(90 days)
Gambro PrismaSate™ solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Gambro PrismaSate solutions are 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 dialysable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used.
The solutions are perfused through the dialysis fluid compartment of hemofilters/dialyzers. The dialysate is separated from the patient's blood by means of a semi-permeable membrane. Excess waste products, fluids and toxins found in the blood of a patient with acute renal failure pass through the membrane into the dialysate and eventually go to waste. The therapy is aimed at normalizing the blood.
CRRT is used for acute renal failure patients that may be too unstable to tolerate conventional hemodialysis, in which this function occurs much more rapidly (3-4 hours per treatment) and intermittently (3-6 times a week). In CRRT, the balancing is done on a continuous basis, 24 hours a day, in order to mimic kidney function.
The provided text describes a 510(k) premarket notification for a dialysis solution, not a medical device that utilizes AI or requires a study comparing its performance to acceptance criteria in the way a diagnostic algorithm would. Therefore, most of the requested information (sample sizes, experts, adjudication methods, MRMC studies, standalone performance, training sets) is not applicable.
The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical or technical study of the device's diagnostic or predictive capabilities.
Here's the closest interpretation of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (dialysis solution), the "acceptance criteria" are primarily related to its chemical composition, sterility, packaging, and intended use being equivalent to already cleared devices. The "reported device performance" is the statement of its characteristics.
| Acceptance Criteria (based on Predicate Devices) | Reported Device Characteristics (Gambro PrismaSate) |
|---|---|
| Intended Use: Dialysate for use in Continuous Renal Replacement Therapy. | Dialysate for use in Continuous Renal Replacement Therapy. Indicated for treatment of acute renal failure and other cases necessitating fluid or solute removal. |
| Chemical Composition: Ranges of sodium, calcium, potassium, magnesium, bicarbonate, lactate, acetate, dextrose. (Specific ranges from predicate devices were compared). | Ranges of Sodium 137 - 142 mEq/L, Calcium 0 - 4 mEq/L, Potassium 0 - 4 mEq/L, Magnesium 0.5 - 1.5 mEq/L, Bicarbonate 0 - 36 mEq/L, Lactate 0 - 40 mEq/L, Acetate 0 mEq/L, Dextrose 0 - 2 g/L. (Note: Higher lactate concentration than predicates, but within European Pharmacopoeia Monograph standard). |
| Sterility: Terminally Sterilized or Manufactured as a sterile product. | Terminally Sterilized |
| Packaging: PVC Bag, Glass Vials, PP/PE containers. | PVC Bag |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a medical device submission for a dialysis solution, not an AI or diagnostic device that uses a test set of data. The "test" is the comparison of its characteristics and intended use to predicate devices and recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of an AI or diagnostic device, is not relevant here. The "ground truth" for chemical composition would be established by analytical chemistry techniques, and for sterility by microbiological testing, but these are part of standard manufacturing and quality control, not a "test set" in the AI sense.
4. Adjudication method for the test set
- Not Applicable. See reasons for #2 and #3.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not have an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the chemical composition and sterility, the "ground truth" would be established by analytical chemistry testing (e.g., spectrophotometry, chromatography) and microbiological testing (e.g., sterility tests). For the intended use and technological characteristics, the "ground truth" is established by comparison to regulatory definitions and established predicate devices. The document explicitly states: "Comparing the proposed device to the predicate devices, its ranges of chemical compositions, packaging, and sterility are equivalent to one or more of the predicate devices."
8. The sample size for the training set
- Not Applicable. There is no training set for this type of device.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set.
Summary of the Study/Demonstration of Acceptance:
The "study" in this context is a comparative analysis of the device's characteristics against legally marketed predicate devices, as detailed in the "Comparison to Predicate Devices" section of the 510(k) summary. The manufacturer, Gambro Renal Products, asserts that their PrismaSate Dialysis Solutions are substantially equivalent to the following predicate devices:
- Premixed Dialysate for Hemodiafiltration (K910270, Baxter Healthcare Corp.)
- Normocarb Sterile Bicarbonate Renal Dialysis Concentrate (K001059, Dialysis Solutions, Inc. / Novex Pharma)
- Hemodialysis Bath Concentrate Solutions for Hemodialysis (K864265, Dial Medical of Florida, Inc.)
- Dry AC Acid Concentrate Mix for Bicarbonate Hemodialysis (K011368, Gambro Renal Products)
The documentation highlights that the PrismaSate solutions' chemical compositions, packaging, and sterility are equivalent to one or more of these predicates. A specific point of comparison was the lactate concentration, where PrismaSate's upper level (40 mEq/L) was higher than the predicate devices but was justified as being within the European Pharmacopoeia Monograph for Solutions for Hemofiltration and Hemodiafiltration (30-60 mEq/L), which is an accepted reference standard. The manufacturer argued that the higher lactate concentration brings the pH closer to physiological plasma pH and has no adverse effect on safety or effectiveness.
Ultimately, the FDA's letter states that they reviewed the 510(k) and "determined the device is substantially equivalent (...) to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets the necessary regulatory "acceptance criteria" for market clearance.
§ 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.