(81 days)
PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
PrismaSATE dialysis solutions are ready to use sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used with commercially available CRRT systems as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags. The composition of the fluid used in renal therapies mirrors normal plasma water, since normalization of the blood is the objective.
PrismaSATE solutions, like other currently available dialysate solutions, consist of various quantities of the following chemicals: sodium chloride, potassium chloride, magnesium chloride, calcium chloride, dextrose, and a buffer of lactose and/or bicarbonate. The solution is prescribed by a physician; the physician selects the appropriate formulation based on the patient's blood electrolyte level and desired traits. PrismaSATE dialysate solutions are offered in a range of electrolyte concentrations which mirror the range of electrolytes in plasma. The solution may be buffered using lactate, bicarbonate using lactic acid as a pH adjustor, or bicarbonate using hydrochloric acid as a pH-adjusting excipient.
This document is a 510(k) premarket notification for a medical device called "PrismaSATE dialysis solutions" by Baxter Healthcare Corporation.
Based on the provided text, the device is the PrismaSATE dialysis solutions buffered with bicarbonate using hydrochloric acid as a pH-adjusting excipient, packaged in polyolefin primary packaging materials. The purpose of this 510(k) is to expand the existing PrismaSATE solution formulations into a different packaging material.
Here's an analysis of the acceptance criteria and the "study" (design verification in this case) that aims to prove the device meets these criteria:
1. A table of acceptance criteria and the reported device performance:
The document states: "Baxter Healthcare Corporation performed design verification for the modification. The result met its acceptance criteria, and supports that the proposed device is appropriately designed for its intended use." However, it does not explicitly list the acceptance criteria or specific numerical performance results of this "design verification".
Instead, it refers to the modification of packaging material. The acceptance criteria would likely relate to the integrity and compatibility of the solution with the new polyolefin packaging, and the maintenance of the solution's properties.
Based on the "Device Comparison Table" (Table 3) and the "Discussion of Nonclinical Tests," the implied performance criteria and the device's reported ability to meet them are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Same Indications for Use as Predicate Devices | "Same: PrismaSATE Solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy." |
| Sterile (Sterilization Assurance Level) | "Same: Steam sterilized, to a Sterilization Assurance Level of at least 10-6." |
| Non-Pyrogenic | "Same: Non-pyrogenic solution" |
| Single Use | "Same: Yes" |
| Solution Formulation (same as K120333) | "Same as predicate K120333" |
| Primary Packaging Material (same as K072908) | "Same as predicate K072908: Polyolefin" |
| Shelf Life (demonstrate equivalency to K072908 shelf life) | "Same as predicate K072908: 18 months" |
| No new risks identified from the combination | "No new risks were identified." (from risk analysis) |
| Appropriately designed for intended use with modification | "The result met its acceptance criteria, and supports that the proposed device is appropriately designed for its intended use." |
| No new materials introduced (for biocompatibility) | "No new materials are introduced in this Special 510(k)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document explicitly states: "No performance data is included in this Special 510(k)." This implies that no new testing with a specific test set was conducted or provided in this submission to demonstrate performance with the new packaging. The submission relies on the substantial equivalence to predicate devices, where performance data would have been established for the individual components (solution formulation and packaging material).
Therefore, specific sample sizes, country of origin, or retrospective/prospective nature of the data for this specific submission are not provided. The "design verification" mentioned is described broadly without these details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No new test set data is presented for which ground truth would need to be established by experts for performance evaluation. The "design verification" would likely involve internal company experts in engineering, quality, and manufacturing, but their specific roles or number are not specified for "ground truth" establishment in a performance study context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of a performance study involving interpretation or scoring of data that would require an adjudication method.
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 dialysis solution and its packaging, not an AI or imaging diagnostic device that would require an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the conventional sense of a clinical performance study for an AI or diagnostic device. The "ground truth" for this submission is effectively the established performance and safety profiles of the predicate devices. The "design verification" likely relied on manufacturing specifications, chemical analysis, stability testing, and packaging integrity tests, rather than a clinical "ground truth" established by external experts.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.