate Catheter or IC), 510(k) #K152202 | | | | | | | | | | | |
| 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 Radial
Access Catheter 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 Radial Access
Catheter 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 Radial Access
Catheter 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. | | | | | | | | |
| Biological Effect | Test | Results | Conclusion | | | | | | | | |
| Cytotoxicity | ISO MEM Elution | The test article is
considered non-cytotoxic
under the conditions of
this test. No abnormal
events such as pH
change or debris were
noted. | The RIST Radial
Access Catheter is
non-cytotoxic. | | | | | | | | |
| | | | | Sensitization | ISO Guinea Pig
Maximization
Sensitization | Under the conditions of
this protocol, the test
article did not elicit a
sensitization response. | The RIST Radial
Access Catheter is
classified as a non-
sensitizer. | | | | |
| | | | | | | | | Irritation | ISO Intracutaneous
Irritation | No significant dermal
reactions were observed
at the injected test and
control sites in any of the
test subjects. | The RIST Radial
Access Catheter is
non-irritant. |
| Systemic Toxicity | ISO Acute Systemic
Injection | None of the study
subjects were observed
with abnormal clinical
signs indicative of
toxicity during the test
period. | The RIST Radial
Access Catheter is
non-cytotoxic. | | | | | | | | |
| | | | | | Complement Activation,
SC5b-9 Assay | The test article results in
the SC5b-9 assay were
not statistically
significant (p>0.05)
when compared to the
reference material and
comparison article. | The compliment
activation of the SC5b
assays were similar for
test and comparison
articles. | | | | |
| | | | | | | | | Hemocompatibility | ASTM Hemolysis -
Direct Contact and
Extract Method | For Direct Contact
method and Extract
method, the test article
returned a blank
corrected percent
hemolysis above the
negative control of 0.0%. | The RIST Radial
Access Catheter is
non-hemolytic. |
| | | | | | | | | | | | |
| | | | | Pyrogenicity | Materials Mediated
Rabbit Pyrogen | The test article extracts
did not cause a
pyrogenic response and
all validity criteria were
met during the assay. | The RIST Radial
Access Catheter is
non-pyrogenic. | | | | |
Table 2 - Summary of Performance Testing Conducted on RIST Radial Access Catheter
7
8
9
10
11
12
13
14
Table 3 – Summary of Testing Leveraged from Previous Submissions
15
5. Biocompatibility Testing
The RIST Radial Access Catheter 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 4 .
16
Table 4 – Summary of Biocompatibility Testing
17
The results of the testing demonstrate the biocompatibility of the RIST Radial Access Catheter 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 Radial Access Catheter, is substantially equivalent to the predicate Penumbra 5F Select Catheter which was cleared as part of the Benchmark Intracranial Access System, K142321, on January 26, 2015. Any differences between the subject and the predicate devices do not raise any issues of safety and effectiveness.