(90 days)
Diasol-BiCarb Schutions are indicated for use in acute and chronic hemodialysis and have to be used in conjunction with Diasol acid concentrate or any other commercially available concentrate in the correct proportioning and AAMI standard water as Dialysate solution for hemodialysis .For use in 3 stream dialysis machines calibrated for use with acid and bicarbonate concentrate.
Sodium Bicarbonate is part of the dialysate concentrate for hemodialysis. When mixed with AAM standard water and Acid Concentrate, it creates a dialysate solution for use in renal dialysis therapy. read diarysis therepy . Diasol-BiCarb solution is in a ready to use form that is convenient for use in chronic care dialysis unit as well as acute care, dialysis thin as well as noter care. Sodium bicarbonate Hemodialysis grade, a white, water soluble powder is mixed with South block one of the case your Chloride USP (for 36.83 proportioning) in adequate proportions to provide the bicarbonate part of the dialysate. proportions to provide the breat benefits plastic container (HDPE) similar to the predicate. The solution is non-sterile, non-pyrogenic. Finished product is gamma radiated. The southout is non-centions have been taken to assure that the finished product does not promote bacterial growth.
This document describes a 510(k) premarket notification for the DIASOL-BiCarb, a liquid sodium bicarbonate solution for hemodialysis. As such, the submission focuses on demonstrating "substantial equivalence" to a predicate device rather than conducting a full clinical study with acceptance criteria and a detailed study report as would be typical for novel devices.
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1. Table of Acceptance Criteria and Reported Device Performance
No explicit "acceptance criteria" for performance metrics are provided in the document in the way one would see for a diagnostic or therapeutic device with measurable outcomes (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this 510(k) submission are implicit in demonstrating substantial equivalence to predicate devices. This means proving that the new device is as safe and effective as a legally marketed device.
The "reported device performance" is essentially that the DIASOL-BiCarb is substantially equivalent to the predicate devices (RENOSOL K792213 and K781967, and STERILYTE K971053) based on its intended use, composition, raw materials, manufacturing processes, and packaging.
| Feature/Criterion | DIASOL-BiCarb Performance/Description |
|---|---|
| Intended Use | Same as predicate, for hemodialysis dialysate. |
| Raw Materials | Same grade of raw material as predicates (Sodium Bicarbonate Hemodialysis grade, Sodium Chloride USP). |
| Composition | Similar to predicate (bicarbonate component of dialysate). |
| Packaging | Same type of packaging as predicates (HDPE plastic container). |
| Sterility | Non-sterile, non-pyrogenic; finished product is gamma radiated to prevent bacterial growth. |
| Microbiological Standards | Observes AAMI microbiological standards; LAL and microbiological cultures performed on all batches using AAMI approved methods. |
| Safety and Effectiveness Conclusion | Substantially equivalent to predicate devices RENOSOL and STERILYTE. |
2. Sample Size Used for the Test Set and Data Provenance
This is not a clinical study involving a "test set" of patients or biological samples in the traditional sense. The "test set" here refers to the manufacturing and quality control data of the DIASOL-BiCarb product itself, compared against the known characteristics and standards of the predicate devices.
- Sample Size: Not specified as a number of "cases." Instead, it refers to "all batches" of the manufactured product on which LAL and microbiological cultures are performed.
- Data Provenance: The data comes from the manufacturing and quality control processes of Diasol Inc. for the DIASOL-BiCarb. There is no information about country of origin of patient data or whether it's retrospective/prospective, as this is a materials/process equivalence submission, not a patient outcome study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of submission typically does not involve medical experts establishing "ground truth" derived from patient data. The "ground truth" for chemical composition, sterility, and adherence to AAMI standards would be established by:
- Internal experts within Diasol Inc.: Quality control specialists, chemists, microbiologists, and manufacturing engineers who ensure compliance with specified formulations, raw material quality, and AAMI standards. Their qualifications would include relevant scientific degrees and experience in pharmaceutical/medical device manufacturing and quality control.
- Regulatory Experts at FDA: The FDA reviewers who assess the 510(k) submission act as experts in determining if the provided data is sufficient to establish substantial equivalence.
No specific number of experts or detailed qualifications are provided in the public summary.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" needing expert adjudication in the context of clinical outcomes. Quality control tests (like LAL, microbiological cultures) have predefined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic imaging or human-in-the-loop AI device, so MRMC studies are not relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)
Not applicable. This device is a chemical solution used in a hemodialysis system, not a software algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" employed for this device is based on:
- Chemical composition and purity standards: Ensuring the ingredients (Sodium Bicarbonate, Sodium Chloride USP, water) meet required grades and proportions.
- Microbiological standards: Adherence to AAMI microbiological standards, confirmed through LAL and microbiological cultures.
- Manufacturing process controls: Ensuring the production methods consistently yield a product meeting specifications.
- Predicate device characteristics: The known specifications, safety profile, and effectiveness of the legally marketed predicate devices (RENOSOL and STERILYTE) serve as the benchmark for "ground truth" in demonstrating equivalence.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.