(157 days)
No new claims or indications are made.
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.
While K962081 describes a medical device kit, the provided text does not contain any information regarding specific acceptance criteria, performance data, or a study that proves the device meets those criteria.
The document primarily focuses on demonstrating that the kit's components are either legally marketed individually, substantially equivalent to existing products, or have undergone basic functional and biocompatibility testing. It explicitly states, "No new claims or indications are made." This suggests that the device, as a kit, is not undergoing a novel performance evaluation but rather demonstrating the safety and equivalence of its combined components.
Therefore, I cannot fulfill your request as there is no information in the provided input about acceptance criteria or a study demonstrating performance against those criteria.
To provide the requested information, the input would need to include details such as:
- Specific performance metrics: e.g., accuracy, sensitivity, specificity, or other functional parameters.
- Target thresholds for these metrics: e.g., "sensitivity ≥ 90%."
- Study design: e.g., clinical trial, retrospective analysis, lab-based performance testing.
- Results of the study: The device's achieved performance against the defined metrics.
- Details about the data used: sample size, provenance, ground truth establishment, etc.
Without this kind of information, it's impossible to create the table or answer the specific questions about the study design and results.
§ 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.