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SafeTouch™ Breast Lump Relocation Device Patent Information
II. Device Name
Trade name: SafeTouch™
Common name: Breast/Body Examination Recording Device
Proprietary name: SafeTouch™
Classification name: None
III. Patent Number 6,412,491
IV. FDA Classification: Unclassified
Panel: OB/GYN
Procode: To be determined
V. Performance Standards: Not applicable
VI. Labeling
1. Statement of Intended Use
This device is meant to be utilized in the physician's office as a solution to the
problem of how to convey the location of discovered breast lumps from one medical
examiner to subsequent examiners or from one examination to the next examination,
by the same examiner.
Without a method of conveying this information in a standard, dependable
fashion, there has been the potential for confusion, anxiety, and missed lesions.
Primary consideration is given to the representation of discovered breast lesions,
but the device is also capable of reproducibly conveying the location of lesions found
elsewhere on the human body.
2. Cautionary Statement
a. This device is not intended to be used as a PHYSICAL EXAMINATION
DEVICE. This product makes no explicit or implied claim to find breast cancer,
breast lumps, or any other breast disease.
b. This is an assist device only and as such it is meant to be utilized only after a
breast lesion or a body lesion is found. Its expressed purpose is to represent the
location of a discovered lesion from one medical examiner to the next or from one
examination, by the same examiner, to subsequent examinations.
c. Due to the variability in size and consistency of human body parts and human
breasts in particular, we make no claim that this device is suitable for use with every
patient or under all conditions.
d. This is a very 'low tech' solution to the problem we are trying to address. (See
statement of intended use above) Because of error introduced by various examiners
utilizing the device at different times, we make no claims regarding the absolute
accuracy of lesion location from one examination to the next. The device is meant to
serve as a general guide to the location of suspected lesions only.
Visionary Concepts, Elegant Design, Dependable Function
{Rusin Medical Devices, LLC}
{Dr. James D. Rusin, MD, MBA}
{SafeTouch™ Instructions}
{Request More Info}
{SafeTouch(TM)}
| | SafeTouch™ Marker Sheet
Dr. James Rusin, MD, MBA
PO Box 445, Anoka, Minnesota 55303 |
| | info@rusinmedical.com | 763-712-0274 | www.rusinmedical.com |
| | © Copyright 2002-2008 Rusin Medical Devices, LLC
SafeTouch™ is a registered Trademark of Rusin Medical Devices, LLC.
US Patents #6,412,491 and #6,622,728 |
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