(132 days)
PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
PORT-A-CATH® II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
P.A.S. PORT® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.
The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The PORT-A-CATH® venous systems can be placed in the chest.
The PORT-A-CATH® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components; a portal. catheter and connector. The components are assembled during implantation. The portals are available in titanium standard or Low Profile", and the ULTRA-LOCK® catheter connector is utilized in the PORT-A-CATH® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. PORT-A-CATH® Implantable Venous Access Systems, The systems are offered in either a kit or a tray configuration.
The PORT-A-CATH® II Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The PORT-A-CATH® II venous systems can be placed in the chest.
The PORT-A-CATH® II Implantable Venous Access Systems with Dual Laver Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are assembled during implantation. The portals are available in polysulfone/titanium standard or Low Profile", and the ULTRA-LOCK® catheter connector is utilized in the PORT-A-CATH® II systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. PORT-A-CATH® II Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
The ProPort® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The ProPort venous systems can be placed in the chest.
The ProPort® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are during implantation. The portals are available in plastic standard or Low Profile", and the SlideLock connector is utilized in the ProPort® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. ProPort® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems and are designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids nutritional solutions and for the sampling of venous blood. The P.A.S. PORT® venous systems can be placed in the arm or chest.
The P.A.S. PORT® Implantable Venous Access Systems with Dual Layer Catheter are totally implantable access systems consisting of the following components: a portal, catheter and connector. The components are assembled during implantation. The portals are available in titanium or plastic/titanium standard or Low Profile™, and the ULTRA-LOCK® catheter connector is utilized in the P.A.S. PORT® systems. The catheter is a Polyether block amide outer lining and an aliphatic polyurethane inner lining. This catheter will replace the current single layer polyurethane catheters on the equivalent Smiths Medical MD, Inc. P.A.S. PORT® Implantable Venous Access Systems. The systems are offered in either a kit or a tray configuration.
Here's a breakdown of the acceptance criteria and the study information for the PORT-A-CATH® and related implantable venous access systems:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Testing: Met product specification (in accordance with FDA guidance "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters," dated March 16, 1995) | All testing met product specification. |
| In-vivo Testing: Evaluated product performance of the new catheter material. | All testing met product specification. |
| Biocompatibility Testing: Conducted on system components. | All testing passed. |
| Packaging and Sterilization Systems: Unchanged from predicate devices. (Implied acceptance: continued safe and effective based on predicate device performance) | Unchanged from predicate devices. (No new specific performance reported, but this implies equivalency to the predicate). |
| Substantial Equivalence: To predicate devices (PORT-A-CATH®, PORT-A-CATH® II, ProPort®, and P.A.S. PORT® Implantable Venous Access Systems) with respect to indications for use and performance features. (This is the overarching acceptance criterion for 510(k) clearance). | The devices were found to be substantially equivalent to their respective predicate systems. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes in-vitro and in-vivo testing. It refers to these as studies, but the nature of the data is not patient-specific in the way a clinical trial would be.
- Sample Size for Test Set: Not explicitly stated as a number of "samples" in a clinical human subject sense. The testing involved "functional testing," "in-vivo testing of the new catheter material," and "biocompatibility testing." The sample size would be related to the number of devices or components tested in these laboratory and animal (implied by "in-vivo" for material evaluation) environments.
- Data Provenance:
- In-vitro Testing: Performed in accordance with FDA guidance, suggesting laboratory testing.
- In-vivo Testing: Conducted to evaluate product performance of the new catheter material. This typically refers to animal studies for material biocompatibility and performance, not human clinical data.
- Retrospective or Prospective: These tests are inherently prospective as they are conducted specifically for the purpose of demonstrating device safety and effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device and study. The "ground truth" for this type of medical device clearance (510(k)) is established through adherence to engineering and clinical performance standards, and comparison to legally marketed predicate devices, rather than through expert consensus on medical image interpretation or diagnosis. The "experts" involved would be the engineers, scientists, and regulatory professionals conducting and evaluating the tests against established specifications.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., imaging) to establish a consensus ground truth. This is not a clinical study, but rather a set of functional and biological performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as this device is an implantable venous access system, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical and material properties when implanted.
7. Type of Ground Truth Used
The ground truth for this submission is based on:
- Product Specifications: The device was tested to ensure it met pre-defined product specifications for functional performance, material properties, and biocompatibility.
- Predicate Device Performance: The primary "ground truth" for 510(k) clearance is demonstrated substantial equivalence to legally marketed predicate devices in terms of indications for use and performance features. This means the new device performs at least as safely and effectively as the existing, approved devices.
- Industry Standards/Guidance: Adherence to FDA guidance for intravascular catheters (e.g., "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters").
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or artificial intelligence device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.