(90 days)
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No
The device description and intended use describe a purely mechanical caliper and ruler for manual measurement. There is no mention of any computational or data-driven processes that would indicate AI/ML.
No.
The device is a measuring tool (graft sizer) used to determine appropriate graft dimensions, not to directly treat or diagnose a medical condition.
No
The device is designed to measure the dimensions of blood vessels and grafts, which is a measurement tool for surgical planning. It does not diagnose a medical condition or disease.
No
The device description clearly states it is a "caliper-type design consisting of two parts: a graft sizer scale and a graft sizer pointer," indicating it is a physical, hardware device.
No, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bard Vascular Graft Sizer is a physical tool (a caliper-type design with a ruler) used to measure the dimensions of blood vessels and grafts during a surgical procedure. It does not analyze biological samples or provide diagnostic information based on those samples.
- Intended Use: The intended use is to assist a physician in determining the appropriate size of a vascular graft based on physical measurements of the blood vessel. This is a procedural aid, not a diagnostic test.
The device is a surgical instrument used for measurement, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The Bard" Vascular Graft Sizer is designed to assist the physician in determining the relationship between the inner and outer diameter of the patient's blood vessel and the appropriate vascular graft diameter. The ruler may also aid in determining vessel/graft lengths.
Product codes
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Device Description
This vascular graft sizer is a caliper-type design consisting of two parts: a graft sizer scale and a graft sizer pointer. These are joined together with an eyelet to allow the pointer to rotate. This device may measure inner diameter (I.D.) Of a blood vessel from 6mm to 38mm and the outer diameter (O.D.) From 2mm to 38mm. In addition, on the opposite side, there is a 9cm ruler, graded to a 1mm scale.
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
patient's blood vessel
Indicated Patient Age Range
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Intended User / Care Setting
physician
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)
The Bard Vascular Graft Sizer was subjected to biocompatibility testing as outlined in FDA's May 1, 1995 General Program memorandum- #G95-1 Attachment A. All testing was successfully completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Meadox Graft Sizer
Reference Device(s)
Not Found
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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KY61134
JUN 19 1996
Bard Vascular Systems Division C.R. Bard, Inc. 25 Computer Drive Haverhill, MA 01832 508-373-1000
影
510(k) SUMMARY FOR THE BARD® GRAFT SIZER
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.
A. Submitter Information
Submitter's Name: Bard Vascular Systems, C.R. Bard Inc. Address: 25 Computer Drive, Haverhill, MA 01832 Phone #: (508) 373-1000 Fax #: (508) 374-6200 Contact Person: Sandra L. Perreand Date of Preparation: March 20, 1996
B. Device Name
Trade Name: Bard Vascular Graft Sizer Common/Usual Name: graft sizer Classification Name: vascular graft prosthesis, 6mm greater accessory
C. Predicate Device
Trade Name: Meadox Graft Sizer
D. Device Description
This vascular graft sizer is a caliper-type design consisting of two parts: a graft sizer scale and a graft sizer pointer. These are joined together with an eyelet to allow the pointer to rotate. This device may measure inner diameter (I.D.) Of a blood vessel from 6mm to 38mm and the outer diameter (O.D.) From 2mm to 38mm. In addition, on the opposite side, there is a 9cm ruler, graded to a 1mm scale.
E. Intended Use
The Bard" Vascular Graft Sizer is designed to assist the physician in determining the relationship between the inner and outer diameter of the patient's blood vessel and the appropriate vascular graft diameter. The ruler may also aid in determining vessel/graft lengths.
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F. Technological Characteristics Summary
Both the Bard graft sizer and the Meadox graft sizer are intended to be used in assisting the physician in measuring a patient's blood vessel(s) in order that he/she may select a vascular graft of appropriate size. Both devices are hand held, manually operated devices which obtain measurements by aligning the edges of the device to the inner or outer edge of the vessel, however, the Bard Graft Sizer is of a different design and is manufactured using slightly different materials than the Meadox Graft Sizer. For a comparison of the two device designs and material characteristics see Table VI-I below.
| Table VI-I Comparison of General Characteristics | |||
|---|---|---|---|
| CHARACTERISTICS | BARD GRAFT SIZER | MEADOX GRAFT SIZER | |
| Indications For Use | |||
| (from the device's | |||
| IFU) | The Bard Vascular Graft | ||
| Sizer is designed to assist | |||
| the physician in determining | |||
| the relationship between the | |||
| inner and outer diameter of | |||
| the patient's blood vessel | |||
| and the appropriate vascular | |||
| graft diameter. The ruler | |||
| may also aid in determining | |||
| vessel/graft lengths. | The MEADOX Graft sizer | ||
| is designed to aid the | |||
| physician in determining the | |||
| relationship between the size | |||
| of the patient's blood vessel | |||
| and the appropriate graft | |||
| diameter. | |||
| Contraindications | None | None | |
| Packaging | Peel Pull style pouch. Each | ||
| unit is placed in it's own | |||
| unit box. | Peel Pull style pouch. Each | ||
| unit is boxed with a vascular | |||
| graft. | |||
| Sterilization | Gamma Radiation | Gamma Radiation | |
| Method of Operation | Manual | Manual | |
| Range of Measure | From 6mm-38mm ID | ||
| From 2mm-38mm OD | Obturators available in sizes | ||
| 5,6,7,8,9,10,11,12,14,16,18 | |||
| 20,22, and 24 mm. | |||
| Component Materials | Pointer | Polyester | N/A |
| Scale | Polystyrene | N/A | |
| Eyelet | brass | N/A | |
| Pointer | |||
| silkscreen | Medical Grade PVC ink | N/A | |
| Scale | |||
| Silkscreen | Medical Grade PVC ink | N/A | |
| Meadox | |||
| obturators | N/A | polystyrene |
VI-I Comperison of General Characteristics
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G. Performance Data
The Bard Vascular Graft Sizer was subjected to biocompatibility testing as outlined in FDA's May 1, 1995 General Program memorandum- #G95-1 Attachment A. All testing was successfully completed.