(57 days)
A system is indicated when a patient requires repeated venous access for injection (bolus) or infusion therapy and/or venous blood sampling.
PORT-A-CATH® II Dual-Lumen Low Profile™ Systems are similar in design and function to the current commercially available PORT-A-CATH® II Dual-Lumen Systems. These systems differ from current commercially available PORT-A-CATH® systems in that the portal is dimensionally smaller and a dual-lumen polyurethane catheter is being offered. These systems consist of one low profile dual-lumen portal (titanium/polysulfone), one radiopaque catheter (polyurethane), one catheter connector, one access needle, one blunt needle and one vein pick. Introducer sets and a Fluoro-Free™ system will also be made available.
The provided document describes the 510(k) premarket notification for the PORT-A-CATH® II Dual-Lumen Low Profile™ Systems. This type of filing is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the document focuses on functional testing and biocompatibility to demonstrate that the new device is as safe and effective as existing, legally marketed devices.
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 document doesn't explicitly state quantitative acceptance criteria in a table format with specific thresholds. Instead, the acceptance is based on the device functioning "according to specification" and the materials being "biocompatible," implying general safety and functional equivalence to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to predicate devices in mechanical performance. | "Results of the testing indicated that PORT-A-CATH® II Dual-Lumen Low Profile™ Systems function according to specification." |
| Biocompatibility of all system components. | "Biocompatibility testing was conducted on all system components." |
| "…the materials used in the system are biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "In-vitro mechanical testing was conducted" and "Biocompatibility testing was conducted," but does not provide details on the number of units tested for these in-vitro studies.
- Data Provenance: The document implies the tests were conducted by the manufacturer, SIMS Deltec, Inc. The data is retrospective for the purpose of the 510(k) submission, as it was generated prior to the submission date. The country of origin for the data is not explicitly stated, but the applicant is based in St. Paul, Minnesota, USA, suggesting the testing was likely performed in the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. The "ground truth" for this medical device, in the context of its 510(k) submission, is its compliance with established engineering specifications and biocompatibility standards, not an expert assessment of clinical images or patient outcomes.
- Qualifications of Experts: Not applicable for establishing ground truth in this submission. The "experts" involved would be the engineers, scientists, and regulatory affairs personnel at SIMS Deltec, Inc. who performed and interpreted the functional and biocompatibility tests.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This device is not an AI algorithm requiring adjudication of interpretations. The acceptance is based on compliance of physical and material properties with technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done? No. This type of study is relevant for AI algorithms or diagnostic tools where human interpretation is involved. The PORT-A-CATH® II is an implantable access system, not a diagnostic device.
- Effect Size of Human Readers: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was it done? No. This is not an AI algorithm. The performance of the device is assessed through engineering tests and material studies, not an algorithm's output.
7. Type of Ground Truth Used:
- Ground Truth: The "ground truth" for this device's acceptance is based on adherence to engineering specifications for functional performance (e.g., flow rates, pressure resistance, structural integrity) and biocompatibility standards (e.g., ISO 10993 series for medical devices). The document references "Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990," which would outline the specific tests and performance criteria for such devices.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This is not an AI algorithm. There is no "training set" in the context of the device's design verification and validation for this 510(k) submission.
9. How the Ground Truth for the Training Set was Established:
- How Established: Not applicable. As there is no AI algorithm or training set, this question is not relevant.
§ 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.