(8 days)
The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.
The blood tubing sets consist of a family of products which are used during extracorporeal procedures to provide a means to connect blood access devices to a hemodialysis or hemofiltration machine and a hemodialyzer or hemofilter. To facilitate a hemodialysis procedure, for example, the arterial and/or venous blood tubing sets may contain features such as air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines with or without transducer protectors. Numerous product codes are produced to accommodate various manufacturer's dialysis machines, as well as differing clinical preferences and clinical procedures.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the performance of the blood tubing sets. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical bench testing.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Device | "Results of this testing have documented that the subject blood tubing set is substantially equivalent to the predicate device and is suitable for the labeled indications for use." |
| Adequacy for Labeled Indications for Use | "NxStage Medical, Inc. believes that the information and data provided in this submission clearly describes the subject device and demonstrates that the device is adequately designed for the labeled indications for use." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the non-clinical bench testing.
- Data Provenance: The testing was "Non-Clinical Test/Performance Testing - Bench" conducted by NxStage Medical, Inc. This indicates it was internal, prospective bench testing. The country of origin for the data is not specified beyond being generated by the submitter (NxStage Medical, Inc. in Lawrence, MA, USA, with manufacturing sites in Mexico and Thailand, and sterilization sites in the USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a blood tubing set, and the evaluation is based on non-clinical bench testing, not image analysis or diagnostic performance requiring human expert ground truth.
4. Adjudication Method for the Test Set
Not applicable, as ground truth derived from human experts is not relevant for this type of device evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a medical device for blood transport, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a hardware medical device, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is the functional performance and safety characteristics of the blood tubing sets as demonstrated through validated non-clinical bench testing, showing they meet design specifications and are comparable to the predicate device. It's based on engineering and performance specifications/standards.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.