Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-R 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-R 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 the 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 Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, manufactured by Renal Systems, Inc.
The instructions provided by the manufacturer of the chosen reprocessing (3) agent must be followed in reprocessing the dialyzer.
The reprocessed dialyzer may be used only on dialysis systems equipped with (4) volumetric ultrafiltration controllers.

Device Description

The AM-R Series Dialyzers are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The performance of these dialyzers, when new for single or initial (first) use and when reprocessed for reuse, have been documented through laboratory (in vitro) testing and confirmatory clinical testing. Assahi AM-R Series Dialyzers are constructed of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer. Asahi AM-R Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after its sterile package is opened for the initial (first) use.

AI/ML Overview

This document describes the Asahi AM-R Series Dialyzers and their approval for reuse after reprocessing. The acceptance criteria and supporting studies are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Residual Total Cell Volume (TCV)	At least 80% of the original TCV after reprocessing for up to 15 cycles.
Biocompatibility	Pass: Cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and pyrogenicity after 15 reuse cycles.
Ultrafiltration Coefficient (Kuf)	Maintained after reprocessing with formalin/Renalin for up to 15 cycles.
Clearances (Urea, Creatinine, Vitamin B12)	Maintained after reprocessing with formalin/Renalin for up to 15 cycles.
Removal Rates (Urea, Creatinine, Albumin)	Maintained after reprocessing with formalin/Renalin for up to 15 cycles.
Dialyzer leakage or damage	No unacceptable leakage or damage reported, to be followed by institutional policies.
Residual blood	Institutional policies regarding residual blood should be followed.
Reprocessing Agent	4% Formaldehyde (Formalin) with Seratronics DRS4™/DPS4™ OR Renalin® with Renatron® Dialyzer Reprocessing System.
Reprocessing System Manufacturer Instructions	Manufacturer instructions for the chosen reprocessing agent must be followed.
Dialysis System Compatibility	Must be used only on dialysis systems equipped with volumetric ultrafiltration controllers.

2. Sample Size Used for the Test Set and Data Provenance

Non-clinical (In Vitro) Testing:
- Biocompatibility: The largest model (AM-R-90U) was subjected to 15 reprocessing cycles.
- Performance (Kuf, Urea, Creatinine, Vitamin B12 clearances): The smallest model (AM-R-50M) and the largest model (AM-R-90U) were tested in vitro for initial use and up to 15 reuse cycles. Outdated human blood from a blood bank was used.
Clinical Testing:
- The largest model (AM-R-90U) was tested in confirmatory clinical studies for initial use and up to 15 reuse cycles.
- Sample Size: Minimum of 12 patients enrolled at each of two clinical sites. A minimum of 50% of these patients reused the dialyzer 15 times.
- Data Provenance: The study was a prospective clinical study conducted at two clinical sites that utilized both formalin and Renalin® reprocessing agents. The country of origin of the data is not explicitly stated, but it refers to typical US dialysis practices and FDA guidance, suggesting a US context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the clinical studies. However, it mentions that "dialysis sessions were conducted and patients were managed in accordance with established dialysis practices for the respective institutions," implying that qualified medical professionals (e.g., nephrologists, dialysis nurses) were involved in managing patient care and assessing outcomes.

4. Adjudication Method for the Test Set

The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the test set. Clinical outcomes were assessed by comparing reprocessed device performance against initial use performance within each patient, following established clinical protocols at the participating institutions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The study focuses on the device's performance with and without reuse, not on the improvement of human readers with AI assistance, as this is a medical device (dialyzer) and not an AI diagnostic tool.

6. Standalone Performance

A standalone performance evaluation was conducted in both non-clinical (in vitro) and clinical settings. The device's performance metrics (biocompatibility, ultrafiltration coefficient, clearances, and removal rates) were measured directly, independent of human interpretation beyond typical clinical monitoring.

7. Type of Ground Truth Used

Non-clinical (In Vitro) Testing:
- Biocompatibility: Standardized laboratory tests for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and pyrogenicity, which have established scientific ground truths.
- Performance (Kuf, Urea, Creatinine, Vitamin B12 clearances): In vitro measurements using outdated human blood, with ground truth established by laboratory analytical methods.
Clinical Testing:
- Performance (Kuf, Urea, Creatinine, Albumin removal rates): In vivo measurements in patients with chronic renal failure or acute renal failure. The "ground truth" for clinical performance was the patient's own initial dialysis session results, serving as a baseline for comparison with subsequent reused sessions. Outcome data included physiological measurements and patient stability.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" in the context of machine learning, as this is a medical device (dialyzer) evaluation, not an AI model development. The reported studies evaluate the device's performance directly.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the machine learning sense, this question is not applicable to the information provided. The evaluations are direct performance assessments of the dialyzer, not data used to train an algorithm.

Summary

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970650

Page 1 of 5

SEP 3 0 1957

Submitter

Asahi Medical Co., Ltd. The Imperial Tower 1-1, Uchisaiwaicho 1-chome Chiyoda-ku, Tokyo 100, Japan 81-3-3507-2594 Telephone: Facsimile: 81-3-3507-2492

Date summary was prepared

February 3, 1997

Name of the device

Asahi AM-R Series Dialyzers

Identification of predicate device

Asahi AM-Series Dialyzers

Description of the device

Intended Use

Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.

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Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations. Asahi AM-R 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-R 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 (1) (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of the 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 (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, 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.

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Comparison of device characteristics to predicate

The design, materials of fabrication, and manufacturing of the Asahi AM-R Series Dialyzers remain unchanged from the Asahi AM-Series Dialyzers cleared by FDA for marketing in the U.S. under K892374 and K892375. Therefore, from the perspective of technological characteristics, the AM-R Series Dialyzers under this 510(k) are identical to the predicate device under K892374 and K892375.

Non clinical testing

(1) The largest model (AM-R-90U) has been subjected to the reprocessing agents and/or processes for 15 cycles and subsequently tested for biocompatibility. The biocompatibility tests comprised: cytotoxicity, sensitization, irritation or intracutaneous reactivity, systemic toxicity (acute), genotoxicity, hemocompatibility, and pyrogenicity.
The smallest model (AM-R-50M) and the largest model (AM-R-90U) have been tested (2) in vitro under initial use and reprocessed/reused conditions for 15 cycles using outdated human blood from a blood bank to produce in vitro measurements of ultrafiltration coefficient (Kir) and clearances for urea, creatinine, and vitamin B 12 . Reflecting the dominant use pattern in modern hemodialysis facilities, the in vitro performance testing was performed using dialysis machines (COBE Centry III) equipped with volumetric ultrafiltration controllers. Also to evaluate the effects of reprocessing, widely utilized reprocessing agents formaldehyde (also known as

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Page 4 of 5

K970656

formalin) and Renalin® and associated automated reprocessing systems (Seratronics machine and Renatron® machine, respectively) were utilized.

Clinical testing

In accordance with FDA's May 23, 1996, letter and its accompanying Guidance for Hemodialyzer Reuse Labeling, the performance of selected models of the family of AM-R Series Dialyzers have been evaluated under reuse conditions. The family of dialyzers, as it will be constituted under this 510(k) are all conventional hemodialysis membranes. Accordinaly, the largest model (AM-R-90U) has been tested in confirmatory clinical studies under initial use and reprocessed reused conditions for up to 15 reuse cycles to produce in vivo measurements of ultrafiltration coefficient (Kor) and removal rates for urea, creatinine, and albumin. To evaluate the effects of reprocessing, widely utilized reprocessing agents formaldehyde (also known as formalin) and Renalin® and associated automated reprocessing systems (Seratronics DRS4TM and DPS4TM machines and Renatron® machine, respectively) were utilized.

Specifically, two clinical sites were chosen to study the effects of reprocessing the dialyzers with the two chosen reprocessing agents and/or processes. The reprocessing was performed in accordance with the instructions of the manufacturer of the reprocessing machines used at the respective institutions. The clinical study protocol was identical for both sites, although dialysis sessions were conducted and patients were managed in accordance with established dialysis practices for the respective institutions.

The study was a prospective study. The initial dialysis procedures served as the baselines for comparison for the subsequent dialysis procedures performed with the reprocessed devices. The study continued at each site until a minimum of 12 patients were enrolled at the site, of which a minimum of 50% reused the dialyzer 15 times. The main inclusion criteria were patients who receive chronic dialysis and who are stable on thrice weekly dialysis.

Conclusion

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characteristics, the AM-R Series Dialyzers under this 510(k) are identical, hence, substantially equivalent to the same device under K892374 and K892375.

The performance characteristics of the AM-R Series Dialyzers after reprocessing for reuse, as reflected in the biocompatibility testing, in vitro performance testing, and confirmatory clinical testing, are fully comparable to their conventional hemodialysis performance characteristics for single or initial (first) use. The single or initial (first) use, as well as reuse, performance characteristics will be included in device labeling, providing clinical users accurate information on the comparable performance of these conventional hemodialysis membranes. Therefore, from the perspective of performance characteristics, the AM-R Series Dialyzers under this 510(k) are substantially equivalent to the same device under K892374 and K892375.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a series of thick, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ED 30 1997

Asahi Medical Co., Ltd. c/o David L. West, Ph.D. Senior Technical Advisor Quintiles Medical Technology Consultants 15825 Shady Grove Road, Suite 90 Rockville, Maryland 20850

Re: K970650

Asahi AM-R Series Dialyzers - Multiple Use Labeling Dated: July 22, 1997 Received: July 22, 1997 Regulatory class: II 21 CFR §876.5820/Product code: 78 MSE

Dear Dr. West:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W. Kiau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K97 0650

page 1 of 2

510(k) Number

None assigned as of this time

Device Name

Asahi AM-R Series Dialyzers

Indications for Use

Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.

(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 the 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 Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, manufactured by Renal Systems, Inc.

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The instructions provided by the manufacturer of the chosen reprocessing (3) agent must be followed in reprocessing the dialyzer.
The reprocessed dialyzer may be used only on dialysis systems equipped with (4) volumetric ultrafiltration controllers.

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻟﻠ Prescription Use (per 21 CFR 801.109)

Over-the Counter Use
Roho R Rathing/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 11970650 510(k) Number _

Regulation Number and Section

§ 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.