(29 days)
The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.
The CVC WAND™ Safety Introducer with Valved Peelable Sheath (hereafter CVC WAND™) is a catheter introducer device that is virtually identical to the predicate device, the CVC WAND™ Safety Introducer with Valved Peelable Sheath, cleared for commercial distribution under 510(k) K131148. When assembled for use, it is an all-inone preassembled intravascular catheter introducer, that provides the clinician with a simple and accelerated approach to the Seldinger Technique for placing in-dwelling intravascular catheters. The device is composed of the following key components:
- Introducer Needle
- Guidewire
- Dilator
- Valved Peelable Sheath Introducer
The CVC WAND™ includes a 21-gauge microaccess needle, nylon tissue dilator, FEP peelable sheath and Nitinol guidewire. This device has an integrated valve within the body of the Peelable Sheath Introducer hub which is designed to reduce inflow of air into the bloodstream and outflow of blood when the guidewire, introducer needle and dilator are removed, but it is not a hemostasis valve. The device also has a blood flashback window proximal to the needle's tip which allows the clinician to observe blood flashback upon entering the vessel with the Safety Introducer. The microaccess needle is echogenic and provides the pathway for the guidewire insertion, while the dilator facilitates placement of the peelable sheath and ultimately catheter placement.
The CVC WAND™ is individually packaged in a PETG. glvcol modified polyethylene terephthalate, plastic tray. The tray is heat sealed with a Tyvek® lid. The device is provided 'STERILE' (ethylene oxide gas) and is for 'single-use' only.
The FDA 510(k) summary for "The CVC WAND Safety Introducer with Valved Peelable Sheath" (K182243) does not describe a study involving AI or human readers. The summary focuses on validating a material change in a component of the device (from silicone to thermoplastic elastomer in the valve of the peelable sheath introducer) and demonstrating its substantial equivalence to a previously cleared predicate device (K131148). Therefore, many of the requested categories are not applicable to this submission.
Here's a breakdown of the information provided based on your request, with an emphasis on what is not applicable due to the nature of the device and the submission:
1. A table of acceptance criteria and the reported device performance
The document describes various tests conducted and generally states that the results "satisfied the acceptance criteria of the relevant ISO 10993 standards" or "satisfy acceptance criteria identified in applicable standards and/or the device design specification." However, specific numerical acceptance criteria or detailed performance metrics are not explicitly provided in a table format as requested. The document primarily lists the tests performed and a high-level outcome of meeting criteria.
| Test Category | Specific Tests Mentioned | Reported Device Performance |
|---|---|---|
| Biocompatibility (New Material) | - Cytotoxicity (ISO 10993-5:2009) | Satisfied acceptance criteria of relevant ISO 10993 standards. (GLP conducted for applicable tests) |
| - Sensitization (ISO 10993-10:2010) | ||
| - Intracutaneous Reactivity (ISO 10993-10:2010) | ||
| - Acute Systemic Toxicity (ISO 10993-11:2006) | ||
| - Hemolysis (ASTM, ISO 10993-4:2002) | ||
| - Material Mediated Pyrogenicity (ISO 10993-11:2006) | ||
| - Partial Thromboplastic Time (PTT) (ISO 10993-4:2002) | ||
| - In Vitro Platelet and Leucocyte Counts (ISO 10993-4:2002) | ||
| - Complement Activation (ISO 10993-4:2002) | ||
| Performance Testing (New Valve) | - Valve Air Leakage | Satisfied acceptance criteria identified in applicable standards and/or device design specification. |
| - Valve Liquid Leakage | ||
| - Valve Flexibility | ||
| - Valve Patency | ||
| - Valve Integrity | ||
| Device System Testing | - Particulate Matter USP (Reference only) | Satisfied acceptance criteria identified in applicable standards and/or device design specification. |
| Leveraged Predicate Testing | Lumen patency, Tensile strength, Air leak, Corrosion resistance, Distal Tip Columnar Strength, Strength of Union, Fracture testing, Flex testing, Axial Forces, "Fast-Flash™" Evaluation, Insertability, Needle-stick safety, Guidewire cap snap-on force, Protective Cover Removal Force, Needle lock to Needle hub separation force. | Results from the predicate device (K131148) were considered acceptable and leveraged as these aspects were not affected by the material change in the valve. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for any of the individual tests. The submission describes conducting "designed verification testing."
- Data Provenance: The document indicates that tests were conducted according to ISO and ASTM standards, and some were GLP (Good Laboratory Practice) compliant. This suggests controlled laboratory settings. It doesn't specify a country of origin for the data or whether the data was retrospective or prospective, though performance testing is inherently prospective for the device being tested.
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 is not applicable. The device is a medical instrument (catheter introducer), not a diagnostic imaging device or an AI algorithm requiring expert ground truth for its performance assessment. Its performance is evaluated through physical, chemical, and biological tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. See the explanation for point 3.
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 is not applicable. This device is a physical medical instrument, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical medical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility and performance testing, the "ground truth" or reference for comparison are established international standards (ISO, ASTM, USP) and the device's own design specifications for functional requirements. For example, for biocompatibility, the reference is what constitutes a non-toxic or non-irritating response according to ISO 10993. For mechanical tests, it's meeting specified engineering tolerances.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI system with a training set.
9. How the ground truth for the training set was established
This is not applicable. See the explanation for point 8.
In summary, the K182243 submission focuses on demonstrating the safety and performance of a modified medical device through standard engineering and biocompatibility testing, rather than the evaluation of an AI-powered diagnostic tool. Therefore, many of your questions related to AI studies and their methodologies are not relevant to this particular FDA submission.
§ 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).