(102 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses on the mechanical function of balloon dilatation and measurement.
Yes
The device is used for balloon dilatation of stenotic arterial lesions and post-delivery expansion of balloon expandable stents, which are therapeutic interventions.
No
The device is primarily indicated for therapeutic interventions (balloon dilatation and post-delivery expansion of stents) and anatomical measurements, not for diagnosing conditions. While it measures arterial lumen cross-sectional area and diameter, this is a measurement and not a diagnostic function in itself.
No
The summary describes a "Metricath Gemini-P System" used for balloon dilatation and measurement within arteries. This strongly implies a physical catheter and associated hardware, not a software-only device. The lack of a device description further supports this, as a software-only device would typically have a detailed software description.
Based on the provided information, the Metricath Gemini-P System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Metricath Gemini-P System's Intended Use: The intended use describes a system used within the body (in the renal, iliac, and femoral arteries) for procedures like balloon dilatation and measurement of arterial lumen. This is an in vivo procedure, not an in vitro test.
The device is a medical device used for interventional procedures within the vascular system, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for:
- Balloon dilatation of the stenotic portion of an arterial lesion
- Post-delivery expansion of balloon expandable stents
- Measurement of arterial lumen cross sectional area and diameter proximal to a lesion, or within a stented section of artery.
Product codes
LIT
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
renal, iliac and femoral arteries
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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§ 870.1250 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).
0
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 5 - 2005
. when d > 0
b. when d