Search Results

The Vaxcel TM Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

The Vaxcel™ Port device is intended for use in patients who require long- term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal. The device is available in standard and mini port configurations made of either Titanium or Polysulfone materials.

Unfortunately, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as the provided text from K032375 does not contain any information about acceptance criteria or performance studies.

This document is a 510(k) premarket notification summary for a medical device (Vaxcel™ Low Profile Port-8F Non-Valved- Polysulfone). The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove the device meets specific performance criteria through new clinical or non-clinical studies.

Here's what the document does state, which explains why your requested information isn't present:

• "Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act": This explicitly states that there are no FDA-mandated performance standards that this device needs to meet.
• "Summary of Substantial Equivalence: The Vaxcel™ Port system have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.": This is the core of a 510(k) submission. The "study" here is a comparison to a predicate device (Vaxcel™ with PASV Port (K031844)), not an independent performance study against acceptance criteria. The claim is that it's "substantially equivalent," meaning it's as safe and effective as the predicate, which has already been cleared.
• "Biocompatibility: The Vaxcel™ Port system have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use.": This is the only type of "testing" mentioned, and it's for biocompatibility, not overall device performance against specific acceptance criteria.

Therefore, I cannot generate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not provided in the document. The 510(k) process for this device did not require such detailed performance studies as it relied on demonstrating equivalence to an existing device.

Ask a specific question about this device