(28 days)
This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates
The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate is a modified version of the Fresenius Biosol Powder Bicarbonate Concentrate. The Fresenius modified Naturalyte® Sodium Bicarbonate Liquid Concentrate is substantially equivalent in chemical formulation, chemical composition, and intended use to the commercially available Biosol Powder Bicarbonate Concentrates currently distributed as Fresenius Naturalyte® Dry Pack Bicarbonate Concentrates.
This document is a 510(k) Premarket Notification for a medical device called "Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate "Special"". It is a submission to the FDA to demonstrate substantial equivalence to a predicate device.
Based on the provided text, a conventional acceptance criteria and study report of device performance in the typical sense (e.g., sensitivity, specificity, accuracy, etc., for a diagnostic device, or clinical outcome data for a therapeutic device) are not applicable because:
- Device Type: This is a submission for a dialysate concentrate, which is a medical fluid used in hemodialysis. It is not a diagnostic imaging device, a treatment device with a measurable "performance" in terms of clinical outcomes presented in this document, or an AI-powered system.
- Nature of the Submission: This is a 510(k) Premarket Notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This equivalence is typically proven by showing similar intended use, technological characteristics, and safety/effectiveness profiles, rather than through a detailed clinical efficacy trial with specific performance metrics and acceptance criteria in the way envisioned by the prompt's questions.
- Content of the Document: The document focuses on comparing the modified device to its predicate in terms of chemical formulation, composition, and intended use. It explicitly states: "The Fresenius modified Naturalyte® Sodium Bicarbonate Liquid Concentrates is a modified versions of the Biosol Powder Bicarbonate Concentrates. The technological characteristics of the modified devices are equivalent to those of the unmodified devices and raise no new types of safety or effectiveness questions."
Therefore, the prompt's questions regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth are not directly addressed or applicable to this type of regulatory submission for this specific device.
Instead, the "acceptance criteria" can be broadly interpreted as the FDA's criteria for determining "substantial equivalence," and "device performance" as successful demonstration of that equivalence.
Here's how to interpret the provided information given the context of a 510(k) submission for a dialysate concentrate:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (for Substantial Equivalence via 510(k)):
| Criteria | Reported "Device Performance" / How Met |
|---|---|
| Is the product a device? (21 CFR §201 [321] (h)) | YES - "The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate is a device pursuant to 21 CFR §201 [321] (h)." |
| Does the new device have the same intended use as the predicate? | YES - "The intended use for the modified device is equivalent to the unmodified device." Both are "formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates." |
| Does the device have technological characteristics that raise new types of safety or effectiveness questions? | NO - "The technological characteristics of the modified devices are equivalent to those of the unmodified devices and raise no new types of safety or effectiveness questions." This implies chemical formulation and function are considered equivalent by the applicant. |
| Does descriptive or performance information demonstrate equivalence? | YES - "Fresenius Medical Care North America believes that the information provided in this submission clearly describes the modified Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate and demonstrates that it is substantially equivalent to the unmodified devices." |
| The document states, "testing of the modified device indicates that the formulations are safe and effective for its intended use." | |
| Safety and Effectiveness Concerns | The device is deemed "substantially equivalent in chemical formulation, chemical composition, and intended use to the commercially available Biosol Powder Bicarbonate Concentrates." General safety warnings are also provided (e.g., "Not for Parenteral Use"). |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable in the traditional sense. This submission does not report results from a clinical "test set" for performance metrics like sensitivity or specificity. Equivalence is primarily based on the chemical and functional characteristics compared to the predicate, and a statement about "testing of the modified device" which likely refers to bench testing or analytical chemistry, not human subject data in the way implied by the question.
- Data Provenance: Not explicitly stated as human subject data. Chemical characteristic data would be from laboratory analysis.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. The "ground truth" here is the regulatory determination of substantial equivalence, based on the provided documentation and comparison to the predicate device, reviewed by FDA staff. It does not involve expert consensus on clinical findings in a dataset.
4. Adjudication Method for the Test Set
- Not Applicable. No test set or adjudication process for human-interpreted data is described. The FDA performs regulatory review.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an imaging device or an AI system that would typically involve an MRMC study to compare human readers with and without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not Applicable. This is a chemical concentrate, not an algorithm or AI system.
7. Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is the chemical formulation, composition, and intended use of the predicate device (Fresenius Biosol Powder Bicarbonate Concentrate K981043). The modified device is compared against these known characteristics to establish substantial equivalence. Implicitly, safety and effectiveness knowledge about the predicate device forms part of this "ground truth."
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant. The "ground truth" (predicate device's characteristics) was established through its prior regulatory clearance (K981043) and its documented chemical and functional properties.
§ 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.