(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-220 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, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer. Each AF-220 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 describes a 510(k) summary for the AF-220 Hemodialyzer, which is a medical device for treating renal failure. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Altra Flux 200 Hemodialyzer) rather than a study proving the device meets specific quantitative acceptance criteria using a new algorithm or AI.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is primarily related to functional testing and biocompatibility, aimed at showing equivalence.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Predicate Device Equivalence) | Reported Device Performance |
|---|---|
| Functional performance equivalent to Altra Flux 200 Hemodialyzer | "Functional testing has been conducted... and test results showed significant equivalence." "the AF-220 Hemodialyzer conforms to its specifications and has demonstrated that it is suitable for its intended use." |
| Biocompatibility in accordance with ISO10993 for a hemodialyzer device | "Test results showed that the AF-220 Hemodialyzer passed the panel of tests indicated for a hemodialyzer device." |
| Intended Use: Artificial kidney in hemodialysis system to treat patients with acute or chronic renal failure | "The AF-220 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." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document globally refers to "functional testing" and "biocompatibility testing" without providing specific sample counts for individual tests.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the study described is not evaluating an AI/algorithm's performance against expert-defined ground truth, but rather the functional and biocompatibility characteristics of a physical device.
4. Adjudication method for the test set
- Not applicable for the reasons stated above.
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
- No, a MRMC comparative effectiveness study was not done. This device is a physical hemodialyzer, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference standards for the testing would have been based on established engineering specifications for functional performance (e.g., ultrafiltration coefficient, clearance rates, material integrity) and ISO 10993 standards for biocompatibility (e.g., cytotoxicity, sensitization, irritation tests). It is not expert consensus, pathology, or outcomes data in the context of diagnostic algorithms.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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.”