(450 days)
The POLYSITE implanable infusion Port is indicated for long term access to the central venous system and allows for repeated vascular access.
POLYSITE Implantable Infusion venous access ports are used to administer chemotherapy, antibiotics and antiviral drugs. They can also be used for parenteral nutrition, collection of blood samples and transfusion of blood products.
A non-coring needle must be used to access POLYSITE Implantable Infusion Ports.
Some references of POLYSITE Pressure Injectable Implantable Infusion Port-PI references) can be used for high pressure injection of contrast media during diagnosic studies. The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 ml/s.
For high pressure injection of contrast media, a high pressure needle must be used to access the POLYSITE Pressure Injectable implantable Infusion port. The manufacturer recommends the use of PPS PI Pressure Injectable Safety Huber needle.
POLYSITE Implantable Infusion Port is composed of a radiopaque dome or housing and a self sealing septum, connected to a radiopaque catheter by a connecting ring (supplied unassembled). The port is accessed percutaneously by using a non-coring needle.
The POLYSITE® Implantable Infusion Port is indicated for long-term access to the central venous system and for repeated vascular access. It can be used to administer chemotherapy, antibiotics, and antiviral drugs, for parenteral nutrition, and for collecting blood samples and transfusions. Some references of the POLYSITE Pressure Injectable Implantable Infusion Port-PI can also be used for high-pressure injection of contrast media during diagnostic studies, with the maximum flow rate of power injector equipment not exceeding 5 mL/s.
The device's acceptance criteria and performance data are based on safety and functionality testing and biocompatibility assessments, rather than a clinical study. The device did not require a clinical trial to demonstrate safety and effectiveness because it was found to be substantially equivalent to previously marketed predicate devices (PowerPort isp Implantable Port with attachable 8Fr. Chronoflex Polyurethane Catheter (K072215) and Slimport Titanium implantable port with attachable 6F Chronoflex Open-ended single-lumen venous catheter (K870260)).
Here are the details regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Attribute | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility, Implantation (26-week), Genotoxicity, Carcinogenicity, Chronic Toxicity | All tests defined by ISO 10993-1: 2009 for permanent implantable devices with limited blood contact. | The device met all biocompatibility requirements according to ISO 10993-1: 2009. |
| Safety and Functionality | Catheter to port connection (dry and wet conditions) | Secure connection without leakage or disconnection under specified conditions. | Testing demonstrated secure and leak-free catheter to port connection under both dry and wet conditions, in accordance with FDA guidance. |
| Septum puncture (with 19, 20, and 22 Gauge needles) | Ability to withstand multiple punctures with specified needle gauges without leakage or damage compromising integrity. | The septum demonstrated satisfactory performance after repeated punctures with 19, 20, and 22 Gauge needles, maintaining integrity and preventing leakage, in accordance with FDA guidance. | |
| Port leak testing (air method) | No air leakage when tested with the specified air method. | No air leakage was detected during port leak testing using the air method, in accordance with FDA guidance. | |
| Clearance (fluids dynamic test) | Adequate internal fluid flow characteristics. | The device demonstrated satisfactory fluid dynamic clearance, in accordance with FDA guidance. | |
| Radioopacity determination | Sufficient radioopacity for clear visualization under X-ray. | The device exhibited sufficient radioopacity, allowing for clear visualization under X-ray. The markers of POLYSITE Pressure Injectable are visible under X-ray and visible light. | |
| Evaluation of magnetic field interactions, heating and artifacts at 3 Tesla | Minimal magnetic field interaction, heating, and artifacts at 3 Tesla MRI. | The device demonstrated acceptable performance with minimal magnetic field interactions, heating, and artifacts when evaluated at 3 Tesla. | |
| High pressure injection simulation | Ability to withstand specified high-pressure injections without failure (for PI references). | The POLYSITE Pressure Injectable references successfully withstood high-pressure injection simulations without failure. | |
| Static burst test | Withstand a specified amount of internal pressure without bursting. | The device passed the static burst test, demonstrating its ability to withstand the specified internal pressure. | |
| Contrast media injection limits | Maintain integrity and functionality within specified contrast media injection limits (for PI references). | The POLYSITE Pressure Injectable references performed effectively within the specified contrast media injection limits, with the maximum flow rate not exceeding 5 mL/s. | |
| Catheter tensile strength | Exhibit sufficient tensile strength to prevent breakage under physiological and clinical forces. | The catheter demonstrated adequate tensile strength. | |
| Maximum flow rate | Achieve and maintain specified maximum flow rates (for PI references during high-pressure injection). The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 mL/s. | The POLYSITE Pressure Injectable references achieved and maintained the specified maximum flow rates, within the 5 mL/s limit for power injector equipment. | |
| Absence of septum leak after 19 Gauge needle punctures | No leakage after a specified number of punctures with a 19 Gauge needle. | The septum showed no leakage after repeated punctures with a 19 Gauge needle. | |
| Coring absence | No evidence of coring (material shearing) upon needle insertion. | No coring was observed during needle insertion tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The information provided specifies that "Performance data included with this submission" consisted of Biocompatibility testing according to ISO 10993-1: 2009 and Safety and functionality testing "in accordance with the FDA's 'Guidance on 510(k) Submissions for Implanted Infusion Ports' dated October 1990." These are laboratory/bench tests, not studies with human subjects. Therefore, the concept of a "test set" in the context of clinical data, or data provenance (country of origin, retrospective/prospective clinical data) and human sample size, is not applicable here. The data provenance would be the testing laboratories in France where Perouse Medical performed these in vitro and bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable since no clinical studies involving expert interpretation of data or ground truth establishment from patient cases were conducted or required. The "ground truth" for the performance data comes from the objective results of the specified physical and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there was no clinical test set requiring expert adjudication.
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 such study was done. The device is a physical medical device (implantable infusion port), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance was established through:
- Standardized laboratory protocols and measurements for physical and mechanical properties (e.g., leak testing, tensile strength, flow rate).
- Internationally recognized biocompatibility standards (ISO 10993-1: 2009) for biological safety.
- FDA guidance documents for specific performance testing related to implanted infusion ports.
8. The sample size for the training set
This is not applicable as there was no "training set" in the context of an algorithm or machine learning. The device design and testing are based on engineering principles and regulatory standards.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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.