(74 days)
THE MEDCOMP SILICONE Vascu-PICC™ CATHETERS ARE DESIGNED FOR LONG-TERM CENTRAL VENOUS CATHETERIZATION OR PROLONGED INTRAVENOUS ADMINISTRATION OF FLUIDS, MEDICATION, AND /OR WHEN NUTRITIONAL THERAPY IS PRESCRIBED.
THIS CATHETER MAY BE INSERTED VIA THE BASILIC OR CEPHALIC VEIN.
The Medcomp Silicone Vascu-PICC™ Catheters are designed for peripheral vein catheterization. The Silicone Vascu-PICC™ lumen is comprised of a soft radiopaque silicone material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration.
The catheters are available in 3F, 4F, and 5F single lumen versions, and 4F, 5F, and 6F double lumen versions. All versions are 60 cm long with depth markings in 5cm increments.
The Silicone Vascu-PICC™ Catheter product line is packaged with the necessary accessories to facilitate catheter insertion.
Here's a breakdown of the acceptance criteria and study information for the Medcomp Silicone Vascu-PICC™ Catheter, based on the provided 510(k) summary:
This device is not an AI/ML device. Therefore, the specific questions related to AI/ML device evaluations (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable. The provided document concerns a traditional medical device (intravascular catheter) and its clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: To demonstrate substantial equivalence to the predicate device and assure reliable design and performance.
The 510(k) summary implicitly defines the acceptance criteria as meeting relevant international standards for medical devices and demonstrating biocompatibility.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Performance Testing | Reliable design and performance in accordance with ISO 10555-1 and 10555-3 | "In vitro testing was performed on the Medcomp Silicone Vascu-PICC™ Catheter to assure reliable design and performance in accordance with ISO 10555-1 and 10555-3." |
| Biocompatibility | Meet requirements of ISO 10993 for a permanent contact device | "Biocompatibility testing on the Medcomp Silicone Vascu-PICC™ Catheter demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device." |
| Substantial Equivalence | Equivalent to predicate device in terms of: intended use, insertion method, anatomical location, design, material type, performance, labeling, manufacturing process, and method of sterilization. | "The Medcomp Silicone Vascu-PICC™ Catheter is substantially equivalent to the predicate device in terms of intended use, insertion method, anatomical location, design, material type, performance, labeling, manufacturing process, and method of sterilization." |
2. Sample Size for the Test Set and Data Provenance
Not applicable as this is not an AI/ML device and does not involve a "test set" in the context of algorithm evaluation. The performance data cited refers to in vitro testing and biocompatibility testing of the physical device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable as this is not an AI/ML device. Ground truth for a physical medical device typically comes from established international standards and validated testing methodologies, not expert consensus on data interpretation.
4. Adjudication Method for the Test Set
Not applicable as this is not an AI/ML device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not applicable as this is not an AI/ML device. MRMC studies are specific to evaluating the impact of AI/ML on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable as this is not an AI/ML device. "Standalone performance" in this context would refer to the physical device's performance characteristics (e.g., flow rates, tensile strength) as measured in in vitro tests, which were stated as being conducted.
7. The type of ground truth used
For the performance data mentioned:
- Performance Testing (ISO 10555-1 and 10555-3): The "ground truth" is defined by the technical specifications and requirements outlined in these international standards for sterile, single-use intravascular catheters. Meeting these standards confirms the device's functional integrity.
- Biocompatibility Testing (ISO 10993): The "ground truth" is defined by the biological safety requirements of the ISO 10993 series of standards, which assess the potential for adverse biological reactions.
For the substantial equivalence claim:
- The "ground truth" for substantial equivalence is the existence and characteristics of the legally marketed predicate device (A137605 Cook PICC Catheters) and the established regulatory framework for comparing new devices to predicates.
8. The Sample Size for the Training Set
Not applicable as this is not an AI/ML device. "Training set" is a concept specific to machine learning model development.
9. How the Ground Truth for the Training Set was Established
Not applicable as this is not an AI/ML device.
§ 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.”