The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.

Device Description

Asahi AM-R Series Dialyzers cleared under 510(k) K970650 are designed as reusable, hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing of styrene butadiene block polymer.

AI/ML Overview

The provided text describes a 510(k) submission for the Asahi AM-R Series Dialyzers. It focuses on a modification to the device (update of dialyzer casings) and assesses its substantial equivalence to a predicate device.

Crucially, this document is a 510(k) summary and approval letter, not a study report detailing acceptance criteria and performance data in the manner typically associated with clinical or standalone performance studies for AI/software devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because it is not a study report designed to evaluate such metrics.

Here's what can be extracted and what cannot:

A table of acceptance criteria and the reported device performance:
- Cannot be provided. This document does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy) like you would find for a diagnostic or AI device. The "performance" assessment is qualitative, stating "Revisions to the casing dimensions... are demonstrated to have an insignificant impact on the performance of the dialyzers."

Acceptance Criteria	Reported Device Performance
Not specified	Insignificant impact on performance

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. The document does not describe a "test set" in the context of typical AI/software device evaluation. It refers to a modification of a physical medical device (dialyzer casing) and likely involved engineering tests or bench testing, not a data-driven test set.
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):
- Cannot be provided. Ground truth, in the context of AI, refers to independently verified labels for data. This document describes a physical device modification, not an AI model requiring annotated data. The assessment of "insignificant impact on performance" would have been made by engineers and regulatory reviewers based on design specifications and potentially bench testing, not expert-labeled test sets.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. Not applicable to this type of device modification submission.
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:
- Cannot be provided. Not applicable. This is not an AI/software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. Not applicable. This is not an AI/software device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided. Not applicable.
The sample size for the training set:
- Cannot be provided. Not applicable. This is not an AI/software device.
How the ground truth for the training set was established:
- Cannot be provided. Not applicable.

Summary based on the document:

This 510(k) submission is for a physical medical device (dialyzer), specifically a modification to its casing. The core of the submission is to demonstrate that this physical change does not alter the safety or effectiveness of the device compared to its legally marketed predicate.

The "study" referenced is the comparison to the predicate device and the demonstration that the casing revisions have an "insignificant impact on the performance of the dialyzers." This implies a technical assessment (likely engineering and/or bench testing) rather than a clinical trial or AI model validation study.

The acceptance criterion, implicitly, is that the modified device's performance characteristics related to its intended use (hemodialysis) remain substantially equivalent to the predicate device, thereby ensuring no new issues of safety or effectiveness are raised. The document states this outcome was achieved.

Summary

{0}------------------------------------------------

JUL 29 1999

K991512
Page 1 of 1

Asahi AM-R Series Dialyzers

Submitter:	Asahi Medical Company, Ltd.9-1, Kanda MitoshirochoChiyoda-ku, Tokyo 101-8482Japan
Date summary was prepared:	April 2, 1999
Name(s) of the device:	Asahi AM-R Series Dialyzers
Identification of predicate device(s):	Asahi AM-R Series Dialyzers

Description of the device:

Intended Use:

Comparison To Predicate:

The previously cleared Asahi AM-R Series Dialzyers are being modified to update the dialyzer casings. No other changes to the dialyzers are being made.

Conclusion:

Revisions to the casing dimensions for the AM-R Series dialyzers are demonstrated to have an insignificant impact on the performance of the dialyzers. The indications for use remains unchanged and no new issues of safety or effectiveness are expected to be raised as a consequence of this modification. Therefore the modified AM-R series dialyzers are considered substantially equivalent to the original AM-R series dialyzers.

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Image /page/1/Picture/0 description: The image is a circular logo for the Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a sphere. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1999

Asahi Medical Company, Ltd. c/o David L. West, Ph.D. Vice President Quintiles Consulting 15825 Shady Grove Road, Suite 130 Rockville, MD 20850-4008

Re: K991512 Asahi AM-R Series of Dialyzers Dated: April 29, 1999 Received: April 30, 1999 Requlatory Class: II 21 CFR §876.5820/Procode: 78 FJI

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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 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 (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requirements, as set forth in the Quality System Regulation (QS) 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 regult 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 the Electronic Product 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), piease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

None assigned as of this time

Device Name:

510(k) Number:

Asahi AM-R Series Dialyzers

Indications for Use:

==============================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Image /page/2/Picture/8 description: The image shows a simple square shape. The square is formed by four straight lines, creating a closed geometric figure. The lines appear to be of uniform thickness, and the square is oriented with its sides parallel to the horizontal and vertical axes.

Over-the Counter Use

David A. Bergman

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991512

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.