(101 days)
The Althin Medical AB Altracart II is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor and acid concentrate solutions.
The Althin Medical AB Altracart II is a column, which contains sodium bicarbonate formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and acid concentrate solution. It is designed to fit into a holder with a connecting system where a spike punctures a membrane at the top and bottom of the cartridge/column which then permits water to flow through the column and mix with the sodium bicarbonate. The connections to the column are sealed by a standard 0-ring, which allows an internal positive or negative pressure to be created in the column. The Altracart II is fitted with a mesh filter to prevent the sodium bicarbonate powder from entering the dialysis machine before it is dissolved or placed in solution with water. The Altracart is supplied in the following 2 configurations: 750 and 1000 grams of sodium bicarbonate.
This document describes the Althin Medical AB Altracart II, a column containing sodium bicarbonate for use in hemodialysis. The submission focuses on demonstrating substantial equivalence to predicate devices rather than independent performance metrics.
Here's the breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the legally marketed predicate device, the Gambro BiCart Columns (K873155 and K940601). The "reported device performance" is essentially that the Altracart II performs "as well as the predicate device" in terms of chemical composition and intended use.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Chemical Composition: Chemical composition and range of composition are substantially equivalent to the predicate device. Ensures the final dialysis solution has specific concentrations (e.g., 135-140 mmol of sodium, 32-42 mmol of bicarbonate per liter). | Chemical Composition: "In vitro testing was performed to determine the chemical composition and range of composition. The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." The Altracart II is designed to achieve final dialysis solutions with 135-140 mmol of sodium and 32-42 mmol of bicarbonate per liter, depending on the acid concentrate and hemodialysis machine used. |
| Intended Use: The device is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis, and to be used with appropriate hemodialysis machines/monitors and acid concentrate solutions. This intended use should be essentially the same as the predicate device. | Intended Use: "The Althin Medical AB Altracart II is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor and acid concentrate solutions. This indication statement is essentially the same as the indication statement for the predicate device." |
| Technological Characteristics: The device utilizes the same range of chemical compositions, packaging, and formulations as the predicate device, with no significant differences. | Technological Characteristics: "Comparing the proposed device to the predicate devices utilize the same range of chemical compositions, packaging and formulations. There are no significant differences." The Altracart II is "identical in design and construction to the currently marketed Gambro BiCart Columns." It is also capable of being used with various conventional and commercially available hemodialysis machines (e.g., Althin System 1000, Tina, Altra Touch machines, and Cobe Centry 3 hemodialysis machines), including those equipped with cartridge holders for other manufacturers' columns. Retrofit kits are provided for specific Althin machines. |
| Safety and Effectiveness: The device is safe, effective, and performs as well as the predicate device when used in accordance with instructions. | Safety and Effectiveness: "Testing performed on the Althin Medical AB Altracart II indicates that they are safe, effective, and perform as well as the predicate device, when used in accordance with the instructions for use." This conclusion is drawn from the in-vitro testing and comparison to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the "in vitro testing." It only generally states that "in vitro testing was performed to determine the chemical composition and range of composition."
- Data Provenance: The document implies the data was generated by Althin Medical AB, a Swedish company. It is an "in vitro" study, meaning it was conducted in a controlled environment (e.g., laboratory) rather than a clinical setting. It is inherently prospective in the sense that the tests were specifically conducted to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This medical device primarily concerns chemical composition and compatibility, which are validated through instrumental analysis and engineering assessment rather than expert radiographic or clinical interpretation establishing "ground truth" in the diagnostic sense. The comparison is made against the established performance of predicate devices.
4. Adjudication Method for the Test Set
N/A. There was no expert adjudication process as would be typical for image-based diagnostic devices. The acceptance was based on direct comparison of chemical properties and functional equivalence to the predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. An MRMC study is not applicable as this is not a diagnostic device requiring human interpretation of results. The device is a component used in hemodialysis.
6. Standalone (Algorithm Only) Performance Study
N/A. This is not a software algorithm; it is a physical medical device (a column containing sodium bicarbonate). The "performance" is its ability to deliver the correct chemical composition for hemodialysis.
7. Type of Ground Truth Used
The "ground truth" for the Altracart II is the established chemical composition, intended use, and performance of the legally marketed predicate devices (Gambro BiCart Columns). The substantial equivalence argument relies on demonstrating that the Altracart II matches these characteristics. In-vitro testing (chemical analysis) serves as the basis for this comparison.
8. Sample Size for the Training Set
N/A. This submission primarily relies on substantial equivalence and in-vitro testing, not machine learning or AI models that require training sets.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for a machine learning model, this question is not applicable.
§ 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.