(385 days)
The Nipro Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.
The SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. One device package includes 1 arterial line (A226Y), 1 venous line (V813), 1 attached but removable priming set and two pre-attached Transducer Protectors. The SLIMLINE is packaged sterile and labeled for single use only. There is no ability to clean and reuse this device. It is restricted for sale by or on the order of a physician.
The document provided is a 510(k) summary for a medical device called the "Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, much of the information requested about acceptance criteria and studies in the context of AI/diagnostic devices (e.g., sample size, ground truth, expert consensus, MRMC studies) is not applicable here.
However, I can extract information related to the device's performance, the type of testing conducted, and the basis for its clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance in the way one might see for an AI diagnostic algorithm's sensitivity/specificity. Instead, it details bench testing conducted to demonstrate that the device is safe and effective and performs equivalently to its predicate. The "acceptance criteria" in this context are implicitly that the device passes these bench tests successfully.
| Test Category | Specific Test (Implicit Acceptance Criteria: Successful Completion/Passing) | Reported Device Performance (Implicit: Passed All Tests) |
|---|---|---|
| Physical Integrity | Package integrity | Passed |
| Pressure leak (positive and negative) | Passed | |
| Tensile testing of joints and materials of all tubing segments | Passed | |
| Performance testing of tubing to resist kinking after repeated clamping, particularly in the post pump tubing segment | Passed | |
| Functional Performance | Endurance test of pump segment at maximum flow rate and pressures of the dialysis machine | Passed |
| Pump segment performance | Passed | |
| Endurance testing of any injection port after penetrated by 18G hypodermic needle | Passed | |
| Priming volume assessment | Passed | |
| Ability of Transducer protector to withstand leakage when subjected to pressures up to 2 times the maximum labeled pressure (Strikethrough test) | Passed | |
| Performance test of the device's clamps | Passed | |
| Biocompatibility | Hemocompatibility test | Passed |
The successful completion of these non-clinical (bench) tests forms the basis for the conclusion that the device performs equivalently to the predicate device and is safe and effective when used as intended.
The following questions are not applicable to this 510(k) submission, as it pertains to a physical medical device (blood tubing set) and relies on bench testing for substantial equivalence, not clinical studies or AI algorithm performance validation.
- Sample sizes used for the test set and the data provenance: Not applicable. Bench testing, not a diagnostic test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense needed for this device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical device like this is its ability to meet performance specifications and safety criteria through bench testing.
- The sample size for the training set: Not applicable. This is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.
§ 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.