(88 days)
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.
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.