(202 days)
The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pre-treatment and post-treatment.
Aqua Pure's D.I. Exchange Tanks for Dialysis are FRP tanks filled with mixed bed resin. Widget 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 D.I. exchange tanks are based on the Ameriwater Dialysis Deionizer Exchange Tanks K991519.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aqua Pure D.I. Exchange Tanks for Dialysis (K072158).
Summary of Findings:
The provided 510(k) relies on substantial equivalence to a predicate device (Ameriwater Dialysis Deionizer Exchange Tanks, K991519) rather than a direct performance study with acceptance criteria. This means the device is deemed acceptable because it is designed to be functionally identical to a previously approved device. Therefore, a traditional "study proving the device meets acceptance criteria" as might be seen for a novel device with new performance claims, is not present.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Tanks, resin, alarm, tubing, connectors, heads, fill plugs, standpipe, and distributor baskets are the same as the predicate device. | All components (Tank type and manufacturer, Resin type and manufacturer, Audio alarm type, Interconnecting tubing, Connectors, Heads and fill plugs, Stand pipe and distributor baskets) are identical to the predicate device, K991519. Both use FRP tanks from Park International, MBD-10 Resin from ResinTech, Resi-Lite 1 megohm audio/visual alarm, high purity PVC tubing, Widget connectors of glass-filled Noryl, PVC schedule 80 machined heads with fill plugs, and PVC schedule standpipe and distributor baskets. |
| Indications for Use Equivalence: Intended to supply dialysis grade water according to AAMI standards (RD 62), for use in dialysis, concentrate preparation systems, dialyzer reuse systems, and rinsing sterilants. Can be used for primary or emergency backup water purification as part of a complete water treatment system. | The device's "Indications for Use" are identical to those of the predicate device, specified as being used "according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants." It also notes it can be used for primary or emergency backup and must be part of a complete water treatment system. |
| Fundamental Scientific Technologies Equivalence: No alteration of fundamental scientific technologies from the predicate device. | The submission explicitly states the device has "not altered the fundamental scientific technologies or materials used in the predicate device." |
Study Details (As Per 510(k) Substantial Equivalence Process):
Since this is a substantial equivalence submission, the "study" is effectively a comparative analysis against the predicate, not a performance study in the typical sense.
- Sample size used for the test set and the data provenance: Not applicable. There was no "test set" of performance data in the traditional sense, as the claim is based on identical design and materials to a device already deemed safe and effective. The provenance is the design specifications of the new device compared to the predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance was not established via expert review of a test set. Equivalence was established by comparing design specifications and indications for use.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (water purification tanks), not an AI diagnostic or assistance tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used: The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (Ameriwater Dialysis Deionizer Exchange Tanks, K991519), based on its design, materials, and intended use as assessed by the FDA. The submission demonstrates that the new device shares this "ground truth" by being substantively the same.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The Aqua Pure D.I. Exchange Tanks for Dialysis gained 510(k) clearance by demonstrating substantial equivalence to a legally marketed predicate device. This means the FDA determined that the new device has the same intended use and the same technological characteristics (or different characteristics that do not raise new questions of safety and effectiveness) as the predicate device. Therefore, no new performance studies, clinical trials, or expert adjudications were required from the applicant to prove that the device meets specific performance acceptance criteria. The "study" was a detailed comparison of its components, materials, and intended use against the predicate device, which the FDA found to be sufficiently similar to allow market entry.
§ 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.