Search Results

The CT Midlines are indicated for Short-Term peripheral access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The CT Midlines are designed for peripheral vein catheterization and power injection of contrast media, available in 4Fx20cm single-lumen or 5Fx20cm double-lumen configurations. Fundamentally, the proposed device is physically identical to the predicate K 121094 aside from the clamp, which is now colored purple to indicate power injection.

The provided document is a 510(k) summary for the Medcomp CT Midline device, indicating that it is being submitted for substantial equivalence to existing predicate devices, K121094 (Midline) and K091953 (Pro-PICC CT). The primary focus of the submission is to demonstrate that the CT Midline, while otherwise identical to predicate K121094, is also safe and effective for power injection, an indication shared with predicate K091953.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly labeled as such but are derived from the performance data presented for the proposed CT Midline and compared against the predicate devices, particularly the Pro-PICC CT (K091953) for power injection capabilities. The document asserts that the proposed device is "substantially equivalent" to predicate devices. For mechanical performance, specifically power injection, the CT Midline is compared to the Pro-PICC CT.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a nonclinical performance test study. It specifically focused on the power injection capabilities, as this was the key performance difference between the proposed CT Midline and the primary predicate (K121094).

The document states: "The following tests were performed to establish the device's equivalence to the relevant predicate device: o Power Injection Flow Rate o Max Static Burst. These tests highlight the relevant difference between the proposed device and predicate K121094 by testing for the safety and effectiveness of the proposed device with regard to the expanded indication for use of power injection."

The reported performance data for the CT Midline in the table above demonstrates that for both 4F and 5F configurations, the proposed device achieved equal or higher flow rates and burst pressures compared to the predicate Pro-PICC CT (K091953) for power injection. This indicates that the CT Midline meets or exceeds the power injection performance of the predicate device with that indication.

For air leakage, liquid leakage, biocompatibility, and sterility, the claims of substantial equivalence are based on either being identical in materials to a cleared predicate or passing relevant ISO standards, which implies meeting the acceptance criteria set by those standards.

The remaining information requested is largely not applicable (NA) or not explicitly provided in the given excerpts, as this is a 510(k) summary for a medical device (catheter), not an AI/software device or a clinical study in the typical sense that would involve human readers, ground truth consensus, or training data for an algorithm.

2. Sample size used for the test set and the data provenance:

• Sample Size: The exact sample sizes for the power injection and static burst tests are not explicitly stated as "n=X". However, for the Max Static Burst, the standard deviation and range are provided (e.g., "302±5psi," "range of burst pressures was 292-312 psi"), which implies multiple tests were performed on multiple units to generate an average and range. Without the full Section 18 (reference testing summaries and protocols), the specific number of units tested is unknown.
• Data Provenance: This is an in-vitro nonclinical performance test, conducted by the manufacturer (Medcomp). Therefore, it is a prospective test conducted on manufactured devices, likely in a laboratory setting. Country of origin of the data is the US, where Medcomp is located.

3. 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):

• NA. This is a hardware device performance test. There are no human experts establishing ground truth for image interpretation or diagnosis. The "ground truth" is defined by the physical properties of the device and its performance under specified testing conditions as measured by instruments.

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

• NA. There is no adjudication method as this is a physical performance test, not a subjective judgment task.

5. 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:

• NA. This is not an AI or imaging device subject to MRMC studies.

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

• NA. This is not an algorithm. Standalone performance refers to the device's functional attributes (e.g., flow rate, burst pressure) under test conditions as measured by equipment.

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

• For the nonclinical performance tests (power injection, static burst, leakage, biocompatibility), the "ground truth" is defined by the measured physical properties and performance characteristics of the device under controlled laboratory conditions, verified against established ISO standards and the performance of legally marketed predicate devices.

8. The sample size for the training set:

• NA. This is a physical device, not an algorithm that requires a training set.

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

• NA. This is a physical device, not an algorithm that requires a training set and its associated ground truth establishment.

Ask a specific question about this device

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.

Ask a specific question about this device