(208 days)
Asahi AM-BIO Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-BIO Series Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient. Asahi AM-BIO 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 AM-BIO 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 AM-BIO 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: 1. 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 instructions for use and the instructions 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. 2. The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4" and DPS4"), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc. 3. The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer. 4. The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
The line of Asahi AM-BIO Series Dialyzers is a family of hemodialysis membranes, or hollow fiber dialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The device is intended for use in patients who have chronic renal failure or acute renal failure, for both single or initial use and when reprocessed for reuse for a maximum of 15 reprocessing reuse cycles on the same patient. The membrane fibers are made of modified cellulose (i.e., alkyl ether polymer grafted cellulose), derived from cuprammonium rayon. The cuprammonium rayon is manufactured to have a thin layer of modified cellulose exposed to blood contact surfaces. The modification to the cellulose yields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3, and C5,) when compared to regular cellulose membrane dialyzers. The membranes are housed within a plastic casing of styrene butadiene block polymer. Nonremovable casing end caps are also made of styrene butadiene block polymer. The potting material (sealant) is polyurethane and the port caps (stoppers) are made of hydrogenated styrene butadiene block polymer. The AM-BIO Series Dialyzers will be offered for sale in both a "wet" model and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models are 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. The fluid in wet dialyzers is made of water containing 600 ppm sodium pyrosulfite and 300 ppm sodium carbonate. All Asahi AM-BIO Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after it is accessed for the initial use.
Here's a breakdown of the acceptance criteria and the study details for the Asahi AM-BIO Series Dialyzers, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | All tested models showed acceptable biocompatibility after 15 reprocessing cycles. |
| - Cytotoxicity | Met |
| - Sensitization | Met |
| - Irritation or Intracutaneous Reactivity | Met |
| - Systemic Toxicity (Acute) | Met |
| - Genotoxicity | Met |
| - Hemocompatibility (Lower complement activation C3, C5 compared to regular cellulose membranes and other hemocompatible membranes) | Demonstrated |
| - Pyrogenicity | Met |
| In vitro Performance after 15 Reprocessing Cycles: | Maintained acceptable performance for 15 cycles. |
| - Ultrafiltration Coefficient (Kur) | Maintained acceptable levels. |
| - Clearances for Urea | Maintained acceptable levels. |
| - Clearances for Creatinine | Maintained acceptable levels. |
| - Clearances for Vitamin B12 | Maintained acceptable levels. |
| Clinical Performance after 15 Reprocessing Cycles (for reuse): | Maintained acceptable performance and safety for 15 cycles. |
| - Ultrafiltration Coefficient (Kur) | Maintained acceptable levels. |
| - Removal rates for Urea | Maintained acceptable levels. |
| - Removal rates for Creatinine | Maintained acceptable levels. |
| - Removal rates for Albumin | Maintained acceptable levels. |
| - Safety (effect of repeated patient exposures) | Demonstrated through 36 consecutive treatments. |
| - Hemocompatibility (Complement activation C3a and C5a) | Monitored and documented during the study. |
| Reprocessed Dialyzer Usability: | |
| - Residual Total Cell Volume (TCV) | At least 80% of original TCV (as a condition for reuse, not a direct performance measure of the device itself but a user-level acceptance). |
2. Sample Size Used for the Test Set and Data Provenance
-
Test Set (Clinical Study):
- Sample Size: 12 patients per clinical site. The study aimed for each patient to be treated 36 consecutive times, reusing the dialyzer up to 15 times on each subject.
- Data Provenance: Prospective, from two clinical sites (country of origin not explicitly stated, but the company is Japanese and the submission to the FDA, suggesting US or international involvement).
-
Test Set (In vitro study):
- Sample Size: Not explicitly stated as a number of individual dialyzers, but involved "the smallest wet model (AM-BIO-50) and the largest wet model (AM-BIO-100)" tested with 15 reprocessing cycles.
- Data Provenance: Used "outdated human blood from a blood bank".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications for establishing ground truth within the clinical or in-vitro tests conducted for this 510(k) submission. Clinical measurements were taken, and general "established dialysis practices" were followed at the institutions. However, the overall "ground truth" for product safety and effectiveness in K983720 is based on substantial equivalence to predicate devices, which themselves would have been cleared based on existing medical consensus on hemodialysis.
4. Adjudication Method for the Test Set
The document does not mention a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical study's outcomes. Clinical measurements (Kur, removal rates, complement activation) were likely gathered and analyzed according to the study protocol.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This device is a medical device (dialyzer) for organ support, not an AI or imaging diagnostic software that typically involves human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the performance of the dialyzer itself (the "algorithm" in this context) was evaluated in standalone in-vitro and clinical studies without human-in-the-loop performance influencing its function. Humans operate the reprocessing systems and dialysis machines, but the device's efficacy (filtration, biocompatibility) is an intrinsic property.
7. The Type of Ground Truth Used
- For in-vitro testing: Measured physical and chemical parameters (Kur, clearances for urea, creatinine, B12) using standard laboratory methods, established as "ground truth" through direct measurement.
- For clinical testing:
- Performance: Clinical measurements of Kur, removal rates for urea, creatinine, and albumin, which serve as direct, objective "ground truth" for the device's function in a patient setting.
- Safety/Biocompatibility: Monitoring of complement activation (C3a and C5a) and characterization of patient effects over 36 treatments provide "ground truth" for the device's safety profile.
- Overall: Substantial equivalence to predicate devices, meaning the "ground truth" for overall safety and effectiveness is largely benchmarked against well-established and legally marketed hemodialyzers.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here, as this is a medical device (dialyzer), not an AI algorithm. The device's design and manufacturing process are based on established engineering principles and prior research, not a machine learning training paradigm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI algorithm. The design of the dialyzer and its membrane material (modified cellulose) were engineered to achieve specific performance characteristics and enhanced hemocompatibility, likely based on R&D, material science, and prior knowledge of hemodialysis.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.