(71 days)
The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce Closed Fluid Collection System. The Closed Fluid Collection System is used for acute and longterm abscess drainage, pleura drainage, and chest drainage.
The Closed Fluid Collection System is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
The provided text is a 510(k) summary for a Closed Fluid Collection System from 1996. It describes the device, its materials, and claims substantial equivalence to previously marketed devices. However, it does not contain information related to specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters you've requested (such as sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
Regulatory submissions for medical devices in 1996, especially for Class II devices claiming substantial equivalence, often focused on material compatibility and functional equivalence to predicate devices rather than elaborate clinical studies with defined performance metrics like those described in your prompt. The document primarily highlights:
- Substantial Equivalence: The device is equivalent in materials, form, and intended use to existing devices by Merit Medical and NAMIC.
- Safety and Effectiveness: "All finished products are tested and must meet all required release specifications before distribution." This includes "physical testing" and "visual examination." These are described as conforming to "product design specifications" and established "Quality Control Test Procedure documents."
Therefore, I cannot populate the requested table or answer the specific questions because the necessary information is not present in the provided text. The document describes a manufacturing quality control process rather than a study designed to demonstrate performance against specific, quantifiable acceptance criteria in a clinical or simulated clinical setting.
§ 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.