(378 days)
The device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.
The WPT Water purification System has been developed around the Osmonics 23G Reverse Osmosis machine and the use of deionizer exchange tanks to demineralize the feed water. The feed water passes through three separate stages in the purification process before the required quality of product water is achieved. These stages are referred to as: Pre-treatment using a Water Softener to remove scale forming minerals, a Multi-media Filter and Pre-Filter to remove suspended particulate solids and Activated Carbon Filters to remove organics e.g. chlorines and chloramines. Primary Treatment using a Reverse Osmosis (RO) Machine and/or Mixed Bed Deionizers (DI), both of which have already been approved by the FDA, to demineralize the water. Post Treatment using Mixed Bed Deionizers (DI), Ultraviolet Disinfection (UV) and a Submicron Post Filter to remove suspended solids and bacteria from product water prior to distribution to the point of use.
The provided document is a 510(k) summary for a Water Purification System intended for hemodialysis. It describes the device, its intended use, and its technological characteristics by comparing it to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a medical diagnostic AI device would.
The document explicitly states:
- Non-clinical tests: "Following the installation of the Water Purification System a sample of the product water, produced by the system, is taken and analyzed by an independent laboratory to determine the level of contaminants present in the water. These laboratory results are compared with the maximum permitted level for each contaminant in order to determine that the water produced by the system meets the customers requirements for purified water."
- Clinical tests: "There are no clinical tests submitted, referenced or relied upon in this submission."
Therefore, I cannot extract the requested information regarding acceptance criteria and performance study details that are typically associated with AI-based medical devices or comparative effectiveness studies. The device is a physical water purification system, not an AI or diagnostic algorithm, and its "performance" is assessed by laboratory water quality analysis against established contaminant levels, not through metrics like sensitivity, specificity, or reader studies.
If you are looking for an example of a device that would contain the information you are requesting in its 510(k) submission, it would typically be a diagnostic imaging AI algorithm or a similar software-as-a-medical-device (SaMD).
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.