(71 days)
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.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”