(679 days)
No
The device description mentions "image processing suite" and "image quality assessment algorithms," but there is no mention of AI, ML, or any related concepts like training or test sets for such algorithms. The "OpacityViewer" is described as a "digital filter" that performs a difference calculation between two images, which is a standard image processing technique, not necessarily AI/ML.
No
The device is a digital colposcope used for imaging and diagnostic purposes, but it does not directly treat or provide therapy to the patient. Its function is to aid in the detection of abnormal appearances, not to provide therapy.
Yes
Explanation: The device is a digital colposcope whose intended use is to image the cervix and lower genital tract to "affirm normality or detect abnormal appearances consistent with neoplasia," which is a diagnostic purpose.
No
The device description clearly states it is a "digital colposcope designed to image the cervix and lower genital tract under illumination and magnification," and mentions hardware components like "illumination and optical design," "optical subsystem," and "Two liquid crystal displays (LCDs)." While it includes software features like image processing and filters, it is fundamentally a hardware device with integrated software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The UltraSightHD™ with ImageSense™ is a digital colposcope that directly images the cervix and lower genital tract in vivo (within the living body). It does not analyze samples like blood, urine, or tissue biopsies in a laboratory setting.
- The intended use is for imaging and visualization. The device is designed to provide illuminated and magnified images of the cervix and lower genital tract for visual examination by a clinician. While it uses image processing (ImageSense™) to enhance the visualization of certain features (like acetowhitening), this processing is applied to in vivo images, not in vitro specimens.
- The description focuses on imaging technology and image processing. The device description details the optical system, illumination, image quality assessment algorithms, and image processing filters. These are characteristic of imaging devices, not IVDs.
- The performance studies mentioned are related to image registration. The clinical studies conducted were to validate image registration, which is a function of an imaging device, not an IVD. The lack of clinical studies demonstrating improved clinical performance using the OpacityViewer filter further supports that its primary function is image enhancement for visual interpretation, not a diagnostic test on a specimen.
In summary, the UltraSightHD™ with ImageSense™ is a medical imaging device used for direct visualization of the cervix and lower genital tract, which falls outside the definition of an In Vitro Diagnostic.
N/A
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.
Product codes
HEX
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix and lower genital tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Test results indicate that the device meets the performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1630 Colposcope.
(a)
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.(b)
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.
0
7. 510(k) SUMMARY
DEC 2 0 2010
General Information
{
| Classification | Class II |
|---|---|
| Trade Name | UltraSightHD™ Digital Colposcopy System with ImageSense™ |
| Technology | |
| Common Name: | Colposcope (21 CFR 884.1630), |
| Manufacturer | STI Medical Systems, LLC |
| 99-193 Aiea Heights Drive, Suite 139 | |
| Aiea, HI USA 96701 | |
| Contact | Rolf Wolters |
| Senior Vice President | |
| Telephone Number: (808) 540-4728 |
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
1
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.
2
Test results indicate that the device meets the performance specifications.
Summary of Substantial Equivalence
く
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.
3
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
4
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 (800) 638-2041 or (301) 796-7100 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
5
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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