(98 days)
Not Found
No
The 510(k) summary describes a physical catheter device and its intended use for delivering interventional devices and diagnostic agents. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on physical characteristics and compatibility, not algorithmic performance.
No
The device is described as an access catheter for introducing interventional devices and diagnostic agents, not for directly treating a condition.
No
The device is a catheter used to introduce other interventional devices and facilitate the introduction of diagnostic agents, but it does not perform a diagnostic function itself. It is a tool for delivering diagnostic agents, not a device that diagnoses.
No
The device description clearly details a physical catheter with specific dimensions, materials (stainless steel), and a luer connector, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the introduction of interventional devices and facilitating introduction of diagnostic agents into the vasculature. This is a procedural device used in vivo (within the body) during medical procedures.
- Device Description: The description details a catheter designed for accessing blood vessels and delivering other devices or substances. This aligns with an interventional or diagnostic access tool used directly on the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of biological specimens outside the body.
The device is a medical device used for accessing and navigating within the patient's vascular system for diagnostic and interventional purposes.
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.
It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
Product codes (comma separated list FDA assigned to the subject device)
QJP, DQO
Device Description
The RIST Radial Access Catheter is a flexible, single lumen catheter compatible with 0.038inch quidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature, facilitate introduction of diagnostic agents in the neuro vasculature, and is intended to provide access to the target site via transradial access. The RIST Radial Access Catheter consists of a radiopaque catheter shaft reinforced with stainless steel and has a luer connector at its proximal end for the attachment of accessories and the infusion of fluids. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes, namely Simmons 2 (SIM2) and Berenstein (BER), The catheter has a nominal outer diameter of 0.070 inches and a nominal inner diameter of 0.040 inches. It is available in two working lengths: 120 cm. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-the-shelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
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 devices. There are no known performance standards for this device, the verification and validation test data, including biocompatibility were leveraged from data that had been generated from testing done on a previously cleared device. The summary of these tests is included in Table d.2.
To support the indication for use for the subject device RIST Radial Access Catheter in diagnostic angiography procedures, the following additional testing was performed: Power Injection testing. A summary of this test is presented in Table d.1.
Table d. 1 Summary of Additional testing Conducted:
Test Performed: Power Injection
Test Method / Applicable Standard: Testing was completed per ISO 10555-1 connecting units to power injector at different flow rates using test fluid.
Results: All units met the power injection acceptance criteria.
Table d.2 Summary of Testing leveraged from previous cleared device:
Test Performed: Tensile Strength
Test Method / Applicable Standard: Testing was completed per ISO 10555-1. Using a force gauge, test samples were pulled until failure.
Results: All units met the Tensile Strength acceptance criteria.
Test Performed: Torque Strength
Test Method / Applicable Standard: The distal end of the unit was held rigid while the proximal end was turned until failure.
Results: All units met the Torque Strength acceptance criteria.
Test Performed: Particulates
Test Method / Applicable Standard: Particulate testing was performed in a tortuous model and particulate count was evaluated per USP .
Results: The acceptance criteria for Particulate testing was met.
Test Performed: Dimensional Verification - ID
Test Method / Applicable Standard: The ID was measured to ensure the acceptance criteria was met.
Results: The acceptance criteria for ID Dimensional Verification was met.
Test Performed: Dimensional Verification -OD
Test Method / Applicable Standard: The OD was measured to ensure the acceptance criteria was met.
Results: The acceptance criteria for OD Dimensional Verification was met.
Test Performed: Dimensional Verification - Working Length
Test Method / Applicable Standard: The working length was measured to ensure the acceptance criteria were met.
Results: The acceptance criteria for Working Length Dimensional Verification was met.
Test Performed: Dimensional Verification - Tip Length
Test Method / Applicable Standard: The tip length was measured to ensure the acceptance criteria were met.
Results: The acceptance criteria for Tip Length Dimensional Verification were met.
Test Performed: Kink Resistance
Test Method / Applicable Standard: Test units were wrapped around progressively smaller diameter pegs and/or mandrels until a kink was observed.
Results: All units met the Kink Resistance acceptance criteria.
Test Performed: Visual Inspection (Tip Taper/Transitions)
Test Method / Applicable Standard: Samples were visually inspected to ensure the acceptance criteria were met.
Results: All units met the Tip Taper/Transition Visual Inspection acceptance criteria.
Test Performed: Shape Retention (Catheter Tip Shape)
Test Method / Applicable Standard: Samples were individually inspected to ensure that the shape met the specified specification.
Results: All units met the Shape Retention Acceptance criteria.
Test Performed: Radiopacity
Test Method / Applicable Standard: 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.
Results: All acceptance criteria were met.
Test Performed: Burst Test
Test Method / Applicable Standard: Testing was completed per ISO 10555-1 by clamping the distal end and pressurizing the assembly was pressurized and peak pressure was recorded.
Results: All units met the Catheter Burst acceptance criteria.
Test Performed: Liquid Leak Test
Test Method / Applicable Standard: 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.
Results: All units met the Liquid Leak acceptance criteria.
Test Performed: Air Leak Test
Test Method / Applicable Standard: Testing was conducted per ISO 80369-7 to ensure no air leaks into the product assembly.
Results: All units met the Air Leak Test acceptance criteria.
Test Performed: Hub Compatibility
Test Method / Applicable Standard: Catheter luers were tested per ISO 594.
Results: All units met the Hub Compatibility acceptance criteria.
Test Performed: Chemical Compatibility
Test Method / Applicable Standard: 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.
Results: All units met the Chemical Compatibility acceptance criteria.
Test Performed: Corrosion
Test Method / Applicable Standard: Testing was conducted per ISO 10555-1 Annex A.
Results: All units met the Corrosion acceptance criteria.
Test Performed: Packaging - Visual Inspection
Test Method / Applicable Standard: 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.
Results: All units met the Packaging Visual Inspection.
Test Performed: Packaging - Pouch Leak
Test Method / Applicable Standard: 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.
Results: All units met the Pouch Leak test.
Test Performed: Packaging - Pouch Peel
Test Method / Applicable Standard: 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.
Results: All units met the Pouch Peel test.
Test Performed: Packaging - Seal Width
Test Method / Applicable Standard: The in-house pouch seal width was measured to ensure the acceptance criteria were met.
Results: All seals met the acceptance criteria for Seal Width.
Test Performed: Labeling Legibility - Label
Test Method / Applicable Standard: Labeling was inspected to ensure test remained legible after transportation and environmental conditioning.
Results: The acceptance criteria for Labeling Legibility was met.
Test Performed: Barcode
Test Method / Applicable Standard: Barcode was scanned on randomly selected carton and pouch to ensure the scan matches the appropriate information.
Results: The acceptance criteria for Barcode was met.
Test Performed: Labeling Legibility - IFU
Test Method / Applicable Standard: Labeling was inspected to ensure test remained legible after transportation and environmental conditioning.
Results: The acceptance criteria for IFU Legibility was met.
Test Performed: Sterilization
Test Method / Applicable Standard: Testing was performed per ANSI/AAMI/ISO 11135:2014 and AAMI TIR 28:2016
Results: Product was sterile.
Test Performed: Biocompatibility - Cytotoxicity (ISO MEM Elution)
Results: The test article is considered non-cytotoxic under the conditions of this test. No abnormal events such as pH change or debris were noted.
Test Performed: Biocompatibility - Sensitization (ISO Guinea Pig Maximization Sensitization)
Results: Under the conditions of this protocol, the test article did not elicit a sensitization response.
Test Performed: Biocompatibility - Irritation (ISO Intracutaneous Irritation)
Results: No significant dermal reactions were observed at the injected test and control sites in any of the test subjects.
Test Performed: Biocompatibility - Systemic Toxicity (ISO Acute Systemic Injection)
Results: None of the study subjects were observed with abnormal clinical signs indicative of toxicity during the test period.
Test Performed: Hemocompatibility - Complement Activation, SC5b-9 Assay
Results: 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.
Test Performed: Hemocompatibility - ASTM Hemolysis - Direct Contact and Extract Method
Results: For Direct Contact method and Extract method, the test article returned a blank corrected percent hemolysis above the negative control of 0.0%.
Test Performed: Hemocompatibility - In Vivo Thromboresistance Evaluation
Results: Implantation of the test and control devices resulted in no adverse effects or clinical signs.
Test Performed: Pyrogenicity - Materials Mediated Rabbit Pyrogen
Results: The test article extracts did not cause a pyrogenic response and all validity criteria were met during the assay.
Test Performed: Friction Force
Test Method / Applicable Standard: The frictional forces of the RIST Radial Access Catheter and the predicate device were measured when deployed and retracted in a simulated-use anatomical model.
Results: The RIST Radial Access Catheter had comparable friction forces to it's predicate devices.
Test Performed: In vitro Simulated Use Study - Bench
Test Method / Applicable Standard: 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.
Results: All acceptance criteria were met.
Test Performed: In vitro Simulated Use Study - Usability
Test Method / Applicable Standard: Evaluators representative of the intended user population evaluated the RIST Radial Access Catheter as per the Instructions for Use.
Results: All acceptance criteria were met.
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.
SOFIA 6F Plus/Distal Access Catheter (K150366), RIST Radial Access Catheter (K200417)
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.
Not Found
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
§ 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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
September 28, 2020
RIST Neurovascular, Inc. Vyoma Chikara Design Quality/Regulatory Affairs 11611 Interchange Circle South Miramar, Florida 33025
Re: K201682
Trade/Device Name: RIST Radial Access Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQO Dated: August 28, 2020 Received: August 31, 2020
Dear Vyoma Chikara:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradvan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201682
Device Name RIST Radial Access Catheter
Indications for Use (Describe)
The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 510K SUMMARY | K201682 |
|---|---|
| Date Summary Prepared: | September 23, 2020 |
| Submitter: | RIST Neurovascular, Inc. |
| 11611 Interchange Circle South | |
| Miramar, FL 33025 | |
| Primary Submission Contact: | Vyoma Upadhya Chikara |
| Design Quality & Requlatory Affairs | |
| 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 |
| Requlation Number: | 21 CFR 870.1250 |
| Device Common or | |
| Classification Name: | Percutaneous Catheter |
| Product Class: | Class II |
| Product Panel: | Neurovascular |
| Product Code: | QJP |
| Secondary Product Code: | DQO |
| Predicate Devices: | SOFIA 6F Plus/Distal Access Catheter (K150366) |
| RIST Radial Access Catheter (K200417) |
4
A) Device Description
The RIST Radial Access Catheter is a flexible, single lumen catheter compatible with 0.038inch quidewires. It is designed to deliver interventional devices into the peripheral, coronary, and neuro vasculature, facilitate introduction of diagnostic agents in the neuro vasculature, and is intended to provide access to the target site via transradial access. The RIST Radial Access Catheter consists of a radiopaque catheter shaft reinforced with stainless steel and has a luer connector at its proximal end for the attachment of accessories and the infusion of fluids. The distal tip of the catheter is shaped to have a smooth, rounded tip and is offered in two different distal segment shapes, namely Simmons 2 (SIM2) and Berenstein (BER), The catheter has a nominal outer diameter of 0.070 inches and a nominal inner diameter of 0.040 inches. It is available in two working lengths: 120 cm. The RIST Radial Access Catheter is compatible with the RIST Cath Radial Access Long Sheath (K191551) and off-the-shelf accessories. The RIST Radial Access Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
B) Indications for Use
The RIST Radial Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.
It can be used to facilitate introduction of diagnostic agents in the neuro vasculature. It is not intended to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
C) Technological Characteristics and Basis for Substantial Equivalence
The RIST Radial Access Catheter, subject of this 510(k) submission, is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, sterilization method and performance to the predicate devices, the SOFIA 6F Plus/Distal Access Catheter (K150366), and RIST Radial Access Catheter (K200417). A comparison of the technological characteristics of the subject device, the predicate devices, is summarized in Table c.1 below.
| Parameter | Subject Device
RIST Radial Access Catheter | Predicate Device
SOFIA 6Fr PLUS/Distal
Access Catheter
(K150366) | Predicate Device
RIST Radial Access Catheter
(K200417) |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The RIST Radial Access
Catheter is indicated for the
introduction of interventional
devices into the peripheral,
coronary and neuro
vasculature.
It can be used to facilitate
introduction of diagnostic
agents in the neuro
vasculature. It is not intended to
facilitate introduction of
diagnostic agents in coronary
or peripheral arteries. | The SOFIA PLUS/Distal
Access Catheters are
indicated for general
intravascular use, including
the neuro and peripheral
vasculature. It can be used to
facilitate introduction of
diagnostic and therapeutic
agents. It is not intended for
use in coronary arteries. | RIST Radial Access Catheter is
indicated for the introduction of
interventional devices into the
peripheral, coronary, and neuro
vasculature. |
| Principles of
operation | The device is advanced into the
vasculature over a guidewire. | Same | Same |
| Parameter | Subject Device
RIST Radial Access Catheter | Predicate Device
SOFIA 6Fr PLUS/Distal
Access Catheter
(K150366) | Predicate Device
RIST Radial Access Catheter
(K200417) |
| | once advanced and placed into
the desired vasculature, the
inner lumen is used to deliver
devices or diagnostic agents. | | |
| Performance
Testing | The product performance has
been evaluated per ISO10555-
-
| Same | Same |
| Product Code | QJP, DQO | DQY, DQO | QJP, DQY |
| Classification | Class II | Same | Same |
| Material | Catheter Body:
Outer polymer jacket of
Polyether Block Amide
(PEBAX) with BaSO4
Inner polymer layer of
Polyether Block Amide
(PEBAX) with BaSO4 | Catheter Body:
Outer polymer jacket of
Polyamide (Grilamid),
Polyether Block Amide
(PEBAX), and polyurethane
elastomer (Polyblend and
Pellethane)
Inner polymer layer of PTFE
and polyolefin elastomer | Same as subject device |
| | Reinforcement layer:
Stainless Steel Braid | Reinforcement layer:
Stainless Steel Braid/Coil | Same as subject device |
| | Strain Relief: Polyolefin Hub:
Polycarbonate (Makrolon) | Strain Relief: Polyurethane
Hub: Nylon | Same as subject device |
| Catheter Shaft
Reinforcement
Pattern | Braid | Same | Same |
| Hydrophilic
Coating | No | Yes | Same as subject device |
| Visibility under
fluoroscopy | Yes | Same | Same |
| Working Length | 120 and 130 cm | 115cm - 135cm | Same as subject device |
| Outer Diameter | 5.5Fr | 5Fr and 6Fr | Same as subject device |
| Inner Diameter | 0.040 inches | 0.055 inches and 0.070
inches | Same as subject device |
| Tip Shapes
Offered | Yes | Steam Shapeable by user | Same as subject device |
| Packaging | Pouch & Carton | Same | Same |
| Sterilization | Ethylene Oxide | Same | Same |
| Number of Uses | Single Use | Same | Same |
Table c.1 Technological Characteristics comparison
5
6
D) Performance Data
Design verification and validation were performed to ensure that the RIST Radial Access Catheter meets its performance specifications and demonstrates substantial equivalence to the predicate devices. There are no known performance standards for this device, the verification and validation test data, including biocompatibility were leveraged from data that had been generated from testing done on a previously cleared device. The summary of these tests is included in Table d.2.
To support the indication for use for the subject device RIST Radial Access Catheter in diagnostic angiography procedures, the following additional testing was performed: Power Injection testing. A summary of this test is presented in Table d.1.
| Test Performed | Test Method / Applicable Standard | Results |
|---|---|---|
| Power Injection | Testing was completed per ISO 10555-1 connecting | |
| units to power injector at different flow rates using test | ||
| fluid. | All units met the power injection | |
| acceptance criteria. |
Table d. 1 Summary of Additional testing Conducted
| Table d.2 Summary of Testing leveraged from previous cleared device | ||
|---|---|---|
| Test Performed | Test Method / Applicable Standard | Results |
| Testing Leveraged from RIST RADIAL ACCESS Catheter (K200417) | ||
| Tensile Strength | Testing was completed per ISO 10555-1. Using a | |
| force gauge, test samples were pulled until failure. | All units met the Tensile Strength | |
| acceptance criteria. | ||
| 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. | ||
| Particulates | Particulate testing was performed in a tortuous | |
| model and particulate count was evaluated per USP | ||
| . | The acceptance criteria for | |
| Particulate testing was met. | ||
| Dimensional | ||
| Verification - ID | The ID was measured to ensure the acceptance | |
| criteria was met. | The acceptance criteria for ID | |
| Dimensional Verification was met. | ||
| Dimensional | ||
| Verification -OD | The OD was measured to ensure the acceptance | |
| criteria was met. | The acceptance criteria for OD | |
| Dimensional Verification was met. | ||
| 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. | ||
| 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. | ||
| 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. | ||
| 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 | ||
| 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. | ||
| 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. | |
| Test Performed | Test Method / Applicable Standard | Results |
| Testing Leveraged from RIST RADIAL ACCESS Catheter (K200417) | ||
| 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. | ||
| 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. | ||
| 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. | ||
| Hub Compatibility | Catheter luers were tested per ISO 594. | All units met the Hub Compatibility |
| acceptance criteria | ||
| 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. | ||
| Corrosion | Testing was conducted per ISO 10555-1 Annex A. | All units met the Corrosion |
| acceptance criteria. | ||
| 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. | ||
| 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 | |
| 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. | |
| 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. | ||
| Labeling Legibility - | ||
| Label | Labeling was inspected to ensure test remained | |
| legible after transportation and environmental | ||
| conditioning. | The acceptance criteria for Labeling | |
| Legibility was met. | ||
| 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. | ||
| Labeling Legibility - | ||
| IFU | Labeling was inspected to ensure test remained | |
| legible after transportation and environmental | ||
| conditioning. | The acceptance criteria for IFU | |
| Legibility was met. | ||
| Sterilization | Testing was performed per ANSI/AAMI/ISO | |
| 11135:2014 and AAMI TIR 28:2016 | Product was sterile. | |
| Biocompatibility | Cytotoxicity | |
| (ISO MEM Elution) | The test article is considered non- | |
| cytotoxic under the conditions of 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. | ||
| Test Performed | Test Method / Applicable Standard | Results |
| Testing Leveraged from RIST RADIAL ACCESS Catheter (K200417) | ||
| 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. | ||
| Hemocompatibility | ||
| 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%. | ||
| Hemocompatibility | ||
| In Vivo Thromboresistance Evaluation | Implantation of the test and control | |
| devices resulted in no adverse effects | ||
| or clinical signs. | ||
| Pyrogenicity | ||
| Materials Mediated Rabbit Pyrogen | The test article extracts did not cause | |
| a pyrogenic response and all validity | ||
| criteria were met during the assay. | ||
| Friction Force | The frictional forces of the RIST Radial Access | |
| Catheter and the predicate device were measured | ||
| when deployed and retracted in a simulated-use | ||
| anatomical model. | The RIST Radial Access Catheter | |
| had comparable friction forces to it's | ||
| predicate devices. | ||
| 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 | All acceptance criteria were met. | |
| In vitro Simulated Use | ||
| Study - Usability | ratings. | |
| Evaluators representative of the intended user | ||
| population evaluated the RIST Radial Access | ||
| Catheter as per the Instructions for Use. | All acceptance criteria were met. |
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E) Shelf Life Testing
The labeled shelf life for the RIST Radial Access Catheter is 6months. Shelf life testing (product and packaging) and Distribution Shipping Challenge Conditioning and testing results were leveraged from data generated to support the previously cleared predicate device RIST Radial Access Catheter (K200417). All results met established criteria.
F) Conclusion
Review of the test data, as well as comparison of the device classifications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device,
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the RIST Radial Access Catheter, is substantially equivalent to the predicates SOFIA 6F Plus/Distal Access Catheter (K150366) and RIST Radial Access Catheter (K200417). Any differences between the subject and the predicate devices do not raise new issues of safety and effectiveness.