(327 days)
The JMS Blood Tubing Sets with transducer protector and priming sets are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis.
The tubing sets that JMS intended to market include arterial and venous dialysis blood tubing as described in 21 CFR 876.5820. Various models of blood tubing sets are being manufactured for application with different dialysis machines, such as Baxter, Fresenius, Althin, etc. All components of blood tubing set, including drip chambers, infusion tubing, monitoring lines, ports, and segments which are use to pump blood, retain and capture air and blood debris, infuse medications or fluid, sampling blood, pressure monitoring and making connections to other devices, are all included. The materials used are mainly, polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), acrylonitrite butadiene styrene (ABS), and polycarbonate (PC).
The provided text is a 510(k) summary for a medical device called "JMS Blood Tubing Sets." This document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. As such, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.
The document highlights the following:
- Device Type: Hemodialysis system and accessories (blood tubing sets).
- Intended Use: To transfer blood from patients' vascular access system to the hemodialyzer through an arterial tubing, and from the hemodialyzer to the patient vascular system via a venous tubing.
- Substantial Equivalence: The manufacturer asserts that the JMS Blood Tubing Sets are substantially equivalent to several legally marketed predicate devices in terms of intended use, design, safety, and effectiveness.
- Testing: The document mentions compliance with the AAMI/ANSI RD 17:1994 standard for "Hemodialyzer Tubing set" and biocompatibility testing according to ISO 10993. These are engineering and biocompatibility standards, not clinical performance acceptance criteria or studies involving AI/algorithms.
Therefore, I cannot extract the requested information (table of acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types, or training set details) from the provided text because it is not a clinical study report for an AI/algorithm-based 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.