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The Peripherally Inserted Central Vein Access Catheters are designed for long or shortterm peripheral access to the central venous system for intravenous therapy and blood sampling and allows for central venous pressure monitoring.

The Vascu-PICC taperless catheters are designed for peripheral vein catheterization. The Vascu-i TOO taponoos cansion comprised of a soft radiopaque polyurethane The lument is an open oncediopacity. The lumen is connected to the extensions material with bandin suitate for facts passement. 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 a range of French sizes in single, double and triple The Cathelers are available in a fange on a fange on throughout the length of the lument "The outside diameter of the lamon to sculature consistent luminal sizing. The Catherer, providing patiente with capseter and numerical marks every 5" centimeter and lumen has depth mants overy continues have in-line clamps to control fluid are available in a thin uble of am. I the gauge size and French size and French size. The Vascu-PICC® catheter product line is packaged sterile with the necessary accessories to facilitate catheter insertion.

Acceptance Criteria and Study for Vascu-PICC® Catheters

The provided document describes the Vascu-PICC® catheter, intended for peripheral vein catheterization, and a 510(k) submission (K122423) demonstrating its substantial equivalence to predicate devices. The "study" described is a series of in-vitro bench and performance tests, along with biocompatibility testing, rather than a clinical study with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria with specific numerical thresholds for each test, as might be found in a later-stage clinical trial. Instead, it refers to ensuring "reliable design and performance in accordance with ISO standards" and meeting "the requirements of ISO 10993" for biocompatibility. The reported device performance is a general statement of compliance rather than discrete data points.

• Air Leakage
• Liquid Leakage
• Force at Break
• Elongation
• Gravity Flow Rate
• Infusion Simulation
• Priming Volume
• Catheter Collapse
• Aging
• Chemical Testing
  Conclusion: "The proposed devices meet the performance criteria of design verification as specified throughout test protocols." |
  | Biocompatibility: (Meet the requirements of ISO 10993) | "All materials used for the Vascu-PICC are identical to the predicate Vascu-PICC (...) and have been submitted in (K12 1094 and R00 1000) and = Satir 100 (sic)."
  "All biocompatibility testing demonstrated the materials used meet the requirements of ISO 10993." |

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of catheters tested) for each in-vitro bench test. It generically states that "in-vitro testing was performed."

• Sample Size: Not specified.
• Data Provenance: The testing was in-vitro (bench testing). The origin is the manufacturer, MEDCOMP®, located in Harleysville, PA, USA. This is not patient data, so "retrospective or prospective" does not apply in the traditional sense, but the testing was conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable. The "test set" in this context refers to physical devices, and "ground truth" is established by direct measurement of physical properties and material characteristics against documented ISO standards and internal test protocols. No human expert interpretation of images or clinical data was involved in this type of testing.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically apply to the interpretation of clinical data (e.g., medical images) by multiple human readers to establish a definitive "ground truth." For in-vitro bench testing, the results are derived directly from scientific measurements and comparisons to established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or mentioned. This type of study is relevant for diagnostic or screening devices where human readers interpret medical data (e.g., images), and the AI's impact on their performance is being evaluated. The Vascu-PICC® is an intravascular catheter, and its performance is evaluated through physical and material properties, not through interpretation of medical images or data by human readers.

6. Standalone (Algorithm Only) Performance

This section is not applicable. The Vascu-PICC® is a physical medical device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. Type of Ground Truth Used

The "ground truth" for this catheter's performance is based on engineering specifications, established ISO standards (e.g., for safety, performance, and biocompatibility), and internal test protocols defined by the manufacturer. For biocompatibility, the ground truth is whether materials meet the requirements of ISO 10993. For performance tests, the ground truth is whether physical properties (e.g., air leakage, force at break, flow rate) fall within acceptable ranges defined by these standards and protocols.

8. Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of a physical medical device and its in-vitro performance testing. Training sets are relevant for AI/machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for this device.

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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.

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