Rist 071 Radial Access Guide Catheter
Device Facts
| Record ID | K211990 |
|---|---|
| Device Name | Rist 071 Radial Access Guide Catheter |
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
| Product Code | DQY · Cardiovascular |
| Decision Date | Jul 27, 2021 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Device Story
The Rist™ 071 Radial Access Guide Catheter is a single-lumen, variable-stiffness catheter designed for transradial access. It features a stainless-steel and nitinol-reinforced shaft with a PTFE-lined lumen to minimize friction. The proximal section uses stainless-steel flat wire cross-coiling, transitioning to a nitinol round wire single coil at the distal end. A radiopaque platinum/iridium marker band is located at the distal tip for fluoroscopic visualization. The distal 25 cm includes a hydrophilic coating to reduce insertion force. The device is used by physicians in clinical settings to provide a reinforcing conduit for the delivery of other intravascular interventional devices. It is supplied sterile for single use and includes a radial access dilator as an accessory. By facilitating smooth navigation through the vasculature, the catheter enables the delivery of therapeutic devices to target sites, potentially improving procedural efficiency and patient outcomes.
Clinical Evidence
Bench testing only. No clinical data. Performance was validated through in vitro simulated use studies by physicians, confirming trackability and support ratings. Biocompatibility, sterilization, packaging, and mechanical performance (tensile strength, torque, burst pressure, kink resistance, leak testing) met all acceptance criteria.
Technological Characteristics
Single-lumen catheter; stainless steel flat wire and nitinol round wire reinforcement; PTFE-lined lumen; hydrophilic coating (distal 25 cm); platinum/iridium marker band; polycarbonate hub; dimensions: 0.084" OD, 0.071" ID; lengths: 95, 100, 105 cm. Materials: Chronoflex AL 75A, Polyblend 55A, Chronoflex C 85A/45D, Pebax, Vestamid. Sterilization: Ethylene Oxide. No software or electronic components.
Indications for Use
Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature in patients requiring such access.
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Predicate Devices
- RIST™ Cath Radial Access Long Sheath (K191551)
Submission Summary (Full Text)
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July 27, 2021
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular % Marianne Grunwaldt Senior Director of Quality Assurance and Regulatory Affairs InNeuroCo. Inc. 19700 Sterling Road. Suite 1 Pembroke Pines, Florida 33332
Re: K211990
Trade/Device Name: Rist 071 Radial Access Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: June 25, 2021 Received: June 28, 2021
Dear Marianne Grunwaldt:
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
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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,
Naira Muradyan, 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
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## Indications for Use
510(k) Number (if known) K211990
Device Name Rist™ 071 Radial Access Guide Catheter
Indications for Use (Describe)
The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) SUMMARY
| 510(k) Number | K211990 |
|------------------------------------------|------------------------------------------------|
| Date Summary Prepared | June 25, 2021 |
| Sponsor | Micro Therapeutics, Inc. |
| | d/b/a ev3 Neurovascular |
| | 9775 Toledo Way |
| | Irvine, CA 92618 |
| | Establishment Registration: 2029214 |
| Sponsor Contact | Amnon Talmor |
| | E-mail Address: amnon.talmor@medtronic.com |
| Prepared By | Marianne Grunwaldt |
| | E-mail Address: marianne@inneuroco.com |
| Trade Name: | Rist™ 071 Radial Access Guide Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Device Common or<br>Classification Name: | Percutaneous Catheter |
| Product Class: | Class II |
| Product Panel: | Cardiovascular, Neurovascular |
| Product Code: | DQY, QJP |
| Predicate Devices: | RIST™ Cath Radial Access Long Sheath (K191551) |
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#### A) Device Description
The Rist™ 071 Radial Access Guide Catheter is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft to provide support. The embedded stainless-steel flat wire cross coil is in the proximal section of the catheter, which transitions to a nitinol round wire single coil in the distal end. The catheter has a radiopaque platinum/iridium marker band on the distal end to aid in visualization. The distal 25 cm of the Rist™ 071 Radial Access Guide Catheter has a hydrophilic coating which reduces the insertion force and allows the catheter to traverse the vasculature more easily. The catheter has a nominal outer diameter of 0.084 inches and a nominal inner diameter of 0.071 inches. It is available in three working lengths: 95 cm, 100 cm, and 105 cm. The Rist™ 071 Radial Access Guide Catheter has a PTFE-lined lumen to reduce friction with other devices introduced through the lumen. It is intended to provide access to the target site via transradial access and, once in place, provides a reinforcing conduit for other intravascular devices. A radial access dilator is included as an accessory. The Rist™ 071 Radial Access Guide Catheter is supplied sterile, non-pyrogenic, and intended for single use only.
## B) Indications for Use
The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
#### C) Technological Characteristics and Basis for Substantial Equivalence
The Rist™ 071 Radial Access Guide Catheter, is substantially equivalent in its intended use/indications for use, technology and principle of operation, materials, sterilization method and performance to the predicate device, the RIST™ Cath Radial Access Long Sheath 510(k) #K191551. A comparison of the technological characteristics of the subject device and the predicate device, is summarized in Table C.1 below.
| Parameter | Predicate Device<br>RIST™ Cath Radial Access<br>Long Sheath | Subject Device<br>Rist™ 071 Radial Access Guide<br>Catheter |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K191551 | K211990 |
| Classification | Class II | Same |
| Product Code | DQY | DQY, QJP |
| Review Panel | Cardiology | Cardiology, Neurology |
| Indications for<br>Use | The RIST™ Cath Radial Access Long<br>Sheath is indicated for the introduction<br>of interventional devices into the<br>peripheral, coronary, and neuro<br>vasculature. | The Rist™ 071 Radial Access Guide<br>Catheter is indicated for the<br>introduction of interventional devices<br>into the peripheral, coronary, and neuro<br>vasculature. |
| Table C.1 Technological Characteristics Comparison | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | Predicate Device | Subject Device |
| Parameter | RIST TM Cath Radial Access<br>Long Sheath | RistTM 071 Radial Access Guide<br>Catheter |
| Catheter Shaft<br>Outer Jacket | Chronoflex AL 75A, Polyblend 55A<br>blend | Chronoflex AL 75A, Polyblend 55A<br>blend with revised Polyolefin |
| | Chronoflex C 85A | Chronoflex C 85A purchased from a new<br>vendor resulting in a polyurethane soft<br>block change |
| | Chronoflex C 45D | Same |
| | Pebax | Same |
| | Vestamid/72D Coextrusion | Same |
| Liner | Etched PTFE | Same |
| Catheter Shaft<br>Reinforcement | Stainless Steel Flat Wire<br>Nitinol Round Wire | Same |
| Marker Band | 90% Platinum/10% Iridium | Same |
| Hub Material | Polycarbonate (Makrolon) | Same |
| Strain Relief | Polyolefin | Same |
| Coating | Hydrophilic Coating | Same |
| Catheter Working<br>Length | 95, 100, 105* cm | 95, 100, 105 cm |
| Catheter Inner<br>Diameter | 0.079 inches | 0.071 inches |
| Catheter Outer<br>Diameter | 0.093 inches | 0.084 inches |
| Dilator<br>Working Length | 115 cm | Same |
| Dilator - ID | 0.037 inches | 0.040 inches |
| Dilator - OD | 0.072 inches | 0.068 inches |
| Dilator - Material | Pebax 72D with BaSO4 with<br>polycarbonate (Makrolon hub) | Same |
| Accessories | Dilator* | Same |
| Parameter | Predicate Device<br>RISTTM Cath Radial Access<br>Long Sheath | Subject Device<br>RistTM 071 Radial Access Guide<br>Catheter |
| Packaging | Tyvek/Nylon pouch | Tyvek/Nylon pouch with revised Anti-<br>blocking agent. |
| | Polyethylene support tube | Polyethylene support tube with revised<br>additive package antioxidant |
| | Packaging card | Same |
| | Solid Bleached Sulfate (SBS) carton | Same |
| Sterilization | Ethylene Oxide | Same |
| Number of Uses | Single Use | Same |
| * Since the clearance of the RISTTM Cath Radial Access Long Sheath two changes were made and documented<br>as per the FDA guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device." | | |
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Table C.1 Technological Characteristics Comparison
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Table C.1 Technological Characteristics Comparison
The two changes were the removal of the hemostasis valve originally included as an accessory, and the addition of a catheter with 105 cm working length.
## D) Performance Data
Design verification and validation were performed to ensure that the Rist™ 071 Radial Access Guide Catheter meets its performance specifications and to support substantial equivalence to the predicate device. Based on the risk analysis, it was determined that certain tests conducted for the predicate device could apply to the subject device, and certain tests should be repeated. The summary of tests performed on the subject Rist™ 071 Radial Access Guide Catheter is included in Table D.1, and a summary of the prior tests deemed applicable to the subject device is included in Table D.2.
| Test Performed | Test Method / Applicable Standard | Results |
|------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Cytotoxicity<br>(ISO MEM Elution) | The test article is considered<br>non-cytotoxic under the<br>conditions of this test. No<br>abnormal events such as pH<br>change or debris were noted. |
| | Sensitization<br>(ISO Magnusson-Kligman Method) | Under the conditions of this<br>protocol, the test article did not<br>elicit a sensitization response. |
| | Irritation<br>(ISO Intracutaneous Toxicity) | No significant dermal reactions<br>were observed at the injected test<br>and control sites in any of the<br>test subjects. |
| | Acute Systemic Toxicity<br>(ISO Systemic Injection) | None of the study subjects were<br>observed with abnormal clinical |
| | | Table D.1 List of Tests Conducted on the Rist™ 071 Radial Access Guide Catheter |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Test Performed | Test Method / Applicable Standard | Results |
| | | signs indicative of toxicity<br>during the test period. |
| | Pyrogenicity<br>(Material Mediated Pyrogenicity) | The test article extracts did not<br>cause a pyrogenic response and<br>all validity criteria were met<br>during the assay. |
| | Hemocompatibility<br>(Complement Activation, SC5b-9 Assay) | The test article results in the<br>Sc5b-9 assay were not<br>statistically significant (p>0.05)<br>when compared to the reference<br>material and comparison article. |
| | Hemocompatibility<br>(ASTM Hemolysis - Direct Contact and Indirect<br>Method) | For Direct Contact method and<br>Indirect method, the test article<br>returned a blank corrected<br>percent hemolysis above the<br>negative control of 0.0%. |
| | Hemocompatibility<br>(Platelet & Leukocyte Count) | Under the conditions of this<br>protocol, the platelet count was<br>within specification. |
| | Hemocompatibility<br>(Partial Thromboplastin Time (PTT) | The test article did not create<br>any more material mediated<br>coagulation abnormalities in the<br>intrinsic pathway when<br>compared to the predicate. |
| Sterilization<br>Validation | Testing was performed per ANSI/AAMI/ISO<br>11135:2014 and AAMI TIR 28:2016 | Product was sterile. |
| Packaging | The packaging was tested to ensure the sterile barrier<br>was not compromised. | All units met all the packaging<br>acceptance criteria. |
| Catheter and<br>Dilator Tensile<br>Strength | Testing was completed per ISO 10555-1:2013/Amd.<br>1:2017(E). Using a force gauge, test samples were<br>pulled until failure. | All units met the tensile strength<br>acceptance criteria. |
| Catheter PTFE<br>Delamination | Samples of the proximal and distal sections of the<br>catheter were tested to evaluate the adhesion of the<br>etched PTFE layer to the catheter shaft. | All units met the catheter PTFE<br>delamination acceptance criteria. |
| Torque | The distal end of the unit was held rigid while the<br>proximal end was turned until failure. | All units met the torque<br>acceptance criteria. |
| Catheter Burst<br>Pressure | Testing was completed per ISO 10555-1:2013/Amd.<br>1:2017(E) by clamping the distal end and pressurizing<br>the assembly was pressurized and peak pressure was<br>recorded. | All units met the catheter burst<br>pressure acceptance criteria. |
| Particulate<br>Testing | Particulate testing was performed in a tortuous model<br>and particulate count was evaluated per USP <788>. | All units met the particulate<br>testing acceptance criteria. |
| Coating Integrity | Catheter samples were inspected under magnification<br>before and after conditioning and being passed through<br>a tortuous path for surface irregularities. | All units met the coating<br>integrity acceptance criteria. |
| Leak (Liquid) | Testing was completed per ISO 10555-1:2013/Amd.<br>1:2017(E) by connecting the catheter to test equipment,<br>sealing the distal end of the catheter, pressurizing the | All units met the liquid leak test<br>acceptance criteria. |
| Test Performed | Test Method / Applicable Standard | Results |
| | catheter, holding the pressure, and ensuring there was<br>no leakage. | |
| Leak (Air) | Testing was conducted per ISO 10555-1:2013/Amd.<br>1:2017(E) to ensure no air leaks into the product<br>assembly. | All units met the air leak test<br>acceptance criteria. |
| Catheter<br>Dimensional<br>Inspection | The ID, OD, and working length were measured to<br>ensure the acceptance criteria were met. | All units met the catheter<br>dimensional inspection<br>acceptance criteria. |
| Dilator<br>Dimensional<br>Inspection | The ID and OD of the dilator were measured to ensure<br>the acceptance criteria were met. | All units met the dilator<br>dimensional inspection<br>acceptance criteria. |
| Chemical<br>Compatibility | Samples of catheter and accessories were exposed to<br>saline, dextrose, heparin, and radiocontrast and then<br>inspected for any signs of degradation and ensure the<br>ID had no obstruction. | All units met the chemical<br>compatibility acceptance criteria. |
| Visual Inspection<br>of Catheter and<br>Dilator | The catheter and dilator were inspected to ensure<br>smooth tip transition points and no surface defects<br>were present. | All units met the visual<br>inspection acceptance criteria. |
| Catheter Coating<br>Length | Catheter samples were inspected under magnification<br>after hydrating the coating, and the length of the<br>catheter covered with the hydrophilic coating was<br>measured to ensure specification was met. | All units met the catheter coating<br>length acceptance criteria. |
| Kink Resistance | Test units were wrapped around progressively smaller<br>diameter pegs and mandrels until a kink was<br>observed. | All units met the kink resistance<br>acceptance criteria. |
| In vitro<br>Simulated Use<br>Study | The Rist™ 071 Radial Access Guide Catheter was<br>prepared per the IFU. A simulated interventional<br>procedure was performed by physicians in order to<br>verify the product's performance.<br>Predicate devices were evaluated in order to establish a<br>baseline for trackability and support ratings. | All acceptance criteria were met. |
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Table D.1 List of Tests Conducted on the Rist™ 071 Radial Access Guide Catheter
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Table D.1 List of Tests Conducted on the Rist™ 071 Radial Access Guide Catheter
#### Table D.2 List of Tests Applied from the Predicate RIST™ Cath Radial Access Long Sheath (K191551)
| Test Performed | Test Method / Applicable Standard | Results |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Corrosion | Testing was conducted per ISO 10555-<br>1:2013/Amd. 1:2017(E) | All units met the corrosion<br>acceptance criteria. |
| Hub Compatibility | Catheter luers were tested per ISO 594-1:1986<br>and ISO 594-2:1998. | All units met the hub<br>compatibility acceptance<br>criteria. |
| Radiopacity | Physicians were shown fluoroscopic images<br>of the RIST Cath Radial Access Long Sheath<br>and asked to identify the location of the distal<br>tip, the shape of the catheter, and the location<br>of each curve along the shape of the catheter. | All acceptance criteria were met. |
| Label Content | Product label content is reviewed to ensure the<br>information included is accurate. | All units met the acceptance<br>criteria for label content. |
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| Test Performed | Test Method / Applicable Standard | Results |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Label Legibility | Labeling was inspected to ensure it remained<br>legible after transportation and environmental<br>conditioning. | All units met the acceptance<br>criteria for label legibility. |
| Barcode | Barcode was scanned on randomly selected<br>carton and pouch to ensure the scan matches<br>the appropriate information. | All units met the acceptance<br>criteria for barcode. |
| Dilator Working Length | The dilator length was measured to ensure it<br>met the dilator specification. | All units met the acceptance<br>criteria for dilator working length. |
| Useability (as part of<br>Design Validation) | Evaluators representative of the intended user<br>population evaluated the RIST™ Cath Radial<br>Access Long Sheath as per the Instructions<br>for Use. | All acceptance criteria were met. |
Table D.2 List of Tests Applied from the Predicate RIST™ Cath Radial Access Long Sheath
#### E) Shelf-Life Testing
The labeled shelf life for the Rist™ 071 Radial Access Guide Catheter is 6 months. Shelf-life testing (product and packaging) to support the labeled shelf life was performed. All acceptance criteria were met.
#### F) Conclusion
Based on the verification and validation testing conducted for the subject device and the tests applied from the predicate, as well as the comparison of indications for use, operating principle and technological characteristics, Rist™ 071 Radial Access Guide Catheter is substantially equivalent to the predicate device RIST™ Cath Radial Access Long Sheath (K191551).
