(52 days)
Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.
The A-18 Hemodialyzer is a conventional hemodialyzer that is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer.
Each A-18 Hemodialyzer is packaged in a plastic bag and 20 hemodialyzers are packed in a cardboard box.
It is sterilized by gamma radiation and intended, and labeled, for single use only.
The Althin Medical AB A-18 Hemodialyzer is a conventional hemodialyzer used to treat patients with acute or chronic renal failure. The device was deemed substantially equivalent to the Althin Medical Inc Altra Nova 170 Hemodialyzer (K945621).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional equivalence to predicate device (Altra Nova 170 Hemodialyzer) | "Testing was based on the specification cleared for the predicate device and test results showed significant equivalence." |
| Conformance to specifications | "the results of the functional testing attest that the A-18 Hemodialyzer conforms to its specifications" |
| Suitability for intended use | "demonstrated that it is suitable for its intended use." |
| Biocompatibility (ISO10993) | "Test results showed that the A-18 Hemodialyzer passed the panel of tests indicated for a hemodialyzer device." |
| Similar design | "similar in design" to the predicate |
| Similar materials | "similar in materials" to the predicate |
| Similar intended uses, indications, and contraindications | "similar in intended uses, indications and contraindications" to the predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the functional testing. It only mentions "functional testing has been conducted to evaluate the functional performance of the A-18 Hemodialyzer."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to "specifications cleared for the predicate device" as the basis for testing, implying a comparison against established performance standards rather than expert-defined ground truth for specific cases.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The submission focuses on demonstrating substantial equivalence to a predicate device through functional and biocompatibility testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a hemodialyzer, a physical medical device, not an algorithm or AI system. Therefore, standalone performance in the context of AI algorithms is not relevant. The "functional testing" described evaluates the device's physical performance.
7. The Type of Ground Truth Used
The ground truth for the functional testing appears to be based on the specifications and performance characteristics of the legally marketed predicate device (Altra Nova 170 Hemodialyzer), along with established industry standards for biocompatibility (ISO10993). This is a comparative "ground truth" rather than an expert consensus, pathology, or outcomes-based ground truth typical for diagnostic AI.
8. The Sample Size for the Training Set
This question is not applicable as the A-18 Hemodialyzer is a physical medical device and does not involve a training set in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason 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.