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The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.

The document provided describes the primeMIDLINE™ Catheters and their substantial equivalence to a predicate device, PowerMidline Catheters. It outlines verification testing performed to demonstrate that the device performs as intended and meets established acceptance criteria.

However, the document does not contain information about a study comparing the device's performance against specific acceptance criteria in the format requested. While it lists various performance testing categories, it does not provide:

• A table of specific quantitative acceptance criteria for each test (e.g., "Tensile Strength should be > X N") and the reported device performance against those criteria.
• Details on sample sizes for a "test set" in the context of device performance, data provenance, or the number/qualifications of experts for ground truth.
• Information on adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance, as these are typically relevant to AI/diagnostic imaging devices, not direct hardware performance.
• The type of ground truth used for performance validation.
• Training set sample size or how ground truth was established for a training set (again, this points more towards AI/ML studies).

Instead, the document states: "The subject devices met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This is a general statement that the device passed all tests, but without quantifying the criteria or the results.

Therefore, based on the provided text, I cannot complete the table or answer most of the requested questions because the specific data is not available.

Summary of available information:

• Device: primeMIDLINE™ Catheters
• Predicate Device: PowerMidline Catheters (K153393)

1. Table of Acceptance Criteria and Reported Device Performance:

Study Information (based on available text):

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

• Not specified. The document states "design verification testing" was conducted but does not provide sample sizes for individual tests or data provenance.

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):

• Not applicable/Not specified. The testing described is performance testing of a physical device against standards, not expert-adjudicated diagnostic performance.

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

• Not applicable/Not specified.

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:

• No. This type of study is for diagnostic tools, typically AI-powered. The device is a physical catheter.

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

• No. This is not an algorithm.

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

• "Predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This refers to objective measurements against established engineering and safety standards.

8. The sample size for the training set:

• 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:

• Not applicable.

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The SYNERGY™ CT PICC is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. The intended use has not changed from that of the predicate devices. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The SYNERGY™ CT PICC is indicated for short or long term (less than or greater than 30 days) peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec.

The SYNERGY™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each SYNERGY™ CT PICC has a kink resistant, reverse tapered catheter design. The SYNERGY™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.

The SYNERGY™ CT PICC is indicated for dwell times shorter or greater than 30 days. The SYNERGY™ CT PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.

The SYNERGY™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen, 5 Fr and 6 Fr dual lumen and 6 Fr triple lumen. All catheters are approximately 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All SYNERGY™ CT PICC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The provided text describes a 510(k) premarket notification for the SYNERGY™ CT PICC device. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than providing detailed standalone performance studies with specific statistical metrics against predefined acceptance criteria for novel clinical claims.

Based on the information provided, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance

The submission indicates that "The SYNERGY™ CT PICC met all established acceptance criteria for performance testing and design verification testing." However, the specific quantitative acceptance criteria or the detailed reported device performance values related to infusion rates, pressure, or other functional aspects are not explicitly listed in the provided text in a table format.

What is mentioned as a performance characteristic is:
"The SYNERGY™ CT PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi."
And, "All SYNERGY™ CT PICC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi."

This implies that the acceptance criteria for power injection performance were to withstand 5 ml/sec and 300 psi without failure. The reported performance is that the device "met all established acceptance criteria" for this.

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

The document mentions "Verification testing was performed according to protocols based on the above-referenced vicince document recommendations and additional standards." It also states, "Performance data gathered in design verification testing demonstrated that the SYNERGY™ CT PICC is substantially equivalent to the noted predicate devices."

However, the specific sample size used for performance testing (test set) is not provided in the given text.

The data provenance is from "Health Line International Corporation," the manufacturer, which implies the testing was conducted by or for the manufacturer. The location is Centerville, Utah, USA. The data would be considered prospective in the sense that the tests were performed specifically for this 510(k) submission.

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

This type of information (expert consensus for a test set) is typically relevant for interpretative diagnostic devices or those involving subjective assessments. For a medical device like a Percutaneously Inserted Central Catheter (PICC) that focuses on mechanical and functional performance (e.g., ability to withstand pressure and flow rates), expert opinion is not usually used to establish "ground truth" for the device's technical specifications. Instead, performance is measured objectively through engineering tests.

Therefore, this information is not applicable and not provided in the text.

4. Adjudication Method for the Test Set

As explained above, adjudication methods (like 2+1, 3+1) are usually for situations requiring human interpretation or subjective assessment to establish ground truth or resolve discrepancies. For the performance testing of a PICC, where objective measurements of pressure, flow, and material integrity are key, adjudication methods are not applicable and not mentioned in the text.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where different readers interpret cases, and the AI's impact on their performance is evaluated. For a catheter, this is not a relevant study design.

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

Yes, a standalone performance assessment was done. The entire 510(k) submission is dedicated to demonstrating the standalone performance of the SYNERGY™ CT PICC device itself through "performance testing and design verification testing" against established standards and predicate devices. There is no mention of an algorithm or human-in-the-loop component for this device. The device is a physical medical instrument.

7. The Type of Ground Truth Used

For the performance and design verification testing of the SYNERGY™ CT PICC, the "ground truth" is established by objective engineering measurements and adherence to recognized industry standards (e.g., ISO 11135:2007 for sterilization, ISO-10993 for biocompatibility, and FDA Guidance for Intravascular Catheters). The device's ability to withstand specific pressures and flow rates without failure constitutes its "performance ground truth" for these technical aspects.

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. It is a physical medical device (PICC catheter). Therefore, this information is not applicable and not provided.

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

As this is not an AI/ML device with a training set, this information is not applicable and not provided.

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