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The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician or other licensed practitioner.

The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS includes arterial and venous dialysis blood tubing (non-implanted blood access device) as described in 21 CFR 876.5820. The devices are packaged together for convenient use during for hemodialysis procedures. Three models of the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS (AV06A-P, AV06B-P, AV06C-P) are being manufactured for use with the Nikkiso DBB-05 Hemodialysis Delivery System (K061519). The components of the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS include pump tubing, air trap chambers, transducer filters, pressure monitoring lines, infusion lines for saline, access ports and tubing clamps which are all used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood, monitor pressure, and make connections to other devices. Major materials used for the various components are Polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP). Materials in direct contact with blood are Polycarbonate (PC), Polyvinyl chloride (PVC), Silicone, Polypropylene (PP) and Polytetrafluoroethylene (PTFE). The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are restricted for sale by or on the orders of a physician. The NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS are packaged sterile and labeled for single use only and non-pyrogenic.

The provided document describes the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, a medical device intended for hemodialysis, and its substantial equivalence to a predicate device, the Nipro® Blood Tubing Set with Transducer Protectors and Priming Set (K010264). The acceptance criteria and the study proving conformance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of a dataset for algorithmic evaluation. Instead, the testing described appears to be for verification and validation of the physical device according to established standards.

• Sample Size: Not explicitly stated for each specific test, but the document implies that "all tests required in RD17" were performed on both the NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS and the Nipro tubing set.
• Data Provenance: The tests were performed by NIKKISO CO., LTD. for their device and were compared against the predicate device's performance which was also evaluated against the same standard by Nipro. The country of origin for NIKKISO CO., LTD. is Japan. The data is prospective in the sense that the tests were conducted specifically for the submission.

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

Not applicable. The ground truth for this device's performance is established by conformance to recognized international and national standards (ANSI/AAMI RD17: 2007 and ISO10993), rather than expert consensus on a test set.

4. Adjudication Method

Not applicable. The evaluation is based on meeting pre-defined criteria in engineering and biological safety standards, not on subjective expert assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical medical accessory for hemodialysis tubing, not an AI or diagnostic imaging device that would typically undergo an MRMC study for human reader performance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth is based on established industry standards and regulatory requirements as defined in:

• ANSI/AAMI RD17: 2007 "Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofitters"
• ISO10993 (various parts for biocompatibility)
• ISO11134 and EN554 (for steam sterilization validation)
• ISO11135-1 (for Ethylene Oxide sterilization, referenced for the predicate)

8. Sample Size for the Training Set

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

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

Not applicable, as no training set is relevant for this device.

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