(217 days)
Acid Concentrate is indicated for use as acid concentrate in hemodialysis therapy.
Baxter's Acid Concentrate is used in the preparation of hemodialysis solutions when mixed and proportioned with the appropriate volumes of purified water and bicarbonate concentrate solution. These acid concentrate products are mixed and proportioned in a three-stream hemodialysis machine, in which the acid concentrate is proportioned into one stream, a bicarbonate concentrate solution is proportioned into the second stream, and purified water that meets AAMI Standards is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution. The proportioned hemodialysis solution is then heated to body temperature and passed through the dialysis fluid compartment of a hemodialyzer counter-current to the flow of the patient's blood.
The provided text describes a 510(k) premarket notification for Baxter's Acid Concentrate, a medical device. The information primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics from a formal study for new device acceptance criteria against specific numerical targets.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, specific numerical acceptance criteria and their corresponding reported device performance values are not explicitly stated in a quantifiable table format. The assessment is qualitative, focusing on equivalence.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | "as safe as the predicate devices" |
| Effectiveness | "as effective as the predicate devices" |
| Appropriate Design for Intended Use | "devices are appropriately designed for their intended use." |
| Compliance with Regulatory Standards | "verified against established standards and guidelines for its intended use." |
| Chemical Composition | "utilizes... the same chemicals and compositions as the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/Not provided. The document does not describe a test set with individual samples for statistical analysis of performance. Instead, it refers to a "risk assessment" and "design verification tests" which are internal to the manufacturer.
- Data Provenance: The "assessment of nonclinical data" and "design verification tests" are conducted by Baxter Healthcare Corporation (the manufacturer). This implies internal testing during the device's development and validation. The document does not specify country of origin for any external data, nor if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. The document does not describe a process of establishing ground truth using external experts for a test set in the way one might for an AI/diagnostic device. The "ground truth" here is the established safety and effectiveness of the predicate devices and compliance with regulatory standards, which is then demonstrated by Baxter's device.
4. Adjudication method for the test set:
- Not applicable/Not provided. There is no mention of an adjudication method, as there isn't a described test set requiring expert adjudication for ground truth.
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:
- No. This type of study (MRMC, AI assistance) is not relevant to this device. Baxter's Acid Concentrate is a chemical solution used in hemodialysis, not an imaging or diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This concept is not applicable to this device. There is no algorithm or AI component in Baxter's Acid Concentrate.
7. The type of ground truth used:
- The "ground truth" in this context is the established safety, effectiveness, and chemical composition of the legally marketed predicate devices, as well as relevant established standards and guidelines (e.g., ISO 14971:2003, AAMI Standards). The new device is compared to these established truths to demonstrate substantial equivalence.
8. The sample size for the training set:
- Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" here would be the development and testing performed by the manufacturer to ensure the product meets its specifications and regulatory requirements.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. Since there's no training set in the AI/ML sense, there's no ground truth established in that manner. The "ground truth" for the overall development and validation revolves around adherence to established chemical formulations, manufacturing processes, and successful performance in internal design verification tests against industry standards and predicate device characteristics.
§ 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.