(29 days)
The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
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.
The Rist™ 071 Radial Access Guide Catheter is a medical device intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The acceptance criteria and supporting studies are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent extensive testing, and the results consistently indicated that "All units met the acceptance criteria" or similar statements. Specific numerical acceptance criteria were not explicitly provided in the document for most tests, but the qualitative statement of meeting criteria is present.
| Test Performed | Acceptance Criteria (Explicit or Qualitative) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxicity, no abnormal events (pH change, debris) | The test article is considered non-cytotoxic... No abnormal events such as pH change or debris were noted. |
| Sensitization | No sensitization response | The test article did not elicit a sensitization response. |
| Irritation | No significant dermal reactions | No significant dermal reactions were observed. |
| Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity | None of the study subjects were observed with abnormal clinical signs indicative of toxicity. |
| Pyrogenicity | No pyrogenic response; all validity criteria met | The test article extracts did not cause a pyrogenic response and all validity criteria were met. |
| Hemocompatibility (Complement Activation) | Not statistically significant (p>0.05) to reference material/comparison article | The test article results... were not statistically significant (p>0.05). |
| Hemocompatibility (Hemolysis) | Blank corrected percent hemolysis above negative control of 0.0% | The test article returned a blank corrected percent hemolysis above the negative control of 0.0%. |
| Hemocompatibility (Platelet & Leukocyte Count) | Platelet count within specification | The platelet count was within specification. |
| Hemocompatibility (Partial Thromboplastin Time) | No more material mediated coagulation abnormalities than predicate in intrinsic pathway | The test article did not create any more material mediated coagulation abnormalities... when compared to the predicate. |
| Sterilization Validation | Product sterility per ANSI/AAMI/ISO 11135:2014 and AAMI TIR 28:2016 | Product was sterile. |
| Packaging | Sterile barrier not compromised | All units met all the packaging acceptance criteria. |
| Catheter and Dilator Tensile Strength | Met tensile strength acceptance criteria per ISO 10555-1:2013/Amd. 1:2017(E) | All units met the tensile strength acceptance criteria. |
| Catheter PTFE Delamination | Met PTFE delamination acceptance criteria | All units met the catheter PTFE delamination acceptance criteria. |
| Torque | Met torque acceptance criteria | All units met the torque acceptance criteria. |
| Catheter Burst Pressure | Met burst pressure acceptance criteria per ISO 10555-1:2013/Amd. 1:2017(E) | All units met the catheter burst pressure acceptance criteria. |
| Particulate Testing | Met particulate acceptance criteria per USP <788> | All units met the particulate testing acceptance criteria. |
| Coating Integrity | Met coating integrity acceptance criteria (no surface irregularities after conditioning and tortuous path) | All units met the coating integrity acceptance criteria. |
| Leak (Liquid) | No leakage per ISO 10555-1:2013/Amd. 1:2017(E) | All units met the liquid leak test acceptance criteria. |
| Leak (Air) | No air leaks per ISO 10555-1:2013/Amd. 1:2017(E) | All units met the air leak test acceptance criteria. |
| Catheter Dimensional Inspection | ID, OD, and working length met acceptance criteria | All units met the catheter dimensional inspection acceptance criteria. |
| Dilator Dimensional Inspection | ID and OD met acceptance criteria | All units met the dilator dimensional inspection acceptance criteria. |
| Chemical Compatibility | No signs of degradation, no obstruction of ID after exposure to saline, dextrose, heparin, radiocontrast | All units met the chemical compatibility acceptance criteria. |
| Visual Inspection of Catheter and Dilator | Smooth tip transition points, no surface defects | All units met the visual inspection acceptance criteria. |
| Catheter Coating Length | Length of hydrophilic coating met specification | All units met the catheter coating length acceptance criteria. |
| Kink Resistance | Met kink resistance acceptance criteria | All units met the kink resistance acceptance criteria. |
| In vitro Simulated Use Study | Product performance verified by physicians | All acceptance criteria were met. |
| Corrosion (from predicate) | Met corrosion acceptance criteria per ISO 10555-1:2013/Amd. 1:2017(E) | All units met the corrosion acceptance criteria. |
| Hub Compatibility (from predicate) | Met hub compatibility acceptance criteria per ISO 594-1:1986 and ISO 594-2:1998 | All units met the hub compatibility acceptance criteria. |
| Radiopacity (from predicate) | Physicians identified distal tip location, catheter shape, and curve locations on fluoroscopic images | All acceptance criteria were met. |
| Label Content (from predicate) | Information included is accurate | All units met the acceptance criteria for label content. |
| Label Legibility (from predicate) | Labeling remained legible after transportation and conditioning | All units met the acceptance criteria for label legibility. |
| Barcode (from predicate) | Scanned barcode matched appropriate information | All units met the acceptance criteria for barcode. |
| Dilator Working Length (from predicate) | Dilator length met specification | All units met the acceptance criteria for dilator working length. |
| Useability (from predicate) | Evaluators confirmed usability as per Instructions for Use | All acceptance criteria were met. |
| Shelf-Life Testing | Product and packaging met all acceptance criteria for 6-month shelf life | All acceptance criteria were met. |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test in the "Test Set." However, it repeatedly mentions "All units" or "All units met" indicating that a sufficient number of samples were tested to achieve statistical significance or to demonstrate compliance.
The data provenance is not specified in terms of country of origin. The studies are described as "Design verification and validation" (in-house testing) and based on applicable ISO/ASTM/USP standards, suggesting a laboratory-based, prospective testing approach. No mention of retrospective or prospective clinical data for the test set is present, as this is a pre-market submission focused on device performance rather than clinical outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For the "In vitro Simulated Use Study," it states that "A simulated interventional procedure was performed by physicians." The exact number of physicians or their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.
For the "Radiopacity" test (from the predicate device), "Physicians were shown fluoroscopic images." Again, the specific number and qualifications of these physicians are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the tests. The results indicate a direct pass/fail or "met acceptance criteria" outcome, implying consensus on the directly measurable or observable results rather than a subjective assessment requiring adjudication. For physician-evaluated tests, the document indicates a general 'acceptance criteria met' without detailing disagreement resolution.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The studies focused on device performance characteristics rather than comparing human reader performance with or without AI assistance. The device itself is a physical catheter, not an AI-powered diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No standalone algorithm performance study was done. This is consistent with the nature of the device as a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
The ground truth for most performance tests was established by adherence to recognized international standards (ISO, ASTM, USP) and predefined internal specifications for various physical, chemical, and biological properties. This includes:
- Physical Measurements: Dimensional accuracy (ID, OD, length), tensile strength metrics, burst pressure values, torque limits, kink resistance thresholds.
- Chemical/Biological Properties: Biocompatibility assays (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility), chemical compatibility.
- Functional Performance: Leak testing, coating integrity, particulate count, simulated use performance, radiopacity (as confirmed by physicians).
- Sterility and Packaging Integrity: Demonstrated through sterilization validation and packaging tests.
8. Sample Size for the Training Set
No training set is applicable or mentioned. This device is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for a physical device.
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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 orClassification 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 DeviceRIST™ Cath Radial AccessLong Sheath | Subject DeviceRist™ 071 Radial Access GuideCatheter |
|---|---|---|
| 510(k) Number | K191551 | K211990 |
| Classification | Class II | Same |
| Product Code | DQY | DQY, QJP |
| Review Panel | Cardiology | Cardiology, Neurology |
| Indications forUse | The RIST™ Cath Radial Access LongSheath is indicated for the introductionof interventional devices into theperipheral, coronary, and neurovasculature. | The Rist™ 071 Radial Access GuideCatheter is indicated for theintroduction of interventional devicesinto the peripheral, coronary, and neurovasculature. |
| Table C.1 Technological Characteristics Comparison | ||
|---|---|---|
| Predicate Device | Subject Device | |
| Parameter | RIST TM Cath Radial AccessLong Sheath | RistTM 071 Radial Access GuideCatheter |
| Catheter ShaftOuter Jacket | Chronoflex AL 75A, Polyblend 55Ablend | Chronoflex AL 75A, Polyblend 55Ablend with revised Polyolefin |
| Chronoflex C 85A | Chronoflex C 85A purchased from a newvendor resulting in a polyurethane softblock change | |
| Chronoflex C 45D | Same | |
| Pebax | Same | |
| Vestamid/72D Coextrusion | Same | |
| Liner | Etched PTFE | Same |
| Catheter ShaftReinforcement | Stainless Steel Flat WireNitinol Round Wire | Same |
| Marker Band | 90% Platinum/10% Iridium | Same |
| Hub Material | Polycarbonate (Makrolon) | Same |
| Strain Relief | Polyolefin | Same |
| Coating | Hydrophilic Coating | Same |
| Catheter WorkingLength | 95, 100, 105* cm | 95, 100, 105 cm |
| Catheter InnerDiameter | 0.079 inches | 0.071 inches |
| Catheter OuterDiameter | 0.093 inches | 0.084 inches |
| DilatorWorking 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 withpolycarbonate (Makrolon hub) | Same |
| Accessories | Dilator* | Same |
| Parameter | Predicate DeviceRISTTM Cath Radial AccessLong Sheath | Subject DeviceRistTM 071 Radial Access GuideCatheter |
| Packaging | Tyvek/Nylon pouch | Tyvek/Nylon pouch with revised Anti-blocking agent. |
| Polyethylene support tube | Polyethylene support tube with revisedadditive 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 documentedas 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(ISO MEM Elution) | The test article is considerednon-cytotoxic under theconditions of this test. Noabnormal events such as pHchange or debris were noted. |
| Sensitization(ISO Magnusson-Kligman Method) | Under the conditions of thisprotocol, the test article did notelicit a sensitization response. | |
| Irritation(ISO Intracutaneous Toxicity) | No significant dermal reactionswere observed at the injected testand control sites in any of thetest subjects. | |
| Acute Systemic Toxicity(ISO Systemic Injection) | None of the study subjects wereobserved 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 toxicityduring the test period. | ||
| Pyrogenicity(Material Mediated Pyrogenicity) | The test article extracts did notcause a pyrogenic response andall validity criteria were metduring the assay. | |
| Hemocompatibility(Complement Activation, SC5b-9 Assay) | The test article results in theSc5b-9 assay were notstatistically significant (p>0.05)when compared to the referencematerial and comparison article. | |
| Hemocompatibility(ASTM Hemolysis - Direct Contact and IndirectMethod) | For Direct Contact method andIndirect method, the test articlereturned a blank correctedpercent hemolysis above thenegative control of 0.0%. | |
| Hemocompatibility(Platelet & Leukocyte Count) | Under the conditions of thisprotocol, the platelet count waswithin specification. | |
| Hemocompatibility(Partial Thromboplastin Time (PTT) | The test article did not createany more material mediatedcoagulation abnormalities in theintrinsic pathway whencompared to the predicate. | |
| SterilizationValidation | Testing was performed per ANSI/AAMI/ISO11135:2014 and AAMI TIR 28:2016 | Product was sterile. |
| Packaging | The packaging was tested to ensure the sterile barrierwas not compromised. | All units met all the packagingacceptance criteria. |
| Catheter andDilator TensileStrength | Testing was completed per ISO 10555-1:2013/Amd.1:2017(E). Using a force gauge, test samples werepulled until failure. | All units met the tensile strengthacceptance criteria. |
| Catheter PTFEDelamination | Samples of the proximal and distal sections of thecatheter were tested to evaluate the adhesion of theetched PTFE layer to the catheter shaft. | All units met the catheter PTFEdelamination acceptance criteria. |
| Torque | The distal end of the unit was held rigid while theproximal end was turned until failure. | All units met the torqueacceptance criteria. |
| Catheter BurstPressure | Testing was completed per ISO 10555-1:2013/Amd.1:2017(E) by clamping the distal end and pressurizingthe assembly was pressurized and peak pressure wasrecorded. | All units met the catheter burstpressure acceptance criteria. |
| ParticulateTesting | Particulate testing was performed in a tortuous modeland particulate count was evaluated per USP <788>. | All units met the particulatetesting acceptance criteria. |
| Coating Integrity | Catheter samples were inspected under magnificationbefore and after conditioning and being passed througha tortuous path for surface irregularities. | All units met the coatingintegrity acceptance criteria. |
| Leak (Liquid) | Testing was completed per ISO 10555-1:2013/Amd.1:2017(E) by connecting the catheter to test equipment,sealing the distal end of the catheter, pressurizing the | All units met the liquid leak testacceptance criteria. |
| Test Performed | Test Method / Applicable Standard | Results |
| catheter, holding the pressure, and ensuring there wasno leakage. | ||
| Leak (Air) | Testing was conducted per ISO 10555-1:2013/Amd.1:2017(E) to ensure no air leaks into the productassembly. | All units met the air leak testacceptance criteria. |
| CatheterDimensionalInspection | The ID, OD, and working length were measured toensure the acceptance criteria were met. | All units met the catheterdimensional inspectionacceptance criteria. |
| DilatorDimensionalInspection | The ID and OD of the dilator were measured to ensurethe acceptance criteria were met. | All units met the dilatordimensional inspectionacceptance criteria. |
| ChemicalCompatibility | Samples of catheter and accessories were exposed tosaline, dextrose, heparin, and radiocontrast and theninspected for any signs of degradation and ensure theID had no obstruction. | All units met the chemicalcompatibility acceptance criteria. |
| Visual Inspectionof Catheter andDilator | The catheter and dilator were inspected to ensuresmooth tip transition points and no surface defectswere present. | All units met the visualinspection acceptance criteria. |
| Catheter CoatingLength | Catheter samples were inspected under magnificationafter hydrating the coating, and the length of thecatheter covered with the hydrophilic coating wasmeasured to ensure specification was met. | All units met the catheter coatinglength acceptance criteria. |
| Kink Resistance | Test units were wrapped around progressively smallerdiameter pegs and mandrels until a kink wasobserved. | All units met the kink resistanceacceptance criteria. |
| In vitroSimulated UseStudy | The Rist™ 071 Radial Access Guide Catheter wasprepared per the IFU. A simulated interventionalprocedure was performed by physicians in order toverify the product's performance.Predicate devices were evaluated in order to establish abaseline 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 10555-1:2013/Amd. 1:2017(E) | All units met the corrosionacceptance criteria. |
| Hub Compatibility | Catheter luers were tested per ISO 594-1:1986and ISO 594-2:1998. | All units met the hubcompatibility acceptancecriteria. |
| Radiopacity | Physicians were shown fluoroscopic imagesof the RIST Cath Radial Access Long Sheathand asked to identify the location of the distaltip, the shape of the catheter, and the locationof each curve along the shape of the catheter. | All acceptance criteria were met. |
| Label Content | Product label content is reviewed to ensure theinformation included is accurate. | All units met the acceptancecriteria for label content. |
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| Test Performed | Test Method / Applicable Standard | Results |
|---|---|---|
| Label Legibility | Labeling was inspected to ensure it remainedlegible after transportation and environmentalconditioning. | All units met the acceptancecriteria for label legibility. |
| Barcode | Barcode was scanned on randomly selectedcarton and pouch to ensure the scan matchesthe appropriate information. | All units met the acceptancecriteria for barcode. |
| Dilator Working Length | The dilator length was measured to ensure itmet the dilator specification. | All units met the acceptancecriteria for dilator working length. |
| Useability (as part ofDesign Validation) | Evaluators representative of the intended userpopulation evaluated the RIST™ Cath RadialAccess Long Sheath as per the Instructionsfor 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).
§ 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).