(92 days)
These Water Purification Devices are intended to be used as components of a water purification system to remove organic and inorganic substances from water that is used to dilute dialysis concentrate to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
The BJJ&A water purification component for hemodialysis will be used with a hemodialysis system. The Water purffication system will remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate, bicarbonate, acetate and sterilant for dialyzer reprocessing.
The purified water will also be used in the equipment disinfection process, equipment rinsing and any other application the clinic/customer deems appropriate. This system will meet all the requirements put forth by the United States Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and any other laws that may apply.
The BJJ&A water purfication components, both activated carbon filtration and deionization, utilize no new water purification techniques.
Deionization tanks from both BJJ&A and AmeriWater are utilized to remove dissolved solids from the water. Both utilize mixed bed resin, consisting of anion and cation resin, to remove the charged particles from the water. Both utilize parts and materials which are "NSF" and/or FDA approved.
Activated carbon filtration is utilized by both BJJ&A and AmeriWater to filter out chlorine and chloramines from the water. BJJ&A uses carbon filter made from materials, which are FDA or NSF approved. Both companies use two carbon fitters in a series configuration. A minimum total contact time of 10 empty bed contact time minutes are incorporated into both designs as recommended by the FDA for chlorine and chloramines removal. Both BJJ&A and AmeriWater recommended the chlorine and chloramine levels be checked before each patient shift. Both companies recommend hard plumbed bypass piping of the carbon tanks not be allowed on either component. Both components will utilize an activated carbon with an lodine number of 900 or greater. BJJ&A always recommends using a dual carbon filter in series in every dialysis water system installed, including single patient systems.
The provided text is a 510(k) Premarket Notification Summary for "Water Purification Components for Hemodialysis" (K060942) by Bob J. Johnson & Associates, Inc. (BJJ&A). It outlines the device's purpose and its asserted substantial equivalence to a predicate device.
Key takeaway regarding device acceptance criteria and study:
The submission explicitly states that BJJ&A is claiming substantial equivalence to an existing legally marketed predicate device (AmeriWater Company Purification System, K99159). This means that, for this specific type of regulatory submission (510(k)), the "acceptance criteria" are demonstrating that the new device is as safe and effective as the predicate device. The "study" proving this substantial equivalence is primarily a comparison of features and principles of operation, rather than a clinical trial with performance metrics.
Here's a breakdown based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission claiming substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating that the new device shares the same technological characteristics and principles of operation with a legally marketed predicate device, and does not raise new questions of safety or effectiveness.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance / Justification |
|---|---|
| Similar Intended Use | Both BJJ&A components and the predicate device (AmeriWater) are intended for water purification in hemodialysis systems to remove organic, inorganic substances, and microbial contaminants. |
| Similar Technological Characteristics | Deionization tanks: Both utilize mixed bed resin (anion and cation) to remove charged particles. Both use NSF and/or FDA approved parts/materials. |
| Activated carbon filtration: Both use carbon filters to remove chlorine and chloramines. Both use two carbon filters in a series configuration. Both incorporate a minimum total contact time of 10 empty bed contact time minutes. Both recommend checking chlorine/chloramine levels before each patient shift. Both advise against hard plumbed bypass piping. Both utilize activated carbon with an Iodine number of 900 or greater. | |
| Same Principles of Operation | The submission explicitly states: "The BJJ&A water purification components, both activated carbon filtration and deionization, utilize no new water purification techniques. The predicate device components we are claiming SE to, utilizes the exact same water purification principles." |
| Meet applicable standards (FDA, AAMI) | The system "will meet all the requirements put forth by the United States Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and any other laws that may apply." (This is a statement of intent for the overall system, which these components contribute to.) |
| No New Questions of Safety/Effectiveness | Implied by the comparison showing similar design, materials, and operation to a legally marketed device. |
2. Sample size used for the test set and the data provenance
- No "test set" in the traditional sense of a clinical or performance study. This 510(k) submission relies on a comparison to a predicate device.
- The "data provenance" would be the specifications and operational principles of the BJJ&A components and the predicate AmeriWater components, described in the summary. There is no mention of country of origin of data or whether it's retrospective/prospective, as it's not a data-driven performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" requiring expert consensus for ground truth establishment in this type of submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no "test set" and thus no need for an adjudication method.
5. 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 device is water purification components, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is water purification components, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this 510(k) submission is the established safety and efficacy of the legally marketed predicate device (AmeriWater K99159) as determined by the FDA's original clearance of that device. The manufacturer is asserting their new components are equivalent to these established standards.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI device.
In summary:
This 510(k) Premarket Notification primarily functions by showing that the BJJ&A water purification components are substantially equivalent to a predicate device (AmeriWater K99159) based on shared intended use, similar technological characteristics, and identical principles of operation. The "study" demonstrating this involves a detailed comparison of the BJJ&A components' design and function against the predicate device, rather than a clinical trial or performance study with a test set, experts, or ground truth in the manner typical for diagnostic or therapeutic devices.
§ 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.