(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 | 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.
§ 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).