(105 days)
The Medcomp PRO-LINE™ CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE™ CT Power Injectable CVC may not exceed 300 psi.
The Medcomp® PRO-LINE™ CT Power Injectable CVC's are designed for central venous catheterization. The PRO-LINE™ CT Power Injectable CVC lumen is comprised of a soft radiopaque polyurethane material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Cuff attachment to the lumen provides for tissue ingrown. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. Purple colorant has been added to the catheter materials to differentiate it from other non-power injectable catheters and identify it as a power injectable catheter. The extensions also are printed with the words power injectable.
The PRO-LINE™ CT Power Injectable CVC's are available in 5F single lumen and 6F double lumen version. The catheters are 60 cm long with depth markings in 5cm increments. Stylet and adaptor sideport is provided to assist in catheter insertion.
The catheter product line is packaged with the necessary accessories to facilitate catheter insertion.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp® PRO-LINE™ CT Power Injectable CVC:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Air/Liquid Leakage | No air/liquid leakage | Reliable design and performance (met) |
| Cuff Shear | Sufficient cuff integrity | Reliable design and performance (met) | |
| Force at Break | Sufficient strength | Reliable design and performance (met) | |
| Elongation | Appropriate flexibility/durability | Reliable design and performance (met) | |
| Gravity Flow | Adequate flow rate | Reliable design and performance (met) | |
| Static Burst Pressure | Withstand specified pressure | Reliable design and performance (met) | |
| High Pressure Injection Flow Rate | Maximum infusion rate of 5cc/sec and pressure of 300 psi | Reliable design and performance (met); specifically designed for these parameters | |
| Biocompatibility | Biocompatibility Testing | Meet requirements of ISO 10993 for permanent contact device | Materials meet ISO 10993 requirements |
Key takeaway for Table: The document states that testing was performed in accordance with ISO 10555-1 and 10555-3 for mechanical performance, and ISO 10993 for biocompatibility. These ISO standards inherently contain the "acceptance criteria" for various tests, which the device is reported to have met. The document, however, does not explicitly list the numerical or qualitative acceptance criteria for each specific test (e.g., "burst pressure must be >X psi"), but rather states that the device "assure[s] reliable design and performance" and "demonstrates that the materials used meet the requirements."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size for the in vitro tests. It only mentions "in vitro testing was performed."
- Data Provenance: The data is from in vitro testing. No country of origin is mentioned, as it's not clinical data. The study is not applicable as retrospective or prospective given it's laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This information is for clinical studies. The study described is an in vitro study, meaning it was conducted in a lab setting and relied on standardized test methods (ISO standards) rather than expert interpretation of clinical data. Therefore, there was no "ground truth" established by human experts in the context of this submission.
4. Adjudication Method for the Test Set:
- Not Applicable. As this was an in vitro mechanical and biocompatibility study, there was no adjudication method involving multiple human reviewers or experts. The results would be based on instrument readings and adherence to pre-defined test protocols within the ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study was not conducted. The document 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."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
- Not Applicable. This device is a physical medical device (catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
- Standardized Test Results/Compliance with ISO Standards. For the in vitro tests, the "ground truth" was established by the methodologies and pass/fail criteria outlined in the relevant ISO standards (ISO 10555-1, 10555-3, and ISO 10993). The device's performance was measured against these predefined, objective standards.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI or machine learning device. There is no concept of a "training set." The testing involved physical samples of the catheters.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for this type of device, no ground truth needed to be established in that context.
§ 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.”