(119 days)
The SmartPort CT Port Access System is indicated for any adult patient requiring repeated access of the vascular system or other selected body site, for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.
The SmartPort CT Series ports are also indicated for power injection of CT contrast media.
The SmartPort CT Series Port Access System is indicated for any pationt requiring repeated access of the vascular system for the delivery of medications, nutritional supplementation, fluids, blood, blood products, and the sampling of blood.
The SmartPort CT Series Port Access System is also indicated for power injection of contrast media at a maximum infusion rate of 3 ml/sec or 5 ml/sec when used with 20 Ga or 19 Ga power injectable infusion sets.
The SmartPort CT Series ports are Titanium or plastic, single or dual ports with a self sealing silicone rubber septum designed to maintain integrity after punctures with a noncoring needle. The port has a hollow area, or reservoir, under the septum through which fluid passes during infusion or aspiration.
The Vortex design features a proprietary reservoir with rounded walls giving it a toroidal shape. The outlet stem is located tangential to the reservoir wall allows fluid to pass between the reservoir and the catheter.
The SmartPort CT Series port systems offers models with catheters from 6.6FR to 12FR. The catheters contain radiopacifiers and have depth markings.
The provided text describes a 510(k) submission for the "SmartPort CT Series Port Access System," a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study in the same way a new drug or novel medical device might.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size and ground truth) are not applicable to this type of regulatory submission and are not present in the provided document.
The document primarily focuses on demonstrating equivalence to predicate devices through design comparison, intended use, and performance claims derived from the predicate devices or standard engineering tests.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial's primary or secondary endpoints. Instead, it highlights performance characteristics of the SmartPort CT Series Port Access System in comparison to predicate devices, particularly regarding power injection. The performance claims are typically based on engineering testing to demonstrate the device can withstand the specified pressures and flow rates for power injection.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Design) | Reported Device Performance (SmartPort CT Series Vortex Ports) |
|---|---|---|
| Intended Use: Power Injection | Maximum 3 ml/sec or 5 ml/sec injection rate of contrast dye injected at up to 300 psi (from predicates) | Maximum 3 ml/sec or 5 ml/sec injection rate of contrast dye injected at up to 300 psi |
| Pressure Withstand (Dynamic) | 300 PSI (from predicates K072375, K062414) | 300 PSI |
| Needles for Access | 19 or 20 Ga power injectable infusion set (from predicates K072375, K062414) | 19 or 20 Ga power injectable infusion set |
| Material (Port) | Titanium or Plastic (matches predicates) | Titanium or Plastic |
| Material (Catheter) | Polyurethane or Silicone (matches predicates) | Polyurethane or Silicone |
| Catheter Size | 6.6-12 FR (matches predicate K905841, K953529, etc.) | 6.6-12 FR |
| Septum Material | Silicone (matches all predicates) | Silicone |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes a 510(k) submission for substantial equivalence based on device design and performance specifications, not a clinical study with a "test set" of patients in the typical sense. Data provenance would be from engineering bench testing if performed, but specific details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical ground truth established by experts is mentioned for a test set.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is mentioned as it's not a clinical study.
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 device is a vascular access port, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For a device like this, "ground truth" would relate to its structural integrity, material compatibility, and ability to withstand specified pressures and flow rates, typically verified through engineering and biocompatibility testing, rather than clinical outcomes or pathology from a patient cohort for establishing "ground truth." The substantial equivalence is based on meeting the design and performance characteristics of predicate devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or associated ground truth establishment.
Summary of the Study/Evidence that Proves the Device Meets the (Implied) Acceptance Criteria:
The document leverages the Substantial Equivalence (SE) pathway for Class II medical devices. The primary "study" is the comparison to legally marketed predicate devices and the assertion that the SmartPort CT Series Port Access System is as safe and effective as those predicates.
- Comparison of Technical Characteristics: The bulk of the justification is presented in the "Device comparison table" (Page 2). This table directly compares the new device's features (intended use for power injection, design, materials, catheter size, shape, septum material, pressure withstand, needles used) to several AngioDynamics SmartPort CT models (K072375, K062414) and Horizon Medical Vortex Ports (K905841, K953529, K010189, K032557).
- Performance Claims based on Predicates: The ability to withstand 300 PSI and allow 3 ml/sec or 5 ml/sec injection rates of contrast media is directly aligned with the performance of the cited AngioDynamics SmartPort CT predicate devices. The assumption is that if the design and materials are equivalent, and the manufacturing process is controlled (Good Manufacturing Practices, GMP), then the performance will also be equivalent.
- Non-Clinical Bench Testing (Implied): While not detailed in this summary, a 510(k) submission for a device like this would typically include non-clinical (bench) testing results to demonstrate that the device physically meets these performance claims (e.g., pressure resistance, flow rates, septum resealability, material compatibility, sterilization efficacy). These tests are performed to show that the device performs as intended and is equivalent to the predicate in these specific aspects. The claim of "300 PSI" pressure withstand and "3 ml/sec or 5 ml/sec" injection rates implicitly refers to the successful completion of such engineering tests.
- Biocompatibility Testing (Implied): As an implanted device, biocompatibility testing (not detailed here but required for 510(k) submissions) would also be conducted to ensure the materials are safe for human contact.
In essence, the "study" is the comprehensive technical comparison and the regulatory assertion of substantial equivalence, supported by implied bench testing, rather than a clinical trial with patient-specific outcome data.
§ 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.