COMBILINES HEMODIALYSIS BLOOD TUBING SET

K962081 · National Medical Care, Medical Products Div., Inc. · FJK · Nov 1, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962081
• Device Name: COMBILINES HEMODIALYSIS BLOOD TUBING SET
• Applicant: National Medical Care, Medical Products Div., Inc.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Device Story

Kit containing I.V. sets, transducer protectors, and arterial/venous bloodlines; components used for bloodline management in clinical settings; bloodlines facilitate fluid/blood transport; transducer protectors prevent contamination of monitoring equipment; kit assembly involves no modifications affecting safety or efficacy; components are legally marketed individual items; bonded connections and biocompatibility verified through functional testing.

Clinical Evidence

Bench testing only; functional testing of bloodlines and bonded connections performed; biocompatibility testing of blood-contacting materials provided.

Technological Characteristics

Kit components include I.V. sets, transducer protectors, and arterial/venous bloodlines. Materials tested for biocompatibility. Integrity of bonded connections verified. Sterilization method and packaging consistent with legally marketed predicate components.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}

K962081

# NOV 1 1996 SUMMARY OF SAFETY AND EFFICACY

The proposed kit raises no new issues of safety or efficacy. In incorporating the components into a kit no modifications have been made which will affect safety or efficacy. Sterilization method and packaging are essentially the same.

The I.V. sets and transducer protectors are legally marketed as individual components. The arterial and venous bloodlines are substantially equivalent to legally marketed bloodlines. These bloodlines have been functionally tested and data provided. The blood contact materials of the arterial and venous bloodlines have been tested for biocompatibility and data provided.

The integrity of the bonded connections of the bloodlines and of the connection of the transducer protectors to the monitor lines have been tested and data provided.

No new claims or indications are made.