Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series

K230514 · NIKKISO CO., LTD. · KOC · Jun 16, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230514
• Device Name: Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
• Applicant: NIKKISO CO., LTD.
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Jun 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Disposable blood tubing lines for hemodialysis; used with NIKKISO DBB-06 Hemodialysis Delivery System. Components include tubing, drip chambers, infusion lines, pressure monitoring lines, ports, clamps, and filters. Functions: pump blood, capture debris, infuse fluids/medications, sample blood, monitor pressure. Used in hospitals and dialysis clinics by qualified operators. Provides extracorporeal access to patient blood. Output: physical blood circuit connectivity and pressure monitoring interface. Benefits: enables safe extracorporeal blood circulation during hemodialysis treatment.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by extensive non-clinical bench testing, including structural integrity, tensile strength, mechanical hemolysis, flow dynamics, and simulated treatment performance.

Technological Characteristics

Disposable blood tubing set. Materials: Styrenic thermoplastic elastomer (SEBS), Isoprene rubber (IR), Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS). Components: tubing, drip chambers, infusion lines, pressure monitoring lines, ports, clamps, filters, and pressure monitor pods (PODs). Sterilization: EOG. Connectivity: physical connection to DBB-06 Hemodialysis Delivery System. Form factor: multi-component tubing assembly.

Indications for Use

Indicated for adult patients with acute and chronic renal failure requiring hemodialysis. Not indicated for pediatric patients. Not for home use.

Regulatory Classification

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.

Predicate Devices

• NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AV06B-P, AV06C-P (K082719)

Submission Summary (Full Text)

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June 16, 2023

NIKKISO Co., Ltd. Fumiaki Kanai President & CEO MIC International 4-32-16 Ryogoku Sumida-ku, Tokyo 130-0023 JAPAN

Re: K230514

> Trade/Device Name: Blood Tubing Lines for Hemodialysis AL Series (Archloop); AL-ADC-E(U)06, AL-CDC-E(U)06 Blood Tubing Lines for Hemodialysis C18 Series; C18BDD-E(U)06, C18RDC-E(U)06, C18SFD-E(U)06 Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: KOC Dated: June 5, 2023 Received: June 7, 2023

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 (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 located 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.

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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices

(21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

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-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-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Gema Gonzalez -S

Gema Gonzalez, MS Acting 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

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Enclosure

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### Indications for Use

510(k) Number (if known) K230514

Device Name BLOOD TUBING LINES FOR HEMODIAL YSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIAL YSIS C18 Series

#### Indications for Use (Describe)

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 pediative 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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 5. 510(k) Summary

| 510(k) Number | K230514 | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Preparation Date | June 15th, 2023 | |
| Submitter | NIKKISO CO., LTD.<br>20-3, Ebisu 4-Chome, Shibuya-ku<br>Tokyo 150-6022, Japan | |
| Contact | Satoko Hina<br>Quality Assurance Department<br>Medical Division<br>NIKKISO CO., LTD.<br>20-3, Ebisu 4-Chome, Shibuya-ku<br>Tokyo 150-6022, Japan<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Subject Device | Device Name:<br>BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)<br>BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series<br>Device Classification Name: Accessories, Blood Circuit, Hemodialysis<br>Regulation Number:<br>21 CFR 876.5820<br>Regulation Description:<br>Hemodialysis system and accessories<br>Device Class:<br>Class II<br>Classification Product Code:<br>KOC<br>Regulation Medical Specialty: Gastroenterology/Urology<br>510(k) Review Panel:<br>Gastroenterology/Urology | |
| Device Description | The BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) includes arterial and<br>venous dialysis blood tubing.<br><br>The devices are packaged together for convenient use during hemodialysis procedures. They are<br>manufactured for application with the DBB-06 Hemodialysis Delivery System. The components<br>of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports,<br>clamps and filters which are used to pump blood, retain and capture blood debris, infuse<br>medications or fluids, sample blood as well as monitor pressure.<br><br>The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned<br>or reused. They are restricted for sale by or on the order of a physician.<br><br>The BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series is one part of a blood tubing<br>lines device for hemodialysis. The devices are packaged together for convenient use during<br>hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis<br>Delivery System. The devices are packaged sterile and labeled for single use only. These devices<br>cannot be cleaned or reused. They are restricted for sale by or on the order of a physician. | |
| Intended Use /<br>Indications for Use | This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and<br>chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is<br>not indicated for pediatric patients. It is not for home use.<br><br>This device is made up of disposable bloodlines intended to provide extracorporeal access to a<br>patient's blood during hemodialysis. It is the responsibility of the physician or other licensed<br>practitioner to ensure compatibility with the available configurations. | |
| Predicate Device | 510(k) Number: | K082719 |
| | Device Name: | NIKKLINE BLOOD TUBING LINES WITH<br>TRANSDUCER PROTECTORS, MODELS<br>AV06A-P, AV06B-P, AV06C-P |
| | Applicant: | NIKKISO CO., LTD. |
| | Device Classification Name: | Accessories, Blood Circuit, Hemodialysis |
| | Regulation Number: | 21 CFR 876.5820 |
| | Regulation Description: | Hemodialysis system and accessories |
| | Device Class: | Class II |
| | Classification Product Code: | KOC |
| | Regulation Medical Specialty: | Gastroenterology/Urology |
| | 510(k) Review Panel: | Gastroenterology/Urology |
| Technological<br>Characteristics | The subject device and predicate device have substantially equivalent technological characteristics:<br>• Similar intended use including similar indication for use.<br>• Similar design and configuration.<br>• Same scientific technology and principles of operation. | |
| | The following are the only minor differences:<br>• EOG sterilization is adopted as the sterilization method.<br>• Newly adopted Styrenic thermoplastic elastomer (SEBS), Isoprene rubber (IR) and Methyl<br>Methacrylate Acrylonitrile Butadiene Styrene (MABS) as new materials.<br>• In addition to traditional transducer protection filters, PODs (Pressure monitor pod) are used<br>as a connection component to the pressure measurement unit.<br>• Compliance with the latest standards and guidance. | |
| FDA Guidance<br>Documents | The following FDA guidance documents were referenced in preparing this premarket notification:<br>• eCopy Program for Medical Device Submissions, issued April 2020<br>• Format for Traditional and Abbreviated 510(k)s, issued September 2019<br>• Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, issued June<br>2012<br>• Hemodialysis Blood Tubing Sets, issued April 2008<br>• Labeling: Regulatory Requirements for Medical Devices, issued August 1989<br>• Recommended Content and Format of Non-Clinical Bench Performance Testing Information<br>in Premarket Submissions, issued December 2019<br>• Shelf Life of Medical Devices, issued April 1991<br>• Submission and Review of Sterility Information in Premarket Notification (510(k))<br>Submissions for Devices Labeled as Sterile, issued January 2016<br>• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk management process", issued June 2016 | |

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# K230514
Page 3 of 4

| No. | Test Item | Report |
|-----|-----------------------------------------------------------|----------------------------------------|
| 1 | Sterilization Barrier System<br>Performance Test | TR-20210412-070442-16<br>(Appendix 24) |
| 2 | Blood Pathway Flow<br>Dynamics | TR-20210331-070442-01<br>(Appendix 25) |
| 3 | Colour Coding | VER-P301201-160<br>(Appendix 26) |
| 4 | Connectors to Haemodialyser | TR-20210412-070442-02<br>(Appendix 27) |
| 5 | Connectors to<br>Ancillary Components | TR-20210412-070442-15<br>(Appendix 28) |
| 6 | Connectors to<br>Vascular Access Device | TR-20210412-070442-03<br>(Appendix 29) |
| 7 | Mechanical Hemolysis | TR-20210412-070442-11<br>(Appendix 30) |
| 8 | Needle Access Ports | TR-20210412-070442-04<br>(Appendix 31) |
| 9 | Needleless Access Ports | TR-20210412-070442-05<br>(Appendix 32) |
| 10 | Blood Pathway Volume | TR-20210412-070442-06<br>(Appendix 33) |
| 11 | Structural Integrity | TR-20210412-070442-01<br>(Appendix 34) |
| 12 | Tensile Strength | TR-20210412-070442-13<br>(Appendix 35) |
| 13 | Transducer Protectors | TR-20210412-070442-10<br>(Appendix 36) |
| 14 | Dimensional and<br>Workmanship Analysis | TR-20211101-070442-01<br>(Appendix 37) |
| 15 | Peak Pressure Test of EOG<br>Sterile AL Series for DBB-06 | TR-20230104-070442-01<br>(Appendix 38) |
| 16 | Pump Segment Performance | TR-20221222-070442-01<br>(Appendix 39) |
| 17 | Air-capture Chamber Fill<br>Level | TR-20220707-210531-03<br>(Appendix 40) |
| 18 | Resist Kinking After Repeated<br>Clamping | TR-20220707-210531-02<br>(Appendix 41) |
| 19 | Tubing Compliance | TR-20220707-210531-01<br>(Appendix 42) |
| 20 | Simulated Treatment | TR-20230523-070442-01<br>(Appendix 43) |

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| Performance- Animal | No animal performance data is submitted in this Traditional 510(k). |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance-<br>Clinical | No clinical performance data is submitted in this Traditional 510(k). |
| Substantial<br>Equivalence | The subject devices are substantially equivalent to the predicate device when evaluating intended<br>use and technological characteristics. The subject devices have the same intended use as the predicate device. The subject devices and predicate device are substantially equivalent with only minor technological differences. These differences do not raise new questions of safety and effectiveness. |
| Conclusion | This comparison demonstrates that the subject devices are substantially equivalent to the predicate device. The subject devices are as safe and effective as the predicate device and will perform as intended. |