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The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.

The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions.

The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.

The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.

The provided document does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for a medical device efficacy or performance study. This document is a 510(k) summary for a hemodialysis catheter (T3 CT).

Instead of a clinical study or performance data against specific acceptance criteria, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that instead of proving the device meets certain performance metrics through a new study, the applicant argues that the new device is as safe and effective as devices already on the market because it has the same intended use, materials, anatomical location, basic design, performance, labeling, manufacturing process, and method of sterilization.

Here's an analysis based on the information provided, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there is no explicit table of acceptance criteria and reported device performance from a specific study presented in this 510(k) summary. The submission asserts that the device "meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." However, the details of these criteria or the test results are not included.

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

Not applicable. No new clinical or performance test set (as in a study to evaluate efficacy or performance against specific metrics) is described. The submission relies on equivalence to predicate devices and adherence to design verification standards (ISO, guidance documents, test protocols), but details of these tests are not provided.

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

Not applicable. No ground truth establishment for a test set is described as part of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring an adjudication method is described.

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

Not applicable. This is a medical device 510(k) summary for a catheter, not an AI software or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This is a medical device 510(k) summary for a catheter, not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable in the context of a new efficacy/performance study. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices, based on their prior clearance and market history.

8. Sample Size for the Training Set

Not applicable. This is a medical device 510(k) summary for a catheter. The concept of a "training set" is relevant for machine learning algorithms, which is not what this submission is about.

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

Not applicable. See point 8.

Summary of the Acceptance Criteria and "Study":

The "acceptance criteria" for the Medcomp® T3 CT catheter, as presented in this 510(k) summary, are primarily based on:

• Substantial Equivalence: The device is considered substantially equivalent to legally marketed predicate devices (K033570, K083675, K102605 as primary, and several others as secondary). This is the core "study" or justification for its market clearance. The argument is that "there are no differences that raise new issues of safety and effectiveness."
• Design Verification: The submission states that the "proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." While the specific tests and their results are not detailed, this implies that the device underwent engineering and materials testing to ensure it meets established specifications for medical catheters (e.g., strength, flow rates, material compatibility, etc.).
• Biocompatibility: The materials used meet the requirements of ISO 10993, and all materials have been cleared under past approved 510(k)s. This demonstrates the materials are biologically safe.

Conclusion:

The Medcomp® T3 CT 510(k) submission (K123292) for a hemodialysis catheter does not describe a clinical study to prove device performance against specific efficacy or performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices and adherence to established design verification standards and biocompatibility requirements. This is a common pathway for medical device clearance, especially for devices that are modifications or improvements upon existing technologies rather than entirely novel ones.

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The PRO-PICC® C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media and allows for central venous pressure monitoring when a 20gauge or larger lumen is used. For blood sampling, infusion or therapies use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The PRO-PICC catheter is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® PRO-LINE® CT Power Injectable CVC (K053345) and PRO-PICC® CT (K081904) catheter line. The PRO-PICCo CT catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and 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 and fluid communication. Female luer connectors provide the connection for intravenous administration. The power iniectable extension lines are purple in color to differentiate it from non-power injectable catheters. The extensions are also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection. The dual lumen catheter has one purple colored clamp and one natural colored clamp allowing units to designate power injection on one side and infusion; blood withdraw and pressure monitoring on the other although both lumens are capable of power injection.

The PRO-PICC catheter is available in additional French sizes and either a single or double lumen. The catheter has a usable length of 50cm to 60 cm depending on French size with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp PRO-PICC CT device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria for a new device type. Therefore, explicit, quantitative, and standalone acceptance criteria in the typical sense (e.g., "sensitivity must be > X%") are not present.

Instead, the acceptance criteria are implicitly met by demonstrating that the PRO-PICC CT is substantially equivalent to established predicate devices in terms of:

Important Note: The document explicitly states: "Performance standards for pressure injection have not been established by FDA under section 514 of the Federal Food, Drug and. Cosmetic Act. Testing is based upon internal engineering testing methods." This reinforces that quantitative, pre-defined FDA-mandated performance metrics for the specific function of "power injection" were not applicable as acceptance criteria in this submission.

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

• Sample Size: Not applicable. This submission relies on substantial equivalence and bench testing, not a clinical study with a "test set" of patients or data in the way an AI/ML device would.
• Data Provenance: Not applicable. The "data" refers to engineering bench test results and biocompatibility testing of materials, not clinical data from specific geographic regions.

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

• Number of Experts: Not applicable. There is no "ground truth" establishment by external medical experts for a clinical test set in this 510(k) submission.
• Qualifications of Experts: Not applicable. The evaluation is based on engineering testing and comparison to existing predicate devices.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There is no "test set" requiring adjudication by multiple readers or experts.

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:

• MRMC Study: No. This device is a physical catheter, not an AI/ML-driven diagnostic or assistive tool for human readers.

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

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

7. The Type of Ground Truth Used:

• Ground Truth: In the context of this 510(k), the "ground truth" for the device's acceptable performance is primarily derived from:
  • Predicate Device Performance: The established safety and effectiveness of the existing predicate devices (K053345, K081904, K070996).
  • Bench Test Results: Internal engineering testing demonstrating the device meets its design specifications and performs as intended, consistent with the predicates.
  • Biocompatibility Standards: Compliance with ISO 10993 for materials used.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth Establishment: Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

In summary, the provided document details a traditional 510(k) submission for a physical medical device (catheter) that demonstrates substantial equivalence to predicate devices through bench testing and material biocompatibility, rather than through clinical studies with defined test sets, expert-driven ground truth, or AI/ML performance metrics.

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The PRO-PICC m C catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The PRO-PICC m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and 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 designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The PRO-PICC m C catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.

The provided document, K072509, is a 510(k) premarket notification for a medical device, the PRO-PICC™ CT catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy through clinical trials with specific acceptance criteria in the manner of a new drug or a highly innovative device.

Therefore, the study design and acceptance criteria outlined would be for in vitro (bench) testing designed to show the device performs similarly to or within acceptable limits compared to the predicate device, or to established industry standards (ISO). There are no clinical studies described, nor are there any AI components involved.

Here's a breakdown of the requested information based on the provided text, with a recognition that many items are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing was performed to "assure reliable design and performance in accordance with ISO 10555-1 and 10555-3 and internal engineering protocol." It does not provide specific numerical acceptance criteria or results, but rather a statement of compliance.

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

• Sample Size for Test Set: Not explicitly stated for specific in vitro tests. Typically, in vitro testing for device performance involves a specified number of samples (e.g., 5-10 devices per test condition) to demonstrate consistency and compliance with standards.
• Data Provenance: The document refers to "in vitro testing" and internal engineering protocols. This indicates the testing was conducted prospectively in a laboratory setting by the manufacturer (Medcomp®). There is no mention of country of origin for the data as it's not patient data.

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

• Not applicable. This device submission relies on in vitro engineering testing against established standards, not expert-derived ground truth based on patient data. There are no experts reviewing test images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. As described above, this is an in vitro device performance study, not a study involving human interpretation of data requiring adjudication.

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

• Not applicable. This device is a physical medical catheter, not an AI or imaging analysis tool. No MRMC study was conducted.

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

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

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by international standards (ISO 10555-1, 10555-3, 10993) and the manufacturer's internal engineering protocols. These standards specify acceptable limits for various physical and material properties (e.g., burst pressure, flow rates, biocompatibility), which form the basis of the "ground truth" for demonstrating device safety and reliable performance.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

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

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