(36 days)
The C-Port™ "Power Injectable" Port (family of products) will be used as a subcutaneously implanted device where repeated access to the vascular system is the therapy of choice for delivery of medications, fluids, special fluids such as contrast enhancement fluids or for withdrawal of blood.
When used with a power injectable needle infusion set, the C-Port™ "Power Injectable" Port is indicated for power injection of contrast media using an 8.0Fr or 9.6Fr catheter. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle or 2 ml/s with a 22 gauge non-coring power injectable needle.
For CT diagnostic procedures, it is recommended that the number of CT "power injections" be limited to a maximum number of ten (10) accesses over the life of the device.
The device has a port that is a titanium chamber with a silicone membrane for insertion. The port comes in a standard size to enable use with adult patients. A standard profile is preferable so the chamber enable use with adult pationis. Treatment to a catheter that is long enough to insert into the vena cava for positioning to enable fluid infusion into the heart and insert into the rena catheter is fixed to the port with a catheter lock during a larger vossels. The catheter has a senes of radiopaque marks procodire to ith determination when the catheter is inserted into the vena cava. to enable depth dolorhination whole can be cant insertion, and port implantation for A kit is provided to all hirea "sterile, single use". For product supplied as OEM bulk, non-sterile, the product is vacuum-packaged in a double bag format and built, non blonio, the prelabeler to kit and sterilize). Items such as syringes, vein introducers, trocars, guide wires, sheaths, fixation hubs, Huber needles, and infusion sets may be part of a total kit intended for sterilization.
The provided text describes a 510(k) premarket notification for a medical device, the PHS Medical GmbH C-PortHP "Power Injectable" Port. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies with detailed performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not explicitly present in this type of regulatory document. The 510(k) summary primarily outlines the device description, indications for use, and a claim of substantial equivalence.
However, I can extract information related to the device's functional specifications and safety, which serve as an indirect form of "acceptance criteria" through the lens of equivalence to predicate devices, and the general "study" or testing approach implied by such submissions.
Here's a breakdown of the available information and an explanation of why other requested details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or reader improvement are not typically reported in this summary. Instead, the "performance" for a 510(k) is primarily demonstrating that the device functions as intended and is safe, similar to legally marketed predicate devices.
The "acceptance criteria" here are implied by the performance specifications for power injection:
| Acceptance Criteria (Implied from Intended Use) | Reported Device Performance |
|---|---|
| Maximum Infusion Rate (19 or 20 gauge needle) | 5 ml/s |
| Maximum Infusion Rate (22 gauge needle) | 2 ml/s |
| Catheter Size Compatibility | 8.0Fr or 9.6Fr catheter |
| Limitation on CT Power Injections | Max. 10 accesses over device life (for CT diagnostic procedures) |
| Sterility | Sterile, single-use |
| Biocompatibility | (Implied by materials like titanium and silicone, and equivalence to predicates) |
| Mechanical Integrity (e.g., pressure resistance) | (Implied by "power injectable" function and equivalence to predicates; specific values not in summary) |
Study Details:
The 510(k) summary does not describe a specific clinical study with a defined test set, ground truth, or statistical analysis of performance in the way a clinical trial for a novel device would. Instead, the "study" for a 510(k) involves demonstrating equivalence through:
- Comparison to Predicate Devices: The primary "study" is a comparison to existing, legally marketed devices (C-Port #K030636, Bard Access Systems PowerPort #K060812, MEDCOMP ProFUSET #K070003). This usually involves non-clinical testing (e.g., in-vitro bench testing for flow rates, pressure limits, material compatibility) and sometimes a review of literature or existing data for the predicate devices.
- Engineering and Bench Testing: The claims of "power injectability" at specific rates imply that rigorous bench testing was performed to validate these flow rates and pressure tolerances for the device and its compatibility with specified needle gauges and catheter sizes. These tests would demonstrate the device's ability to withstand the forces associated with power injection.
- Material Compatibility: The use of materials like titanium and silicone membrane implies biocompatibility testing or documentation was performed, likely citing existing data for these common medical device materials.
- Sterilization Validation: The summary mentions that "Sterilization details for validation, verification, bioburden, by can be found in the section on Risk Assessment (7.0) and Sterilization (8.0)". This indicates a comprehensive process for ensuring the device is sterile.
Missing Information (and why):
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a 510(k) of this nature. No "test set" of patient data is described. Performance is primarily established through non-clinical bench testing and comparison to predicates.
- 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): Not applicable. This device does not involve image interpretation or diagnostic performance in a way that would require expert ground truth.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI/diagnostic imaging device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the traditional sense. The "ground truth" for a power-injectable port involves objective physical measurements (flow rates, pressure limits, material properties, sterility) obtained through engineering and laboratory testing, rather than clinical outcomes or expert diagnoses.
- 8. The sample size for the training set: Not applicable. This isn't a machine learning model.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.