(227 days)
Not Found
No
The device description and performance studies focus on the physical components and in-vitro testing of an extracorporeal oxygenator, with no mention of AI or ML capabilities.
Yes
The device directly treats a physiological condition (gas exchange in blood during cardiopulmonary bypass) to restore normal function, which is the definition of a therapeutic device.
No
This device is an oxygenator designed for extracorporeal blood oxygenation and carbon dioxide removal, which are therapeutic functions, not diagnostic ones.
No
The device description clearly details a physical, disposable extracorporeal device with components like a heat exchanger, hollow fibers, ports, and vents, indicating it is a hardware device, not software-only.
Based on the provided information, the Gish Reliance™ Oxygenator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "extracorporeal oxygenation of, and carbon dioxide removal from, human blood" during procedures like cardiopulmonary bypass surgery. This is a therapeutic function, directly treating the patient's blood outside the body.
- Device Description: The description details a device that physically interacts with blood to modify its gas content and temperature. It's a mechanical and gas exchange device, not a device that analyzes blood or other biological samples to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood components, detect markers, or provide any information for diagnosing a condition. Its purpose is to support the patient's physiological function during a medical procedure.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Gish Reliance™ Oxygenator does not perform this type of analysis.
N/A
Intended Use / Indications for Use
The Gish Reliance™ Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of, and carbon dioxide removal from, human blood. It is designed to operate at blood flow rates of one half (0.5) to eight (8.0) liters per minute for periods of up to six (6.0) hours.
Product codes
Not Found
Device Description
The Gish Reliance TM Oxygenator is designed to control blood gases in the extracorporeal circuit during cardiopulmonary bypass surgery. The Gish Reliance ™ Oxygenator is a sterile, non-pyrogenic, single use, disposable extracorporeal device. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood. The Gish Reliance The Oxygenator has one (1) blood inlet located at the bottom of the assembly, an integral heat exchanger intended to control the temperature of blood, a bundle of microporous hollow fibers for the exchange of gases, two (2) blood outlet ports, one (1) gas inlet port, one (1) gas outlet port and three (3) gas vents to prevent over pressurization. The design of the oxygenator allows for a bottom-up flow of blood through the heat exchanger and around and between the hollow fibers of the gas exchange bundle. The bottom-up flow aids in priming and air removal from the unit. Once the blood reaches the top of the unit, it flows into a manifold which directs the blood downward and out the main blood outlet. The other blood outlet port is located at the top of the unit and may be used for air removal or recirculation. Gas enters the oxygenator through a gas inlet located at the top of the unit and then flows downward (countercurrent to the blood flow) through the inside of the hollow fibers. Gas exchange occurs with the blood through diffusion across the hollow fiber membrane. Gas leaves the oxygenator through gas outlets or vents. One (1) gas outlet port is provided to scavenge gas leaving the oxygenator. The integral heat exchanger controls the temperature of blood. Blood flows on the outside of the heat exchanger while heated or cooled water flows on the inside. Heat is transferred between the blood and water by the stainless steel bellows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
COBE Optima Oxygenator (K923272), Sorin MONOLYTH Oxygenator (K922933)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY NAME AND CONTACT PERSON
DEC - 5 1996
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Gish Biomedical. Inc. 2681 Kelvin Avenue Irvine, CA 92714-5821 714.756.5485 (Phone) 714.553.7390 (FAX)
Jack W. Brown President
DEVICE NAME
MODEL NUMBER
Gish Reliance TM Oxygenator
HFFO
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
COBE Optima Oxygenator (K923272) and Sorin MONOLYTH Oxygenator (K922933).
DESCRIPTION OF DEVICE
The Gish Reliance TM Oxygenator is designed to control blood gases in the extracorporeal circuit during cardiopulmonary bypass surgery.
The Gish Reliance ™ Oxygenator is a sterile, non-pyrogenic, single use, disposable extracorporeal device. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood. The Gish Reliance The Oxygenator has one (1) blood inlet located at the bottom of the assembly, an integral heat exchanger intended to control the temperature of blood, a bundle of microporous hollow fibers for the exchange of gases, two (2) blood outlet ports, one (1) gas inlet port, one (1) gas outlet port and three (3) gas vents to prevent over pressurization.
The design of the oxygenator allows for a bottom-up flow of blood through the heat exchanger and around and between the hollow fibers of the gas exchange bundle. The bottom-up flow aids in priming and air removal from the unit. Once the blood reaches the top of the unit, it flows into a manifold which directs the blood downward and out the main blood outlet. The other blood outlet port is located at the top of the unit and may be used for air removal or recirculation.
Gas enters the oxygenator through a gas inlet located at the top of the unit and then flows downward (countercurrent to the blood flow) through the inside of the hollow fibers. Gas exchange occurs with the blood through diffusion across the hollow fiber membrane. Gas leaves the oxygenator through gas outlets or vents. One (1) gas outlet port is provided to scavenge gas leaving the oxygenator.
510(k) NOTIFICATION GISH BIOMEDICAL, INC.
APRIL 18, 1996
CONFIDENTIAL PAGE 350 of 460
1
The integral heat exchanger controls the temperature of blood. Blood flows on the outside of the heat exchanger while heated or cooled water flows on the inside. Heat is transferred between the blood and water by the stainless steel bellows.
STATEMENT OF INTENDED USE
The Gish Reliance™ Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of, and carbon dioxide removal from, human blood. It is designed to operate at blood flow rates of one half (0.5) to eight (8.0) liters per minute for periods of up to six (6.0) hours.
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES
The COBE Optima Open System is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to six hours.
The Sorin MONOLYTH has been designed to substitute lung function in an extracorporeal bypass circuit by providing oxygenation and removal of carbon dioxide from venous blood. The MONOLYTH integrates a high efficiency heat exchanger and a hardshell venous reservoir. The MONOLYTH is indicated for use with blood flows of 1 to 8 liters per minute ("LPM"). The MONOLYTH has been tested for 6 hours of continuous use. Use of this device for more than 6 hours is not advised.
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
The Gish Reliance ™ Oxygenator has technological characteristic which are substantially equivalent to the COBE Optima Oxygenators (K923272) and the Sorin MONOLYTH Oxygenators (K922933). The design, construction, materials and nominal specifications of the Gish Reliance™ Oxygenator are either identical or substantially equivalent to COBE Optima Oxygenators or Sorin MONOLYTH Oxygenators.
A Device Comparison Chart comparing the technological characteristics of the Gish Reliance ™ Oxygenator with two substantially equivalent devices, the COBE Optima Oxygenators and the Sorin MONOLYTH Oxygenators is provided in Appendix III.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This premarket notification submission provides substantial equivalence information and rationale which addresses the introduction to commercial distribution of the Gish Reliance™ Oxygenator. The Gish Reliance TM Oxygenator is substantially equivalent to other oxygenators which are in commercial distribution. These predicate/marketed devices include the COBE Optima Oxygenators (K923272) and the Sorin MONOLYTH Oxygenators (K922933).
The Gish Reliance™ Oxygenator has an intended use which is substantially equivalent to other oxygenators which are in commercial distribution, such as the COBE Optima Oxygenators or Sorin MONOLYTH Oxygenators.
The Gish Reliance ™ Oxygenator has technological characteristic which are substantially equivalent to
510(k) NOTIFICATION GISH BIOMEDICAL, INC.
APRIL 18 , 1996
CONFIDENTIAL PAGE 351 of 460
2
the COBE Optima Oxygenators and the Sorin MONOLYTH Oxygenators. The design, construction, materials and nominal specifications of the Gish Reliance™ Oxygenator are either identical or substantially equivalent to COBE Optima Oxygenators or Sorin MONOLYTH Oxygenators.
A Device Comparison Chart comparing the technological characteristics of the Gish Reliance ™ Oxygenator with two substantially equivalent devices, the COBE Optima Oxygenators and the Sorin MONOLYTH Oxygenators is provided in Appendix III.
In addition to the above assessment of intended use and technological characteristics, Gish Biomedical, Inc. has provided additional information to support substantial equivalence of the Gish Reliance ™ Oxygenator. This includes biocompatibility testing on sterilized product and various in-vitro bench testing on sterilized and aged product. These data support that the Gish Reliance™ oxygenator does not significantly affect safety and effectiveness and is substantially equivalent to other marketed oxygenators.