(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-180 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-180 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 an analysis of the provided text regarding the acceptance criteria and study for the AF-180 Hemodialyzer:
Summary of Acceptance Criteria and Device Performance:
Based on the provided 510(k) summary, the device is being cleared based on substantial equivalence to a predicate device, the Altra Flux 170 Hemodialyzer. This means the acceptance criteria are implicitly that the AF-180 Hemodialyzer performs similarly enough to the predicate device in terms of its functional characteristics and safety profile.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence to Altra Flux 170 Hemodialyzer (except UF coefficient and clearance) | "Functional testing…showed significant equivalence." |
| Biocompatibility (e.g., non-toxic, non-irritating) | "Biocompatibility testing…passed the panel of tests indicated for a hemodialyzer device." |
| Intended Use (Hemodialysis for acute/chronic renal failure) | The device's intended use matches the predicate and is stated explicitly. |
| Design and Materials Similarity | "similar in design, materials, intended uses, indications and contraindications to the previously concurred Altra Flux 170 Hemodialyzer." |
Detailed Study Information:
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A table of acceptance criteria and the reported device performance: See table above.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the sample size for the functional testing or biocompatibility testing. It only states that functional testing was "conducted."
- Data Provenance: Not specified. It's likely the testing was conducted by Althin Medical AB in Sweden, but this is not explicitly stated. The document does not indicate if the data was retrospective or prospective.
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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):
- This information is not provided in the summary. For a medical device like a hemodialyzer, "ground truth" would typically refer to established standards or validated methods for measuring performance parameters (e.g., clearance rates, ultrafiltration coefficients) and safety (biocompatibility). These would be established by engineers, toxicologists, and other relevant experts within the company or external labs, but the specific number or qualifications are not mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None described. The summary describes "functional testing" and "biocompatibility testing" but does not detail any adjudication methods, as this is not typically applicable to this type of device testing where objective measurements are primary.
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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:
- Not applicable. This device is a hemodialyzer, not an AI-assisted diagnostic or imaging device for human readers. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (hemodialyzer), not a software algorithm. The "standalone" performance would be its functional performance and biocompatibility as tested.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance would be:
- Industry Standards and Predicate Device Specifications: Functional testing was "based on the specification cleared for the predicate device."
- Validated Test Methods: Biocompatibility testing was performed "in accordance with ISO10993," which is an international standard for biocompatibility evaluation of medical devices.
- Objective Measurements: Performance parameters like ultrafiltration coefficient and clearance would be measured using validated laboratory methods.
- The "ground truth" for this device's performance would be:
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The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As explained above, there is no AI training set for this 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.”