(339 days)
For DB-203; DB-204; DB-205;
This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate on equivalent in a 36.83x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.
-or-
For DB-206; DB-207; DB-208:
This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 45x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.
-or-
For DB-209; DB-210; DB-211:
This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 35x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.
The MedicaLyte® Bicarbonate Powder devices for bicarbonate dialysis are comprised of USP grade sodium bicarbonate for 35X (DB-209, DB-210 and DB-211) and 45X (DB-206, DB-207 and DB-208) proportioning dialysis machines and USP grade sodium bicarbonate and USP grade sodium chloride for 36.83X proportioning dialysis machines (DB-203, DB-204 and DB-These products may be used in conventional, commercially available hemodialysis 205). machines or monitors as one of the necessary components of three-component hemodialysis solution. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in three-stream hemodialysis machines in which an acid concentrate is proportioned into one stream, a bicarbonate solution is prepared from the bicarbonate powder is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from the patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodializer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodializer with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.
The provided text describes a 510(k) premarket notification for a medical device, MedicaLyte® Bicarbonate Powder. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the context of diagnostic performance.
Therefore, many of the requested elements for a study proving a device meets acceptance criteria (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for this specific product.
The acceptance criteria for a 510(k) submission like this are generally met by demonstrating that the new device has the same intended use and similar technological characteristics as legally marketed predicate devices, without raising new questions of safety or effectiveness.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission based on substantial equivalence for a chemical concentrate, the "acceptance criteria" are typically defined by demonstrating that the new device's chemical composition and yield, when prepared according to label directions, are equivalent to those of established predicate devices. The "reported device performance" is the chemical output of the new device when prepared as directed.
| Acceptance Criterion (Implicit) | Reported Device Performance (MedicaLyte® Bicarbonate Powder) |
|---|---|
| Similar Volume Yields (as predicate devices) | Matches predicate devices: 2.5 Gallons, 15 Gallons, 25 Gallons (for 36.83X & 35X); 2.1 Gallons, 15 Gallons, 25 Gallons (for 45X) |
| Similar Sodium Bicarbonate Yields (as predicate devices) | Matches predicate devices: 39 mEq/L (for 36.83X); 37 mEq/L (for 45X); 35 mEq/L (for 35X) |
| Similar Sodium Chloride Yields (as predicate devices - only applicable for 36.83X) | Matches predicate devices: 20 mEq/L (for 36.83X) |
| Same Chemical Composition | Comprised of USP grade sodium bicarbonate (for 35X and 45X) and USP grade sodium bicarbonate and USP grade sodium chloride (for 36.83X), same as predicates. |
| Same Intended Use | Used with specific proportioning dialysis machines for treating patients in need of hemodialysis, same as predicates. |
Note: The tables in the original document (Table 1, 2, and 3) explicitly state that "The Volume, Component and Yield columns apply equally to the Device and Predicate Device." This is a direct statement of equivalence, which serves as the "acceptance criteria" being met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For chemical concentrates, testing typically involves laboratory analysis of the chemical properties of the prepared solutions, not a "test set" of patient data or clinical images. The data provenance would likely be from the manufacturer's internal quality control and analytical chemistry labs, but these specifics are not stated.
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)
This is not applicable. "Ground truth" in the context of chemical composition is established through analytical chemistry methods and adherence to pharmacopeial standards (USP grade), not through expert consensus in the same way it would be for a diagnostic image.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for this type of device and submission. Adjudication methods are relevant for clinical assessments, especially in cases of subjective interpretation or when establishing a clinical diagnosis.
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
This is not applicable. MRMC studies and AI assistance are relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a chemical concentrate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a chemical concentrate, not an algorithm or an AI-based system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on analytical chemistry verification against established specifications for pharmaceutical-grade ingredients (USP grade sodium bicarbonate and sodium chloride) and the expected mEq/L yield when reconstituted according to label directions. This is implicitly compared to the known specifications and performance of the predicate devices.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of an AI/ML algorithm or a complex diagnostic device for this chemical concentrate.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as 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.