(151 days)
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.
§ 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.