(130 days)
The RMI Hemoconcentrator Preference Pack is a medical device convenience pack that is intended to allow RMI customers to specify their preference for one or more of the following devices that will be provided in their hemoconcentrator pack :
- Rinse-Required Hemoconcentrator with tubing set and prime lines, LCH-500-A
- Pre-Rinsed BioFilterTM 140 Hemoconcentrator, HEM-001
- 24 inch Hemoconcentrator Tubing Set, TS-024
- 36 inch Hemoconcentrator Tubing Set, TS-036
- Hemoconcentrator Adapter Set, HEM-001 Adapters --
- Hemoconcentrator Waste Bag, WB-001
- BioFilterTM 140 with Adapter Set, HEM-001-A -
- BioFilterTM 140 with 24 inch Tubing Set, HEM-024 (
- BioFilter™ 140 with 36 inch Tubing Set, HEM-036 I
- BioFilterTM 140 with 24 inch Tubing Set and Maste Bag, HEM-O24-B
- Biofilter TM 140 with 36 inch Tubing Set and Waste Bag, HEM-024-B
- Hemoconcentrator Pole Mount, WEW OV
- Hemoconcentrator Pole Mount, HEM-OIH
The hemoconcentrator is intended for relief or mitigation of overhadration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.
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This document is a 510(k) premarket notification for the RMI Hemoconcentrator Preference Pack. The FDA has determined that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain information on acceptance criteria or a study that proves the device meets acceptance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria as might be seen for devices undergoing PMA (Premarket Approval) or for AI/ML-based software as a medical device (SaMD).
The provided text only includes:
- Predicate Device Identification: A list of previously cleared or pre-amendment devices to which the RMI Hemoconcentrator Preference Pack claims substantial equivalence.
- FDA Clearance Letter: Official communication from the FDA confirming the device's substantial equivalence and allowing it to be marketed.
- Intended Use Statement: Describes the purpose of the hemoconcentrator (relief of overhydration during cardiopulmonary bypass and decrease plasma water concentration in blood) and the various components that can be included in the preference pack.
Therefore, I cannot fulfill the request to describe acceptance criteria and associated study details based on the provided text.
§ 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.”