(16 days)
The BardPort® and SlimPort™ Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
The X-Port isp port relies on the same basic, fundamental scientific technology as the predicate Hickman port. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone rubber septum. The access path to the vascular system is provided through a catheter attached to the port. The port system serves as a conduit for fluids into, and out of, the central venous system.
The port body consists of an oval shaped plastic base and top. The silicone septum is compressed between the port base and top. The port body profile incorporates smooth transitions, a tapered nose and is intermediate sized. There are only two suture holes, which are adjacent to the stem and are filled with silicone plugs.
The catheters, stems and catheter locks used with the X-Port isp port are unchanged, previously qualified legally marketed devices covered by the predicate device and come in multiple French sizes.
1. Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Port Tests (based on FDA Guidance) | To demonstrate substantial equivalence to the predicate Hickman port or meet predetermined criteria. | "The X-Port isp port met all predetermined acceptance criteria." These tests included: Dimensions, Septum puncture life, Intermittent port leak, Continuous port leak, Septum blowout, Fluid dynamics clearance. The document states these were performed according to protocols based on "Guidance on 510(k) Submission for Implanted Infusion Ports, dated October 1990" and "in-house protocols." |
| Additional Verification Tests | To further demonstrate safety and efficacy for intended use. | "The X-Port isp port met all predetermined acceptance criteria." These tests included: Flow rate, Obturation, Priming volume, Septum needle insertion force, Septum needle retention force, Stem strength, Suture plug retention, Top/base assembly strength. These were performed "in accordance with in-house protocols." |
| Biocompatibility | Meet ISO-10993 and FDA-Modified ISO 10993 Test Profile. | "Biocompatibility requirements of ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing, and the FDA-Modified ISO 10993 Test Profile for a long term implanted device that exhibits tissue contact, indirect blood contact and direct blood contact, were met." (Note: No specific new testing was required as all materials were previously cleared.) |
| Design Validation | Meet recommendations of "Design Control Guidance for Medical Device Manufacturers." | "Design validation was performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify exact sample sizes for each test mentioned (e.g., number of ports tested for septum puncture life). It only states that "Verification and validation testing was performed according to protocols..."
The data provenance is from non-clinical performance testing, meaning internal laboratory and design validation tests. It is not patient or human data; therefore, data provenance regarding country of origin or retrospective/prospective is not applicable in the human study sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This study describes non-clinical performance testing of a medical device (an implanted port), not a diagnostic algorithm or image analysis with human interpretation. The "ground truth" for these tests would be established by engineering specifications, material properties, and established test methodologies, not by expert human consensus on clinical data.
4. Adjudication Method for the Test Set:
Not applicable. As detailed above, this is non-clinical device testing, not a study involving human interpretation or subjective assessments that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
No, an MRMC comparative effectiveness study was not done. This document describes the 510(k) submission for an implanted medical device, not an AI or imaging diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm performance study was not done. This document is for an implanted medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the non-clinical performance tests of the X-Port isp Implanted Port would be based on:
- Engineering Specifications: Defined dimensions, material properties, and performance limits.
- Physical Measurements and Observations: Direct measurement of dimensions, observation of leaks, tracking of puncture cycles, etc.
- Material Science Principles: Ensuring materials meet biocompatibility and mechanical strength requirements.
- Predicate Device Performance: Benchmarking against the previously cleared Hickman port for substantial equivalence.
- Established Test Standards: Adherence to FDA guidance documents (e.g., "Guidance on 510(k) Submission for Implanted Infusion Ports, dated October 1990") and ISO standards (e.g., ISO-10993).
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI study that involves a training set. The "training" for the device's design and manufacturing is derived from established engineering practices, past product development, and regulatory standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of an AI or machine learning model for this device submission. The design and validation relied on established medical device design control procedures, existing scientific and engineering principles, and regulatory guidelines for implanted ports.
§ 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.