(91 days)
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No
The device description and intended use clearly describe a set of physical tools for manual measurement, with no mention of software, algorithms, or any form of computational analysis.
No
This device is a graft sizer, which is used to measure the artery for selecting the correct size of vascular graft. It aids the surgeon in a diagnostic step and does not directly treat or prevent a disease or condition.
No
The device is used to measure the size of an artery to aid in selecting a vascular graft, which is an aid to treatment rather than a diagnostic function. It does not identify or detect a disease, condition, or state.
No
The device description clearly states it consists of physical, double-ended 'C' shaped graft sizers made of a material that underwent biocompatibility testing, indicating it is a hardware device. There is no mention of software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Vascutek Graft Sizer Set is a physical tool used during surgery to measure the size of an artery in vivo (within the body) to help select the correct size of a vascular graft. It does not analyze any biological specimens.
The description clearly indicates its use as a surgical aid for direct measurement on the patient's artery.
N/A
Intended Use / Indications for Use
The Vascutek Graft Sizer Set is designed to aid the surgeon in accurately matching the size of vascular graft to the artery. The size of graft to be selected will correspond with the number indicated on the graft sizer which best fits the outside of the vessel.
Product codes
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Device Description
The Vascutek Graft Sizer Set consists of nine individual double-ended 'C' shaped graft sizers. The nine sizers are secured within a clip and are available in a size range from 5 to 32 mm. The graft sizers are supplied sterile and are for single use only.
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
surgeon
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
Biocompatibility tests conducted on the finished device showed that the material is non-hemolytic, non-cytotoxic, and non-pyrogenic. In addition, extensive biocompatibility testing conducted on the material demonstrates its suitability for medical uses in devices and packaging. In addition, it has been shown that the material meets the requirements of USP Class VI-50, being compatible with blood and demonstrating no cytotoxic, mutagenic, or irritant potential.
Key Metrics
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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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§ 870.3450 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/0 description: The image shows the logo for CarboMedics, a company of Sulzer Medica. The logo features a black hexagon shape on the left, followed by the word "CarboMedics" in a bold, sans-serif font. Below the company name, the text "A company of SULZERmedica" is written in a smaller font. The logo has a registered trademark symbol on the top right.
300 EAST ANDERSON LANE. AUSTIN. TEXAS 78752-1793
K955588
510(k) Summary
Trade Name: Vascutek Graft Sizer Set Common Name: Graft Sizer
December 6, 1995
The Vascutek Graft Sizer Set consists of nine individual double-ended 'C' shaped graft sizers. The nine sizers are secured within a clip and are available in a size range from 5 to 32 mm. The graft sizers are supplied sterile and are for single use only.
The Vascutek Graft Sizer Set is designed to aid the surgeon in accurately matching the size of vascular graft to the artery. The size of graft to be selected will correspond with the number indicated on the graft sizer which best fits the outside of the vessel.
Biocompatibility tests conducted on the finished device showed that the material is non-hemolytic, non-cytotoxic, and non-pyrogenic. In addition, extensive biocompatibility testing conducted on the material demonstrates its suitability for medical uses in devices and packaging. In addition, it has been shown that the material meets the requirements of USP Class VI-50, being compatible with blood and demonstrating no cytotoxic, mutagenic, or irritant potential.
CarboMedics considers the Vascutek Graft Sizer Set to be equivalent in intended use, composition, design, and function to the Meadox Graft Sizer manufactured by Meadox Medical, Inc. Marketing clearance was granted by the FDA for 510(k) number K854431 on May 7, 1986, for the Meadox Graft Sizer.
Contact Person:
Edward E. Newton Regulatory Affairs Specialist CarboMedics, Inc. 1300 East Anderson Lane Austin, TX 78752
Phone: (512) 435-3407 Fax: (512) 435-3350
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