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The Power-V PICC is indicated for patients that require repeated venous access for infusion or injection therapy. The Power-V PICC is indicated for peripheral access to the central venous system for intravenous therapy. The Power-V PICC is indicated for dwell times less than or greater than 30 days. The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi.

The Power-V PICC is a family of peripherally inserted central venous catheters designed to allow for contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted pcriphcrally. Each Power-V PICC has a kink resistant, reverse tapered catheter design. The Power-V PICC is indicated for dwell times greater than 30 days. The Power-V PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 cc/sec with a maximum power injection pressure of 300 psi (scc Appendix B). The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations (scc Appendix C).

The Power-V PICC is illustrated in the drawings at the end of this section. The Power-V PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. All catheters are 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with luer lock fittings for access attachment.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Power-V PICC device.

It's important to note that the provided text is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed scientific study report. As such, information regarding rigorous clinical trial design, statistical analysis, and detailed performance metrics as you might find for a novel drug or a high-risk device is largely absent. The focus of a 510(k) is to demonstrate equivalence to a legally marketed predicate device.

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in the form of numerical thresholds for a specific test. Instead, it refers to the device meeting "all functional requirements and specifications" and demonstrating substantial equivalence to predicate devices. The key performance aspect mentioned is related to power injection capabilities.

The "Intended Use" section reiterates: "The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi." |
| Biocompatibility (conformance with standards). | "Biocompatibility testing on the device was in conformance with ISO 10993-1, and GLP TRIPARTIE." |
| Functional requirements and specifications. | "The Power-V met all functional requirements and specifications." (No specific details provided on these requirements.) |
| Substantial equivalence to predicate devices. | "The design, methods of manufacturing, and materials used in the Power-V device are substantially equivalent to the predicate devices." (Implies meeting similar performance as predicate devices, but no direct quantitative comparison is given). |

Study Details (Based on the provided 510(k) Summary)

The text describes engineering and biocompatibility testing rather than a clinical study in the traditional sense, especially a study involving human subjects or extensive retrospective data analysis for performance metrics beyond physical device capabilities.

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

   • The document refers to "Power-V PICC catheter assemblies" being tested for power injection. It does not specify the number of catheter assemblies used in this test.
   • Data provenance: The testing appears to be prospective laboratory/bench testing conducted by the manufacturer (HDC Corporation) or a contracted lab. There is no mention of country of origin for the data or whether it's retrospective.
   • For biocompatibility, it states "Biocompatibility testing on the device was in conformance with ISO 10993-1, and GLP TRIPARTIE." This would involve specific biological tests on materials, not human testing or data from patients.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This concept is not applicable to the type of testing described. The "ground truth" for power injection performance or biocompatibility is established by the physical and chemical properties of the device and its behavior under controlled laboratory conditions, as measured by instruments and analyzed against engineering specifications and relevant standards. There is no involvement of clinical experts for "ground truth" similar to image interpretation.

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

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation or classification is involved, often for clinical outcomes or image reading. The tests described are objective, physical/chemical tests.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI or human interpretation, to assess reader performance. The Power-V PICC is an intravascular catheter with mechanical and biocompatibility performance as its primary focus.

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

   • No, this is not applicable. The Power-V PICC is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm's output.

6. The type of ground truth used:

   • For power injection: Engineering specifications and measurement data. The ability to withstand 5 cc/sec at 300 psi is measured directly using appropriate laboratory equipment.
   • For biocompatibility: Conformance to international standards (ISO 10993-1, GLP TRIPARTIE), which specify acceptable biological responses to materials. This involves a series of in-vitro and in-vivo tests to assess toxicity, irritation, sensitization, etc.

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set."

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

   • Not applicable for the reason above.

Summary of the "Study" Proving Acceptance:

The "study" in this context refers to bench testing and biocompatibility testing performed by or for HDC Corporation to demonstrate that the Power-V PICC meets its functional specifications and adheres to relevant safety standards. The core claim is not one of clinical superiority or a complex diagnostic performance, but rather that the device is substantially equivalent to existing, legally marketed predicate devices in terms of its design, materials, manufacturing, and basic functional capabilities, particularly its power injection functionality and biocompatibility. The regulatory pathway of a 510(k) relies heavily on this concept of substantial equivalence, meaning rigorous, comparative clinical trials are usually not required if equivalence can be demonstrated through non-clinical means.

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The Medcomp PRO-LINE™ CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. The maximum pressure of power injectors used with the PRO-LINE™ CT Power Injectable CVC may not exceed 300 psi.

The Medcomp® PRO-LINE™ CT Power Injectable CVC's are designed for central venous catheterization. The PRO-LINE™ CT Power Injectable CVC lumen is comprised of a soft radiopaque polyurethane material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Cuff attachment to the lumen provides for tissue ingrown. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. Purple colorant has been added to the catheter materials to differentiate it from other non-power injectable catheters and identify it as a power injectable catheter. The extensions also are printed with the words power injectable.

The PRO-LINE™ CT Power Injectable CVC's are available in 5F single lumen and 6F double lumen version. The catheters are 60 cm long with depth markings in 5cm increments. Stylet and adaptor sideport is provided to assist in catheter insertion.

The catheter product line is packaged 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-LINE™ CT Power Injectable CVC:

1. Table of Acceptance Criteria and Reported Device Performance:

Key takeaway for Table: The document states that testing was performed in accordance with ISO 10555-1 and 10555-3 for mechanical performance, and ISO 10993 for biocompatibility. These ISO standards inherently contain the "acceptance criteria" for various tests, which the device is reported to have met. The document, however, does not explicitly list the numerical or qualitative acceptance criteria for each specific test (e.g., "burst pressure must be >X psi"), but rather states that the device "assure[s] reliable design and performance" and "demonstrates that the materials used meet the requirements."

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

• Sample Size: The document does not specify the exact sample size for the in vitro tests. It only mentions "in vitro testing was performed."
• Data Provenance: The data is from in vitro testing. No country of origin is mentioned, as it's not clinical data. The study is not applicable as retrospective or prospective given it's laboratory testing.

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

• Not Applicable. This information is for clinical studies. The study described is an in vitro study, meaning it was conducted in a lab setting and relied on standardized test methods (ISO standards) rather than expert interpretation of clinical data. Therefore, there was no "ground truth" established by human experts in the context of this submission.

4. Adjudication Method for the Test Set:

• Not Applicable. As this was an in vitro mechanical and biocompatibility study, there was no adjudication method involving multiple human reviewers or experts. The results would be based on instrument readings and adherence to pre-defined test protocols within the ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study was not conducted. The document 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."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

• Not Applicable. This device is a physical medical device (catheter), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• Standardized Test Results/Compliance with ISO Standards. For the in vitro tests, the "ground truth" was established by the methodologies and pass/fail criteria outlined in the relevant ISO standards (ISO 10555-1, 10555-3, and ISO 10993). The device's performance was measured against these predefined, objective standards.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI or machine learning device. There is no concept of a "training set." The testing involved physical samples of the catheters.

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

• Not Applicable. As there is no training set for this type of device, no ground truth needed to be established in that context.

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The PowerPICC™ catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion or therapy, use a 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerPICC catheter may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The Poly Per-O-Cath® Triple Lumen PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling and allows for central venous pressure monitoring. For blood therapy, it is recommended that a 4 French or larger catheter be used. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

PowerHohn and PowerLine Catheters are indicated for short or long term access to the central venous system. They are designed for administering I.V. fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal, power injection of contrast media and allow for central venous pressure monitoring. The maximum recommended infusion rate is 5mL/sec. The maximum pressure of power injectors used with the PowerHohn and PowerLine catheters may not exceed 300 psi. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

Subject devices:

• Catheters range in French size from 3-5 Fr SL; 4-6 Fr DL and 6 Fr TL .
• Catheter usable length ranges from 40 -60 cm. .
• Catheters are open-ended catheters extruded from polyurethane material containing barium ● sulfate for radiopacity.
• The catheter extension legs are polyurethane extrusions. Extension legs are minimum 2.2 in. . in length to promote easy application of occlusive dressings. Each extension leg has a thumb clamp.
• The luer hub base material is Isoplast polyurethane. .
• The catheter has a reverse taper design .
• The user is informed of the gage size in product labeling and it is printed on the luer hub. .
• The catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a . reference for the catheter insertion point
• Catheters are provided sterile and are packaged with legally marketed kit components that are . preferred by clinicians

The provided document describes a 510(k) premarket notification for Central Venous Pressure Monitoring (CVPM) capability in various catheter devices, rather than a standalone device with extensive acceptance criteria and a study demonstrating its performance in a clinical setting against a ground truth.

The document focuses on demonstrating substantial equivalence to existing predicate devices for an expanded indication for use: "allows for central venous pressure monitoring." The key point is that the catheters themselves are not new, but their indicated use now includes CVPM. Therefore, the "acceptance criteria" and "study" are geared towards proving that the existing or slightly modified catheters are suitable for this additional function, specifically focusing on the catheter lumen size for effective CVPM.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a test set in the traditional sense of a clinical trial with a specific number of patients or samples. The "testing" mentioned is bench testing (laboratory studies). Therefore, there is no information on:

• Sample size used for a clinical test set.
• Country of origin of data for a clinical test set.
• Retrospective or prospective nature of a clinical test set.

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

This information is not applicable as the document describes bench testing and design verification, not a clinical study involving human readers or expert consensus to establish a clinical "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document focuses on the device's capability for CVPM, not on human reader performance with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This submission is for physical catheter devices, not AI algorithms.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the central venous pressure monitoring capability was based on recognized and un-recognized standards for invasive blood pressure monitoring equipment and transducers, likely involving physical measurements and comparisons in a controlled bench setting. This is best described as bench test performance against established engineering or medical device performance standards. It is not clinical pathology, expert consensus on images, or patient outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The document describes physical medical devices (catheters) and their expanded indications, not a machine learning model that would require a "training set."

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

This information is not applicable for the same reason as #8.

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