(90 days)
Not Found
No
The summary describes a standard video colonoscope and video processor. While it mentions image data processing for display, there is no mention of AI, ML, or any advanced image analysis beyond formatting for output. The lack of information on training/test sets and performance metrics further supports the absence of AI/ML.
Yes
The "Intended Use / Indications for Use" section states that the device provides "therapeutic access to the Lower Gastrointestinal Tract," indicating it can be used for therapeutic procedures. The "Device Description" mentions a "working channel through which biopsy devices or other devices may be introduced," further supporting its therapeutic capabilities.
Yes
The device provides optical visualization of the lower gastrointestinal tract to observe indications, which is a key step in diagnosing conditions within that area.
No
The device description clearly outlines hardware components such as a flexible insertion tube, control body, umbilicus, light carrying bundles, CCD, working channel, and a Video Processor with a Xenon lamp. While the Video Processor is described as "software controlled," the device as a whole is a physical instrument with integrated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Device Function: The EC-3890LI, Video Colonoscope is used for direct visualization of the lower gastrointestinal tract within the patient's body. It provides optical images and allows for therapeutic access.
- No Specimen Analysis: The device does not collect or analyze specimens outside of the body. It is an in-vivo imaging and therapeutic tool.
Therefore, the function and intended use of the Video Colonoscope clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EC-3890LI, Video Colonoscope is intended to provide optical visualization (via a video monitor) of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes but is not restricted to the organs, tissues and subsystems: Large Bowel and Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediative patient populations.
Product codes
FDF
Device Description
The EC-3890L, Video Colonoscope must be used with a Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices or other devices may be introduced. The Video Processor, EPK-I, contains a 300 watt short Arc Xenon lamp which provides white light is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collect image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical visualization
Anatomical Site
Lower Gastrointestinal Tract. This anatomy includes but is not restricted to the organs, tissues and subsystems: Large Bowel and Cecum.
Indicated Patient Age Range
adult and pediative patient populations
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 submission for substantial equivalence is not based on an assessment of clinical performance data.
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
§ 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
$\bigcirc93037
510(k) Summary
Submitter Information:
Pentax Medical Company, A Division of Pentax America, Inc. 102 Chestnut Ridge Road Montvale, New Jersey 07645-1856
DEC 2 8 2009
Name of Device
| Trade Name: | EC-3890LI, Video Colonoscope |
|---|---|
| Classification Name: | Colonoscope and Accessories Flexible/Rigid {876.1500} tier 2 |
| Product Code: | FDF |
Predicated Device(s) Information
| Model, Description | Manufacturer | PMN # |
|---|---|---|
| EC-3800L, Video Colonoscope | Pentax Medical Company | K951574 |
| EPK-i, Video Processor | Pentax Medical Company | In submission |
| Awaiting clearance |
Intended Use:
The EC-3890LI, Video Colonoscope is intended to provide optical visualization (via a video monitor) of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes but is not restricted to the organs, tissues and subsystems: Large Bowel and Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediative patient populations.
Device Description
The EC-3890L, Video Colonoscope must be used with a Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices or other devices may be introduced. The Video Processor, EPK-I, contains a 300 watt short Arc Xenon lamp which provides white light is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collect image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
Comparison to Predicated Device(s)
The submission for substantial equivalence included literature describing the system including; specifications, the identification of standard set components and optional accessories, tables to summarize the comparisons to the predicated device(s), and system performance testing. The submission for substantial equivalence is not based on an assessment of clinical performance data.
Prepared by: Paul Silva Control Number:
Signature: Paul Silva
Page 1 of 1
te: 2.28.2009
Revision: a
Revision: a
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of three overlapping lines that resemble an abstract representation of a human form or a symbol of interconnectedness.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lisa Lancia Regulatory Affairs Assistant PENTAX Medical Company 102 Chestnut Ridge Road MONTVALE NJ 07645
DEC 2 8 2009
Re: K093037
Trade/Device Name: PENTAX EC-3890LI, Video Colonoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: September 28, 2009 Received: September 29, 2009
Dear Ms. Lancia :
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.
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 (reporting of medical
2
Page 2 -
device-related 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.
Singerely yours
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K093037
Device Name: PENTAX EC-3890LI, Video Colonoscope
Indications For Use:
The EC-3890LI, Video Colonoscope is intended to provide optical visualization (via a video monitor) of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes but is not restricted to the organs, tissues and subsystems: Large Bowel and Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Prescription Use V
AND/OR
Over-The-Counter Use
(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)
Adh C. M
Division Sign-Off) Division of Reproductive, Abdomina and Radiological Dev 510(k) Number
Page 1 of