(91 days)
Accusol Solutions are indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.
Accusol Dialysis Solution is a bicarbonate based solution used in continuous renal replacement therapies
This 510(k) summary describes a dialysis solution, not a device that relies on performance characteristics measured against acceptance criteria in the typical sense of a medical imaging or diagnostic device. Therefore, the requested information elements such as sample sizes, expert ground truth, adjudication methods, and MRMC studies are not applicable.
Instead, the study presented for the "Accusol Dialysis Solution" is a demonstration of substantial equivalence to legally marketed predicate devices, focusing on the formulation and container system.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Formulation Equivalence: Same solution components and quantitative levels as predicate devices. | Accusol Dialysis Solution is formulated of the same solution components to the same quantitative levels as dialysis solutions used to formulate the PrismaSate and BIASOL products. |
| Container System Equivalence: Similar design, materials of construction, and closure system to predicate devices. | The Accusol Dialysis Solution container system is similar in design to the PrismaSate Dialysis Solution container system and to the materials of construction and closure system of the Premixed Dialysate for Hemodiafiltration products. |
| Intended Use Equivalence: Same indications for use as predicate devices. | Accusol Solutions are indicated for use as dialysis solutions in Continuous Renal Replacement Therapy. This matches the implied intended use of the predicate devices (PrismaSate Dialysis Solutions, Premixed Dialysate for Hemodiafiltration, BIASOL Liquid Concentrate), which are also dialysis solutions for similar therapies. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is not a study involving a test set of patient data, but rather a comparison of product specifications and characteristics against existing, approved products. There is no "data provenance" in the sense of patient origin or retrospective/prospective collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth in the context of diagnostic accuracy was established by experts for a test set. The "ground truth" here is the established and approved specifications of the predicate devices.
4. Adjudication method for the test set:
- Not Applicable. No test set requiring expert adjudication was involved.
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 or imaging device, so no MRMC study or AI-related metrics are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device.
7. The type of ground truth used:
- The "ground truth" in this context is the established specifications and regulatory approvals of the predicate legally marketed devices. These predicates, such as PrismaSate Dialysis Solutions and BIASOL Liquid Concentrate, have already undergone their own regulatory review and are accepted as safe and effective for their intended use.
8. The sample size for the training set:
- Not Applicable. This type of submission does not involve a training set as it's not a machine learning or AI-based device.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8)
§ 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.