Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
Asahi AM-BIO Extended Range (AM-BIO-HX 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 Extended Range (AM-BIO-HX series) Dialyzers are intended for single use only.
Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are designed only to be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
The expiration date of ASAHI AM-BIO Extended Range (AM-BIO-HX series) Dialyzers is 3 years from the sterilization date. The user must use the dialyzers before the expiration date.

Device Description

The line of Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series) 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 only single use. 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 (C3g and C52) when compared to regular cellulose membrane dialyzers. The membranes are housed within a plastic casing of styrene butadiene block polymer. Non-removable 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. Like the AM-BIO Series Dialyzers, the AM-BIO Extended Range 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. Asahi AM-BIO Extended Range Series Dialyzers are sterilized by gamma radiation before shipment.

AI/ML Overview

The provided text describes the Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series) and its substantial equivalence to predicate devices, focusing on its intended use, design, manufacturing, and non-clinical testing. However, it does not contain detailed information about acceptance criteria or a study proving the device meets specific performance criteria in a format applicable to AI/ML device evaluations. The document is a 510(k) submission summary for a physical medical device (dialyzer), not a software or AI device.

Therefore, many of the requested elements for an AI/ML device evaluation, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, are not present.

Based on the provided text, here's what can be extracted and what cannot:

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

The document doesn't explicitly state quantitative acceptance criteria or reported performance values in a table format for the new device compared to specific thresholds. It mentions "extended range of performance specifications" due to a change in pore size, but no specific metrics are given.

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

Not applicable. The document describes non-clinical in-vitro testing and biocompatibility testing for a physical dialyzer, not a software device with a test set of data.

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)

Not applicable. This is for a physical device, not an AI/ML evaluation requiring expert-labeled ground truth for imaging or other data.

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

Not applicable. See above.

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 is for a physical device, not an AI/ML device where human readers interact with AI.

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

Not applicable. This is a physical medical device.

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

Not applicable. For the in-vitro tests mentioned (like permeability, clearance rates, cytotoxicity), the "ground truth" would be established by standard laboratory measurement techniques and scientific principles for each specific test parameter, not by expert consensus or pathology in the context of an AI/ML dataset.

8. The sample size for the training set

Not applicable. The device is a physical dialyzer, not an AI/ML model that is "trained."

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

Not applicable. See above.

Summary based on the provided document:

The provided text describes the Asahi AM-BIO Extended Range Series Dialyzers as substantially equivalent to existing predicate devices (Asahi AM-BIO Series Dialyzers, Asahi APS Series Dialyzer, Fresenius Hemoflow). The equivalence is based on similar indications for use, design, and manufacturing, with the new device offering an "extended range of performance specifications" by changing the pore size of the dialyzer fibers.

The "study" equivalent to proving the device meets acceptance criteria in this context is the non-clinical in-vitro testing and biocompatibility testing.

Non-Clinical Testing Performed:

In-vitro testing:
- Permeability - saline
- Permeability - bovine plasma
- Urea clearance rate
- Creatinine clearance rate
- Phosphate clearance rate
Biocompatibility testing:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Systemic Toxicity (Acute)
- Genotoxicity
- Hemocompatibility
- Pyrogenicity

Acceptance Criteria & Performance:

The document implies that the results of these tests met accepted standards for dialyzer performance and safety, allowing the device to be deemed "substantially equivalent" by the FDA. However, specific quantitative acceptance criteria (e.g., "urea clearance must be > X mL/min") and the exact reported performance values are not detailed in this summary document. It states that the device has "extended range of performance specifications," suggesting that its performance in the tested parameters would either meet or exceed the predicate devices.

Summary

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Summary for Public Disclosure

9 2002 JUL

SUBMITTER

Asahi Medical Company, Ltd. 9-1, Kanda Mitoshirocho Chiyoda-ku, Tokyo 101-8482 Japan

Tel: 81-3-3259-5880 Fax: 81-3-3259-5899

DATE SUMMARY WAS PREPARED

July 8,2001

NAME OF DEVICE

Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series)

IDENTIFICATION OF PREDICATE DEVICES

Asahi AM-BIO Series Dialyzers (K983720) Asahi APS Series Dialyzer (K001250) Fresenius Hemoflow (K892262)

DESCRIPTION OF THE DEVICE

Image /page/0/Picture/16 description: The image shows a handwritten text that appears to be a combination of symbols and numbers. The number '14' is clearly visible on the right side of the image. The symbols on the left side are less clear, but they seem to be some kind of handwritten characters. The text is written in black ink on a white background.

K613418

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Page 2/4

KO13418

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 vields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3g and C52) when compared to regular cellulose membrane dialyzers.

The membranes are housed within a plastic casing of styrene butadiene block polymer. Non-removable 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. Like the AM-BIO Series Dialyzers, the AM-BIO Extended Range 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. Asahi AM-BIO Extended Range Series Dialyzers are sterilized by gamma radiation before shipment.

INTENDED USE

The indications for use for the Asahi AM-BIO Extended Range Series Dialyzer is as follows:

Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are a. intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers must be b. used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient.

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Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are c. intended for single use only.
đ. Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are designed only to be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
e. The expiration date of ASAHI AM-BIO Extended Range (AM-BIO-HX series) Dialyzers is 3 years from the sterilization date. The user must use the dialyzers before the expiration date.

Comparison of Device Characteristics to Predicates

The indications for use, design, and manufacturing of the Asahi AM-BIO Extended Range Series Dialyzers are the same as a predicate device, the AM-BIO Series Dialyzers. The AM-BIO Extended Range Series Dialyzers have the same materials and construction as the AM-BIO Series Dialyzers, but with extended range of performance specifications to accommodate a more diverse patient population. The intended changes in performance specifications are achieved by changing the pore size of the dialyzer fibers. Note, the AM-BIO Extended Range Series Dialyzers are labeled for only single use.

Non-clinical Testing

In-vitro testing of the AM-BIO Extended Range Series Dialyzers includes the following:

Permeability saline .
◆ Permeability - bovine plasma
Urea clearance rate ●
Creatinine clearance rate ●
. Phosphate clearance rate

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Additionally, the following testing supports the biocompatibility of the AM-BIO Extended Range Series Dialyzers:

Cytotoxicity ●
Sensitization .
Irritation or Intracutaneous Reactivity .
Systemic Toxicity (Acute) ●
Genotoxicity: ●
Hemocompatibility .
Pyrogenicity ◆

CONCLUSIONS

The indications for use (other than regarding single use), design, and manufacturing of the Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series) are the same as, and therefore substantially equivalent to, the predicate Asahi AM-BIO Series Dialyzers.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2002 JUL

Asahi Medical Company, Ltd. c/o David L. West, Ph.D. Vice President, Medical Device Development Quintiles Consulting 1801 Rockville Pike, Suite 300 ROCKVILLE MD 20852

Re: K013418 Trade/Device Name: AM-BIO Extended Range Series Dialyzers (HX Series) Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: April 10, 2002 Received: April 10, 2002

Dear Dr. West:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Boydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): Device Name: Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series)

Indications For Use:

Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for use ત્ત્વ for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers must be used in b. accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient.
Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for single C. use only.
Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are designed only to be d. used only on dialysis systems equipped with volumetric ultrafiltration controllers.
The expiration date of ASAHI AM-BIO Extended Range (AM-BIO-HX series) e. Dialyzers is 3 years from the sterilization date. The user must use the dialyzers before the expiration date.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Optional Format 3-10-98)

David A. Seymore

510/k) Num

AM-BIO EXTENDED RANGE SERIES DIALYZER Asahi Medical Co., Ltd.

TOTAL P.06

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”