(139 days)
The Catheter Innovations Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.
Catheter Innovations, Inc. Implantable Ports are constructed using a combination of traditional implanted port/catheter technology which is well known in the art (over fifteen years of successful use), Bard Access Systems BardPort™ Implanted Ports with Groshong® catheters-hereafter referred to as BardPorts™ (over eleven years in use) and its own previously approved 510(k) technology. The Catheter Innovations ports, like the BardPorts™ and other traditional ports, are implanted within the body and are used for access to the circulatory system for repeatable or periodic infusion of fluids and/or aspiration of blood. Like many currently marketed ports the Catheter Innovations ports have smooth, contoured titanium port bodies with either one (single-lumen) or two (dual-lumen) independent reservoirs. A radiopaque silicone catheter with one or two lumens is provided with each port body. The catheter may come attached to the port body by the manufacturer or un-attached depending on user preference. If the catheter comes attached to the port, at the time of use the health practitioner measures and cuts off the distal end of the catheter to the desired length. If the catheter is not attached to the port when it is purchased, the catheter is placed, then cut off at the proximal end to the desired length and attached to the port by the practitioner. The port is then placed in a small pocket made just under the skin. The port bodies are designed to facilitate secure seating and anchoring in the port pocket. The port bodies are accessed by inserting a non-coring needle through the skin and into the self-sealing silicone septum which caps these reservoirs. Both BardPorts™ and Catheter Innovations ports contain a thin silicone membrane within their construction. In both cases these membranes have a small slit or cut through them that acts as a valve. In the BardPorts™ this valve is located at the distal end of the attached catheter. In the Catheter Innovations ports the valve is located in a small plastic polysulfone housing which comes attached to the port body. The catheter is connected to this port through this housing. In both examples the valve is used to control the flow of fluids both into and out of the blood stream. The valve remains closed when the ports are not in use and when subjected to normal central venous pressures. When positive fluid pressure is applied through the reservoir, the valve opens, allowing infusion through the catheter. When negative pressure (aspiration) is applied, the valve opens, allowing for withdrawal of blood into a syringe.
The provided text describes a Premarket Notification (510(k)) for Catheter Innovations, Inc.'s Dual-Lumen Implantable Ports. The submission aims to demonstrate substantial equivalence to predicate devices, namely BardPort™ Implanted Ports with Groshong® catheters and Hickman® catheters.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria or specific numerical performance targets. Instead, the "acceptance criteria" are implied to be "substantial equivalence" to the predicate devices for all performance characteristics itemized in the "FDA Guidance on 510(k) Submissions for Implanted Infusion Ports" (October 1990).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for physical characteristics. | "Physical characteristics of Catheter Innovations ports, compared to BardPorts™ with Groshong® and Hickman® catheters, demonstrate that the physical characteristics of the Catheter Innovations ports are identical to the predicate devices for all items listed in the 'FDA Guidance on 510(k) Submissions for Implanted Infusion Ports.'" (Section 8) |
| Substantial equivalence to predicate devices for performance characteristics related to port and valve function. | "Catheter Innovations performance characteristics related to port and valve function were compared to the predicate BardPort™ with Groshong® catheters. Comparison of all other Catheter Innovations port catheter performance characteristics were made to the range of values found for the performance of the predicate BardPort™ with Hickman® and Groshong® catheters. These comparisons indicate that the Catheter Innovations port with catheters performed equivalent to, or better than, the predicate devices for all performance characteristics studied." (Section 9) |
| No new safety or effectiveness issues. | "There are no new safety or effectiveness issues posed by the difference in location of these valves within the body." (Section 8) "Data indicates that the performance characteristics of the Catheter Innovations Port with valved catheters are equivalent or superior to the currently marketed BardPort™ Implanted Ports with Groshong® and Hickman® catheters while posing no new safety or efficacy issues." (Conclusion) "A risk analysis was completed on the products covered by this submission. This analysis showed that these ports have the same inherent risks of use as predicate devices and all other central venous access port/catheter products." (Section 10) |
| Intended Use | Both the Catheter Innovations ports and the predicate devices (BardPorts™ and other approved intravascular port and catheter combinations) share the same indications for use: "long-term access to the central venous system for administration of fluids and for blood specimen withdrawal." (Section 7) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in terms of a distinct group of patients or a specific number of new devices tested separately from general performance comparisons. The study appears to be an engineering or design validation comparison rather than a clinical trial with a defined patient test set.
- Sample Size: Not explicitly stated for any specific "test" of the Catheter Innovations device. The performance characteristics were compared to "the range of values found for the performance of the predicate BardPort™ with Hickman® and Groshong® catheters." This suggests comparison against existing data or specifications of the predicate devices.
- Data Provenance: Not specified. The study seems to rely on "performance test results" and "physical characteristic comparisons" which would typically be conducted in a lab environment. There is no mention of country of origin for any data or whether it's retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given that the submission is for a 510(k) focusing on substantial equivalence through physical and performance characteristic comparisons, the "ground truth" would be established through engineering specifications, test methods, and existing data/performance of the predicate devices, rather than expert clinical consensus on a "test set."
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human-centric "test set" or adjudication process.
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 typically associated with diagnostic imaging devices or algorithms where human readers interpret cases. The device in question is an implantable port, and the submission focuses on its physical and functional equivalence to existing devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the performance assessment described is a "standalone" evaluation of the device's physical and functional characteristics. The "performance test results" and "physical characteristic comparisons" would have been conducted on the device itself, independent of human interaction in a clinical setting for the purpose of this 510(k) submission. There is no "algorithm" involved, but the device's inherent performance is evaluated.
7. The Type of Ground Truth Used
The "ground truth" for the comparison is the established physical characteristics and performance ranges/data of the predicate devices (BardPort™ with Groshong® and Hickman® catheters). This is based on:
- Predicate Device Specifications: "physical characteristics... identical to the predicate devices for all items listed in the 'FDA Guidance...'"
- Predicate Device Performance Data: "Comparison of all other Catheter Innovations port catheter performance characteristics were made to the range of values found for the performance of the predicate BardPort™ with Hickman® and Groshong® catheters."
This is akin to using established engineering standards and existing product performance as a benchmark.
8. The Sample Size for the Training Set
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission describes an implantable medical device, not an AI or algorithmic device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this 510(k) submission for an implantable port.
§ 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.