SGY · Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant

Gastroenterology, Urology · 21 CFR 876.5881 · Class 2

Overview

Identification

The VitaSmart Hypothermic Oxygenated Perfusion (HOPE) System is a device intended for hypothermic oxygenated perfusion of donor livers, after a period of static cold storage (SCS), for eventual transplantation into a recipient. It is indicated for use with Donation after Brain Death (DBD) donor livers ≤ 65 years old; or Donation after Circulatory Death (DCD) donor livers ≤ 55 years old and with ≤ 18 minutes of functional warm ischemic time with macrosteatosis ≤ 10%. The system includes perfusion sets, oxygenators, and other components of the perfusion circuit.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the hypothermic machine perfusion system and accessories for orthotopic liver transplant is subject to the following special controls: (1) Clinical performance testing must demonstrate that the device performs as intended when used with a compatible perfusion solution, and must evaluate:. (i) Organ graft function and survival; (ii) Recipient survival; and (iii) Device-related adverse events, including ischemic and vascular complications and perfusion injury. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated: (i) Mechanical integrity and reliability of the perfusion circuit; and (ii) Controls and monitors for the perfusion parameters including temperature, pressure, flow, and oxygenation. (3) Software verification, validation, and hazard analysis must be performed. (4) The organ-contacting components of the device must be demonstrated to be biocompatible. (5) Performance data must demonstrate the sterility of all organ-contacting components of the device. (6) Performance data must support the shelf-life by demonstrating package integrity, continued sterility, and functionality of the organ-contacting components of the device. (7) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device in the intended use environment, including environments encountered during organ transport. (8) Human factors validation testing must demonstrate that the intended user(s) in the intended use environment can correctly and safely use the device based solely on the directions for use and training program. (9) A training program must be included with sufficient educational elements so that upon completion of the training program, the user can correctly prepare, perfuse, and monitor the organ while mitigating the risk of contamination. (10) Labeling must include: (i) The recommended training required for the safe use of the device; (ii) Information on compatible perfusion solutions; (iii) Information on the organ donor and recipient population from which the device performance was evaluated. (iv) Information on the perfusion protocols and configurations from which the device performance was evaluated; (v) A list of all accessories and components; and (vi) A shelf life or service period.

Recent Cleared Devices (1 of 1)

Top Applicants

• Bridge TO Life, Ltd. — 1 clearance