← Product Code [FET](/productcode/FET) · K102949

# COLONOSCOPY ASSISTANT (K102949)

_Sti Medical Systems, LLC · FET · Jun 15, 2011 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K102949

## Device Facts

- **Applicant:** Sti Medical Systems, LLC
- **Product Code:** [FET](/productcode/FET.md)
- **Decision Date:** Jun 15, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Software as a Medical Device

## 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.

## Device Story

Software application serving as clinical interface for colonoscopy; inputs live video from colonoscope via video digitizer card; performs digital noise reduction; enables high-resolution image capture; provides side-by-side playback of previous exams; estimates scope camera location; stores patient/exam data. Used in clinical settings by gastroenterologists/endoscopy staff. Output displayed on PC monitor for documentation and reference. Benefits include streamlined workflow, improved documentation, and visual reference for longitudinal patient care.

## Clinical Evidence

No clinical data. Bench testing only. Verification and validation performed using NTSC analog video input source to confirm system requirements. Image noise reduction feature verified for efficacy and reproducibility using exam-specific imagery.

## Technological Characteristics

Software-based system requiring PC hardware platform and video digitizer card. Features digital noise reduction filtering. Supports DICOM/HL7 interfaces. Operates on NTSC analog video input.

## Regulatory 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.

## Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:

1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
   1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
   2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
   3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

## Predicate Devices

- Karl Storz AIDA with DICOM and HL7 Interface ([K043324](/device/K043324.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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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

- 2. 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                  |

3. Predicate Device:

Karl Storz AIDA with DICOM and HL7 Interface (K043324)

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### 4. 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.

#### 5. 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.

#### 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 Colonoscopy<br>Assistant | Karl Storz AIDA/<br>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 Exam<br>Information 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<br>(Part 21 CFR 801 Subpart D) |        | ____<br>(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)

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**Source:** [https://fda-staging.innolitics.com/device/K102949](https://fda-staging.innolitics.com/device/K102949)

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