This software is an accessory to standard colonoscopy. It is intended for use in the viewing, recording, archival, localization, documentation, and retrieval of still images, video, and patient data during and after a standard colonoscopic procedure. Standard colonoscopy is indicated for the evaluation of results from an abnormality on barium enema or other imaging study, unexplained gastrointestinal bleeding, screening and surveillance for colonic neoplasia, the excision of a colonic polyp, or the management of chronic inflammatory bowel disease.

Captured, compressed videos from previous exams are for viewing and reference purposes and are not intended for primary diagnosis.

Device Description

Colonoscopy Assistant is a software application designed to provide a streamlined clinical user interface for colonoscopy. The software serves as a portal to useful information before, during, and after a colonoscopic exam. The software displays live video from the colonoscope, enables high-resolution image capture, provides digital noise reduction, displays side-by-side playback of previous exams, estimates the scope camera location during a colon video, and stores all patient and exam information.

AI/ML Overview

This submission (K102949) describes the Colonoscopy Assistant, a software application designed to streamline the clinical user interface for colonoscopy by providing tools for viewing, recording, archiving, localization, documentation, and retrieval of still images, video, and patient data.

Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in the format of a table. Instead, it relies on verification and validation (V&V) testing against system requirements and a comparison to a predicate device to demonstrate safety and effectiveness.

The "Nonclinical Testing" section (Section 7) describes the general approach to validating the device:

Acceptance Criteria (Implied): The software device must meet its system requirements. Specifically for the image noise reduction feature, the algorithm must decrease image noise without adding artifacts and produce reproducible filtering results.
Reported Device Performance:
- V&V test procedures were created and executed on the software using an NTSC analog video input source.
- The results were compiled into V&V test reports, which presumably showed that the system requirements were met.
- Planned risk mitigations in the hazard analysis were verified.
- The image noise reduction feature was verified to ensure it produced safe and effective results, specifically that image noise was decreased without adding image artifacts and that filtering results were reproducible.

Since no specific numerical acceptance criteria or performance metrics are provided, a table of acceptance criteria and reported device performance cannot be generated. The submission emphasizes that all system requirements were met and verified through testing.

Study Details

Sample size used for the test set and the data provenance:
- The submission mentions "exam-specific imagery" and "colon images" were used for testing the image noise reduction feature, and an "NTSC analog video input source" for general V&V. However, the exact sample size (number of images/videos/exams) for the test set is not specified.
- Data provenance is not explicitly stated, but the use of an "NTSC analog video input source" suggests a laboratory or controlled setting for general testing. For "colon images," it's unclear if these were from a specific country or whether they were retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The submission does not mention the involvement of experts to establish ground truth for the test set. The validation appears to be primarily engineering-based, comparing the software's output to defined functional requirements for video capture, archiving, noise reduction, etc.
Adjudication method for the test set:
- No adjudication method is described as the ground truth was not established by multiple experts.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. The device's purpose is as an accessory for viewing, recording, and managing colonoscopy data, not primarily for diagnostic interpretation or aiding human readers in decision-making in a way that would require an MRMC study. Its function is to streamline the workflow and manage visual data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the device is a "software application" and performs functions like digital noise reduction automatically, the submission does not present data specifically illustrating "standalone" diagnostic performance in the way an AI-powered diagnostic tool would. Its functions are assistive to a human-performed procedure (colonoscopy) rather than providing independent diagnostic conclusions. The noise reduction is an algorithmic standalone function, but its "performance" is verified against quality improvement criteria (decreased noise, no artifacts) rather than diagnostic accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The description implies a functional ground truth based on system requirements and expected output. For example, for noise reduction, the ground truth is "decreased image noise without adding image artifacts" and "reproducible filtering results," which would be assessed by visual inspection and technical evaluation rather than, for instance, pathology reports for diagnostic accuracy.
The sample size for the training set:
- This submission describes a software accessory for data management and image processing, not a machine learning model that requires a "training set" in the conventional sense of supervised or unsupervised learning. Therefore, no training set sample size is applicable or provided.
How the ground truth for the training set was established:
- As there is no mention of a training set, the establishment of its ground truth is also not applicable or provided.

Summary

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K1D2949

510(k) Summary

Colonoscopy Assistant™

JUN 1 5 2011

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 99-193 Aiea Heights Dr., Suite 136 Aiea, Hawaii 96701 USA

Contact Person and Telephone Number:

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

Date Prepared: September 30, 2010

1. Device Information

Trade/Proprietary Name:	Colonoscopy Assistant™
Common/Usual Name:	Colonoscope Electronic Media System
Classification Name:	Endoscopic Video Imaging System/Component
Classification Regulation:	21 CFR 876.1500
Device Class:	Class II
Product Code:	FET
Advisory Panel:	Gastroenterology-Urology

Predicate Device:

Karl Storz AIDA with DICOM and HL7 Interface (K043324)

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4. Device Description:

5. Indications for Use:

Captured, compressed videos from previous exams are for viewing and reference purposes and are not intended for primary diagnosis.

6. Comparison of Technological Characteristics:

The Colonoscopy Assistant and the predicate device are both systems that enable viewing, acquiring, recording, archiving and retrieving video and still images of endoscopic procedures.

The following table highlights similarities in technological characteristics between the proposed device and the predicate device:

	STI ColonoscopyAssistant	Karl Storz AIDA/DICOM/HL7
Software-based Technology	Yes	Yes
PC Hardware Platform	Required	Included
Video Digitizer Card	Required	Included
Captures Still Imagery	Yes	Yes
Records Video	Yes	Yes
Stores Patient and ExamInformation along with Imagery	Yes	Yes

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7. Nonclinical Testing:

The software device was verified and validated against the system requirements. V&V test procedures were created and executed on the software using an NTSC analog video input source. The results were compiled into V&V test reports. Furthermore, the planned risk mitigations in the hazard analysis were verified. This testing validates both the safety and efficacy of the software device.

The image noise reduction feature was verified specifically to ensure that the algorithm produced safe and effectiveness results on exam-specific imagery. For this purpose, colon images were processed to verify the image noise is decreased without adding image artifacts and the filtering results are reproducible.

8. Clinical Testing:

N/A

9. Conclusion:

The Indications for Use and technological characteristics of Colonoscopy Assistant™ are entirely similar to that of the predicate device. Furthermore, the proposed device raises no new issues of safety or effectiveness, as evidenced by verification and validation testing. Therefore, the Colonoscopy Assistant is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 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 99-193 Aiea Heights Drive AIEA HI 96701

JUN 1 5 2011

Re: K102949

Trade/Device Name: Colonoscopy Assistant Regulation Number: 21 CFR $876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: June 13, 2011 Received: June 13, 2011

Dear Dr. Wolters:

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/CDRHOffices/ucm115809.htm for 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 Part 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.

Sincerely yours,

Michael Levin MD

erbert 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 Statement 4

510(k) Number (if known): K102949

Device Name: Colonoscopy Assistant

Indications for Use: This software is an accessory to standard colonoscopy. It is intended for use in the viewing, recording, archival, localization, documentation, and retrieval of still images, video, and patient data during and after a standard colonoscopic procedure. Standard colonoscopy is indicated for the evaluation of results from an abnormality on barium enema or other imaging study, unexplained gastrointestinal bleeding, screening and surveillance for colonic neoplasia, the excision of a colonic polyp, or the management of chronic inflammatory bowel disease.

Captured, compressed videos from previous exams are for viewing and reference purposes and are not intended for primary diagnosis.

	Prescription Use	AND/OR	Over-The-Counter Use
	X(Part 21 CFR 801 Subpart D)		____(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)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number	K102949

	4-1
	STI® Proprietary

![](sti logo)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.