(267 days)
- Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
- Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers must be used in accordance with the instructions of a physician familiar with hemodialysis and familiar with the conditions of the patient.
- Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are intended for single use only.
- Asahi AM-BIO Extended Range (AM-BIO-HX series) Dialyzers are designed only to be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
- The expiration date of ASAHI AM-BIO Extended Range (AM-BIO-HX series) Dialyzers is 3 years from the sterilization date. The user must use the dialyzers before the expiration date.
The line of Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series) is a family of hemodialysis membranes, or hollow fiber dialyzers, developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The device is intended for use in patients who have chronic renal failure or acute renal failure, for only single use. The membrane fibers are made of modified cellulose (i.e., alkyl ether polymer grafted cellulose), derived from cuprammonium rayon. The cuprammonium rayon is manufactured to have a thin layer of modified cellulose exposed to blood contact surfaces. The modification to the cellulose yields the fiber more compatible to the patient's blood, manifested through lower complement activation (C3g and C52) when compared to regular cellulose membrane dialyzers. The membranes are housed within a plastic casing of styrene butadiene block polymer. Non-removable casing end caps are also made of styrene butadiene block polymer. The potting material (sealant) is polyurethane and the port caps (stoppers) are made of hydrogenated styrene butadiene block polymer. Like the AM-BIO Series Dialyzers, the AM-BIO Extended Range Series Dialyzers will be offered for sale in both a "wet" model and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models are filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference. The fluid in wet dialyzers is made of water containing 600 ppm sodium pyrosulfite and 300 ppm sodium carbonate. Asahi AM-BIO Extended Range Series Dialyzers are sterilized by gamma radiation before shipment.
The provided text describes the Asahi AM-BIO Extended Range Series Dialyzers (AM-BIO-HX series) and its substantial equivalence to predicate devices, focusing on its intended use, design, manufacturing, and non-clinical testing. However, it does not contain detailed information about acceptance criteria or a study proving the device meets specific performance criteria in a format applicable to AI/ML device evaluations. The document is a 510(k) submission summary for a physical medical device (dialyzer), not a software or AI device.
Therefore, many of the requested elements for an AI/ML device evaluation, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, are not present.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state quantitative acceptance criteria or reported performance values in a table format for the new device compared to specific thresholds. It mentions "extended range of performance specifications" due to a change in pore size, but no specific metrics are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical in-vitro testing and biocompatibility testing for a physical dialyzer, not a software device with a test set of data.
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)
Not applicable. This is for a physical device, not an AI/ML evaluation requiring expert-labeled ground truth for imaging or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See 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
Not applicable. This is for a physical device, not an AI/ML device where human readers interact with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the in-vitro tests mentioned (like permeability, clearance rates, cytotoxicity), the "ground truth" would be established by standard laboratory measurement techniques and scientific principles for each specific test parameter, not by expert consensus or pathology in the context of an AI/ML dataset.
8. The sample size for the training set
Not applicable. The device is a physical dialyzer, not an AI/ML model that is "trained."
9. How the ground truth for the training set was established
Not applicable. See above.
Summary based on the provided document:
The provided text describes the Asahi AM-BIO Extended Range Series Dialyzers as substantially equivalent to existing predicate devices (Asahi AM-BIO Series Dialyzers, Asahi APS Series Dialyzer, Fresenius Hemoflow). The equivalence is based on similar indications for use, design, and manufacturing, with the new device offering an "extended range of performance specifications" by changing the pore size of the dialyzer fibers.
The "study" equivalent to proving the device meets acceptance criteria in this context is the non-clinical in-vitro testing and biocompatibility testing.
Non-Clinical Testing Performed:
- In-vitro testing:
- Permeability - saline
- Permeability - bovine plasma
- Urea clearance rate
- Creatinine clearance rate
- Phosphate clearance rate
- Biocompatibility testing:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Systemic Toxicity (Acute)
- Genotoxicity
- Hemocompatibility
- Pyrogenicity
Acceptance Criteria & Performance:
The document implies that the results of these tests met accepted standards for dialyzer performance and safety, allowing the device to be deemed "substantially equivalent" by the FDA. However, specific quantitative acceptance criteria (e.g., "urea clearance must be > X mL/min") and the exact reported performance values are not detailed in this summary document. It states that the device has "extended range of performance specifications," suggesting that its performance in the tested parameters would either meet or exceed the predicate devices.
§ 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.”