The CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of 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. This device is indicated for single and multiple use.

Device Description

The CLIRANS® T-Series Hollow Fiber Dialyzers consists of cellulose hollow fibers with 9μ wall thickness. Blood is pumped via a roller pump from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers waste products pass through the membrane of the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient.

AI/ML Overview

The CLIRANS® T-Series Hollow Fiber Dialyzers demonstrate substantial equivalence in performance to the predicate device, the CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L). The performance criteria are focused on the device's ability to clear various substances from the blood and its ultrafiltration rate.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (relative to predicate CL*M151L)	Reported Device Performance (CLIRANS® T-Series)
Urea Clearance	Substantially Equivalent	"somewhat higher clearance" than M151L
Creatinine Clearance	Substantially Equivalent	"somewhat higher clearance" than M151L
Phosphates Clearance	Substantially Equivalent	"somewhat higher clearance" than M151L
Vitamin B12 Clearance	Substantially Equivalent	"somewhat higher clearance" than M151L
UFR (In Vitro & In Vivo)	Substantially Equivalent	"somewhat higher...UFR" than M151L
Priming Volume	Substantially Equivalent	Values (101ml, 120ml, 148ml for T-Series models) are similar to M151L (115ml)

Study that Proves the Device Meets the Acceptance Criteria:

The device's performance was evaluated through a comparative study against the predicate device, the CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L), cleared under 510(k) K854280. The study focused on demonstrating "substantial equivalence" rather than absolute performance thresholds.

Noteworthy findings: The T-Series dialyzers exhibited "somewhat higher clearance and UFR" compared to the M151L, which the submission states is "to be expected with the thinner fiber walls in the T-Series dialyzer." Importantly, the document concludes that "none of the data raises any issues of safety or effectiveness," thus supporting the claim of substantial equivalence.

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

The document does not explicitly state the sample size used for the performance tests (e.g., number of dialyzers tested for each metric). The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified. These are likely in-house laboratory tests.

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

This information is not applicable. The study is a laboratory-based comparative performance test of physical devices, not an assessment requiring expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set:

This information is not applicable, as the tests were performance measurements of the device itself, not clinical outcomes requiring adjudication.

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 type of study is typically for evaluating the impact of an AI system on human clinical interpretation, which is not relevant for this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical device (a dialyzer), not a software algorithm or AI system. Its "performance" refers to its physical characteristics and capabilities in a dialysis system.

7. The Type of Ground Truth Used:

The "ground truth" for this study is the established performance characteristics of the legally marketed predicate device, the CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L). The performance metrics (clearance for various substances, UFR, priming volume) of the new device were compared directly against those of the predicate device to establish substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable, as this is not a machine learning device.

Summary

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DEC 19 1997

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

Proprietary Device Name: CLIRANS® T-Series Hollow Fiber Dialyzer

Classification Name: Dialyzer, Capillary, Hollow Fiber

Common Name: Hollow Fiber Dialyzer

INTENDED USE

DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) are substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280.

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SECTION II: Summary and Certification

PRINCIPLE OF OPERATION/TECHNOLOGY

The CLIRANS® T-Series Hollow Fiber Dialyzers operate in the following manner. Blood is taken from the artery of a patient and pumped via a roller pump into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers, and waste products then pass through the membrane of the dialyzer into the dialysate which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer, and back into the veins of the patient.

DESIGN/MATERIALS

Parts	CLIRANS T-Series HollowFiber Dialyzer	Cleared CLIRANS TAF HollowFiber Dialyzer K854280
Hollow Fiber	Cellulose	Cellulose
Housing	Acrylonitrile-Styrene copolymer	Acrylonitrile-Styrene copolymer
Blood Port	Polypropylene	Polypropylene
Screw ring	Acrylonitrile-Styrene copolymer	Acrylonitrile-Styrene copolymer
O-ring	Silicone rubber	Silicone rubber
Adhesive	Polyurethane	Polyurethane
Blood/DialysatePort cap	Polyethylene	Polyethylene

K 170708

p. 2/4

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SECTION II Summary and Certification

SPECIFICATIONS

Parts	CLIRANS T-Series Hollow ·Fiber Dialyzer			Cleared CLIRANS TAFHollow Fiber DialyzerK854280 - Largest EffectiveSurface Area (CL*M151L)
Hollow Fiber	CL*T150L	CL*T175L	CL*T220L	CL*M151L
Inside Diameter	200μ	200μ	200μ	220μ
Wall Thickness	9μ	9μ	9μ	12μ
Effective Length	235mm	235mm	235mm	235mm
Quantity of Fiber	10,000pcs	11,800pcs	15,000pcs	9300pcs
Priming Blood Vol	101ml	120ml	148ml	115ml
Eff. Surface Area	1.5m²	1.75m²	2.2m²	1.5m²

PERFORMANCE

The performance of the CLIRANS® T-Series Hollow Fiber Dialyzers (T-Series) are substantially equivalent to the performance of the currently marketed largest effective surface area CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L). The T-Series dialyzers exhibit a somewhat higher clearance and UFR than the M151L which is to be expected with the thinner fiber walls in the T-Series dialyzer. However, none of the data raises any issues of safety or effectiveness. Therefore, the CLIRANS® T-Series Hollow Fiber Dialyzers performance are substantially equivalent to the predicate devices.

The following clearance tests were performed demonstrating the substantial equivalence of the CLIRANS® T-Series Hollow Fiber Dialyzers submitted in this 510(k) to the largest effective surface area dialyzer (CL*M151L) cleared in the CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280.

· Urea
· Creatinine
· Phosphates
· Vitamin B12
· UFR (In Vitro & In Vivo)
· Priming Volume

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SECTION II: Summary and Certification

ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated according to the AAMI guidelines to provide a Sterility Assurance Level (SAL) of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal register of June 23, 1978 (or as finalized or amended).

Manufacturing control test methods include: functional, extraction and sterility tests.

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." [External Communicating Devices, Circulating Blood, Prolonged (24 hours-30 days) contact duration]. The blood contacting materials were found to be biocompatible.

The expiration dating for the CLRANS® T-Series Hollow Fiber Dialyzers will be 36 months. This dating period is adopted from legally marketed CLIRANS® TAF Hollow Fiber Dialyzer 510(k) K854280. The sterilization process and packaging materials are the same for these products. Verification testing of aged product consists of package permeability, sterility and shelf life functional testing.

CONCLUSION

Date Prepared	February 23, 1997
Prepared by	Keith M. SmithSenior Regulatory Affairs SpecialistRegulatory Affairs
Prepared for	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone (410) 392-7375 or (410) 392-7231Fax (410) 398-6079

< 172 10 % 4/4

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Image /page/4/Picture/0 description: The image shows a partial view of the Department of Health & Human Services logo. The logo includes the department's emblem, which features a stylized human figure with three profiles, representing the department's focus on people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem, indicating the department's name and national affiliation. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 1997

Mr. Keith M. Smith Senior Regulatory Affairs Specialist Terumo Medical Corporation Regulatory Affairs Department 125 Blue Ball Road Elkton, Maryland 21921

Re: K970708

CLIRANS® T-Series Hollow Fiber Coventional Dialyzers for Single and Multiple Use Dated: November 26, 1997 Received: November 28, 1997 Regulatory Class: II 21 CFR §876.5820/Product Code: 78 FJI and MSE

Dear Mr. Smith:

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 Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 Fecteral 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 Ouality 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 vours.

W.Liau Yu
Lillian Yin, Ph.D.

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

Enclosure

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510(k) Number (if known):

CLIRANS® T-Series Hollow Fiber Dialyzers Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Cathey
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K970705

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.