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The MASS TRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.

Single lumen catheter designed to access small, tortuous vasculature for the delivery of diagnostic, embolic, and therapeutic agents. The shaft tapers from 3.0F proximally to 2.8F distally. The catheter has a hydrophilic coating to provide lubrication for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices.

This document, K983003, is a 510(k) premarket notification for the "MASS TRANSIT Infusion Catheter." It describes the device and its intended use but does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) pathway, particularly for a device determined to be "substantially equivalent" to a predicate device, often relies on demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate. This typically involves performance bench testing to show that the device performs as intended and is as safe and effective as the predicate, rather than establishing new clinical effectiveness.

Therefore, I cannot fulfill your request for the following sections based on the provided document:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not present.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance: This is not an AI/software device; this type of study is not relevant here and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not an AI/software device; this type of study is not relevant here and is not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present.
8. The sample size for the training set: This is not an AI/software device; this information is not relevant here and is not mentioned.
9. How the ground truth for the training set was established: This is not an AI/software device; this information is not relevant here and is not mentioned.

Summary based on the provided document:

The provided document, K983003, focuses on demonstrating substantial equivalence of the "MASS TRANSIT Infusion Catheter" to a previously cleared predicate device. It details the device's description, intended use, and claims of biocompatibility and substantial equivalence. It does not describe specific acceptance criteria, performance studies against those criteria, or clinical trial data often associated with proving new device effectiveness. The FDA's letter confirms the determination of substantial equivalence based on the provided information, allowing the device to be marketed.

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