(87 days)
KayBath acid concentrate dialysate is administered with bicarbonate dialysate and AAMI quality water in a 3 stream proportioning artificial kidney equipment to perform hemodialysis in the ES ID population
KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium and potassium), along with dextrose and glacial acetic acid. Pharmaceutical grade water, produced by a reverse osmosis pump under AAMI Standards, is used to mix the salts, dextrose and acetic acid. The solution is formulated and intended for the express purpose of performing hemodialysis. The acidified dialysate is proportioned inside commercially available hemodialysis machines with water and bicarbonate dialysate. The three streams of liquid unite to become the dialysate that runs countercurrent to the blood through the dialyzer at 500cc/min. The hemodialysis device provides the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate. The dialyzer consists of hundreds of hollow strands of a cellulosic or synthetic membrane inside a cylinder. The membrane serves as a selective barrier to the passage of molecules beyond a certain molecular weight. While the blood travels through the hollow strands, undesirable substances in the blood, such as urea, nitrogen, potassium, etc., pass through the semipermeable membrane into the dialysate and are flushed down the drains.
The provided document (K982813) is a 510(k) premarket notification for a medical device: Dialysate Concentrate for Hemodialysis (Liquid or Powder).
Based on the document, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance |
|---|---|---|
| Composition | Same range of chemical compositions as the predicate device. | KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium, potassium), dextrose, and glacial acetic acid. The composition is described as "quite precise and uniform" and there are "no significant differences between those marketed products and this proposed device" (referring to the predicate). |
| Intended Use | Same intended use as the predicate device (Bicarbonate Dialysis Bath Concentrate Solution). | Indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure, with the appropriate hemodialysis machine. This is stated to be "essentially the same as the indication statement of the predicate device." |
| Packaging & Labeling | Same packaging and labeling as the predicate device. | No specific details provided on packaging/labeling, but stated that "both devices utilize the same... packaging and formulations." |
| Formulation | Same formulations as the predicate device. | No specific details provided on formulation, but stated that "both devices utilize the same... formulations." |
| Safety and Effectiveness | Safe, effective, and performs as well as the predicate device, when used in accordance with industry standards. | Conclusion states the device "will be safe, effective, and perform as well as the predicate device, when used in accordance with industry standards." This is a prospective claim based on substantial equivalence, not a direct measurement of performance. |
2. Sample Size Used for the Test Set and Data Provenance
- No test set was used. The device received 510(k) clearance based on substantial equivalence to a predicate device, not on direct clinical or in-vitro testing of the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There was no test set or ground truth established for the proposed device through expert review. The submission relies on the established safety and effectiveness of the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No test set was used.
5. 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
- Not applicable. This device is a concentrate solution for hemodialysis, not an AI-powered diagnostic device. Therefore, no MRMC study was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a concentrate solution for hemodialysis, not an algorithm.
7. The Type of Ground Truth Used
- "Predicate Device Equivalence Ground Truth": The ground truth for this submission is the established safety and effectiveness profile of the legally marketed predicate device (Fresenius USA, Acid Concentrate for Bicarbonate Dialysis, K810925). The fundamental assertion is that the proposed device, being chemically and functionally identical within expected ranges, thereby shares the same safety and effectiveness characteristics.
8. The Sample Size for the Training Set
- Not applicable. The device is a chemical concentrate, not a machine learning model. There was no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There was no training set. The "ground truth" for granting clearance was the existing regulatory approval and market performance of the predicate device, which would have had its own rigorous testing and validation historically.
§ 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.