(105 days)
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No
The description focuses on the mechanical and material properties of a microcatheter, with no mention of AI or ML.
No
The device is intended to facilitate the placement of guide wires and assist in the delivery of contrast media, not to treat a disease or condition.
No
This device is intended to facilitate the placement of guide wires and deliver contrast media, which are interventional and delivery functions, not diagnostic ones.
No
The device description clearly outlines physical components such as a distal tip, shaft tube, radiopaque marker coil, coating, reinforcement wires, and PTFE lining, indicating it is a physical medical device, not software-only.
Based on the provided information, the Asahi Corsair Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) to facilitate procedures in the coronary, peripheral, and abdominal vasculatures. IVDs are used to examine specimens from the body (in vitro), such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. This is consistent with an in vivo medical device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Asahi Corsair Microcatheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Asahi Corsair Microcatheter is intended to provide support to facilitate the placement of Guide wires in the coronary and peripheral vasculatures and can be used to exchange one guide wire for another. The Corsair Microcatheter is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures.
Product codes
DQy
Device Description
The ASAHI Corsair Microcatheter consists of distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The Corsair has a radiopaque marker coil is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the device is coated with sodium hyaluronate on the outer surface of shaft tube to provide a smooth transition in blood vessel. The Distal tip of the Corsair has a tapered shape and is designed to have increased flexiblility towards distal side. PTFE is applied to the inner lumen of Catheter for the purpose of smooth transition and exchange of guidewire. The Microcatheter also reinforcement wires that are knitted between hypoblast and intercellular layer to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.
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
coronary and peripheral vasculatures, abdominal vasculatures
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)
All components that come in direct contact with the patient have a long history of use in medical devices and are proven to be biocompatible for use in the vasculature. Furthermore, this submission contains biocompatibility testing conducted on the subject device. This 510(k) notice also includes mechanical and functional bench testing that demonstrates that the ASAHI Corsair Microcatheter performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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