(259 days)
The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing adequate pretreatment and post-treatment in accordance with current AAMI standards. The exchange tanks are not intended to be used alone. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.
MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new virgin coal based granular activated carbon (GAC). The carbon media removes chlorine, chloramines, and other organics from the source water through the chemical process of adsorption. Only new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater is used in the exchange tanks.The tank sizes are range from 6" x 18" through 16" x 65" common for the dialysis industry. The Carbon Exchange Tanks are dedicated for carbon only. MED-TECH Water Systems Inc. recommends that tanks be installed in worker/polisher configuration with the first tank providing the primary purification and the second tank serving as a polisher and back-up to the primary purification.
The provided text describes a 510(k) premarket notification for MED-TECH Water Systems Inc.'s Exchangeable Carbon Tanks for Dialysis. This document is a regulatory submission for a medical device and therefore does not contain information about the acceptance criteria or a study proving device performance in the context of an AI/ML powered device.
The document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (K944493 G.E.M. Water Systems REVERSE OSMOSIS SYSTEM) rather than presenting a performance study against specific acceptance criteria for a novel AI/ML algorithm.
Here's why the requested information cannot be extracted from this document:
- Device Type: The device described is physical hardware (carbon tanks) for water purification, not an AI/ML software device.
- Regulatory Pathway: The 510(k) pathway involves demonstrating substantial equivalence, which primarily relies on comparing the new device's technological characteristics and intended use to a predicate device. It typically does not require extensive clinical trials or performance studies with acceptance criteria in the way an AI/ML device would.
- "Nonclinical tests": The document mentions "Nonclinical tests were conducted on product water from a replicated exchange tank configuration. Results verify that the device produces endpoints that comply with current AAMI standards for carbon adsorption." However, it does not provide details of these tests, specific acceptance criteria, sample sizes, or ground truth establishment relevant to an AI/ML context. It broadly states compliance with AAMI standards for carbon adsorption, which are likely physical/chemical performance standards, not diagnostic accuracy metrics.
Therefore, I cannot provide the requested table and study details as they are not present in the provided document.
If you have a document describing an AI/ML device, please provide that, and I will be able to answer your questions.
§ 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.