(201 days)
The Purema® H Hemoconcentrator is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass.
It is intended to be used in a hospital setting, in connection with a suitable circuit for extracorporeal blood circulation and a pump that regulates its flow. There are no other accessories.
The Purema® H Hemoconcentrator Models DP07HC, DP09HC, and DP12HC are intended to be used for adult patients.
Purema® H hemoconcentrators are single use hemoconcentrators containing filters composed of a hollow fiber made of polyethersulfone (PUREMA® H). Purema® H hemoconcentrators are hemoconcentrators of various dimensions that can be used in treatments which require the removal of liquids that are in excess. Blood is pumped through a membrane that has high permeability, and the pressure gradient, through the membrane (TMP) determines the passage of water and molecules with a mechanism that is similar to glomerular filtration (convective mechanism). The fraction of filtrated liquid depends on the osmotic pressure, hydrostatic transmembrane pressure, the surface, membrane permeability and patient hematocrit. The Purema® H hemoconcentrators are designed to be used in a healthcare facility.
Purema® H hemoconcentrators can be sterilized using Ethlyene Oxide (EtO). The EtO sterilized Purema® H hemoconcentrators consist of hollow fiber made of polyethersulfone (PUREMA® H), cartridge, rings, connectors, potting (fiber closure seals), and O-rings.
The EtO sterilized Purema® H Hemoconcentrator is available in three models: DP07HC, and DP12HC. The main differences in these models are their total membrane surface areas.
The provided text describes a 510(k) premarket notification for the Purema® H Hemoconcentrator, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against predefined acceptance criteria for a new clinical claim. Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable as this type of study was not performed.
The document states that the Purema® H Hemoconcentrator underwent various tests to demonstrate substantial equivalence to the predicate device, the Terumo Capiox Hemoconcentrator. These studies were focused on biological safety, mechanical characteristics, performance characteristics, and hemocompatibility.
Here's a summary of the types of tests performed, as provided in the document:
Studies Performed to Demonstrate Substantial Equivalence:
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Biological Safety:
- In vitro sterility
- Non pyrogenicity
- Cytotoxicity (ISO 10993-5 (2009) and ISO 10993-11 (2017))
- Acute systemic toxicity tests (ISO 10993-5 (2009) and ISO 10993-11 (2017))
- Intracutaneous reactivity irritation (ISO 10993-12)
- Guinea pig maximization sensitization (delayed hypersensitivity test) (ISO 10993-12)
- Material-mediated pyrogen (USP )
- Reverse Mutation Assay using Bacteria (ISO 10993-1; ISO 10993-3; ISO 10993-12; and ISO/TR 10993-33)
- Mammalian Cell Gene Mutation Assay (ISO 10993-1; 10993-3; and 10993-12)
- Sc5b-9 complement activation assay (FDA Biocompatibility Guidance and ISO 10993-4:2017)
- Non-activated Partial Thromboplastin Time (PTT) assay (ASTM F2382-18)
- Platelet and Leukocyte Count assay (ASTM F2888-19)
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Mechanical Characteristics:
- Blood Compartment Integrity
- Structural integrity
- Hemoconcentrator blood and filtrate ports
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Performance Characteristics:
- Solute clearance
- Sieving coefficient (SC) for albumin
- Ultrafiltration coefficient
- Pressure drop of the blood compartment
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Hemocompatibility:
- Plasma free Hemoglobin
- White Blood Cells and Platelets counts
- Blood Clotting at minimum flow rate
The document states, "All testing met predetermined testing criteria." However, the specific acceptance criteria for each test and the detailed reported device performance values are not provided in this excerpt. The excerpt also does not contain information about human reader studies, AI performance, or data provenance in the way one would expect for an AI/CADe device submission. It describes a conventional medical device's premarket notification.
§ 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.”