The CLIRANS® E-series Hollow Fiber Dialyzers are indicated for use whenever a patient is found to be in acute or chronic renal failure and hemodialysis is prescribed by a physician. The device should be used only at the direction of a physician who has evaluated all of the pertinent features of the patient's illness. This device is indicated for single use only.

Device Description

The 2.0 m2 CLIRANS® E and EE Series dialyzers that are the subject of this 510(k) are a larger size (larger fiber surface area) of the currently cleared dialyzers (K003425).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document describes the submission of Terumo Medical Corporation's CLIRANS® E-Series Dialyzers (specifically a larger 2.0 m² size) for substantial equivalence to existing predicate devices (CLIRANS® E-Series cleared under K003425 and Althin AF-220 cleared under K992573). The acceptance criteria are implicitly defined by demonstrating that the new device's performance is comparable to or better than the predicate devices across a set of physical and functional characteristics.

Acceptance Criterion (Category)	Reported Device Performance
In Vitro Clearance	Performed, no new issues.
Coefficient of Ultrafiltration, Kuf	Performed, no new issues.
In Vitro Kuf	Performed, no new issues.
Pressure Drop (Blood & Dialysate Compartments)	Performed, no new issues.
Priming Volume	Performed, no new issues.
Structural Integrity (Fiber Leak Test)	Performed, no new issues.
Biocompatibility (Blood Contacting Materials)	Tested in accordance with FDA G95-1 (ISO-10993). Results demonstrate biocompatibility.
Sterilization Assurance Level (SAL)	Validated to a SAL of 10⁻⁶ in accordance with ANSI/AAMI/ISO 11134 and EN 554.

Note: The document explicitly states, "None of the data raises any new issues of safety and effectiveness." and "Differences between the devices do not raise any significant or new issues of safety or effectiveness." This implies the performance fell within acceptable limits relative to the predicate devices. Specific quantitative ranges or thresholds for the acceptance criteria are not provided in this document, as the submission focuses on demonstrating substantial equivalence rather than meeting pre-defined specific numerical targets for a novel device.

Study Details

The provided text describes a submission for substantial equivalence for a medical device (dialyzer) and primarily focuses on verification testing to demonstrate equivalence to predicate devices, rather than a clinical trial or algorithm performance study. Therefore, several of the requested sections are not applicable in the context of this document.

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test but alluded to as "tests were performed." In-vitro verification tests typically use a batch or statistically significant number of units.
- Data Provenance: The tests were "performed to demonstrate the substantial equivalence," suggesting a controlled, laboratory-based study, likely performed by the manufacturer (Terumo Medical Corporation). The country of origin of the data is implicitly the USA, where Terumo Medical Corporation is located. The study is prospective in the sense that these tests were conducted specifically for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" here is the established performance characteristics of the predicate devices.
Adjudication method for the test set:
- Not applicable. This is not a study requiring expert adjudication.
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 not a study involving human readers or AI assistance. It concerns the performance of a physical medical device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" or reference standard for comparison is the known performance characteristics of the predicate devices. These characteristics would have been established through a combination of their own verification testing, clinical use data, and regulatory clearances. For biocompatibility, it's adherence to international standards (ISO-10993) and for sterilization, it's adherence to specific standards (ANSI/AAMI/ISO 11134 and EN 554).
The sample size for the training set:
- Not applicable. This report does not describe a machine learning or AI-based device that would require a training set.
How the ground truth for the training set was established:
- Not applicable. No training set is described.

Summary

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NOV 2 0 2001

Terumo Medical Corporation Special 510k - CLIRANS® E-Series Dialyzers Section II. Summary and Certification

K 013550

SECTION II. SUMMARY AND CERTIFICATION

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Device Name A.

CLIRANS® E-Series Dialyzers Proprietary Name Classification Name High Permeability Dialyzer Common Name Hollow Fiber Dialyzer

B. Intended Use

Note: This is the same intended use as the predicate device - CLIRANS® E-Series Hollow Fiber Dialyzer cleared under K003425.

C. Device Description

The 2.0 m2 CLIRANS® E and EE Series dialyzers that are the subject of this 510(k) are a larger size (larger fiber surface area) of the currently cleared dialyzers (K003425).

D. Principle Of Operation / Technology

The 2.0 m2 CLIRANS® E and EE Series dialyzers have the same technological characteristics as the predicate devices.

E. Design / Materials

The 2.0 m2 CLIRANS® E and EE Series dialyzers have the same design and materials as the predicate devices.

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Terumo Medical Corporation Special 510k - CLIRANS® E-Series Dialyzers Section II. Summary and Certification

613550

F. Specifications

The 2.0 m2 CLIRANS® E and EE Series dialyzers have the same specifications as the predicate devices with the exception that they have a larger number of fibers resulting in an increased surface area.

G. Performance

The following verification tests were performed to demonstrate the substantial equivalence of the larger surface area device to the devices cleared under K003425 and to the Althin AF-220 dialyzers:

In Vitro Clearance .
Coefficient of Ultrafiltration, Kuf ●
In Vitro kuf ●
Pressure Drop in Blood and Dialysate Compartments .
Priming Volume ●
Structural Intregrity (Fiber Leak Test) .

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

Additional Safety Information H.

The CLIRANS® E-Series Dialyzers are classified as Externally Communicating Device, Circulating Blood, Prolonged Contact (24 hrs to 30 days). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing". Results of the testing demonstrate that the blood contacting materials are biocompatible.

Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11134 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization and EN 554 Medical Devices -Method for Routine Validation and Control of Sterilization. The device is sterilized to a SAL of 10°.

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Substantial Equivalence I.

The CLIRANS® E-Series dialyzers are substantially equivalent in intended use, 1 no OLIC hology/principles of operation, materials and performance to the design, techniology prillialyzers cleared under K003425 and to the Althin AF-220 dialyzers cleared under K992573. Differences between the devices do not raise any significant or new issues of safety or effectiveness.

Submitter Information J.

Prepared By:	Sandi HartkaManager Regulatory Affairs
Prepared For:	Terumo Medical Corporation
	125 Blue Ball Road
	Elkton, MD 21921
	Phone: (410) 392-7243
	Fax: (410) 398-6079
	Email: sandi.hartka@terumomedical.com
Date Prepared:	October 22, 2001

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

Ms. Sandi Hartka Manager, Regulatory Affairs Terumo Medical Corporation 125 Blue Ball Road ELKTON MD 21921

Re: K013550

Trade/Device Name: CLIRANS® E Series Hollow Fiber Dialyzers Regulation Number: 21 CFR 876.5860 Regulation Name: High Permeability Hemodialysis System Regulatory Class: Class II Product Code: KDI Dated: October 23, 2001 Received: October 24, 2001

Dear Ms. Hartka:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surver to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, the excordance 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 I ou may, dicrorere, mains 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 (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 or uny 1 vith all the Act's requirements, including, but not limited to: registration and listing eonly first Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 Or re rate 80); accoming (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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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 Cbrogdon

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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NOV 2 0 2001

510(k) Number (if known): 013550

CLIRANS® E-Series Hollow Fiber Dialyzers Device Name:

Indications For Use:

The CLIRANS® E-series Hollow Fiber Dialyzers are indicated for use whenever The CDHGATIC Is found to be in acute or chronic renal failure and hemodialysis is a pation it 10 lo a physician. The device should be used only at the direction of a problem of a projects This device is indicated for single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use i (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off) J
Division of Reproductive, Abdominal,
and Radiological Devices K013550
510(k) Number

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.”