Search Results

The PowerPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. The maximum infusion flow rate is 5mL/second for power injection of contral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.

A family of peripherally inserted central catheters made from specially formulated and processed medical grade materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access.

The provided document is a 510(k) summary for the PowerPICC Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing details of a study with acceptance criteria for an AI/ML powered device. Therefore, much of the requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the listed tests, indicating that the device performed as expected under the specified conditions. The document states that the performance tests were conducted "in determining substantial equivalence" and that "the subject PowerPICC Family Catheters have been demonstrated to be substantially equivalent to the cited predicate and reference devices." This implies that the device met the acceptance criteria derived from these tests.

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test. It refers to "testing" in general. The data provenance is not mentioned, as these are in vitro and in vivo performance tests on the device itself, rather than studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are physical and biological performance tests, not clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for physical and biological performance testing, not interpretation of data by 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
Not applicable. This is not an AI/ML device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests are the established scientific and engineering principles, material properties, and regulatory standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F640-12, ISO 10555-3, FDA Guidance on Premarket Notification for Intravascular Catheters, ISO 80369-7, USP 788). The device's performance is measured against these defined benchmarks.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The 5 FR DL Piper PICC Catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and prolonged exposure to intraluminal solutions containing up to 70% ethanol. The maximum recommended infusion rate is 5mL/sec for power injection of contrast media.

The 5 French (FR) Dual Lumen (DL) Piper PICC is a single use peripherally inserted central catheter made from a specially-formulated medical grade polyurethane material.

The Piper PICC is designed to perform infusion, intravenous therapy, blood sampling and power injection of contrast media, and is compatible with intraluminal solutions containing up to 70% ethanol. The maximum recommended infusion rate is 5 mL/sec.

The Piper PICC is a 5 French catheter with two 18-gauge lumens and will be provided with 55cm of effective length. The catheter has a reverse-tapered design. The catheter is inserted peripherally by the clinician and is trimmable to fit different patient sizes. It is inserted with a Seldinger or modified-Seldinger technique with compatibility to guidewires up to 0.019" in outer diameter. The catheter distal tip is positioned in the lower 1/3 of the Superior Vena Cava (SVC). The effective length of the catheter including the distal end is radiopaque, which allows for catheter tip visualization.

The Piper PICC catheter includes an extruded polyurethane catheter shaft molded to an injection molded polyurethane hub with extruded extension legs molded to luer-lock fittings, which provide attachments for IV administration. The junction has suture wings to allow for securement to the patient. Clamps are attached to both extension legs on the catheter.

The distal end of the catheter shaft is a dual lumen symmetrical D-shape design that does not differ in material from the remainder of the shaft. With the exception of the reverse-tapered section of the shaft, the distal end is also dimensionally identical to the remainder of the shaft.

The proximal end of the catheter consists of two power injectable extension legs, which each have a luer lock style connection depicting gage size, thumb clamp, ID tag. The catheter has an average priming volume is 0.61 mL

The Piper PICC is packaged in a catheter only kit and provided sterile to the end user. There are no additional components in the kit.

The provided text describes a 510(k) submission for a medical device, the 5 FR DL Piper PICC, and details the non-clinical performance testing conducted to demonstrate its substantial equivalence to a predicate device. This submission focuses on the safety and performance aspects rather than a study on diagnostic accuracy or AI performance. Therefore, many of the requested categories related to AI studies, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "The 5 FR DL Piper PICC met all of the predetermined acceptance criteria derived from the standards and guidance listed above." It lists the standards and guidance used, and all the tests performed. However, it does not provide a specific table detailing each acceptance criterion and the quantitative reported device performance for each test. It only gives a general statement that all criteria were met.

A list of guidelines and standards employed:

• Guidance on Premarket Notification [510(k)] Submission for Short- Term and Long-Term Intravascular Catheter, March 16, 1995
• Design Control Guidance for Medical Device Manufacturers, March 11, 1997
• ISO 10555-1: 2013, Sterile, single-use intravascular catheters, Part 1: General requirements
• ISO 10555-3: 2013, Intravascular catheters--Sterile and single-use catheters, Part 3: Central venous catheters
• ISO 594-1: 1986, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 1: General Requirements
• ISO 594-2: 1998, Conical fittings with 6% luer taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
• ASTM F640-79 (reapproved 2000): 2012, Standard Test Methods for Radiopacity of Plastics for Medical Use
• ISO 11135:2014, Medical Devices Validation and Routine Control of Ethylene Oxide Sterilization
• ISO 11607-1: 2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 11607-1 AMD 1: 2014, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
• ISO 10993-7: 2008. Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
• ANSI/AAMI ST72:2011, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
• FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, 2010
• ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for externally communicating, blood contacting, permanent devices and FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
• ISO 14971:2007, Medical Devices – Risk Management for Medical Devices.

List of tests performed:

• Dimensional Analysis
• Ink Permanence
• Radiopacity
• Leak Testing
• Extension Leg Leak w/ Clamp
• Pump Flow
• Priming Volume
• Gravity Flow
• Kink Diameter
• Catheter Collapse
• Tip Stability
• Suture Wing Integrity
• Assembly Tensile
• Shaft Tensile
• Catheter Elongation
• Catheter Modulus
• Catheter Fatigue
• Power Injection
• Assembly Burst
• Extension Leg Burst
• ISO Luer Gauging
• ISO Luer Testing
• Sterilization
• Packaging Validation
• Residuals. EO and ECH
• Pyrogenicity Bacterial Endotoxin Test (LAL)
• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous Reactivity
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Hemolysis (indirect/direct)
• Complement Activation
• Partial Thromboplastin Time
• Sheep Thrombogenicity
• Implantation 13 weeks
• Chemical Characterization
• Subacute/ Sub-chronic Toxicity
• Genotoxicity
• Chronic Toxicity
• Carcinogenicity

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., how many catheters were tested for leak testing, power injection, etc.). The study is a non-clinical performance evaluation, likely involving bench testing and some in-vivo animal testing (sheep thrombogenicity, 13-week implantation). No human patient data is mentioned; thus, data provenance in terms of country of origin is not applicable for this type of testing, nor is the retrospective/prospective nature as it's a verification and validation study.

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

Not applicable. This is a non-clinical device performance study, not an AI diagnostic study requiring expert ground truth for interpretation of images or patient data.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Reader Improvement with AI vs Without AI Assistance

Not applicable. This document describes the performance testing of a physical medical device (PICC catheter), not an AI-powered diagnostic tool. No human-in-the-loop study with AI assistance was performed.

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

Not applicable. This document is for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, in essence, is established by adherence to the performance requirements outlined in the referenced national and international standards (e.g., ISO, ASTM, FDA Guidance). The tests performed (e.g., dimensional analysis, leak testing, tensile strength, biocompatibility, sterilization validation) are designed to objectively verify that the device meets these pre-defined engineering and safety specifications. No pathology, outcomes data, or expert consensus in the diagnostic sense is mentioned as ground truth.

For thrombogenicity evaluations, a legally marketed comparative device (LMCD), the Bard 5F Dual Lumen PowerPICC, was used as a reference for in vivo thrombogenicity evaluations to meet ISO 10993-4 requirements. This served as a comparative benchmark rather than a "ground truth" derived from patient outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for a physical medical device.

Ask a specific question about this device

The Biowy PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi.

The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device.

The provided document is a 510(k) summary for the Biowy PICC Catheter, which is a medical device and not an AI/ML software device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, number of experts for ground truth, adjudication methods, or training set details are not applicable in this context. The acceptance criteria and performance are based on physical and biological testing of the catheter.

Here's the information pulled from the document regarding the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

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

The document does not explicitly state the sample sizes for each specific test. The data provenance is not mentioned, and tests appear to be laboratory-based design verification rather than clinical data from human subjects. The study is a non-clinical performance test.

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, as this is a medical device clearance based on non-clinical performance testing and biocompatibility, not an AI/ML algorithm requiring expert ground truth for interpretation of images or other data.

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

Not applicable. This type of adjudication is for studies involving human interpretation or assessments, such as in clinical trials or AI/ML evaluations.

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 is for AI/ML software devices, not a physical medical device like a PICC catheter.

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

Not applicable. This is for AI/ML software devices, not a physical medical device.

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

The "ground truth" for this device is based on established engineering and biological standards (e.g., ISO, ASTM, USP). The device's performance is compared against these predetermined specifications and, in some cases for biocompatibility, against a legally marketed predicate device (5Fr DL PowerPICC® Catheter, K051672).

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device