(432 days)
Diapact is an extracorpeal blood purification septem intended to be used for acute renal failure. The septem provides high flow continuous rinal replacement therapies, emergency intermittent dialipis and plasmapheresis.
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the DIAPACT CRRT - ( Continuous Renal Replacement Therapies). It is an extracorpeal blood purification system intended to be used for acute renal failure. The system provides high flow continuous renal replacement therapies, emergency intermittent dialysis treatment and plasmapheresis.
The provided text describes a 510(k) submission for the Diapact CRRT device, which is an extracorporeal blood purification system. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the manner typically seen for novel AI/machine learning devices.
Due to the nature of this submission (a 510(k) for a medical device that predates the common use of AI and machine learning in such applications), the document does not contain the information requested in your prompt regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert consensus, or MRMC studies.
Instead, the submission states:
- Substantial Equivalence: The DIAPACT CRRT is "identical in materials, form, and intended use" to two predicate devices: SPECTRA - Blood Component Separator Therapeutic (K900105) and PRISMA - CFM - Continuous Fluid Management System (K946279). This is the primary "acceptance criterion" from a regulatory perspective for this type of submission.
- Safety and Effectiveness: It states, "There are no new issues of safety and effectiveness raised by Diapact CRRT."
- Product Testing: "All finished products are tested and must meet all required release specifications before distribution." This includes "physical testing, visual examination (in process and finished product)." These physical tests are defined by Quality Control Test Procedure documents, conforming to product design specifications and GMPs.
Therefore, I cannot populate the table or answer the specific questions as the information is not present in the provided text. The "study" proving acceptance criteria, in this context, is the demonstration of substantial equivalence through comparison to legally marketed predicate devices and internal quality control testing procedures, rather than a clinical performance study with defined metrics against a ground truth.
If this were a submission for a modern AI/ML medical device, the expectations for performance criteria and study details would be much more aligned with your questions.
§ 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.”