(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 A-22 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 A-22 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 device, A-22 Hemodialyzer, does not have clear, distinct acceptance criteria and reported device performance values laid out in a table format within the provided text. The document states that "Functional testing has been conducted to evaluate the functional performance of the A-22 Hemodialyzer. Testing was based on the specification cleared for the predicate device and test results showed significant equivalence. Moreover, the results of the functional testing attest that the A-22 Hemodialyzer conforms to its specifications and has demonstrated that it is suitable for its intended use."
However, specific numerical acceptance criteria or performance metrics for clearance or ultrafiltration, for example, are not detailed in the summary. The core of the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Altra Nova 200 Hemodialyzer, K926379), rather than meeting a pre-defined set of quantitative acceptance criteria for de novo approval.
Therefore, I cannot generate the table as requested with distinct acceptance criteria and reported performance values.
Here's what can be extracted and inferred based on the provided text for the other requested information:
1. A table of acceptance criteria and the reported device performance:
As explained above, specific numerical acceptance criteria and reported device performance values are not explicitly provided in the submitted text. The basis of the submission is "substantial equivalence" to a predicate device. The general statement is: "Testing was based on the specification cleared for the predicate device and test results showed significant equivalence."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The text mentions "functional testing" and "biocompatibility testing" but does not give the number of devices or data points used in these tests.
- Data Provenance: Not explicitly stated. Given the company is "Althin Medical AB" in Sweden, it is reasonable to infer the testing was conducted internally or outsourced within a similar region. The text does not specify if the studies were retrospective or prospective, but functional and biocompatibility testing for a new device are typically 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 evaluation is for a physical medical device (hemodialyzer) based on functional and biocompatibility testing, not on interpretation of data requiring expert radiographic or clinical review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable for the same reason as point 3.
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:
This is not applicable. This is a submission for a physical medical device (hemodialyzer), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. This is a submission for a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the device's performance is established through:
- Functional Testing: Demonstrating the A-22 Hemodialyzer conforms to its specifications and is suitable for its intended use, likely by measuring parameters like ultrafiltration coefficient and clearance. These specifications are "based on the specification cleared for the predicate device."
- Biocompatibility Testing: Performed on the finished sterile device in accordance with ISO10993 to ensure safety when in contact with blood.
8. The sample size for the training set:
This is not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
§ 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.”