(238 days)
THIS HEMODIALYSIS BLOOD LINE SET IS CONNECTED TO THE PATIENT AS A DEVICE WHICH WILL EXTRACT THE BLOOD TO THE ARTIFICIAL ORGAN AND PUMPED BACK TO THE PATIENT.
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The provided text describes an FDA 510(k) clearance letter for a medical device called the "Exel I.V. Blood Line Set." This document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria for a new, AI-powered diagnostic device.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically:
- A table of acceptance criteria and the reported device performance: This document doesn't define specific performance metrics or acceptance thresholds.
- Sample size used for the test set and the data provenance: There's no mention of a test set or its characteristics.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not discussed.
- Adjudication method for the test set: Not applicable as no test set is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not an AI-powered device, so such a study is irrelevant here.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for performance evaluation is not discussed.
- The sample size for the training set: Not applicable as it's not an AI device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document's purpose is to grant marketing clearance based on a finding of "substantial equivalence" to a legally marketed predicate device, as per 21 CFR §876.5820. This process primarily involves comparing the new device's technological characteristics and intended use to an existing, approved device, rather than requiring extensive de novo performance studies with numerical acceptance criteria often seen for novel AI/diagnostic technologies.
§ 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.