(207 days)
The DiPure Deionization Tanks are exchangeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.
The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.
DiPure's DI Exchange Tanks for Dialysis are approved tanks filled with mixed bed resin. Connectors are used in conjunction with a machined PVC schedule 80 head, stand pipe, fill port, and distributor basket. Our tanks are designed to supply AAMI standard water for dialysis through ion exchange. The DI exchange tanks are based on the Ameriwater Dialysis Deionizer Exchange Tanks.
DiPure's Carbon Exchange Tanks for Dialysis are approved tanks filled with activated carbon. Connectors are used in conjunction with a machined PVC schedule 80 head, stand pipe, fill port, and distributor basket. These tanks are designed to remove chlorine and chloramines. These tanks are based on the Ameriwater Carbon Exchange Tanks.
The provided document is a 510(k) summary for "Carbon and DI Exchange Tanks for Hemodialysis," which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device (AmeriWater Dialysis Deionizer and Carbon Exchange Tanks, K991519) rather than presenting a study with acceptance criteria and performance data for a novel device.
Therefore, the requested information elements related to device performance studies (acceptance criteria table, sample size, expert ground truth, adjudication, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission as presented in the provided text.
The document asserts substantial equivalence based on the following comparisons:
- Indications for Use: Both DiPure and AmeriWater tanks are intended to remove ions (deionization tanks) or chlorine and chloramines (carbon exchange tanks) from water to allow safe treatment of hemodialysis patients, and are part of a larger water treatment system.
- Technological Characteristics:
- Deionization tanks: Both utilize mixed bed resins (cation and anion), and use NSF and/or FDA approved parts/materials.
- Carbon exchange tanks: Both utilize activated carbon with an iodine number of 900 or greater, use NSF and/or FDA approved materials, and recommend dual filters in series with pre-shift chlorine/chloramine checks.
- Conclusion: The submission concludes that "the DiPure water purification components and the AmeriWater predicate device components are substantially equivalent to one another. The core water purification components and technology are exactly the same."
Since this is a substantial equivalence claim for water purification components, there is no clinical performance study with acceptance criteria and measured device performance in the traditional sense of a diagnostic or therapeutic medical device. The "performance" is implicitly deemed equivalent to the predicate device's established performance in providing AAMI standard water for dialysis.
§ 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.