(265 days)
NaturaLyte® Dry Bicarbonate Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. NaturaLyte® Dry Bicarbonate Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription.
NaturaLyte Dry Bicarbonate Concentrate is a non-sterile, single use device composed of United States Pharmacopeia (USP) grade sodium bicarbonate. NaturaLyte Dry Bicarbonate Concentrate products are packaged in either bags or cartons. The two (2) bag configurations are constructed from identical materials and only differ in the mass of dry bicarbonate powder contained within. The cartons are used for preparation of individual batches of bicarbonate concentrate.
NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powder and is used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician's prescription. NaturaLyte Dry Bicarbonate Concentrate is formulated for use in 45X proportioning systems which proportion a nominal ratio of 1 : 1.72 : 42.28 (acid : bicarbonate : water) to generate dialysate. The dialysate is intended to be pumped through a dialyzer, creating an osmotic gradient across the dialyzer membrane to exchange solutes with blood during hemodialysis.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for a medical device called "NaturaLyte Dry Bicarbonate Concentrate." This document pertains to the substantial equivalence determination of a dry bicarbonate concentrate used in hemodialysis systems, not an AI/ML-driven device.
Therefore, the specific information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this type of medical device.
The document describes performance testing relevant to a chemical concentrate and its packaging, such as:
- Stability Design Verification: To support a 24-month (2-year) shelf life, monitored as part of routine production testing using real-time stability evaluations.
- Shipping Verification: Performed in accordance with ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) to ensure packaging withstands distribution.
- Biocompatibility Testing: Assessed endpoints including chemical characterization, cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity, and hemocompatibility, along with a toxicological risk assessment.
- Human Factors Validation Testing: Validated for safe and effective use in accordance with FDA guidance for medical devices.
The document explicitly states:
- "Electrical Safety and Electromagnetic Compatibility: Not applicable. The NaturaLyte Dry Bicarbonate Concentrate is not an electrical mechanical device."
- "Software Verification and Validation Testing: Not applicable. The NaturaLyte Dry Bicarbonate Concentrate does not contain software."
- "Animal Studies: No animal studies were performed for NaturaLyte Dry Bicarbonate Concentrate."
- "Clinical Studies: No clinical studies were performed for NaturaLyte Dry Bicarbonate Concentrate."
Conclusion:
The NaturaLyte Dry Bicarbonate Concentrate is a chemical concentrate, not a device that involves AI/ML, image analysis, or human reader performance. As such, the requested details regarding AI/ML acceptance criteria, study design, expert involvement, and ground truth for AI algorithms are not present or relevant in this 510(k) submission.
§ 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.