(100 days)
Tava Surgical Instruments' L31 Series H.V. Pulse Lavage is intended to be utilized in the debridement of the surgical site during trauma cases, hip and knee arthroplasty cases and soft tissue surgery.
Tava Surgical Instruments' L31 H.V. Pulse Lavage is an ergonomically designed pneumatic instrument. The hatch of the cradle is raised in order to insert single-use sterile pump sets which isolates the sterile fluids from the instrument. Activation of the instrument causes engagement of the pump set and pulsates the sterile fluids into the surgical site to remove blood and debris.
The provided document is a 510(k) Summary for a medical device called the "Tava Surgical Instruments L31 H.V. Pulse Lavage." This document is a premarket notification to the FDA asserting substantial equivalence to a predicate device. It is not a detailed scientific study report demonstrating performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC) cannot be found within this document.
Explanation:
The 510(k) submission process is primarily about demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its independent safety and effectiveness through a comprehensive study with specific acceptance criteria. The document focuses on:
- Device Description: What the device is and how it works.
- Comparison to Predicate Device: How it is similar in design, materials, and intended use to an existing device (MicroAire® Hi Speed Pulse Lavage 4740).
- Intended Use: The medical procedures for which it is designed.
- Safety and Effectiveness Claim: A general statement that it is as safe and effective as the predicate device, implicitly relying on the predicate's established performance.
There are no performance metrics, acceptance criteria, or details of a study with specific methodologies (like sample size, ground truth, expert review, or MRMC) presented in this 510(k) Summary.
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.