(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-15 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-15 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 provided text is a 510(k) summary for the Althin Medical AB A-15 Hemodialyzer, which is a medical device. This document does not describe a study involving performance metrics like accuracy, sensitivity, or specificity, which are typically associated with AI/ML model evaluations. Instead, it describes a
The acceptance criteria are that the device perform equivalently to the predicate device. The study performed that demonstrates that the A-15 Hemodialyzer meets this criteria is functional testing. The functional testing was based on the specifications of the predicate device, the Altra Nova 140 Hemodialyzer (K945625). The results of the functional testing showed "significant equivalence." Additionally, biocompatibility testing was performed in accordance with ISO 10993, and the device passed all indicated tests.
Here's a breakdown of the requested information based on the provided text. Please note that many of the categories you requested are typically relevant for AI/ML device evaluations and are not applicable to the traditional medical device submission described here.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional performance equivalent to predicate device (Altra Nova 140 Hemodialyzer, K945625) | Functional testing showed "significant equivalence" to the predicate device's specifications. The device conforms to its specifications and is suitable for its intended use. |
| Biocompatibility | Passed the panel of tests indicated for a hemodialyzer device in accordance with ISO 10993. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in the document. The testing involved "functional testing" and "biocompatibility testing," but the number of units tested is not provided.
- Data provenance: Not explicitly stated. The company, Althin Medical AB, is based in Sweden. The testing would have been conducted to support the 510(k) submission to the FDA in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable. The "ground truth" for this type of device is based on established engineering specifications and industry standards for functional and biocompatibility performance, not expert medical opinion on individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This does not involve interpretation of data by multiple experts.
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
- MRMC study: No. This is a traditional hemodialyzer, not an AI/ML device, so such a study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: The ground truth for this device's performance is based on established engineering specifications for hemodialyzers (e.g., ultrafiltration coefficient, clearance) and the requirements of biocompatibility standards (ISO 10993). Performance is compared against the specifications of a legally marketed predicate device.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not a machine learning device and therefore does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable, as there is no training set for this type of 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.