(132 days)
The devices are for use in patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec using media with a maximum viscosity of 11.8 cP.
The proposed device is exactly the same as the predicate devices.
The provided document describes a 510(k) premarket notification for the Cook Vascular, Inc. Vital-Port Vascular Access System Power Injectable Port. This submission aims to establish a safe and effective way to conduct power injection studies using the device, which was previously marketed without specific claims or instructions for this procedure. The current submission focuses on demonstrating the device's suitability for power injectable diagnostic techniques using contrast media.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Parameters for Power Injection) | Reported Device Performance (Tested Limits) |
|---|---|
| Maximum recommended infusion rate | 5 mL/sec |
| Maximum contrast media viscosity | 11.8 cP |
| Maximum pressure limit | 325 psi |
| Catheter length for testing | > 70 cm |
| Catheter length in assumed implanted range | 20 cm - 50 cm |
| Contrast media pre-heating (clinical context) | Could reduce viscosity by nearly half (e.g., to 4.9 cP) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the numerical sample size for the "test set" in terms of how many individual devices were tested. It refers to "the flowing tests" implying multiple instances or scenarios were subjected to testing.
The data provenance is from Cook Vascular, Inc., a company based in Vandergrift, PA, USA. The tests described are prospective (laboratory testing performed for the purpose of this submission) and are likely simulated rather than using human or animal subjects, as they focus on physical performance under specific conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable in this context. The "ground truth" for this medical device submission is the physical performance and safety characteristics of the device under specific mechanical stress and fluid flow conditions. It's established through engineering tests, not through expert clinical consensus or interpretation of observational data. The tests are designed to measure objective physical properties of the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations of clinical data or images. Since the "test set" involves laboratory-based engineering parameter testing (e.g., flow rates, pressure limits, burst tests), there is no need for such adjudication. The results are objective measurements.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI algorithms where human interpretation is involved. The Cook Vascular, Inc. Vital-Port is a physical vascular access system, not an imaging device or an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is not an algorithm or an AI system. Its performance is entirely mechanical and physical.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance related to power injection is established through physical and mechanical engineering tests. These tests evaluate:
- Dynamic Failure Flow Test: Measures flow characteristics and potential failure modes under dynamic conditions.
- Instantaneous Burst Test: Assesses the device's ability to withstand sudden, high-pressure events.
- Static Burst Test: Determines the maximum pressure the device can tolerate under prolonged static conditions.
- Puncture Life Test: Evaluates the number of times the septum can be punctured before degradation or failure.
- Cyclic Test: Assesses durability under repeated stress cycles.
- Life Cycle Power Injection Test: Simulates repeated power injection procedures to evaluate long-term performance and integrity.
The "ground truth" for the operational parameters (5 mL/sec, 11.8 cP, 325 psi) is derived directly from the results of these tests, confirming that the device can safely tolerate these conditions.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI or machine learning model. The device's performance is determined by its physical design and materials, which are verified through direct testing, not through training data.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of 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.