(194 days)
The RIST Cath Radial Access Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The RIST Cath Radial Access Long Sheath (RIST Cath) is a single lumen, variable stiffness catheter with a stainless steel and nitinol reinforced shaft and has a radiopaque marker band on the distal end to aid in visualization. The catheter has a nominal outer diameter of 0.093 inches and a nominal inner diameter of 0.079 inches. It is available in two working lengths: 95 cm and 100 cm. The RIST Cath is intended to provide access to the target site via transradial access and once in place, provides a reinforcing conduit for other intravascular devices. The RIST Cath Radial Access Long Sheath has a PTFE-lined lumen to facilitate movement of other devices passing through its lumen. Accessories included with the device are a radial access dilator and a hemostasis valve. The RIST Cath is supplied sterile, non-pyrogenic, and intended for single use only.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All pre-determined acceptance criteria were met" for all listed tests. However, it does not explicitly state the numerical acceptance criteria for each test. It primarily reports that the device "met the acceptance criteria" for each specific test.
| Test Performed | Acceptance Criteria (Not explicitly quantified in the document) | Reported Device Performance |
|---|---|---|
| Tensile Strength | Implicit: Structurally sound after simulated use | All units met the Tensile Strength acceptance criteria. |
| PTFE Delamination | Implicit: Liner remains adhered to outer jacket | All units met the PTFE Delamination acceptance criteria. |
| Torque Strength | Implicit: Ability to function in a clinical setting | All units met the Torque Strength acceptance criteria. |
| Hydrophilic Coating | Implicit: Coating integrity after simulation | All units met the Hydrophilic Coating acceptance criteria. |
| Particulates | Implicit: Particle quantities within expected parameters | The acceptance criteria for Particulate testing was met. |
| Dimensional Verification - ID | Implicit: ID within specified range | The acceptance criteria for ID Dimensional Verification was met. |
| Dimensional Verification - OD | Implicit: OD within specified range | The acceptance criteria for OD Dimensional Verification was met. |
| Dimensional Verification - Working Length | Implicit: Working length within specified range | The acceptance criteria for Working Length Dimensional Verification was met. |
| Kink Resistance | Implicit: Maintain structural integrity | All units met the Kink Resistance acceptance criteria. |
| Visual Inspection (Transitions & Tip) | Implicit: Integrity of transitions and tip | All units met the Transition and Tip Visual Inspection acceptance criteria |
| Catheter Burst | Implicit: Integrity under pressure | All units met the Catheter Burst acceptance criteria. |
| Liquid Leak Test | Implicit: No leakage under pressure | All units met the Liquid Leak acceptance criteria. |
| Air Leak Test | Implicit: No air leaks into assembly | All units met the Air Leak Test acceptance criteria. |
| Packaging - Pouch Peel | Implicit: Pouch seal integrity | All units met the Pouch Peel test. |
| Packaging - Pouch Leak | Implicit: No dye penetration through seal | All units met the Pouch Leak acceptance criteria. |
| Packaging - Visual Inspection | Implicit: Integrity of pouch and seals | All units met the Packaging Visual Inspection. |
| Packaging - Seal Width | Implicit: Seal width within specified range | All seals met the acceptance criteria for Seal Width. |
| Chemical Compatibility | Implicit: No degradation after exposure to chemicals | All units met the Chemical Compatibility acceptance criteria. |
| Hub Compatibility | Implicit: Compatibility with mating luer surfaces | All units met the Hub Compatibility acceptance criteria. |
| Corrosion | Implicit: Stainless steel reinforcement resists deterioration | All units met the Corrosion acceptance criteria. |
| Labeling Legibility - Label | Implicit: Legible after transportation and conditioning | The acceptance criteria for Labeling Legibility was met. |
| Labeling Legibility - IFU | Implicit: Legible after transportation and conditioning | The acceptance criteria for IFU Legibility was met. |
| Barcode | Implicit: Scannable and contains appropriate information | The acceptance criteria for Barcode was met. |
| Sterilization | Product was sterile. | Product was sterile. |
| Cytotoxicity | Implicit: Non-cytotoxic | The RIST Cath is non-cytotoxic. |
| Sensitization | Implicit: Non-sensitizer | The RIST Cath is classified as a non-sensitizer. |
| Irritation | Implicit: Non-irritant | The RIST Cath is non-irritant. |
| Material Mediated Pyrogenicity | Implicit: Non-pyrogenic | The RIST Cath is non-pyrogenic. |
| Systemic Toxicity | Implicit: No acute adverse effects | The RIST Cath is non-cytotoxic. |
| Hemolysis, ASTM Method (indirect) | Implicit: Non-hemolytic | The difference between hemolytic indexes is 0.00 percent, placing in non-hemolytic range. |
| Hemolysis, ASTM Method (direct) | Implicit: Non-hemolytic | The RIST Cath is non-hemolytic. |
| Complement Activation, C3a and SC5b-9 | Implicit: Similar to comparison articles | Complement activation of C3a and SC5b assays similar for test and comparison articles. |
| Partial Thromboplastin Time (PTT) | Implicit: Non-activator | P values of clotting time for test article and predicate were "Similar". |
| Dog Thrombogenicity | Implicit: Non-thrombogenic | The RIST Cath is non-thrombogenic. |
| In vitro Simulated Use Study - Bench | Implicit: Performance substantially equivalent to predicate | All acceptance criteria were met. Performance found substantially equivalent to predicate. |
| In vitro Simulated Use Study - Usability | Implicit: Usable as per Instructions for Use | All acceptance criteria were met. Usability demonstrated as per IFU. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set (number of devices tested for each performance criterion). However, for test methods like "Tensile Strength" and "PTFE Delamination," it mentions "All units met..." which suggests that a certain number of units were tested. The overall context is a premarket notification (510(k)) for a medical device seeking substantial equivalence, meaning the data is likely derived from retrospective testing performed by the manufacturer. The data provenance (country of origin) is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the "In vitro Simulated Use Study - Bench," it states that "A simulated interventional procedure was performed by physicians." For the "In vitro Simulated Use Study - Usability," "Evaluators representative of the intended user population evaluated the RIST Cath Radial Access Long Sheath..."
- Number of experts: Not explicitly stated (e.g., "3 physicians").
- Qualifications of experts: "Physicians" for the bench study and "Evaluators representative of the intended user population" for the usability study. Specific specialties or years of experience are not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "Results" column consistently states that "All units met the acceptance criteria" or similar, implying a direct assessment against predefined criteria rather than a consensus among multiple adjudicators for subjective outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study typically assesses the impact of an AI system on human reader performance, which is not relevant for this medical device (a catheter sheath).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical device (a catheter sheath), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant. The performance studies are focused on the physical characteristics and functionality of the device itself.
7. Type of Ground Truth Used
The ground truth for the various performance tests is established by:
- Engineering specifications and standards: Many tests reference ISO standards (e.g., ISO 10555-1, ISO 80369-7, ISO 11135:2014) or ASTM standards (e.g., ASTM F-88/F88M-15).
- Established testing protocols and acceptance criteria: For each test, there were pre-determined acceptance criteria based on the device's design and intended function.
- Visual inspection and measurements: For dimensional checks, visual inspections, etc.
- Biological testing standards: For biocompatibility tests, standards like EN ISO 10993-1 were followed.
- Clinical simulation by physicians: For the in-vitro simulated use study, the performance parameters assessed by physicians against expected clinical performance would serve as the ground truth.
There is no mention of pathology, outcomes data, or expert consensus in the sense of comparing device performance against a gold standard interpretation of a clinical condition (which would be common for diagnostic AI).
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).