(268 days)
Citrasate® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. Citrasate® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
GranuFlo® Dry Acid Concentrate is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. GranuFlo® Dry Acid Concentrate is intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine to a physician's prescription.
Citrasate Dry Acid Concentrate product line consists of eight (8) formulations which differ in potassium chloride and calcium chloride mass. These dry components are packaged in four (4) flexible, laminated, sealed, and low-density polyethylene-based bags. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
GranuFlo Dry Acid Concentrate product line consists of nine (9) formulations which differ in potassium chloride and calcium chloride mass. GranuFlo Dry Acid Concentrate components are packaged in three (3) flexible, laminated, sealed, and low-density polyethylene-based bags. The bags' contents are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate products are intended for use in hemodialysis therapy for acute and chronic renal failure. Both products consist of electrolytes (chloride salts of sodium, calcium, magnesium, and potassium), dextrose, and an organic acid source (citric acid in Citrasate; sodium diacetate in GranuFlo). Citrasate also contains sodium acetate as a secondary pH adjuster.
Citrasate Dry Acid Concentrate is a single use, non-sterile, device offered in 8 formulations which differ in potassium chloride and calcium chloride mass. The product components are contained in a four-bag packaging system. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
GranuFlo Dry Acid Concentrate is a single use, non-sterile, device offered in 9 formulations which differ in potassium chloride and calcium chloride mass. The product components are contained in a three-bag packaging system. These bags are designed to be mixed together using a Fresenius Medical Care Dry Acid Dissolution Unit (K131611).
Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each 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. Both concentrates are 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 text is a 510(k) Premarket Notification for medical devices (Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate) and does not describe acceptance criteria, performance reports, or studies related to an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for these hemodialysis concentrates.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this information is not present in the provided document.
The document describes the following performance data which are relevant to the device's function as a medical concentrate, not an AI/ML algorithm:
- Stability Design Verification: Supported a 24-month (2-year) shelf life through real-time stability evaluations.
- Shipping Verification: Confirmed packaging could withstand distribution based on ASTM D4169-16.
- Biocompatibility Testing: Assessed 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.
The document explicitly states:
- "Not applicable. The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are not electrical mechanical devices." for Electrical Safety and Electromagnetic Compatibility.
- "Not applicable. The Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate do not contain software." for Software Verification and Validation Testing.
- "No animal studies were performed for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate." for Animal Studies.
- "No clinical studies were performed for Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate." for Clinical Studies.
§ 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.