(58 days)
The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port" reservoirs for use in patient therapy requiring long-term vascular access for infusion therapy sampling sampling.
The Mini Polyurethane Catheter is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the Mini Polyurethane Catheter are identical to those used in predicate Vital-Port® system catheters. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing.
This document, a 510(k) Premarket Notification for a Mini Polyurethane Catheter, is a regulatory submission for a medical device and describes its intended use and similarity to existing devices. It is a not a study that proves the device meets acceptance criteria but rather a notification of intent to market based on substantial equivalence. Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable or cannot be extracted from this document.
Here's the breakdown of why and what information can be inferred:
1. A table of acceptance criteria and the reported device performance
Not applicable. This document does not describe specific acceptance criteria or performance data from a study. It focuses on demonstrating substantial equivalence to a predicate device.
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. No test set or data provenance is mentioned as part of a performance study. The submission relies on the established history of the predicate device and the materials used.
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. There is no mention of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication is described.
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 physical medical catheter, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth for a performance study is not discussed. The "ground truth" for this regulatory submission is the established safety and efficacy of the predicate device and the biocompatibility of the materials.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device or a study involving data training.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of Extracted Information relevant to the prompt (though not fitting the direct questions due to the nature of the document):
- Device Name: Mini Polyurethane Catheter
- Intended Use: For use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
- Predicate Devices: Catheters supplied with Vital-Port® systems manufactured by COOK Vascular™ Incorporated.
- Reason for Substantial Equivalence Claim:
- Same intended use, design, and materials of construction as predicate catheters.
- Biocompatibility of materials is established by their history of use in medical product manufacturing.
- Will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to predicate devices.
- Regulatory Outcome: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing its 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.