(272 days)
The S.A.M CRRT Unit is intended for:
- Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
- Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
For all treatments performed utilizing the S.A.M CRRT Unit, use of the treatment device must be carried out as per the manufacturers' specifications.
All treatments administered via the S.A.M unit must be prescribed by a physician and are intended in the environment of the Intensive Care Unit or Emergency Department of the hospital.
Rx Only.
The S.A.M Cassette CRRT is intended for single use in continuous renal replacement and therapeutic plasma exchange therapies using the S.A.M CRRT Unit. The S.A.M Cassette for CRRT is indicated for patients weighing 20 kg or more. Rx Only.
The S.A.M CRRT Unit is a software controlled device that performs the following functions:
- Primes the SAM disposable cassette automatically.
- Pumps blood through the blood flow path of the disposable cassette.
- Delivers anticoagulant into the blood flow path.
- Pumps sterile infusion solutions into the blood flow path of the disposable according to therapy in use.
- Pumps sterile dialysate into the fluid compartment of the filter in CRRT therapies.
- Controls the patient fluid removal or plasma loss according to the therapy in use.
- Monitors the system and alerts the operator to abnormal situations through alarms.
The S.A.M CRRT Unit has a touchscreen interface that provides operating instructions to the user. The system is used in conjunction with the S.A.M Cassette tubing set.
The provided text describes the 510(k) premarket notification for the S.A.M CRRT Unit, a medical device for Continuous Renal Replacement Therapy (CRRT) and Therapeutic Plasma Exchange (TPE). However, the document does not contain information about an AI/ML-driven device, nor does it discuss acceptance criteria and performance data for such a device in the context of diagnostic accuracy, image analysis, or human-in-the-loop studies (MRMC, standalone performance, etc.).
The document focuses on the substantial equivalence of the S.A.M CRRT Unit to a predicate device (Prismaflex K110823) based on its intended use, technological characteristics, and conformance to electrical safety and biocompatibility standards.
Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from the provided text. The questions posed in your prompt (e.g., sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies) are relevant to the evaluation of AI/ML-powered medical devices, but not to the S.A.M CRRT Unit as described in this 510(k) summary.
§ 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.”