A Look Inside

A Device That
Looks Inside
You
Group B2
Jakob Killin, Dana Drage, Austin Wanek, Avery Maddox,
Alex Hoyle, and Taylor Oldiges

Background

Endoscopy: medical procedure that examines the interior of a body using an

endoscope.
14 different types of endoscopies, including bronchoscopy, colonoscopy,
and laparoscopy.
Endoscope: a medical device built of a long, thin tube which has a light and a
video camera.
Can be easily fitted with other surgical instruments.
Commonly used to confirm diagnoses, perform biopsies, and aid in surgery.

A Look Down the Camera

Clinical Need

In 2010, around 51.43 million endoscopies were performed in the US.

9% of surgery rooms were designated for endoscopy.
27% of single-specialty surgery centers were focused on gastroenterology
procedures.
There is a forecasted 6.8% compound annual growth rate from 2013 to 2019.
This is the only way to perform minimally invasive surgeries.
Which allows for smaller or no incisions in the patient.
Allows for more precise movements during the surgery.

Constraints

Sterilizability

Size
Heat production

Drape burns

Mobility

Risk of infection
Highly disinfected or sterilized
Dismantle to remove bioburden

Risk of perforating lining

Maneuvering within patients

Ease of use

Time to completion
Collisions with surface
Impression of physician and staff

How it works

In order to produce an image, light must be introduced to the tissue and

reflected back to the camera
The endoscope utilizes fiber optics to accomplish this.
Within the snake of the endoscope, there are many tubes

half are used to relay the light to the tissue from a light source
The other half relays the reflected light to the camera

How it Works, cont.

The endoscopic camera serves as the input in the overall

function of the endoscope
In order to render the image, each pixel is provided a tent of
the light reflected from the body
The CMOS pixel design is a newer method to the CCD pixel
design. The camera utilizes the CMOS design.

How It Works

This camera also has infravision capabilities utilizing

blackbody radiation for wavelengths 7.5-14 m.

Patents
January 1999--US 6224542 B1

Scope + Camera Head + Controller

Voice command and real-time viewing
Lessened surgery and recovery time
Still needed to speed up surgery and
reduce need for manual focusing

Patents

March 2003--US 6533271 B1

Automatic focusing
Reduced harm to patient by:

Reducing surgery time

Eliminating need to move the device

frequently
Lessening the number of small parts

Broke down less

Allowed more power to be provided to
create a higher definition image for the
doctors use
Multiple views inside organs

FDA Approval

FDA Identification for Endoscope and Accessories

510(k)

a device used to provide access, illumination, and allow observation or manipulation of body
cavities, hollow organs, and canals.
Classifies any devices of this type as Class II
Proposal Date: November 18, 2013
Approval Date: December 16, 2013

Predicate Device: Model 888 3-Chip Endoscopic Camera

Identical indications for use

Same intended use
Same technological characteristics

Testing

Proposed using Product code GCJ, Laparoscope

Sterility

Sterilization method
Validation method
Sterility assurance
Packaging information

Performance Data

Bench testing - withstand pressures associated with laparoscopic surgery

Animal Testing - to prove compatibility with tissue
Clinical tests - to confirm the results of first two tests in human population

FDA Standards
Standard

Title of Standard

lEC 60601-2-18: 2009

Medical electrical equipment - Part 2-18: Particular requirements for the

basic safety and essential performance of endoscopic equipment

ISO 8600-1: 2005

Optics and photonics -- Medical endoscopes and endotherapy devices -Part 1: General requirements

ISO 8600-4: 1997

Optics and optical instruments -- Medical endoscopes and certain

accessories -Part 4: Determination of maximum width of insertion portion

ISO 8600-3: 1997 +

Amendment I

Optics and optical instruments - Medical endoscopes and endoscopic

accessories Part 3: Determination of field of view and direction of view of
endoscopes with optics

ISO 8600-5: 2005

Optics and photonics - Medical endoscopes and endotherapy devices Part 5: Determination of optical resolution of rigid endoscopes with optics

ISO 8600-6: 2005

Optics and photonics - Medical endoscopes and endotherapy devices Part 6: Vocabulary

Product Development
Stryker Model 888 3-Chip Camera
1st -generation 3-Chip Camera
Operated on 30W light source
image resolution was low quality
768 x 494p
Required manual sterilization

Product Development (cont.)

Stryker Model 1188 HD Autoclavable 3-Chip Camera
Ability to steam-sterilize
Higher resolution images
1280 x 1024p

Product Development (cont.)

Stryker Model 1288 HD 3-Chip Endoscopic Camera

Wireless transmission capability

High Resolution
1920 x 1080p

Product Development (cont.)

Stryker Model 1488 HD 3-Chip Endoscopic Camera

Approved for retail 2013

Nine specialty surgical settings
300W light source

Development Summary
888

1188 HD

1288 HD

1488 HD

Wattage

30W

300W (X8000)

300W (L9000)

300W

Resolution

786x494p

1280x1024p

1920x1080p

1920x1080p

Sterilization

manual

steam

steam

steam

Wireless
Surgical Settings
Infravision

References
[1] Accessdata.fda.gov, 'CFR - Code of Federal Regulations Title 21', 2015. [Online]. Available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=876.1500. [Accessed: 01- Dec- 2015].

[2] Beutter, R, Endoscopic camera system with automatic non-mechanical focus. Retrieved November 2015. Available: https://www.google.com/patents/US6533721?
dq=US+6533721+B1&hl=en&sa=X&ved=0ahUKEwjW19aJ2LnJAhWBVD4KHa1FBd0Q6AEIHTAA.
[3] Center for Disease Control, 'Number of All-Listed Procedures for Discharges from Short-Stay Hospitals, by Procedure Category and Age', 2010.
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