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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.

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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.

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.

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Carbon Filters and Water Softeners 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 components utilize no new water purification techniques, carbon filtration and water softening. The predicate device system we are claiming SE to, utilizes the exact same water purification principles. The following is a comparison summary of the BJJ&A water treatment components and the predicate device.

BJJ&A and U.S. Filter both utilize a water softener made of materials, which are "NSF" and/or FDA approved. U.S. Filters' softener is installed with a single regeneration tank and electrically interlocked to shut down the RO unit operation during the softener regeneration cycle. BJJ&A softeners are installed in a single regeneration tank configuration such as USF or in a duplex-twin alternating fashion to provide softened water to the system 24 hours a day. While one regeneration tank is in a regeneration cycle the other regeneration tank is on line providing soft water to the system. This will prevent the possibility of softener regeneration or a salt dump into the water purification system during a patient shift. This also eliminates the need to shut down the RO unit for softener regeneration.

Carbon filtration is utilized by both BJJ&A and U.S. Filter 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 filters in a series configuration with test ports installed after each filter. 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 chloramine removal. Both BJJ&A and U.S. Filter recommended the chlorine and chloramine levels be checked before each patient shift. Hard plumbed bypass piping of the carbon tanks is not allowed on either component. Both components will utilize an activated carbon with an Iodine number of 900 or greater. Both BJJ&A and U.S. Filter uses in line carbon regeneration filters. U.S. Filter uses a single carbon filter in its single patient dialysis system. BIJ&A always uses a dual carbon filter in series in every dialysis water system installed, including single patient systems.

BJJ&A and U.S. Filter incorporate emergency equipment bypass lines and valving that are clearly labeled and tagged. Instructions for usage will be included with the water components and staff in-service will be provided to the clinic/customer by BJJ&A. The use of dead legged bypass piping will be avoided. Carbon filters will not have hard plumbed bypass lines. U.S. Filter emergency equipment bypass utilizes a dry bypass technique. This method uses breakable unions and isolation valves at the end of each bypass line so that stagnant water will not be present in the line in the event of an emergency bypass condition. BJJ&A emergency equipment bypass is a wt bypass method. In this method the bypass valve is installed with no more than one half pipe a diameter length in this methou the bypass valve to avoid water stagnation. The use of dead leg bypass piping is unacceptable.

BJJ&A water distribution piping will be configured with no dead legs longer than 6 pipe diameters. U.S. Filter installs sanitization/sanitant introduction valve(s) or introduction port must be incorporated to allow chemical injection of sanitants to allow sanitization of the RO must be incorporated to anow chemical injoined in connections or through the top of the storage system and storage and the the sites for sanitant introduction BJJ&A avoids having any additional deadleg bypass valving installed into the original piping system and this further avoids water stagnation.

I am sorry, but based on the provided document, I cannot answer the question as it pertains to acceptance criteria and performance study details. The document is a 510(k) Premarket Notification summary for "Water Purification Components for Hemodialysis".

The document primarily focuses on establishing substantial equivalence to a predicate device (U.S. Filter Water Purification System, K980182) by comparing device features and purification principles. It mentions that 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 discusses technical comparisons of water softeners and carbon filtration, including contact times and bypass methods.

However, it does not contain:

1. A table of acceptance criteria or reported device performance metrics.
2. Details about sample sizes for test sets, data provenance, or training sets.
3. Information about the number or qualifications of experts, ground truth establishment, or adjudication methods for any study.
4. Any mention of multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.

Therefore, since the document does not present the specific information requested about acceptance criteria and a study proving their fulfillment, I cannot extract this data.

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