(306 days)
The Power WAND™ Safety Introducer with an Extended Dwell Catheter is used to gain access to the vascular system to sample blood and administer fluids intravenously. May be used for power injection of contrast media at a rate of 5cc/sec at up to 300 psi fluid pressure.
The Power WAND™ Safety Introducer with an Extended Dwell Catheter is an all-in-one pre-assembled device that combines the functionality of a catheter introducer system with an extended dwcll (> 72 hours but
This document, K101422, describes the Power WAND™ Safety Introducer with an Extended Dwell Catheter. It focuses on demonstrating substantial equivalence to predicate devices through various testing. Here's an analysis of the provided information, specifically addressing the requested points regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document lists numerous tests conducted, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it generally concludes that the device "satisfied the acceptance criteria" or "satisfy performance requirements of the product specification and are equivalent to the predicate device."
Here's an attempt to present the information as requested, with the caveat that specific numerical acceptance criteria are not provided in the document:
| Test | Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing (Table 5.1) | All materials meet ISO standards for biocompatibility. | "All materials satisfied the acceptance criteria of the biocompatibility testing." |
| Cytotoxicity (ISO MEM Elution) | Non-toxic / No cytotoxic effects | Satisfied acceptance criteria (implied) |
| Sensitization (ISO 10993-10:2002) | No significant sensitization | Satisfied acceptance criteria (implied) |
| Intracutaneous Reactivity (ISO 10993-10:2002) | No significant intracutaneous reactivity | Satisfied acceptance criteria (implied) |
| Acute Systemic Toxicity (ISO 10993-11:2006) | No significant acute systemic toxicity | Satisfied acceptance criteria (implied) |
| Hemolysis - Direct Contact (ISO10993-4:2002) | Acceptable levels of hemolysis | Satisfied acceptance criteria (implied) |
| Hemolysis - Extract (ISO10993-4:2002) | Acceptable levels of hemolysis | Satisfied acceptance criteria (implied) |
| Material Mediated Pyrogenicity (ISO 10993-11:2006) | Non-pyrogenic | Satisfied acceptance criteria (implied) |
| In Vivo Thrombogenicity (ISO 10993-4:2002) | No significant thrombogenicity | Satisfied acceptance criteria (implied) |
| Complement Activation (ISO 10993-4:2002) | Acceptable levels of complement activation | Satisfied acceptance criteria (implied) |
| Genotoxicity: Bacterial Reverse Mutation (Ames) (ISO 10993-3:2003) | Non-genotoxic | Satisfied acceptance criteria (implied) |
| Genotoxicity: In Vitro Mouse Lymphoma (ISO10993-3:2003) | Non-genotoxic | Satisfied acceptance criteria (implied) |
| Genotoxicity: In Vivo Mouse Micronucleus (ISO10993-3:2003) | Non-genotoxic | Satisfied acceptance criteria (implied) |
| Subchronic Intravenous Toxicity (ISO 10993-11:2006) | No significant subchronic intravenous toxicity | Satisfied acceptance criteria (implied) |
| Subacute Intraperitoneal Toxicity (ISO 10993-11:2006) | No significant subacute intraperitoneal toxicity | Satisfied acceptance criteria (implied) |
| Subcutaneous Implant (ISO 10993-6:2007) | Acceptable tissue response to implant | Satisfied acceptance criteria (implied) |
| Performance Testing (Implied Predicate Equivalence & Specifications) | Meets product specifications and performance equivalent to predicate devices. | "in vitro performance testing has demonstrated that the IV Catheter materials are non-toxic and that the IV Catheter performance characteristics satisfy performance requirements of the product specification and are equivalent to the predicate device." "Test results indicate that the device satisfies all performance requirements for its intended use." |
| Lumen patency (21-Gauge Needle) | Maintained patency | Satisfied (Leveraged from K081697) |
| Tensile strength: tube-to-hub bond (21-Gauge Needle) | Adequate bond strength | Satisfied (Leveraged from K081697) |
| Air leak/resistance to stress cracking (21-Gauge Needle) | No air leaks, resistance to cracking | Satisfied (Leveraged from K081697) |
| Corrosion resistance (21-Gauge Needle) | Corrosion resistant | Satisfied (Leveraged from K081697) |
| Fracture testing (0.018" Guidewire) | Resists fracture | Satisfied (Leveraged from K093022) |
| Flex testing (0.018" Guidewire) | Maintains integrity under flexion | Satisfied (Leveraged from K093022) |
| Strength of union: core-to-coil (0.018" Guidewire) | Adequate union strength | Satisfied (Leveraged from K093022) |
| Strength of union: wire-to-cap (0.018" Guidewire) | Adequate union strength | Satisfied (Leveraged from K093022) |
| Corrosion resistance (0.018" Guidewire) | Corrosion resistant | Satisfied (Leveraged from K093022) |
| Needle-stick safety (Introducer System) | Meets safety requirements | Satisfied (Leveraged from K081697) |
| Guidewire cap snap-on force (Introducer System) | Adequate snap-on force | Satisfied (Leveraged from K081697) |
| Needle lock to Needle hub separation force (Introducer System) | Adequate separation force (to prevent accidental separation) | Satisfied (Leveraged from K081697) |
| Distal tip columnar strength (Dilator) | Adequate strength to resist buckling | Satisfied |
| Strength of union: tube-to-hub (Dilator) | Adequate bond strength | Satisfied |
| Collapse Pressure (IV Catheter) | Resists collapse under pressure | Satisfied |
| Distal tip columnar strength (IV Catheter) | Adequate strength to resist buckling | Satisfied |
| Catheter Flow Rate (IV Catheter) | Meets specified flow rates | Satisfied |
| Tensile Strength (IV Catheter) | Adequate tensile strength | Satisfied |
| Priming Volume (IV Catheter) | Meets specified priming volume | Satisfied |
| Catheter Burst Pressure (IV Catheter) | Resists bursting up to a specified pressure | Satisfied |
| Catheter-Hub Gauging (IV Catheter) | Correct gauging | Satisfied |
| Catheter-Hub Liquid Leakage (IV Catheter) | No liquid leakage | Satisfied |
| Catheter-Hub Air Leakage (IV Catheter) | No air leakage | Satisfied |
| Catheter-Hub Separation Force (IV Catheter) | Adequate separation force (to prevent accidental separation) | Satisfied |
| Catheter-Hub Stress Cracking (IV Catheter) | Resists stress cracking | Satisfied |
| Catheter-Hub Unscrewing Torque (IV Catheter) | Appropriate unscrewing torque | Satisfied |
| Catheter-Hub Ease of Assembly (IV Catheter) | Easy assembly | Satisfied |
| Catheter-Hub Resistance to Overriding (IV Catheter) | Resists overriding | Satisfied |
| Infusion Induced Catheter Movement (IV Catheter) | Minimal movement during infusion | Satisfied |
| "Worst-case" pre-conditioning (IV Catheter) | Maintains performance after pre-conditioning | Satisfied |
| Visual Inspection (after pre-conditioning) | No significant degradation | Satisfied |
| Fatigue Testing (after pre-conditioning) | Resists fatigue | Satisfied |
| Power Injection (after pre-conditioning) | Performs as specified for power injection (up to 5cc/sec, 300 psi) | Satisfied |
| Catheter Elongation (after pre-conditioning) | Within acceptable elongation limits | Satisfied |
| Catheter Burst Pressure (after pre-conditioning) | Resists bursting up to a specified pressure | Satisfied |
| Integrated System Testing | System functions as intended | Satisfied |
| Catheter Hub-StatLock IV Ultra® Securement Device Separation Force | Adequate force to prevent accidental separation of secured catheter | Satisfied |
| Dilator to Catheter Fit-up | Proper fit | Satisfied |
| Dilator Hub-Catheter Hub Removal Torque | Appropriate removal torque | Satisfied |
| Dilator Hub-Catheter Hub Separation Force | Adequate force to separate components | Satisfied |
| Axial Forces | Within acceptable axial force limits | Satisfied |
| Fast-flash Evaluation | Proper fast-flash response | Satisfied |
| Introducer System Insertability | Easy and safe insertion | Satisfied |
| Needle Cover Removal Force | Appropriate removal force | Satisfied |
| Needle to Dilator Fit-up | Proper fit | Satisfied |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide specific sample sizes for any of the tests mentioned. It only states that a "program of design verification testing" was conducted.
- Sample Size: Not specified.
- Data Provenance: The studies are described as "design verification testing," "biocompatibility testing," and "in vitro bench testing." This indicates they were prospective tests conducted by the manufacturer, Access Scientific, Inc., which is based in San Diego, CA, USA. The country of origin for the data is implicitly the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the described studies are physical and chemical bench tests (biocompatibility and performance testing) of a medical device, not diagnostic studies requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. No clinical interpretation or adjudication by multiple experts was required for these types of engineering and biocompatibility tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This submission is for a physical medical catheter and introducer system, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. As stated above, this is not an AI algorithm but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" is defined by adherence to specific ISO standards (e.g., ISO 10993 series) and their respective criteria for non-toxicity, non-pyrogenicity, etc.
For performance tests, the "ground truth" or reference is defined by product specifications and comparison to the performance characteristics of the predicate devices. The goal was to show that the new device "satisfy performance requirements of the product specification and are equivalent to the predicate device."
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The "training" in a manufacturing context refers to manufacturing process development and validation, not data-driven model training.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set or ground truth in the context of AI/machine learning.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).