(30 days)
The 1.9F Vascu-PICC® is a long term catheter intended for central venous access via peripheral insertion in neonates, infants, and children. It may be used for administration of fluids, medication, and nutritional therapy.
- Designed for peripheral vein catherization .
- Comprised of a polyurethane material .
- The lumen is connected to the extensions by a hub with a suture wing for . placement.
- A clamp is provided on the extension tube to prevent air/fluid communication. .
- A female luer connector provides the connection for intravenous administration. .
Here's an analysis of the provided text regarding the 1.9F Vascu-PICC® device, focusing on acceptance criteria and supporting studies:
It is important to note that the provided document is a 510(k) summary for a medical device (1.9F Vascu-PICC®). This type of submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against novel acceptance criteria through extensive clinical studies. Therefore, the information typically found in an AI/ML device study, such as specific performance metrics like sensitivity, specificity, F1-score, or ROC AUC, and detailed descriptions of ground truth establishment, reader studies, and training/test set specifics, will not be present.
Instead, the acceptance criteria here relate to demonstrating compliance with recognized standards and substantial equivalence in design, materials, and intended use.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, long-term devices | Met. All materials used were previously cleared for similar applications by Medcomp, Inc. |
| Performance Testing (General) | ISO 10555-1: 1997: Sterile Single Use-Intravascular Catheters, General Requirements | Acceptable safety and performance outcomes. |
| Performance Testing (Central Venous Catheters) | ISO 10555-3: 1997, Sterile Single Use-Intravascular Catheters, Central Venous Catheters | Acceptable safety and performance outcomes. |
| Performance Testing (Conical Fittings) | ISO 594-2: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings | Acceptable safety and performance outcomes. |
| Substantial Equivalence | Equivalence in design, materials, sterilization, and indications for use to the predicate device (1.9F Vascu-PICC™ K061986). | Meets requirements for intended use and is substantially equivalent to the cited predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The "test set" in this context refers to the physical samples of the device undergoing laboratory testing against ISO standards, not a data set for an AI/ML algorithm. The document doesn't specify the number of units 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 information is not applicable/provided. The ground truth for this type of device (a physical medical catheter) is established by adherence to engineering performance standards (e.g., tensile strength, flow rates, leak testing, biocompatibility) and regulatory guidelines, rather than expert consensus on diagnostic images. The assessment is based on the device's physical properties and material safety.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are typically relevant for subjective assessments, such as interpreting medical images where multiple experts might disagree. For mechanical and material performance testing, the results are typically quantitative and objective, measured against predefined thresholds in the standards.
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
There was no MRMC comparative effectiveness study done. This type of study is specific to AI-powered diagnostic or assistive devices, which the 1.9F Vascu-PICC® (a physical catheter) is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone algorithm performance study done. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by objective measurements and assessments against internationally recognized performance standards (ISO 10993-1, ISO 10555-1, ISO 10555-3, ISO 594-2) and the material properties of components previously cleared for similar applications.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no "training set." For the safety and performance studies mentioned, the "ground truth" (i.e., acceptable performance) is defined by the requirements outlined in the specified ISO standards.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”