(17 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 device.
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.
There are no new operating principles. The X-Port duo™ port with 9.5 Fr. polyurethane catheter has the same basic, fundamental scientific technology as the predicate X-Port duo™ port. Access to the port is made percutaneously with a non-coring needle that enters the port reservour 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 a lightweight plastic base and top with a tapered nose and farge . silicone septa.
The catheter is a 9.5 Fr. dual lumen polyurethane catheter.
Here's a summary of the acceptance criteria and study information for the {0}X-Port duo™ Implanted Port with 9.5 Fr. Polyurethane Catheter{/0} based on the provided text, where applicable:
This device (X-Port duo™ Implanted Port with 9.5 Fr. Polyurethane Catheter) is a modification of a previously cleared device (predicate device: X-Port duo™ port with 10 Fr. silicone catheter, K032044). The primary difference is the catheter material (polyurethane vs. silicone) and a slight change in catheter size (9.5 Fr vs. 10 Fr). The submission focuses on demonstrating substantial equivalence rather than presenting an exhaustive new performance study.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of specific acceptance criteria with quantitative thresholds for each test, nor does it list detailed reported device performance metrics side-by-side. Instead, it states that:
- "Performance data gathered in design verification and validation testing demonstrated that the X-Port duo™ port with 9.5 Fr. nolyurethane catheter is substantially equivalent to the predicate X-Port duo™ port with 10 Fr. silicone catheter and/or met predetermined acceptance criteria"
- "...and the risks associated with use of the new device were found acceptable when evaluated by FMEA."
The "predetermined acceptance criteria" are not detailed in this summary. The tests performed were "appropriate design verification tests... in accordance with Guidance on 510(k) Submission for Implanted Infusion Ports, dated October 1990 and other applicable guidance documents and standards." These would typically cover aspects like mechanical strength, flow rates, biocompatibility, etc.
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a "test set" sample size in the context of a clinical performance study.
- The testing discussed is "nonclinical performance testing" (design verification and validation testing). The sample sizes for these engineering tests are not provided.
- Data provenance: Not applicable as these were nonclinical (engineering/bench) tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "test set" refers to engineering/bench testing for device performance and equivalence, not a clinical study requiring expert ground truth for interpretation (e.g., image analysis).
4. Adjudication Method for the Test Set:
- Not applicable, as this was nonclinical performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. The document explicitly states: "{1}Clinical Performance Testing 6.8 Clinical performance testing was not required.{/1}"
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Not applicable. This is a medical device (implanted port and catheter), not an AI algorithm.
7. Type of Ground Truth Used:
- For the nonclinical performance testing, the "ground truth" would be established by the specifications and standards to which the device was tested (e.g., material properties, mechanical performance criteria, flow rate targets). These are inherent to the properties of the device and its function, not expert consensus or pathology in a clinical sense.
8. Sample Size for the Training Set:
- Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for 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.