(90 days)
The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure. This concentrate is formulated to be used with a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is designed to be used as direct product replacement for the current Granuflo@ Concentrate (Series 1000, 2400, and 3000). The new product will be available in a non-granulated formula. It is used only during hemodialysis. It is manufactured using the same raw materials. The new Fresenius Naturalyte® Granuflo® Dry Acid Concentrate has the same chemical composition as the predicate devices. It is for single use only. It is supplied non-sterile and is non-pyrogenic.
The provided document is a 510(k) Premarket Notification for a medical device: Fresenius Naturalyte® Granuflo® Dry Acid Concentrate.
This document describes a submission for demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria for performance in the way clinical studies often do for novel devices.
Therefore, many of the requested categories for a clinical study on device performance are not applicable or cannot be extracted from this type of regulatory submission. The document explicitly states: "The safety and effectiveness of the Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is supported by the substantial equivalence information, materials data, device description, and performance testing."
Here's a breakdown of what can be inferred or directly stated from the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
This information is typically found in detailed test reports or clinical trial summaries. For a 510(k) submission based on substantial equivalence, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "performance" is generally demonstrated by showing identical or highly similar characteristics to the predicate.
| Acceptance Criteria (Implied by 510(k) SE) | Reported Device Performance (from text) |
|---|---|
| Intended Use: Device must have the same or highly similar intended use as the predicate device. | "The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure." (Matches predicate's implied use as a dialysate concentrate) |
| Technological Characteristics: Device must have the same or highly similar technological characteristics as the predicate. | "The new product will be available in a non-granulated formula." (A minor change in form, but overall chemical composition and function are presented as the same) |
| "The new Fresenius Naturalyte® Granuflo® Dry Acid Concentrate has the same chemical composition as the predicate devices." | |
| "It is manufactured using the same raw materials." | |
| "It is for single use only. It is supplied non-sterile and is non-pyrogenic." | |
| Safety and Effectiveness: Device must be as safe and effective as the predicate device. | "The intended use, technological characteristics, design features, and materials are substantially equivalent to the predicate devices previously cleared for market." |
| "The safety and effectiveness of the Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is supported by the substantial equivalence information, materials data, device description, and performance testing." (No specific quantitative performance metrics are provided in the summary) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a "test set" for a clinical study assessing performance in humans. The submission relies on "performance testing" of the product itself, "materials data," and "device description" to demonstrate substantial equivalence to existing predicate devices. Specific sample sizes for such engineering or chemical testing are not provided in this summary.
- Data Provenance: The document does not specify the country of origin for any "performance testing" data, nor whether it was retrospective or prospective. Given the nature of a chemical concentrate, direct patient data might not be the primary evidentiary support for substantial equivalence, but rather chemical and functional validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The basis for clearance is substantial equivalence to existing, legally marketed devices (predicates: Granulyte Powder Dialysate Concentrates and Mixer; K911459, and Granulyte Dialysate Concentrate; K922005). The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices and the demonstration that the new device is essentially the same. Expert consensus would apply to the FDA reviewers comparing the device.
4. Adjudication Method for the Test Set
Not applicable. There's no "test set" in the sense of a set of cases requiring adjudication by multiple experts. The FDA's review process determines substantial equivalence based on the submitted documentation compared to the predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is typically performed for diagnostic imaging devices or software where human readers interpret results, often with and without AI assistance, to assess the impact of the AI. This device is a chemical concentrate for hemodialysis, and therefore, an MRMC study is not relevant or performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a chemical concentrate, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The new device's characteristics (chemical composition, raw materials, intended use, technological characteristics, design features) are compared against these known predicates to demonstrate equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML 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.