Search Results

The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

The principles of operation and technology incorporated in the Big Bag 3000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion of fluids.

The provided text is a 510(k) summary for the Byron Medical Big Bag 3000 Pressure Infusor, which is a device used for general surgical fluid irrigation and infiltration. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed study results as one might find for a novel or entirely new class of medical device.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth used for performance validation.
• Sample size for the training set or how ground truth for the training set was established.

Explanation of document content:

The core of this 510(k) submission is to establish that the Big Bag 3000 Pressure Infusor is "substantially equivalent" to legally marketed predicate devices. This means that its fundamental technology, principles of operation, and indications for use are similar enough to existing devices that it does not raise new questions of safety or effectiveness.

The document explicitly states:

• "The principles of operation and technology incorporated in the Big Bag 3000 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid for infusion of fluids." (Page 1)
• "The principles of operation and technology Substantial Equivalence Claim: incorporated in the Byron Medical Big Bag 3000 are similar to other irrigation devices with the function to pressurizing bags of fluid which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below." (Page 1)

It then lists several predicate devices (e.g., Medex. Inc. Pressure Infusor, Davol, Inc. Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer) with their 510(k) numbers and substantial equivalence dates. This is the primary "proof" provided – a comparison to devices already cleared by the FDA.

In summary, this document is a regulatory submission for substantial equivalence based on technological similarity to existing devices, not a detailed clinical or performance study with specific quantitative acceptance criteria.

Ask a specific question about this device