(209 days)
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No
The summary describes a physical medical device (a catheter) and its mechanical properties and performance, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for extracorporeal life support procedures, which is a therapeutic intervention.
No
The device is a cannula used for extracorporeal life support procedures, facilitating the drainage and re-infusion of blood. Its described function relates to blood circulation management rather than diagnosing a condition.
No
The device description clearly describes a physical catheter with a wire reinforcement layer, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a catheter designed for insertion into a blood vessel. This is consistent with a medical device used for treatment or support, not for diagnostic testing of a sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
In summary, the device is a medical device used for a therapeutic/supportive procedure within the patient's body, not for in vitro diagnostic testing of a sample.
N/A
Intended Use / Indications for Use
The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less.
Product codes
DWF
Device Description
The OriGen Reinforced Dual Lumen catheter (RDLC) is the same design as the OriGen Dual Lumen Catheter (the predicate device), but with the addition of a wire reinforcement layer on the tip of the device. Both are dual lumen catheters with unequal lumen areas for drainage and reinfusion. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. Other characteristics of the catheter are the same.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
internal jugular vein
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non Clinical Test Results: Applicable tests were carried out in accordance with the requirements of ISO 10993-1 and the FDA 1995 memorandum on the use of that standard for biocompatibility testing of materials.
In Vitro Test Results: In vitro testing was carried out to demonstrate both substantial equivalence with the predicate device and to demonstrate the safety and effectiveness of the new catheter test results supplied in the 510(k) premarket notification include performance and mechanical integrity tests which all demonstrated both safety and effectiveness. The tests which were performed are listed in the following summarizing table:
Physical /mechanical - structural integrity: Pass
Physical /mechanical - burst testing: Pass
Physical /mechanical - kink testing: Pass
Functional/Performance - flow testing: Pass
The results of the in vitro studies demonstrate that the Origen Dual Lumen Reinforced Catheter performs in a manner substantially equivalent to the predicate device, the Origen Dual Lumen Catheter. Test results of this study demonstrate that the two devices function with substantially equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
OriGen Dual Lumen cannula
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
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