(97 days)
The C-Port family of products will be used as a subcutaneously implanted device where repeated access to the vascular system is the therapy of choice for delivery of medications, fluids, nutritional solutions and blood products or withdrawal of blood.
The CliniSurg family of Vascular Access devices is a group of subcutaneously implantable ports with a catheter either pre-attached or attachable for application by physicians in indicated therapies. The device has a port that is a titanium chamber with a silicone membrane designed for repeated needle insertion. The port comes in various sizes to enable use with larger adults or smaller pediatric patients or the more emaciated adult patient. A higher or lower profile device is chosen by patient evaluation. The port is connected to a catheter that is long enough to insert into the vena cava for positioning to enable fluid infusion into larger vessels. The catheter is fixed to the port with a hub either during a procedure to implant the device or it comes pre-assembled (physician choice for use). The catheter has a series of radiopaque marks to enable depth determination when the catheter is inserted into the vena cava. A kit is provided to aid in catheter placement, insertion, and port implantation. Items such as syringes, vein introducers, trocars, guide wires, sheaths, fixation hubs, Huber needles, and infusion sets may be part of a total kit.
Here's an analysis of the provided text regarding the C-Port and Catheter Kits, focusing on acceptance criteria and supporting studies:
Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Based on the provided 510(k) summary (K030636) for the C-Port and Catheter Kits, the device's acceptance criteria and proof of meeting them are established primarily through substantial equivalence to existing legally marketed predicate devices, rather than through new clinical studies demonstrating specific performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for functional performance paired with reported device performance in the manner typically seen for novel devices.
Instead, the acceptance criteria are implicitly met by demonstrating that the device components and materials are equivalent to, and have been tested to meet the same specifications as, those used in predicate devices. The "reported device performance" is largely an assertion of this equivalence.
However, the document lists "Testing of components" which can be interpreted as demonstrating the device meets established engineering and biological specifications. Here's a table based on that:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Component Material Equivalence: Materials used are safe and have a history of use in similar medical devices. | All materials (Titanium, Silicone, Polyurethane) have been successfully used in predicate devices and other Vascular Access products without presenting new or unacceptable risks. |
| Catheter to Port connection strength/integrity | Tested and meets required specifications. |
| Septum puncture resistance/integrity | Tested and meets required specifications (designed for repeated needle insertion). |
| Port leak integrity | Tested and meets required specifications. |
| Fluid dynamics performance | Tested and meets required specifications. |
| Biocompatibility/Toxicity | Tested (Biological evaluation) and meets required specifications (materials purchased to medical device specifications). |
| Catheter body tensile strength | Tested and meets required specifications. |
| Catheter elongation strength | Tested and meets required specifications. |
| Sterility | Sterilized by ethylene oxide gas; validation, verification, and bioburden details available in supporting sections. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a clinical test set. The "testing of components" (e.g., septum puncture, leak test) would have involved a sample size of devices, but this information is not detailed in the summary.
- Data Provenance: The justification for substantial equivalence relies on the known performance and safety profiles of predicate devices (Titan Port, Vortex Port) and the established use of the materials in similar medical devices. No new, specific patient data (retrospective or prospective) is presented to prove the device's clinical performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This is not applicable as no clinical test set for performance was established. The "ground truth" for the device's safety and effectiveness is largely based on the historical performance and established safety of predicate devices and their materials, as evaluated by the FDA and industry standards.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set with human interpretation requiring adjudication was conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed as part of this 510(K) process as the product is identical to products currently cleared for marketing and can be applied for under the substantial equivalence claim." Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance, as AI is not mentioned as part of this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (implantable port and catheter), not an algorithm or AI-driven system.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is primarily:
- Predicate Device Performance and Safety: The established safety and effectiveness of the Titan Port and Vortex Port (K830000).
- Material Safety and Biocompatibility Data: Long-standing data and specifications for the medical-grade Titanium, Silicone Rubber, and Polyurethane used in implantable devices.
- Engineering Specifications and Bench Testing: Data from mechanical and functional tests like connection strength, puncture tests, leak tests, fluid dynamics, tensile strength, and elongation strength.
8. The Sample Size for the Training Set
- Not applicable. There's no AI/algorithm component requiring a training set. If interpreted as "training data" for product design, it refers to the vast body of knowledge and specifications used in the design of similar medical devices over time, rather than a specific, quantifiable set for this submission.
9. How the Ground Truth for the Training Set was Established
- Not applicable due to the absence of a training set for an AI/algorithm. For the physical device, the "ground truth" concerning its design and material suitability was established through decades of medical device manufacturing experience, regulatory standards, and clinical use of similar products, leading to the establishment of industry-standard specifications and successful predicate devices.
§ 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.