(253 days)
Not Found
No
The document describes standard image processing techniques (noise reduction) and data management features, but does not mention AI, ML, or related concepts like deep learning or neural networks.
No
The device is described as software that assists with viewing, recording, and managing data during colonoscopy, but it does not directly treat or diagnose a disease.
No
The "Intended Use" section explicitly states that "Captured, compressed videos from previous exams are for viewing and reference purposes and are not intended for primary diagnosis." This indicates the device is not used for diagnostic purposes.
Yes
The device description explicitly states it is a "software application" and the performance studies focus on software verification and validation using a video input source. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This software is an accessory to standard colonoscopy. Its primary functions are related to the viewing, recording, archival, localization, documentation, and retrieval of images and video captured during a colonoscopy procedure. It processes and manages visual information obtained directly from the colonoscope within the body.
- Intended Use: The intended use clearly states it's for use during and after a standard colonoscopic procedure and for managing the visual data from that procedure. It explicitly states that captured videos from previous exams are for viewing and reference and not intended for primary diagnosis.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It processes live video and images captured within the body.
While the device is used in a clinical setting and provides information relevant to a medical procedure, it does not perform the type of analysis on biological samples that defines an IVD. It's a tool for managing and enhancing the visual data acquired during an in-vivo procedure (colonoscopy).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FET
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Colon
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)
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.
Clinical Testing:
N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
-
- 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:
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
Assistant | 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 Exam
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
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/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 |
