(194 days)
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
| Item | Acceptance Criteria (based on AAMI RD17:2007 and ISO10993) | Reported Device Performance (NIKKLINE BLOOD TUBING LINES) |
|---|---|---|
| Biological Safety | Meets ANSI/AAMI RD17: 2007 and ISO10993 requirements | Met ANSI/AAMI RD17: 2007 and ISO10993 (no concerns regarding cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility, genotoxicity) |
| Sterility (Method) | N/A (Predicate method: Ethylene Oxide) | Steam sterilization |
| Sterility (SAL) | Assured SAL 10-6 | Assured SAL 10-6 by validation met ISO11134 and EN554 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use or Reuse | Single use only | Single use only |
| Structural Integrity | Meets 4.4.1 Structural integrity AAMI RD17: 2007 | Met 4.4.1 Structural integrity AAMI RD17: 2007 |
| Connection to Hemodialyzer/Hemofilter | Meets 4.4.2 AAMI RD17: 2007 | Met 4.4.2 AAMI RD17: 2007 |
| Connection to Vascular Access Device | Meets 4.4.3 AAMI RD17: 2007 | Met 4.4.3 AAMI RD17: 2007 |
| Connection to Ancillary Components | Meets 4.4.4 AAMI RD17: 2007 | Met 4.4.4 AAMI RD17: 2007 |
| Color Coding | Meets 4.4.5 AAMI RD17: 2007 | Met 4.4.5 AAMI RD17: 2007 (arterial red, venous blue) |
| Needle Access Ports | Meets 4.4.6.1 AAMI RD17: 2007 | Met 4.4.6.1 AAMI RD17: 2007 |
| Transducer Protector | Meets 4.4.9.1 Integral transducer protectors AAMI RD17: 2007 | Met 4.4.9.1 Integral transducer protectors AAMI RD17: 2007 |
| Blood pathway volume | (Not explicitly specified as a numerical criterion, but evaluated per AAMI RD17:2007) | Performed successfully in accordance with AAMI RD17: 2007 |
| Blood pathway flow dynamics | (Not explicitly specified as a numerical criterion, but evaluated per AAMI RD17:2007) | Performed successfully in accordance with AAMI RD17: 2007 |
| Pump segment performance | (Not explicitly specified as a numerical criterion, but evaluated per AAMI RD17:2007) | Performed successfully in accordance with AAMI RD17: 2007 |
| Occlusive clamping of tubing | (Not explicitly specified as a numerical criterion, but evaluated per AAMI RD17:2007) | Performed successfully in accordance with AAMI RD17: 2007 |
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.
§ 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.