Search Results

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

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.

Ask a specific question about this device

The Dual Lumen ELC catheters are peripheral venous access catheters, inserted preferably in the basilic vein (arm) and antecubital region respectively, and specifically for use with the System 100. The catheter is not intended for the infusion of medications or fluids, for laboratory sampling, or other venous access needs. The System 100 is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

The dELC is a 6 French, polyurethane, dual lumen extended-length catheter. It is intended to provide short-term peripheral venous access to facilitate blood removal and return for the purposes of ultrafiltration. The catheter has a low profile, flexible hub with suture wings for securement to the skin. The dual lumen tubing in the proximal portion of the catheter shaft is a double-D configuration and is bonded to a single lumen tube for the distal portion. The blood is drawn up through the single lumen tubing, and infused back into the vessel through the short proximal section of the catheter shaft. The catheter will connect directly to the UF circuit of the System 100 to conduct blood to and from the patient for the purposes of ultrafiltration.

The provided text is a 510(k) summary for a medical device called the "Dual-Lumen Extended Length Catheter (dELC)". It describes the device, its intended use, and states that bench tests demonstrate its compatibility with the System 100. However, it does not include information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trials or performance studies. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, packaging, sterilization, and limited bench testing.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what cannot:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. The document only mentions "bench tests," which are typically laboratory-based and do not involve human patient data in the context of this 510(k) summary. No details on the number of samples or data provenance are given.

2. 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):

   • Not applicable/Not provided. Since "bench tests" are mentioned for compatibility, there's no indication of a test set requiring expert-established ground truth in the traditional sense of diagnostic or clinical performance studies.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. As stated above, this type of adjudication is typically for clinical or diagnostic performance studies, which are not described here.

4. 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:

   • No. This device is a physical medical catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not conducted.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable/Not provided. For the "bench tests" mentioned, the "ground truth" would likely be the physical properties and functional performance of the catheter according to engineering specifications and compatibility with the System 100. This is not explicitly detailed.

7. The sample size for the training set:

   • Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided. There is no training set for this type of device.

Summary of Device and Evidence Presented in 510(k):

The 510(k) submission for the Dual-Lumen Extended Length Cathether (dELC) demonstrates its substantial equivalence to predicate devices (B. Braun Accuguide®, CHF Solutions System 100, and medComp® VASCU-PICC™ and Duo-Flow™) by:

• Being similar in materials of construction.
• Being identical for packaging and sterilization.
• Being provided sterile and nonpyrogenic.
• Having "bench tests" that demonstrate compatibility with the System 100.

The document uses these points to conclude that the device is "safe and effective for its intended use" for temporary peripheral venous access for ultrafiltration treatments for patients with fluid overload, and is therefore "substantially equivalent" to legally marketed predicate devices. The evidence presented focuses on design, materials, manufacturing processes, and general functional compatibility rather than detailed quantitative performance metrics from a formal "study" with set acceptance criteria in the clinical sense.

Ask a specific question about this device