(169 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 AF-150 Hemodialyzer is a high permeability 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.
A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.
Each AF-150 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.
Here's a breakdown of the acceptance criteria and the study information for the Althin Medical AB AF-150 Hemodialyzer, based on the provided 510(k) summary:
This device submission does not involve Artificial Intelligence (AI). The submission is for a medical device (hemodialyzer) and the "study" referred to is functional testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device. Therefore, many of the requested AI-specific details (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI models) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary indicates that the AF-150 Hemodialyzer's performance was evaluated against the specifications cleared for its predicate device, the Altra Flux 140 Hemodialyzer (K945620). The key performance characteristics are related to its function as a high permeability hemodialyzer.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from predicate) | Reported Device Performance (AF-150 Hemodialyzer) |
|---|---|---|
| Functional Performance | Equivalent to predicate device specifications (e.g., clearance, ultrafiltration coefficient, as per predicate K945620) | "Functional testing... showed significant equivalence." |
| Biocompatibility | Compliance with ISO 10993 standards for hemodialyzers | "Test results showed that the AF-150 Hemodialyzer passed the panel of tests indicated for a hemodialyzer device." |
| Sterilization | Effective sterilization by gamma radiation | Sterilized by gamma radiation |
| Single Use Only | Designed for single use, no re-use | Labeled for single use only |
Note: Specific quantitative acceptance criteria (e.g., exact clearance rates, ultrafiltration coefficients) are not provided in this summary but are implied to be met in comparison to the predicate device's cleared specifications.
Regarding AI-Specific Information:
Since this is a traditional medical device (hemodialyzer) and not an AI/ML-based device, the following points are not applicable and cannot be answered from the provided text. The "study" here refers to standard medical device functional and biocompatibility testing, not an AI model's performance evaluation.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (N/A) for AI/ML. For functional testing of a physical medical device, the "sample size" would refer to the number of devices tested. This information is not provided in the summary. Data provenance is also not relevant in the context of device functional testing described here.
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)
- N/A for AI/ML. Ground truth, in the context of AI, involves expert annotations or diagnoses. For a physical device, functional performance is measured objectively through testing (e.g., laboratory measurements for clearance, ultrafiltration) against defined specifications, not through expert consensus on a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A for AI/ML. Adjudication methods are used in AI performance studies to resolve discrepancies in expert annotations for ground truth. This is not relevant for functional device testing.
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
- N/A. MRMC studies are specific to evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a hemodialyzer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This refers to AI algorithm performance. The device is a physical hemodialyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A for AI/ML. The "ground truth" for the device's functional evaluation comprises objective measurements based on established test methodologies for hemodialyzers (e.g., measuring ultrafiltration coefficients, clearance rates, and confirmed biocompatibility according to ISO 10993).
8. The sample size for the training set
- N/A. This device does not use a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- N/A. This device does not use a training set or ground truth in the AI context.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”