(29 days)
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No
The summary describes a vascular graft, a passive implantable device, and contains no mention of AI, ML, image processing, or any other computational technology typically associated with AI/ML in medical devices.
Yes
The device is described as a graft intended for use in arterial vascular reconstruction, segmental bypass, and arteriovenous vascular access, which are interventions aimed at treating medical conditions.
No
The device is a graft intended for surgical reconstruction and vascular access, which are therapeutic and restorative functions, not diagnostic.
No
The 510(k) summary describes a physical graft intended for vascular reconstruction, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for surgical procedures within the body (arterial vascular reconstruction, segmental bypass, arteriovenous vascular access). This is a direct intervention on the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of biological samples.
Therefore, the Atrium (Wrapped) Advanta™ Graft is a surgical implant or device used for vascular procedures, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Atrium (Wrapped) Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.
Product codes
74 DYF
Device Description
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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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human profiles or abstract shapes, often referred to as the "Human Services Symbol" or "HHS Symbol."
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1000
Ms. Karen Hall RA/QA Manager Atrium Medical Corporation 5 Wentworth Drive Hudson, NH 03051
Re : K992958 Atrium Advanta™ Graft (