(76 days)
The rinse lines are used to connect one blood port of a dialyzer to the opposite blood port to create a loop. When both blood ports are so connected, the line itself is connected to a pump on a rinse machine which primes the dialyzer with rinse solution and fills it with a sterilant solution, so the dialyzer can be disinfected, while it is stored on the shelf awaiting its next use. The rinse line is also used for taking a sample of the sterilant solution. This is done by inserting a needle through an access site on the rinse line, and taking a sample for testing. The devices are clean, but not sterile.
The t-connectors are used during the rinse procedure of the dialyzer. They connect each end of the two blood ports on a dialyzer to the reprocessing system and allow cleaning solutions to be passed through the membrane of the dialyzer. The devices are clean, but not sterile.
Pump Segment Rinse Lines & T-Connectors
Pump segment rinse line w/ slip-on connector (Our Catalog No. PS100R)
Pump segment rinse line w/ luer-lock connector (Our Catalog No. PS100B)
T-connector, short, w/ slip-on connector (Our Catalog No. ST100R)
T-connector, short, w/ luer-lock connector (Our Catalog No. ST100B)
T-connector, long, w/ slip-on connector (Our Catalog No. LT100R)
T-connector, long, w/ luer-lock connector (Our Catalog No. LT100B)
The connecting ends of the rinse lines and the t-connectors are of two possible types: a slip-on connector or a luer-lock, screw-on connector.
The slip-on connector is tapered to securely adhere to the "male" end of the blood port. It is released by pulling it straight off. The surface of the blood port and the surface of the slip-on connector meet, and create a frction seal that prevents any fluids from leaking out of the dialyzer.
The luer-lock, screw-on connector securely screws on to the "male" end of the blood port. It is released by unscrewing it. The surface of the blood port and the surface of the luer-lock, screw-on connector meet, and create a frotion seal that prevents any fluids from leaking out of the dia
The provided text is a 510(k) premarket notification letter from the FDA to DaySpring Medical, Inc. regarding their Pump Segment Rinse Lines and T-Connectors. This document does not contain any information about acceptance criteria or a study proving device performance as it relates to software or AI.
The letter simply states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and general controls, not on specific performance studies or acceptance criteria for a device that would typically involve AI or software components.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to a medical device that appears to be physical components (rinse lines and T-connectors) used in dialyzer reprocessing, without any mention of AI or software performance.
§ 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.