This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use.

This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

Device Description

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Steam) includes arterial and venous dialysis blood tubing.

The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System.

The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.

The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only.

These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

AI/ML Overview

Based on the provided FDA 510(k) Clearance Letter for "BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) and C18 Series," the device in question is blood tubing lines, not an AI/software device. Therefore, many of the typical acceptance criteria and study components associated with AI-powered medical devices (like those requiring test sets, expert ground truth, MRMC studies, standalone performance, and extensive training data) are not applicable to this product.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

Technological Characteristics: Same intended use, design, configuration, scientific technology, and principles of operation.
Material Equivalence: Similar materials, with no new or additional materials posing unaddressed risks.
Performance Testing: Bench testing, sterilization validation, shelf-life testing, and biological safety testing.
Compatibility: Ensuring compatibility with the intended hemodialysis delivery system.

Given that this is a physical medical device (blood tubing lines) and not a software/AI device, the request for a table of acceptance criteria and study details as typically applied to AI devices cannot be fully fulfilled from the provided document. The document confirms that no clinical performance data and no animal performance data were submitted for this 510(k). This is typical for Class II devices demonstrating substantial equivalence where bench and preclinical testing are sufficient based on established predicate devices and known risks.

However, I can extract the types of performance testing and safety evaluations that were conducted to "prove the device meets acceptance criteria" for a physical medical device:

Acceptance Criteria and Study for BLOOD TUBING LINES FOR HEMODIALYSIS (K242479)

Context: This device is a physical medical device (blood tubing lines) used in hemodialysis, not an AI or software-based device. Therefore, the "acceptance criteria" and "study" described below relate to the physical and biological performance of the tubing lines themselves, demonstrating their safety and effectiveness through substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Criterion	Reported Device Performance/Conclusion in 510(k) Summary
Material Safety	Cytotoxicity (Unaged & Aged)	Completed, confirmed safety.
	Sensitization	Completed, confirmed safety.
	Intracutaneous Reactivity	Completed, confirmed safety.
	Acute Systemic Toxicity	Completed, confirmed safety.
	Pyrogenicity	Completed, confirmed safety. (Guidance ref: Pyrogen and Endotoxins Testing)
	Subchronic Systemic Toxicity	Completed, confirmed safety.
	Genotoxicity (BRM & MLA)	Completed, confirmed safety.
	Hemocompatibility (Hemolysis Unaged & Aged, Complement Activation, Thrombogenicity, Mechanical Hemolysis)	Completed, confirmed safety.
	Chemical Characterization (Extractable Analysis)	Completed, confirmed safety.
	Biological Risk Assessment	Completed, confirmed safety.
Sterilization & Shelf Life	Sterilization Validation	Completed using subject device.
	Shelf Life Testing	Completed using subject device.
Bench Performance	Structural Integrity	Completed, confirmed substantial equivalence.
	Pump Segment Performance	Completed, confirmed substantial equivalence.
	Needle Access Ports	Completed, confirmed substantial equivalence.
	Needleless Access Ports	Completed, confirmed substantial equivalence.
	Blood Pathway Volume	Completed, confirmed substantial equivalence.
	Tensile Strength	Completed, confirmed substantial equivalence.
	Transducer Protectors	Completed, confirmed substantial equivalence.
	Tubing Compliance	Completed, confirmed substantial equivalence.
	Mechanical Hemolysis	Completed, confirmed substantial equivalence.
	Resist Kinking After Repeated Clamping	Completed, confirmed substantial equivalence.
	Simulated Treatment	Completed, confirmed substantial equivalence.
	Connector to Haemodialyser	Completed, confirmed substantial equivalence.
	Connectors to Vascular Access Device	Completed, confirmed substantial equivalence.
	Connectors to Ancillary Components	Completed, confirmed substantial equivalence.
	Colour Coding	Completed, confirmed substantial equivalence.
	Air-Capture Chamber Fill Level	Completed, confirmed substantial equivalence.
	Blood Pathway Flow Dynamics	Completed, confirmed substantial equivalence.
Compatibility	Compatibility with DBB-06 PRO Hemodialysis Delivery System	Performance tests confirmed compatibility.

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

Sample Size: The document does not specify exact sample sizes for each bench, biological, sterilization, or shelf-life test. This information is typically detailed in the full submission, not the summary.
Data Provenance: The studies are described as "completed" by the submitter, NIKKISO CO., LTD. The typical provenance for such tests would be internal lab testing or accredited third-party labs where the devices are manufactured or tested. No country of origin for the data itself is specified beyond the applicant being from Japan. These are pre-market, prospective tests performed specifically for this 510(k) submission.

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

Not Applicable. This is a physical device clearance based on engineering performance and biological safety tests, not an AI device requiring expert-labeled medical imaging or clinical data. Ground truth for these types of tests is established through standardized methodologies (e.g., ISO standards, ASTM standards, AAMI standards) and quantitative measurements rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

Not Applicable. As above, no "test set" in the context of expert adjudication for AI models exists for this device. Performance is determined by meeting pre-defined quantitative thresholds and qualitative observations in laboratory settings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No. An MRMC comparative effectiveness study is designed to evaluate the impact of an AI system on human reader performance for diagnostic tasks. This device is blood tubing lines, not an AI diagnostic tool.
The 510(k) summary explicitly states: "No clinical performance data is submitted in this 510(k)." and "No animal performance data is submitted in this 510(k)."

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

Not Applicable. This is not a software algorithm. The "standalone performance" of the blood tubing refers to its ability to perform its function (e.g., maintain structural integrity, prevent kinking, ensure blood flow pathways) independently, which is covered by the extensive bench testing listed.

7. The Type of Ground Truth Used

For Physical Performance/Bench Testing: Ground truth is defined by objective engineering specifications, performance standards (e.g., ISO, AAMI, ASTM), and quantitative measurements (e.g., tensile strength values, flow rates, volume measurements, pressure limits). These are often derived from predicate device performance and established medical device standards.
For Biological Safety Testing: Ground truth is established by the results of standardized biological assays conforming to ISO 10993 series and FDA guidance, where specific chemical or biological reactions (e.g., cytotoxicity, hemolysis, pyrogenicity) are measured against predefined safety limits.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of machine learning for this physical medical device. The device itself is manufactured, not "trained."

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

Not Applicable. As there is no training set for an AI/software model, no ground truth needed to be established for it. The design and manufacturing process for the blood tubing lines are validated through the various tests described above, ensuring they meet the specified performance and safety characteristics.

Summary

FDA 510(k) Clearance Letter - Blood Tubing Lines for Hemodialysis

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 15, 2025

Nikkiso Co., LTD.
℅ Fumiaki Kanai
President
MIC International
4-32-16 Ryogoku
Sumida-ku, Tokyo 130-0026
Japan

Re: K242479
Trade/Device Name: BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)
BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU)
Regulation Number: 21 CFR§ 876.5820
Regulation Name: Hemodialysis System and Accessories
Regulatory Class: II
Product Code: KOC
Dated: April 14, 2025
Received: April 14, 2025

Dear Fumiaki Kanai:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Page 2

K242479 - Fumiaki Kanai Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

Page 3

K242479 - Fumiaki Kanai Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Maura Rooney -S

Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K242479
Please provide the device trade name(s).

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)
BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU)

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).	☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) Page 13 of 57

Page 5

510(k) Summary

510(k) Number	K242479
Preparation Date	April 11, 2025
Submitter	NIKKISO CO., LTD.20-3, Ebisu 4-Chome, Shibuya-kuTokyo 150-6022, Japan
Primary Contact	Satoko HinaRegulatory Affairs DepartmentMedical DivisionNIKKISO CO., LTD.20-3, Ebisu 4-Chome, Shibuya-ku Tokyo 150-6022, JapanPhone: +81-3-3443-3754Fax: +81-3-3473-4965Email: MedicalRA@nikkiso.co.jp
Subject Device	Device Name: BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU)Device Classification Name: Accessories, Blood Circuit, HemodialysisRegulation Number: 21 CFR 876.5820Regulation Description: Hemodialysis system and accessoriesDevice Class: Class IIClassification Product Code: KOCRegulation Medical Specialty: Gastroenterology/Urology510(k) Review Panel: Gastroenterology/Urology
Device Description	The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Steam) includes arterial and venous dialysis blood tubing.The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System.The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only.These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.
Intended Use / Indications for Use	This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use.This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

NIKKISO CO., LTD. CONFIDENTIAL 510(k) Summary Attachment 08-01 1/4

K242479 Page 1 of 4

Page 6

Predicate Device	510(k) Number: K230514Device Name: BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)BLOOD TUBING LINES FOR HEMODIALYSIS C18 SeriesApplicant: NIKKISO CO. LTD.Device Classification Name: Accessories, Blood Circuit, HemodialysisRegulation Number: 21 CFR 876.5820Regulation Description: Hemodialysis system and accessoriesDevice Class: Class IIClassification Product Code: KOCRegulation Medical Specialty: Gastroenterology/Urology510(k) Review Panel: Gastroenterology/Urology
Technological Characteristics	The Subject Device and Predicate Device have substantially equivalent technological characteristics:• Same Intended Use• Same design and configuration• Same scientific technology and principles of operationThe Subject Device differs from the Predicate Device in two respects:• Hemodialysis Delivery System for Subject Device• Sterilization method• Material for Subject DeviceThe Subject Device does not contain any new materials compared to the Predicate Device.Materials included in the Subject Device are as follows:This device is made primarily of polyvinyl chloride (plasticizer DEHP).Materials with direct or indirect contact with blood:- Polyvinylchloride (PVC)- Polycarbonate (PC)- Polypropylene (PP)- Silicone rubber (SR)- Polytetrafluoroethylene (PTFE)- Styrenic thermoplastic elastomer (alias is SEBS: Styrene/Ethylene-Butylene/Styrene)Materials included in the Predicate Device are as follows:This device is made primarily of polyvinyl chloride (plasticizer DEHP).Materials with direct or indirect contact with blood:- Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS)- Polyvinylchloride (PVC)- Polycarbonate (PC)- Polypropylene (PP)- Silicone rubber (SR)- Polytetrafluoroethylene (PTFE)- Styrenic thermoplastic elastomer (alias is SEBS: Styrene/Ethylene-Butylene/Styrene)- Isoprene rubber (IR)

Predicate Device

510(k) Number: K230514Device Name: BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)BLOOD TUBING LINES FOR HEMODIALYSIS C18 SeriesApplicant: NIKKISO CO. LTD.Device Classification Name: Accessories, Blood Circuit, HemodialysisRegulation Number: 21 CFR 876.5820Regulation Description: Hemodialysis system and accessoriesDevice Class: Class IIClassification Product Code: KOCRegulation Medical Specialty: Gastroenterology/Urology510(k) Review Panel: Gastroenterology/Urology

Technological Characteristics

The Subject Device and Predicate Device have substantially equivalent technological characteristics:• Same Intended Use• Same design and configuration• Same scientific technology and principles of operationThe Subject Device differs from the Predicate Device in two respects:• Hemodialysis Delivery System for Subject Device• Sterilization method• Material for Subject DeviceThe Subject Device does not contain any new materials compared to the Predicate Device.Materials included in the Subject Device are as follows:This device is made primarily of polyvinyl chloride (plasticizer DEHP).Materials with direct or indirect contact with blood:- Polyvinylchloride (PVC)- Polycarbonate (PC)- Polypropylene (PP)- Silicone rubber (SR)- Polytetrafluoroethylene (PTFE)- Styrenic thermoplastic elastomer (alias is SEBS: Styrene/Ethylene-Butylene/Styrene)Materials included in the Predicate Device are as follows:This device is made primarily of polyvinyl chloride (plasticizer DEHP).Materials with direct or indirect contact with blood:- Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS)- Polyvinylchloride (PVC)- Polycarbonate (PC)- Polypropylene (PP)- Silicone rubber (SR)- Polytetrafluoroethylene (PTFE)- Styrenic thermoplastic elastomer (alias is SEBS: Styrene/Ethylene-Butylene/Styrene)- Isoprene rubber (IR)

NIKKISO CO., LTD. CONFIDENTIAL 510(k) Summary Attachment 08-01 2/4

K242479 Page 2 of 4

Page 7

FDA Guidance Documents	The following FDA guidance documents were referenced in preparing this premarket notification:• Electronic Submission Template for Medical Device 510(k) Submissions Guidance for Industry and Food and Drug Administration Staff October 2023• Format for Traditional and Abbreviated 510(k)s, issued September 2019• Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, issued June 2012• Hemodialysis Blood Tubing Sets, issued April 2008• Labeling: Regulatory Requirements for Medical Devices, issued August 1989• Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, issued December 2019• Shelf Life of Medical Devices, issued April 1991• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 2016• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 2016
Sterilization and Shelf Life	Sterilization validation and shelf life testing was completed using the subject device BLOOD TUBING LINES FOR HEMODIALYSIS AL Series
Biological Safety	Biological safety testing was completed to confirm the safety of the subject device:• Cytotoxicity Unaged• Cytotoxicity Aged• Sensitization• Intracutaneous Reactivity• Acute Systemic Toxicity• Pyrogenicity• Subchronic Systemic Toxicity• Genotoxicity BRM• Genotoxicity MLA• Hemocompatibility Hemolysis Unaged• Hemocompatibility Hemolysis Aged• Hemocompatibility Complement Activation• Hemocompatibility Thrombogenicity• Hemocompatibility Thrombogenicity• Hemocompatibility Mechanical Hemolysis• Chemical Characterization• Extractable Analysis• Biological Risk Assessment

FDA Guidance Documents

The following FDA guidance documents were referenced in preparing this premarket notification:• Electronic Submission Template for Medical Device 510(k) Submissions Guidance for Industry and Food and Drug Administration Staff October 2023• Format for Traditional and Abbreviated 510(k)s, issued September 2019• Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, issued June 2012• Hemodialysis Blood Tubing Sets, issued April 2008• Labeling: Regulatory Requirements for Medical Devices, issued August 1989• Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions, issued December 2019• Shelf Life of Medical Devices, issued April 1991• Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 2016• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 2016

Sterilization and Shelf Life

Sterilization validation and shelf life testing was completed using the subject device BLOOD TUBING LINES FOR HEMODIALYSIS AL Series

Biological Safety

Biological safety testing was completed to confirm the safety of the subject device:• Cytotoxicity Unaged• Cytotoxicity Aged• Sensitization• Intracutaneous Reactivity• Acute Systemic Toxicity• Pyrogenicity• Subchronic Systemic Toxicity• Genotoxicity BRM• Genotoxicity MLA• Hemocompatibility Hemolysis Unaged• Hemocompatibility Hemolysis Aged• Hemocompatibility Complement Activation• Hemocompatibility Thrombogenicity• Hemocompatibility Thrombogenicity• Hemocompatibility Mechanical Hemolysis• Chemical Characterization• Extractable Analysis• Biological Risk Assessment

NIKKISO CO., LTD. CONFIDENTIAL 510(k) Summary Attachment 08-01 3/4

K242479 Page 3 of 4

Page 8

Performance - Bench	Bench testing was completed to confirm the subject device is substantially equivalent to the predicate device in performance:• Structural Integrity• Pump Segment Performance• Needle Access Ports• Needleless Access Ports• Blood Pathway Volume• Tensile Strength• Transducer Protectors• Tubing Compliance• Mechanical Hemolysis• Resist Kinking After Repeated Clamping• Simulated Treatment• Connector to Haemodialyser• Connectors to Vascular Access Device• Connectors to Ancillary Components• Colour Coding• Air-Capture Chamber Fill Level• Blood Pathway Flow Dynamics
Performance - Animal	No animal performance data is submitted in this 510(k).
Performance - Clinical	No clinical performance data is submitted in this 510(k).
Substantial Equivalence	The Subject Device has the same intended use as the Predicate Device.The Subject Device has the same design and configuration as the Predicate Device.The scientific technology and principles of operation are the same between the Subject Device and the Predicate Device.Materials used for the Subject Device and the Predicate Device are similar and no new or additional materials are used in the Subject Device other than materials used in the Predicate Device.The dialysis machine model, sterilization method and the shape of the connection part of the pressure measurement part used in the Subject Device is different for the Predicate Device.Several performance tests confirmed compatibility of the Subject Device with the dialysis machine as for the Predicate Device.In conclusion, based on the above considerations, the Subject Device does not raise any new questions regarding safety and effectiveness, and the Subject Device is substantially equivalent to the Predicate Device.
Conclusion	This comparison demonstrates that the Subject Device is substantially equivalent to the predicate device. The Subject Device is as safe and effective as the predicate device and will perform as intended.

NIKKISO CO., LTD. CONFIDENTIAL 510(k) Summary Attachment 08-01 4/4

K242479 Page 4 of 4

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.