(21 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.
The Medcomp 1.9F Vascu-PICC™ catheter is designed for peripheral vein catheterization. The 1.9F Vascu-PICC™is 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. The twisted wire stylet is made of stainless steel with a nylon and high density polyethylene handle. The stylet aids in insertion of the catheter.
The provided text describes a 510(k) premarket notification for the Medcomp 1.9F Vascu-PICC™ catheter. It primarily focuses on demonstrating substantial equivalence to a predicate device through in vitro testing and biocompatibility.
Here's an analysis of the acceptance criteria and study information based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (from In Vitro Testing) |
|---|---|
| ISO 10555-1 Compliance | Tested per ISO 10555-1 and 10555-3 |
| ISO 10555-3 Compliance | Tested per ISO 10555-1 and 10555-3 |
| Gravity Flow | Testing performed, details of results not provided. |
| Air Leakage | Testing performed, details of results not provided. |
| Liquid Leakage | Testing performed, details of results not provided. |
| Tensile Strength | Testing performed, details of results not provided. |
| Elongation | Testing performed, details of results not provided. |
| Air Priming Volume | Testing performed, details of results not provided. |
| ISO 10993 Biocompatibility (Permanent Contact Device) | Materials meet ISO 10993 requirements (reference K974236, K003682). |
| ISO 10993 Biocompatibility (Limited Externally Communicating Device with Indirect Blood Path) | Stylet meets ISO 10993 requirements (vendor testing). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the sample size for the in vitro tests. It only states that "In vitro testing was performed."
- Data Provenance: The data provenance is internal laboratory testing (in vitro), conducted by Medcomp and its vendor for the stylet. There is no mention of country of origin for the data or whether it was retrospective or prospective, as it was in vitro testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable to this submission. The "ground truth" for the performance criteria was established by regulatory standards (ISO 10555-1, ISO 10555-3, ISO 10993) and evaluated through physical and chemical testing, not by expert human assessment of clinical data.
4. Adjudication Method for the Test Set
- This question is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions on clinical data. In this case, the evaluation was based on objective, standardized in vitro tests against predefined technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device." Therefore, there is no effect size reported for human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- This question is not applicable to this submission. The device is a physical medical catheter, not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance was established by international consensus standards (ISO 10555-1, ISO 10555-3, ISO 10993) for catheter safety and performance, and biocompatibility.
8. The Sample Size for the Training Set
- This question is not applicable to this submission. There is no mention of a "training set" as this is not a machine learning or AI device. The device's design and materials were likely developed through engineering processes, but not "trained" in the typical AI sense.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8. There was no training set in the context of this device's development or regulatory submission.
§ 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.”