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The Tubing Indications for use are general surgical fluid, exudate, rne Tubing me aspiration and general surgical fluid irrigation/infiltration.

The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery.

This document, K974295, describes a 510(k) submission for the Byron Medical Aspiration and Infiltration/Irrigation Tubing. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be gleaned from the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

Not Applicable. This 510(k) submission does not present specific acceptance criteria or performance data for the Byron Medical Tubing. Its primary goal is to establish "substantial equivalence" to existing, legally marketed devices. This means that instead of proving specific performance metrics, the device is asserted to be safe and effective because its operational principles, technology, and intended use are similar to predicate devices that have already been cleared by the FDA.

Study Details

Since this is a substantial equivalence claim, it does not involve the type of clinical or performance study you are asking about. Therefore, the following information is not provided in the document:

• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no test set requiring ground truth establishment.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
• 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 Substantial Equivalence Claim

The document explicitly states:

• Device Description: "The principles of operation and technology incorporated in the Tubing are equivalent to other standard surgical tubing that acts as a pathway between the operative site and either an aspiration or irrigation source for fluid or soft tissue removal and fluid delivery."
• Substantial Equivalence Claim: "The principles of operation and technology incorporated in the Tubing are similar to other tubing devices with the function to deliver fluids or remove soft tissue and general aspirate which the FDA has founded to be substantially equivalent to pre-amendment devices..."

The submission lists several predicate devices to which the Byron Medical Tubing claims substantial equivalence:

• VCI Suction and Irrigation Tubing Sets (Vital Concepts, K93482, 01 February 1994)
• Irrigation and Aspiration Tubing (ARMM. Inc., K923201, Substantial Equivalence Date: Unknown)
• Ackrad Fluid Connecting Set (Ackrad Laboratories, Inc., K820937, 26 April 1982)
• Disposable Tubing (Wells Johnson Company., 510(k) Number: Unknown, Substantial Equivalence Date: Unknown)

Conclusion:

This 510(k) submission for the Byron Medical Aspiration and Infiltration/Irrigation Tubing relies on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data against pre-defined acceptance criteria from a specific study. Therefore, the detailed information requested about study design, sample sizes, ground truth establishment, and expert involvement is not present in this document, as it is generally not required for this type of regulatory pathway.

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The wound drainage reservoir holder is to be used when the patent is using a Jackson-Pratt 100cc Suction Reservoir and would prefer to have the reservoir attached directly against his or her body instead of attaching it with a safety pin to one of the clothing garments they are wearing.

Wound Drainage Holder

The provided text is a 510(k) clearance letter from the FDA for a device called a "Wound Drainage Holder." This document does not contain any information regarding acceptance criteria, device performance, clinical study details, or ground truth establishment.

The letter primarily states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance requirements.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not on a study proving the device's efficacy or meeting specific acceptance criteria.

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Ask a specific question about this device