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The line of APS Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patient with acute or chronic renal failure. The APS Series Dialyzers are intended for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. This is the same intended use as the predicate device - APS Series Dialyzers cleared under K001250.

• APS Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
• APS Series Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
• APS Series Dialyzers have been tested in vitro and in confirmatory clinical studies under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi APS Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi APS Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly:
  • The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instruction for use and the instruction of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
  • The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin ® (peroxyacetic acid) in conjunction with the Renatron ® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.
  • The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer.
  • The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

The line of Asahi Polysulfone (APS) Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. The Asahi APS Series Dialyzers are designed for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. They are constructed of reusable, hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene butadiene block polymer and are gamma sterilized prior to shipment.

The Asahi APS Series Dialyzers are offered for sale in both a "wet" and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference.

Modifications made to the Asahi APS Series Dialyzers subject of this 510(k) include (1) labeling revised to provide additional information concerning pre-cleaning; (2) modification of the dialyzer housing to diffuse the flow water used in pre-cleaning; and, (3) modification of the shipping carton partition materials and mold.

The acceptance criteria and study information is not available in the provided text. The document refers to "design verification tests" and "risk analysis" that "proved that those modifications to be appropriate" and that "All test results meet the acceptance criteria", but it does not specify what those criteria are or provide details about the study methodology, sample sizes, or ground truth establishment.

Here's a breakdown of what is mentioned concerning acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated. The document only mentions that "All test results meet the acceptance criteria."
• Reported Device Performance: Not explicitly detailed in numerical or quantitative terms in the provided text regarding specific tests. It generally states that the modified devices are "substantially equivalent in intended use, design, principle of operation/technology, materials, specifications and performance to the original APS Series Dialyzers."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• This information is not provided in the text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not provided in the text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not provided in the text.

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:

• This is a medical device (dialyzer), not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• This is a medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• This information is not provided in the text. The document mentions "confirmatory clinical studies" in the Indications for Use, but these relate to reuse conditions, not device performance against a specific ground truth as would be relevant for a diagnostic device.

8. The sample size for the training set:

• This information is not provided in the text. (This would be relevant for AI/ML devices, which this is not.)

9. How the ground truth for the training set was established:

• This information is not provided in the text. (This would be relevant for AI/ML devices, which this is not.)

Summary of what is mentioned regarding the study:

• Study Type: "Design verification tests based on the result of risk analysis" and "confirmatory clinical studies" (related to reuse conditions).
• Methodology Basis: Risk analysis using procedures based on ISO 14971 (2000) Medical Devices -- Application of Risk Management to Medical Devices, specifically Failure Modes and Effects Analysis (FMEA).
• Outcome: All test results met acceptance criteria (unspecified), and proved that modifications made the device "substantially equivalent" to the predicate device. The clinical studies mentioned relate to in-vitro and in-vivo testing for single use and reuse conditions up to 15 cycles.

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