(565 days)
Mar Cor Services, Inc., requests that it's Complete Water Treatment System for Kidney Dialysis be granted substantial equivalence to other water treatment systems currently on the market.
Mar Cor Services, Inc., has developed a complete water treatment system for kidney dialysis. This system is equivalent to such other commercial water treatment systems as the Water Pure RO System (K# 873487) and the C.D. Medical, Inc., Drake Willock RO Water Treatment System (K# 894106), and other comparable water treatment systems.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:
Unfortunately, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document is a summary of a 510(k) notification for a water treatment system for kidney dialysis. Its primary purpose is to declare the system's substantial equivalence to other commercially available systems. It's a regulatory submission document, not a clinical study report or a performance validation document in the way you're requesting.
Therefore, I cannot populate the table or answer the specific questions you've posed.
Here's what the document does tell us, and why it doesn't fit your request:
- Device: A complete water treatment system for kidney dialysis developed by Mar Cor Services, Inc.
- Purpose: To treat incoming water supply for use in kidney dialysis machines.
- Claim: The system is "equivalent to such other commercial water treatment systems" (Water Pure RO System (K# 873487) and C.D. Medical, Inc., Drake Willock RO Water Treatment System (K# 894106)).
- Context: This is a 510(k) notification, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.
To answer your request, I would need a document that describes:
- Specific performance metrics (e.g., water purity levels, filtration efficiency for specific contaminants, flow rates, bacterial load reduction).
- Quantitative targets for these metrics (the "acceptance criteria").
- A study design (e.g., experimental setup, duration, number of samples tested, testing methodology).
- Results from such a study that demonstrate the device meets or exceeds those targets.
Without that information, I cannot provide the details you've requested.
§ 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.