(163 days)
The indications for use of the device are to provide hemodialysis treatments in the acute and chronic setting including high flux hemodialysis.
- The device is intended to be used by trained operators when . prescribed by a physician.
- The device is intended to be used in conjunction with a hollow fiber or parallel plate dialyzer.
- The auto start option is intended to allow up to a three day . delayed start of the fluid path heat clean or rinse cycle.
The Drake Willock® System 1000® Single Patient Dialysate Delivery System is a dialysate proportioning system for hemodialysis. The system fulfills the following functions:
- Mixes concentrate with water in the appropriate proportions to produce dialysate .
- Delivers dialysate at the appropriate temperature and ionic concentration to the . dialyzer,
- Removes the appropriate amount of liquid from the patient's blood .
- Along with the dialyzer and blood pump acts as a total artificial kidney. .
The following option is the subject of this submission that will be implemented with FDA approval.
The fundamental modification is to provide the patient care provider with a means to delay the start of fluid path rinse or heat clean up to 3 calendar days.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is a 510(k) summary for a modification to a dialysate delivery system, focusing on its substantial equivalence to a predicate device.
Here's why I cannot provide the requested information:
- No Acceptance Criteria or Performance Study: The document primarily discusses the "AutoStart" feature, which is a software change to delay the start of heat clean or fluid path rinse. It explicitly states that "The machine and patient safety systems are the same as the predicate devices" and "The only difference is a software change." It does not mention any specific acceptance criteria or an independently designed study to prove the performance of this new software feature. The focus is on demonstrating that the modification itself is safe and effective through design and testing, rather than a standalone performance study as would be described for a new diagnostic or prognostic AI device.
- Focus on Substantial Equivalence: The entire submission is built around demonstrating "substantial equivalence" to existing predicate devices (K910215 and K954987). This means the manufacturer is arguing that the modified device is as safe and effective as devices already on the market, not necessarily presenting novel performance data against a specific set of criteria as might be expected for an AI-powered diagnostic product.
- No AI Component: The device described is a dialysate delivery system, a piece of medical hardware with a software modification. There is no mention of any Artificial Intelligence (AI) component, machine learning algorithms, or image analysis involved. Therefore, questions related to AI performance, such as MRMC studies, standalone algorithm performance, or ground truth for training sets, are not applicable.
- Information Not Present: The document does not contain information on:
- Sample sizes for test sets or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.).
- Sample size for training sets.
- How ground truth for training sets was established.
In summary, the provided text describes a regulatory submission for a minor software modification to an existing medical device, emphasizing its substantial equivalence to predicate devices. It does not contain the kind of detailed performance study information, particularly in the context of AI, that your request anticipates.
§ 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.”