(8 days)
The X-Port duo™ Implanted Port is a totally implantable vascular access device designed to provide long term repeated access to the vascular system.
This is the identical intended use for the predicate MRI® Dual port.
The BardPort®, SlimPort™ and X-Port™ 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 duo™ port has the same basic, fundamental scientific technology as the predicate MRI® Dual 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 base of 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 oblong shaped plastic base and top. The silicone septa are compressed between the port base and top. The port body profile incorporates smooth transitions. There are two suture holes adjacent to the stem and a third suture hole placed opposite the stem on the tapered nose. All suture holes are filled with silicone plugs.
All catheters and catheter/port connection systems used on the X-Port duo port are previously qualified legally marketed configurations covered by the predicate device.
The provided text describes the 510(k) Pre-Market Notification for the X-Port duo™ Implanted Port. This submission relies on substantial equivalence to a predicate device, rather than performance against specific acceptance criteria derived from a clinical study. Therefore, traditional acceptance criteria and study details as might be found for a new diagnostic or AI device are not present.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific acceptance criteria with corresponding performance data in the manner typically seen for clinical trials or new device evaluations. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Withstand material stresses, fluid pressure, connection integrity. | "Performance data gathered in design verification and validation testing demonstrated that the X-Port duo™ port is substantially equivalent to the predicate MRI® Dual port and/or met predetermined acceptance criteria." |
| Biocompatibility | Non-toxic, non-irritating, non-allergenic to body tissues. | Implied by use of similar materials and design to the legally marketed predicate device. |
| Material Properties | Appropriate strength, durability, inertness. | Implied by use of similar materials and design to the legally marketed predicate device. |
| Sterility | (Not explicitly mentioned as a test, but assumed for implantable devices) | Implied by regulatory requirements for implantable devices and the substantial equivalence pathway. |
| Functional Equivalence | Serve as a conduit for fluids into/out of the central venous system, provide long-term repeated vascular access. | "The X-Port duo™ port has the same basic, fundamental scientific technology as the predicate MRI® Dual port." and "The port system serves as a conduit for fluids into, and out of, the central venous system." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" refers to the nonclinical performance testing. The text states "appropriate design verification tests were performed," but does not specify sample sizes for these tests.
- Data Provenance: The testing was "performed in accordance with Guidance on 510(k) Submission for Implanted Infusion Ports, dated October 1990" and "Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997." This indicates internal testing by Bard Access Systems, Inc. The nature of the tests (design verification and validation) suggests laboratory-based, non-clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is an implanted port, not a diagnostic device requiring expert interpretation for ground truth establishment. The evaluation is based on engineering and material performance.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication process as would be used for subjective assessments or diagnostic interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or AI-assisted system that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through engineering performance specifications and comparison to the predicate device's known performance and safety record. The non-clinical performance testing validated that the device met these specifications and was substantially equivalent, ensuring its safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This refers to the training of an algorithm, which is not relevant for this physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" in the context of 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.