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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:

• 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)

• Mechanical Characteristics:

  • Blood Compartment Integrity
  • Structural integrity
  • Hemoconcentrator blood and filtrate ports

• Performance Characteristics:

  • Solute clearance
  • Sieving coefficient (SC) for albumin
  • Ultrafiltration coefficient
  • Pressure drop of the blood compartment

• 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.

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