(14 days)
The intended use of the Silicone Dual Lumen RadPICC Catheter is to provide venous access to infuse intravenous medication, nutritional therapy, or blood therapy.
The Indications for use is: The silicone RadPICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, utilize the larger lumen.
The RadPICC® catheters are open-ended dual lumen catheters that are made of soft silicone elastomer containing barium sulfate throughout the tubing for enhanced radiopacity. The RadPICC® catheters are 5, 6 Fr dual lumen x 60 cm usable length. The catheter lumens are nonsymmetrical rounded D shape for maximized flow and mechanical properties. The proximal end of the RadPICC catheters consists of two luer lock connectors, glued compression sleeves, clear silicone extension legs for visibility during use and non-removable mini thumb clamps. The extension legs are pre-printed with the lumen gauge size. The extension legs are molded into the bifurcation. StatLock® compatible suture wings are molded into the bifurcation to facilitate easy, secure placement. The bifurcation is embossed with identification text. The proximal end of the catheter tubing has a stepped strain relief that minimizes the potential for kinking at the catheter tubing / strain relief interface. The tubing is pre-molded into the bifurcation with a "0" mark that serves as a reference for the catheter insertion point. The catheter can be inserted up to the "0" mark, which is sized to the exit site, thereby allowing the clinician to "plug" the insertion site. The catheter tubing has depth markings in centimeter increments originating from the proximal end and running the full length of the catheter. A stand-along hydrophilic stylet is provided as a kit components and is loaded by the clinician during the placement procedure. Catheters are provided sterile with kit components preferred by interventional radiologists.
This document describes the 510(k) submission for the Silicone Dual Lumen RadPICC® Catheter, seeking clearance based on substantial equivalence to a predicate device. The information provided focuses on the device's characteristics and performance testing rather than the typical acceptance criteria and study design for software or AI models. Therefore, some of the requested information (like sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) is not applicable to this physical medical device submission.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes performance tests performed and states that the device "met all the predetermined performance criteria of design verification" and "met the requirements and were similar to the predicate device." Specific numerical acceptance criteria or performance metrics are not explicitly stated as a table with precise target values and achieved values. Instead, it refers to compliance with guidance and standards.
Here's an inferred table based on the listed tests and statements of compliance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensions | Met requirements and similar to predicate device. |
| Flow Rate | Met requirements and similar to predicate device. |
| Tensile Strength | Met requirements (catheter body, extension leg to hub, extension leg to bifurcation, bifurcation to catheter body). |
| Catheter Stiffness (modulus) | Met requirements and similar to predicate device. |
| Catheter Elongation | Met requirements and similar to predicate device. |
| Leakag | Met requirements (at hub, at hub with burst, assembly leak). |
| Catheter Burst Pressure | Met requirements (assembly, extension leg, extension leg after clamping, catheter shaft tubing). |
| Catheter Collapse | Met requirements and similar to predicate device. |
| Catheter Flexural Fatigue | Met requirements and similar to predicate device. |
| Priming Volume | Met requirements and similar to predicate device. |
| Radiopacity | Met requirements and similar to predicate device. |
| Biocompatibility | Meets requirements of ISO-10993 and FDA Modified ISO 10993 Test Profile. |
| Creep | Performed, results led to substantial equivalence conclusion. |
| Stylet Withdrawal Force | Performed, results led to substantial equivalence conclusion. |
| Kink Resulting in Decreased Flow | Performed, results led to substantial equivalence conclusion. |
| Overall Equivalence | Substantially equivalent to predicate device (Per-Q-Cath PICC, K954104). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each bench test performed. It generally refers to "bench testing" and compliance with "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95, and corresponding ISO Standards.
Data Provenance: The data are from bench testing (laboratory tests) performed on the device by the manufacturer, Bard Access Systems, Inc. The country of origin of the data is not specified beyond the location of the manufacturing company (Salt Lake City, UT). These are not clinical or "real-world" retrospective/prospective data in the context of human studies, but rather engineering and material property tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
This information is not applicable as the "ground truth" for physical device performance tests typically refers to well-defined physical properties or engineering standards, not expert consensus on interpretations. The compliance is against established regulatory guidance and ISO standards.
4. Adjudication Method for the Test Set
This information is not applicable as the testing involves objective measurements against predefined engineering specifications and regulatory standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data, often with or without AI assistance, to assess the impact on human reader performance. This submission is for a physical medical device (catheter) and its inherent performance characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical catheter, not an algorithm or software. Its "standalone performance" refers to its physical and material characteristics as tested in the lab.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on:
- Established engineering specifications and physical properties (e.g., specific dimensions, flow rates, tensile strengths, burst pressures).
- Compliance with guidance documents ("Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters", dated 3/16/95).
- Adherence to relevant ISO Standards (e.g., ISO-10993 for biocompatibility).
- Comparison to the predicate device characteristics, establishing substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of an AI or statistical model. The development of the physical device involves design, prototyping, and iterative testing, but not machine learning training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set."
§ 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.”