UltraSightHD™ C31 with ImageSense™ and Remote Viewer Telemedicine 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. The Remote Viewer Telemedicine Technology is a software feature that enables medical personnel to view live video from the UltrasightHD during an ongoing medical exam from a remote viewing station.

Device Description

The UltraSightHD™ C31 Digital Colposcopy System with ImageSense™ and Remote Viewer Telemedicine Technologies represents a modification to the UltraSightHD (C30) Digital Colposcopy System with ImageSense Technology. It is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy. The illumination and optical design of the device enable the user to capture high resolution digital images. The optical subsystem is augmented by integrated image quality assessment algorithms, ensuring that focused, centered, 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. The ImageSense™ filters highlight certain characteristics of the captured images. The Remote Viewer Telemedicine feature enables medical personnel to view live video of an ongoing medical exam from a remote viewing station.

AI/ML Overview

Here's an analysis of the provided text regarding the UltraSightHD™ C31 Digital Colposcopy System:

Based on the provided 510(k) summary, the device is a modification of an existing predicate device (UltraSightHD (C30) Digital Colposcopy System with ImageSense Technology, K090324). The main modification is the addition of "Remote Viewer Telemedicine Technology."

The document states that the device is not patient contacting and therefore no biocompatibility testing was required. This indicates the acceptance criteria and study focus are not on direct patient interaction safety or efficacy in clinical diagnosis but rather on the overall system's electrical safety, electromagnetic compatibility (EMC), and the functionality of the new telemedicine feature.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical performance metrics for clinical efficacy. The acceptance criteria appear to be compliance with relevant safety and EMC standards, and functional equivalence to the predicate device.

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Safety	Compliance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)	"Successful compliance testing in accordance with IEC 60601-1... was conducted."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests)	"Successful compliance testing in accordance with... 60601-1-2 (Safety and EMC) was conducted."
Biocompatibility	Not applicable for patient contact (no direct patient contact)	"The device is not patient contacting and therefore no biocompatibility testing was required."
Functional Equivalence	Equivalence in indications for use, safety, efficacy, overall design, function, product performance, and materials to the predicate device (K090324)	"The UltraSightHD™ C31 Digital Colposcopy System... is equivalent to the UltraSightHD™ (C30) Digital Colposcopy System... The indications for use, safety and efficacy, basic overall design and function, product performance, and materials used are equivalent. The addition of the remote viewer does not affect the safety and effectiveness of the device."
Remote Viewer Functionality	Enables medical personnel to view live video from the UltrasightHD during an ongoing medical exam from a remote viewing station.	"The addition of the remote viewing capability allows a computer at a different location to securely connect with the device to view the same imagery visible on the colposcope."

2. Sample Size Used for the Test Set and Data Provenance

The document does not report any clinical study with a test set involving patient data for the purpose of demonstrating diagnostic accuracy or clinical efficacy. The testing mentioned refers to engineering and regulatory compliance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical test set requiring expert ground truth was reported for this 510(k). The evaluation focuses on technical equivalence and safety standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was reported for this 510(k).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to a predicate device and technical compliance rather than clinical comparative effectiveness.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The device includes "integrated image quality assessment algorithms" (ImageSense™) and "OpacityViewer™ digital filter for displaying areas of acetowhitening." However, the document does not describe a standalone performance study for these algorithms. The algorithms are described as augmenting the optical subsystem and providing a tool for displaying characteristics, but not as a standalone diagnostic tool. The OpacityViewer™ is explicitly stated as "a tool that should NOT be used as a substitute for a thorough colposcopic evaluation."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical studies requiring ground truth were reported for this 510(k).

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm training data or studies were reported in this 510(k) for the purpose of demonstrating diagnostic performance. The existing ImageSense™ algorithms are mentioned as integrated, but their development or training details are not part of this submission summary.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no machine learning algorithm training data or studies were reported in this 510(k) for the purpose of demonstrating diagnostic performance.

Summary

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STI Medical Systems, LLC

K110147
pg. 1 of 2

510(k) Application

UltraSightHD™ C31 with ImageSense™ and Remote Viewer Telemedicine

510(k) Summary 5

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92

1. General Information

Submitter's Name and Address:

STI Medical Systems, LLC 4275 Executive Square, Suite 825 La Jolla, CA 92037

APR - 8 2011

Contact Person and Telephone Number:

Rolf Wolters, Ph.D.
Senior Vice President
rolf@sti-hawaii.com
(808) 540-4728

Date Prepared:

January 12, 2011

2. Device Information

Trade/Device Name:	UltraSightHD™ C31 Digital Colposcopy System withImageSense™ and Remote Viewer TelemedicineTechnologies
Classification Name:	Colposcope
Classification Regulation:	21 CFR § 884.1630
Regulatory Class:	Class II
Product Code:	HEX

3. Predicate Device(s):

K090324, UltraSightHD (C30) Digital Colposcopy System with ImageSense Technology, STI Medical Systems, December 20, 2010.

4. Device Description:

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STI Medical Systems, LLC

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2 of 2

510(k) Applicatio

UltraSightHD™ C31 with ImageSense™ and Remote Viewer Telemedicine

characteristics of the captured images. The Remote Viewer Telemedicine feature enables medical personnel to view live video of an ongoing medical exam from a remote viewing station.

5. Indications for Use:

6. Comparison of Technological Characteristics:

The materials and technologies in the UltraSightHD™ C31 Digital Colposcope are suitable for their intended use and are entirely similar to those of the predicate device. The addition of the remote viewing capability allows a computer at a different location to securely connect with the device to view the same imagery visible on the colposcope.

7. Testing:

Appropriate risk analysis-driven product testing was conducted to evaluate conformance to product specification. Successful compliance testing in accordance with IEC 60601-1 and 60601-1-2 (Safety and EMC) was conducted. The device is not patient contacting and therefore no biocompatibility testing was required.

8. Conclusion:

The UltraSightHD™ C31 Digital Colposcopy System with ImageSense™ and Remote Viewer Telemedicine Technologies is equivalent to the UltraSightHD™ (C30) Digital Colposcopy System with ImageSense™ Technology. The indications for use, safety and efficacy, basic overall design and function, product performance, and materials used are equivalent. The addition of the remote viewer does not affect the safety and effectiveness of the device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Rolf Wolters, Ph.D. Senior Vice President STI Medical Systems, LLC 4275 Executive Square, Suite 825 LA JOLLA CA 92037

APR - 8 2011

Re:

K 110147
Trade Name: UltraSightHD™ C31 Digital Coloposcopy System with ImageSense™ OltraSignifiD ----------------------------------------------------------------------------------------------------------------------------------------------------------------

Regulation Number: 21 CFR §884.1630 Regulation Name: Colposcope

Regulatory Class: II Product Code: HEX Dated: January 12, 2011 Received: January 18, 2011

Dear Dr. Wolters:

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

We have reviewed your Section 510(k) premarket notification of mtent to market the indication We have reviewed your Section 510(k) premated in substantially equivant (for the indications
referenced above and have develse is substantially equivated in interstate referenced above and have determined the devices narketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally markets breaks device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment with the provisions of the Federal Food, Drug, devices that have been reclassities in accordance will the proval application (PMA).
and Cosmetic Act (Act) that do not require approval or a proval application of the Act. and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general contralize, subjection, lis You may, therefore, market the device, subject to the general registration, listing of
general controls provisions of the Act include requirements for annual registranding an general controls provisions of the Act menus and problibitions against misbranding and devices, good manufacturing practice, labelme, and evaluate information related to contract liability.
adulteration. Please note: CDRH does not evaluate information related adulteration. Please note: CDRH does not evaluate unomation realing must be truthful and not misleading.
warranties. We remind you, however, that device labeling must be t

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in be and the collected and and also Eristing major regulations affec If your device is classified (see above) mo entre class if (opinisms affecting your device can be
may be subject to additional controls. Exista, a Berts 800 n 898. In addit may be subject to additional controls. Existing major rogano of 888. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In the Fede found in the Code of Federal Regulations, Title 20, 2014 - 12:00 PM the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substance other requirements of the Act
that FDA has made a determination that your device complies with other comply that FDA has made a determination that your veries computes websites. You must comply
or any Federal statutes and regulations administed by other Federal agencies. You must or any Federal statutes and regulations administration and listing and listing (21 CFR Part
with all the Act's requirements, including, but not limited to: registration of me with all the Act's requirements, including, but not milled to: regulations of medical device-related

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Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the adverse events) (21 CFR 803); good manufacturily practice rolicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electro quality systems (QS) regulation (21 CFN Far 620), and on apply of the Act); 21 CFR 1000-1050.
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
r and the states and the stime (Fices/CDRH/CDRH/CDRHOffices/ucml 15809.htm If you desire specific advice for your device offices/CDRH/Offices/ucm] I S809.htm for for for for for for for go to http://www.fda.gov/Aboutible.com/res/thics/CDFF/s) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDFH's) Officeation" (21CFR Par the Center for Devices and Radiological Health s (CDN 3) Online of Chication" (21CFR Part
note the regulation entitled, "Misbranding of educere events under the MDK regulatio note the regulation entitled, "Misbranding by reference to promance in the MDR regulation (21 CFR Part 803), please go to

CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of the continues. http://www.fda.gov/MedicalDcvices/Devices/Davision of Postmarket Surveillance.
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general information on your responsibilities and the world.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free numbe Division of Small Mandracturers, 100 or at its Internet address
(800) 638-2041 or (301) 796-7100 or at its Internet of Soul'Indi (800) 638-2041 or (301) 796-7100 of at its internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Lemon MD

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K110147

UltraSightHD™ C31 Digital Colposcopy System with ImageSense™ and Device Name: Remote Viewer Telemedicine Technologies

Indications For Use:

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)

Arry M-Wh

ductive, Gastro-Renal, and 110147

Page 1 of

Regulation Number and Section

§ 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.