(112 days)
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.
The BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) 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 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 or 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 device for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 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.
I'm limited to the information provided and cannot determine the acceptance criteria or reported device performance for NIKKISO Co., Ltd.'s Blood Tubing Lines since the text does not contain such details. The document is a 510(k) summary, which outlines the device description, intended use, and technological characteristics, but does not provide specific performance data or acceptance criteria that a study would prove the device meets. The listed "Test Item" reports are general performance tests and do not include the acceptance criteria or the numerical results that would fulfill the criteria. Therefore, I cannot construct the table you requested.
The document states that no animal or clinical performance data was submitted, so a study with a test set, ground truth, or adjudication methods as requested in your prompt was not provided in this 510(k) submission.
Therefore, for the specific questions:
- A table of acceptance criteria and the reported device performance: Cannot be provided as this information is not present in the document.
- Sample sizes used for the test set and the data provenance: Not applicable, as no performance study results were provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study results were provided.
- Adjudication method for the test set: Not applicable, as no performance study results were provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, no clinical performance data was submitted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical medical device (blood tubing lines), not an AI algorithm, so this question is not applicable. No standalone performance study results were provided.
- The type of ground truth used: Not applicable, as no performance study results were provided.
- The sample size for the training set: Not applicable, as no AI algorithm is involved.
- How the ground truth for the training set was established: Not applicable, as no AI algorithm is involved.
The document lists various "Test Item" reports (e.g., Sterilization Barrier System Performance Test, Mechanical Hemolysis, Structural Integrity), but these are general performance tests for the device's functionality rather than a study designed to meet specific clinical acceptance criteria. The submission declares that the device is "substantially equivalent" to a predicate device (K082719) based on similar intended use and technological characteristics, with only minor differences that "do not raise new questions of safety and effectiveness." This indicates that the regulatory clearance relies on equivalence to a previously approved device rather than presenting new performance data against specific acceptance criteria.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| X 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.20-3, Ebisu 4-Chome, Shibuya-kuTokyo 150-6022, Japan | |
| Contact | Satoko HinaQuality Assurance DepartmentMedical DivisionNIKKISO CO., LTD.20-3, Ebisu 4-Chome, Shibuya-kuTokyo 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 SeriesDevice 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 (Archloop) includes arterial andvenous dialysis blood tubing.The devices are packaged together for convenient use during hemodialysis procedures. They aremanufactured for application with the DBB-06 Hemodialysis Delivery System. The componentsof 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, infusemedications or fluids, sample blood as well as monitor pressure.The devices are packaged sterile and labeled for single use only. These devices cannot be cleanedor 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 tubinglines device for hemodialysis. The devices are packaged together for convenient use duringhemodialysis procedures. They are manufactured for application with the DBB-06 HemodialysisDelivery System. The devices are packaged sterile and labeled for single use only. These devicescannot 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 andchronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device isnot indicated for pediatric patients. It is not for home use.This device is made up of disposable bloodlines intended to provide extracorporeal access to apatient's blood during hemodialysis. It is the responsibility of the physician or other licensedpractitioner to ensure compatibility with the available configurations. | |
| Predicate Device | 510(k) Number: | K082719 |
| Device Name: | NIKKLINE BLOOD TUBING LINES WITHTRANSDUCER PROTECTORS, MODELSAV06A-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 | |
| TechnologicalCharacteristics | The subject device and predicate device have substantially equivalent technological characteristics:• Similar intended use including similar indication for use.• Similar design and configuration.• Same scientific technology and principles of operation. | |
| The following are the only minor differences:• EOG sterilization is adopted as the sterilization method.• Newly adopted Styrenic thermoplastic elastomer (SEBS), Isoprene rubber (IR) and MethylMethacrylate Acrylonitrile Butadiene Styrene (MABS) as new materials.• In addition to traditional transducer protection filters, PODs (Pressure monitor pod) are usedas a connection component to the pressure measurement unit.• Compliance with the latest standards and guidance. | ||
| FDA GuidanceDocuments | The following FDA guidance documents were referenced in preparing this premarket notification:• eCopy Program for Medical Device Submissions, issued April 2020• Format for Traditional and Abbreviated 510(k)s, issued September 2019• Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, issued June2012• 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 Informationin 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 - Part1: 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 SystemPerformance Test | TR-20210412-070442-16(Appendix 24) |
| 2 | Blood Pathway FlowDynamics | TR-20210331-070442-01(Appendix 25) |
| 3 | Colour Coding | VER-P301201-160(Appendix 26) |
| 4 | Connectors to Haemodialyser | TR-20210412-070442-02(Appendix 27) |
| 5 | Connectors toAncillary Components | TR-20210412-070442-15(Appendix 28) |
| 6 | Connectors toVascular Access Device | TR-20210412-070442-03(Appendix 29) |
| 7 | Mechanical Hemolysis | TR-20210412-070442-11(Appendix 30) |
| 8 | Needle Access Ports | TR-20210412-070442-04(Appendix 31) |
| 9 | Needleless Access Ports | TR-20210412-070442-05(Appendix 32) |
| 10 | Blood Pathway Volume | TR-20210412-070442-06(Appendix 33) |
| 11 | Structural Integrity | TR-20210412-070442-01(Appendix 34) |
| 12 | Tensile Strength | TR-20210412-070442-13(Appendix 35) |
| 13 | Transducer Protectors | TR-20210412-070442-10(Appendix 36) |
| 14 | Dimensional andWorkmanship Analysis | TR-20211101-070442-01(Appendix 37) |
| 15 | Peak Pressure Test of EOGSterile AL Series for DBB-06 | TR-20230104-070442-01(Appendix 38) |
| 16 | Pump Segment Performance | TR-20221222-070442-01(Appendix 39) |
| 17 | Air-capture Chamber FillLevel | TR-20220707-210531-03(Appendix 40) |
| 18 | Resist Kinking After RepeatedClamping | TR-20220707-210531-02(Appendix 41) |
| 19 | Tubing Compliance | TR-20220707-210531-01(Appendix 42) |
| 20 | Simulated Treatment | TR-20230523-070442-01(Appendix 43) |
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| Performance- Animal | No animal performance data is submitted in this Traditional 510(k). |
|---|---|
| Performance-Clinical | No clinical performance data is submitted in this Traditional 510(k). |
| SubstantialEquivalence | The subject devices are substantially equivalent to the predicate device when evaluating intendeduse 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. |
§ 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.