(27 days)
The NeoGen One device is indicated for patients who would benefit from a suction device, particularly as the use of that device may promote wound healing. This includes patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under influence of continuous and/or alternating vacuum pressure. This device is restricted to sale by, or on the order of, a physician or licensed practitioner.
NeoGen One. Closed Wound Drain System Part Number: NG9900
The provided text is a 510(k) premarket notification letter from the FDA regarding the NeoGen One. Closed Wound Drain System. This type of document primarily confirms that a new device is "substantially equivalent" to legally marketed predicate devices and does not typically contain detailed information about the acceptance criteria or a comprehensive study proving the device meets those criteria, as one would expect for an AI/ML device.
The document states:
- Trade/Device Name: NeoGen One. Closed Wound Drain System Part Number: NG9900
- Regulation Number: 21 CFR 878.4780
- Regulation Name: Powered Suction Pump
- Regulatory Class: II
- Product Code: OMP
- Intended Use: "The NeoGen One device is indicated for patients who would benefit from a suction device, particularly as the use of that device may promote wound healing. This includes patients who would benefit from vacuum-assisted drainage and removal of infectious material or other fluids from wounds under influence of continuous and/or alternating vacuum pressure. This device is restricted to sale by, or on the order of, a physician or licensed practitioner."
Given this, I cannot provide the specific details requested in the bullet points. This device is a powered suction pump, not an AI/ML diagnostic device, and therefore the concepts of "acceptance criteria" and "studies" in the context of AI performance (like sensitivity, specificity, human reader improvement, ground truth establishment for AI models, training sets, etc.) do not apply to this document.
The "substantial equivalence" determination means the FDA reviewed the device information submitted by the manufacturer (likely including performance data, but not in the detailed format requested for AI studies) and concluded it is as safe and effective as a legally marketed predicate device. The letter itself does not contain the study details that would typically be found in an AI/ML device submission summary.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.