ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY

K090324 · Sti Medical Systems · HEX · Dec 20, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K090324
• Device Name: ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
• Applicant: Sti Medical Systems
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Dec 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

UltraSightHD™ with ImageSense™ is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy. OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

Device Story

Digital colposcope for imaging cervix/lower genital tract under illumination/magnification. Captures high-resolution digital images; utilizes integrated image quality assessment algorithms for focus/contrast. ImageSense™ suite includes UltraGreen™ filter for contrast enhancement and Acetowhite OpacityViewer™ for acetowhitening visualization. OpacityViewer™ compares pre- and post-acetic acid application images to generate a difference map using a gradient color scale (blue to red). System includes two LCDs for display/user interface; supports annotation, filtering, and storage via DICOM to external PACS. Used in clinical settings by healthcare providers. Does not identify neoplasia; biopsy remains required. Benefits include enhanced visualization of tissue changes during colposcopy.

Clinical Evidence

No clinical studies were conducted to demonstrate improved clinical performance of the OpacityViewer filter. Clinical studies were limited to validation of image registration. Bench testing included electrical safety, electromagnetic compatibility, optical radiation, resolution, distortion, illumination variance, image registration, color difference map range, and mechanical subsystem performance.

Technological Characteristics

Digital colposcope with integrated illumination and optical subsystem. Features two LCDs for video/UI. Connectivity via DICOM for PACS integration. Software includes image processing (UltraGreen filter, Acetowhite OpacityViewer) and image quality assessment algorithms. Non-patient contacting; no biocompatibility testing required.

Indications for Use

Indicated for women with abnormal Pap smears to evaluate for cervical neoplasia or confirm normality. Not for use as a substitute for thorough colposcopic evaluation.

Regulatory Classification

Identification

A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

Special Controls

*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• Cervical MD Model C10 (K072691)

Submission Summary (Full Text)

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# 7. 510(k) SUMMARY

# DEC 2 0 2010

General Information

{

| Classification | Class II |
|----------------|----------------------------------------------------------------------------------------|
| Trade Name | UltraSightHD™ Digital Colposcopy System with ImageSense™<br>Technology |
| Common Name: | Colposcope (21 CFR 884.1630), |
| Manufacturer | STI Medical Systems, LLC<br>99-193 Aiea Heights Drive, Suite 139<br>Aiea, HI USA 96701 |
| Contact | Rolf Wolters<br>Senior Vice President<br>Telephone Number: [phone] |

Date Summary Prepared: December 12, 2010

# Intended Use / Indications for use:

UltraSightHD™ with ImageSense™ is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy.

OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

# Predicate Device

The predicate device is the Cervical MD Model C10. STI Medical Systems, K072691, January 31, 2008. The proposed device differs from the predicate with respect to the addition of new imaging features referred to as ImageSense™.

#### Device Description

The UltraSight HD™ Digital Colposcopy System with ImageSense™ Technology is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification.

ImageSense™ is an image processing suite available for the UltraSightHD™ digital colposcope. The ImageSense™ suite consists of two different modules: UltraGreen™ filter and Acetownite OpacityViewer™.

The UltraGreen™ filter provides the user with greater contrast than an unprocessed image. UltraGreen™ is displayed as a reqular full color image, and is available to be used on any stillframe image displayed in the Review Hi-Res Imagery, View ImageSense Results, and Annotate lmage modes.

The Acetowhite OpacityViewer™ compares two images, one taken prior to the application of Acetic Acid and an additional image taken 60 seconds after the application of Acetic Acid, otherwise known as the pre- and post- Acetic Acid images. The Acetowhite OpacityViewer™ then generates a

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difference map that shows the extent of white difference between the two images, which is indicated by a gradient color scale ranging from blue (no measurable difference between the images), through white (some difference) and vellow (moderate difference), to red (large difference). Red, on the difference map, indicates only the greatest color difference between the images.

(Note: The UltraSightHD™ with ImageSense™ has not been shown to identify areas of cervical neoplasia. Therefore, this system should not be used to omit a biopsy selected on the basis of colposcopic examination.)

The illumination and optical design of the device allow the user to capture high resolution digital images. The optical subsystem is augmented by integrated image quality assessment algorithms. ensuring that focused and balanced-contrast images are acquired. Two liquid crystal displays (LCDs) provide video display and user interface information. The software includes functionality for annotating, filtering and storing the images on external PACS servers via the DICOM protocol.

#### Materials

in

The materials in the UltraSightHD™ Digital Colposcope are suitable for their intended use and have been used in previously cleared products. The device is not patient contacting and therefore no biocompatibility testing was required.

# Testing

Appropriate risk analysis-driven product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device.

Testing included assessments of the following:

- Electrical Safetv .
- . Electromagnetic Compatibility
- . Optical Radiation
- . Resolution
- . Distortion
- . Illumination Variance
- . Image Registration
- Color Difference Map Range .
- . Mechanical Subsystem
- Ease of movement o
- Orientation motion of the optic system (pitch/yaw) o
- . 0 Settling time of motion caused by release of aiming handle
- o Affect of internal vibration on image
- Imaging system height adjustment 0

# Clinical Studies

The only clinical studies conducted were run to validate image registration.

No clinical studies were conducted to demonstrate improved clinical performance using the new OpacityViewer digital filter.

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Test results indicate that the device meets the performance specifications.

# Summary of Substantial Equivalence

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The UltraSightHD™ Digital Colposcopy System with ImageSense™ Technology is equivalent to the Cervical MD Model C10 predicate device. The indications for use, basic overall design and function, product performance, and materials used are equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Rolf Walters, Ph.D. Senior Vice President STI Medical Systems, LLC 733 Bishop Street, Suite 3100 HONOLULU HAWAII 96813

DEC 20 2010

Re: K090324

> Trade/Device Name: UltraSightHD"" Digital Colposcopy System with ImageSense" Technology

Regulation Number: 21 CFR §884.1630 Regulation Name: Colposcope Regulatory Class: Il

Product Code: HEX Dated: October 23, 2009 Received: October 29, 2009

Dear Dr. Walters:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHO/Tices/ucm 1178007/jpm fast the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Paul 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

DEC 20 2010

510(k) Number (if known): K090324

UltraSightHD™ Digital Colposcopy System with ImageSense™ Device Name: Technology

Indications For Use:

UltraSightHD™ with ImageSense™ is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy.

OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nalv Ressr

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K090324

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