(234 days)
The Vital-Port® Infusion Pal™ is intended to facilitate locating and stabilizing the port body for accessing the portal septum of a Vital-Port® Vascular Access System.
The Vital-Port® Infusion Pal™ is an open-ringed plastic disk that is intended to facilitate locating and stabilizing the port body for accessing Vital-Port® Vascular Access Systems. The Vital-Port® Infusion Pal™ is placed on the skin surface on the area overlying the port septum. The device is supplied sterile and intended for onetime use.
This K971140 submission describes a simple, non-active medical device (Vital-Port® Infusion Pal™). For such devices, acceptance criteria and detailed study data in the format requested (especially regarding AI/ML performance, ground truth, expert consensus, and MRMC studies) are typically not included as they are irrelevant to the device's function and regulatory review. The review focuses on substantial equivalence to predicate devices based on technological characteristics and intended use.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain explicit performance acceptance criteria or reported device performance in a quantitative manner as would be expected for a complex diagnostic or therapeutic device. For a simple device like the Vital-Port® Infusion Pal™, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to existing predicate devices based on intended use and technological characteristics, and by adhering to general controls (manufacturing, labeling, etc.).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit: Substantial Equivalence to Predicate Devices (Vein Stabilizers) regarding: | The device is "similar to predicate vein stabilizers that are currently marketed in terms of technological characteristics and the same intended use of facilitating location and stabilization for vessel access." |
| - Intended Use | "Used with totally implantable vascular access systems for indirect vessel access." (Same as predicate) |
| - Technological Characteristics | "open-ringed plastic disk that is intended to facilitate locating and stabilizing the port body" (Similar function to predicate vein stabilizers) |
| - Manufacturing Process Adherence | "will be manufactured according to specified process controls and a Quality Assurance Program, undergoing manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Cook Vascular Incorporated." |
| - Sterility | "The device is supplied sterile and intended for one-time use." (Implies meeting sterility standards) |
Notes on the absence of typical AI/ML study information:
The Vital-Port® Infusion Pal™ is a physical, non-active medical device (a locating ring/port stabilizer). Therefore, the following are not applicable and are not found in the 510(k) submission:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (Demonstration of Substantial Equivalence):
The "study" in this context is the 510(k) Pre-Market Notification process itself, which focuses on demonstrating substantial equivalence (SE) to a legally marketed predicate device.
- Device Name: Vital-Port® Infusion Pal™ (Locating Ring, Port Stabilizer)
- Predicate Device(s): "predicate vein stabilizers that are currently marketed"
- Basis for Substantial Equivalence:
- Identical Intended Use: "facilitating location and stabilization for vessel access."
- Similar Technological Characteristics: "open-ringed plastic disk" performing the same function.
- Similar Manufacturing and Quality Control: "manufactured according to specified process controls and a Quality Assurance Program, undergoing manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Cook Vascular Incorporated."
The FDA's letter (K971140) confirms that they "have determined the device is substantially equivalent" based on the information provided in the submission. This determination serves as the "proof" that the device meets the regulatory requirements for market entry.
§ 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.