(90 days)
Not Found
No
The description focuses on standard video endoscopy technology and image display, with no mention of AI, ML, or advanced image analysis beyond formatting for display.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to provide "therapeutic access to the Biliary Tract".
Yes
The device's intended use is to "provide optical visualization ... of ... the Biliary Tract via the Upper GI Tract." Visualization is a key component of diagnosis, allowing medical professionals to observe internal structures for abnormalities. While it also offers "therapeutic access," its primary function of enabling visualization for assessment strongly implies a diagnostic capability.
No
The device description clearly outlines physical hardware components such as a flexible insertion tube, control body, umbilicus, light carrying bundles, CCD, and a working channel. It also mentions a required Video Processor with a Xenon lamp. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The ED-3490TK, Video Duodenoscope, is used for direct visualization of internal anatomy (Upper GI and Biliary Tract) within the body. It also provides therapeutic access.
- No Specimen Testing: The description focuses on optical visualization and image data collection from within the body, not on testing samples taken from the body.
Therefore, the device's function and intended use clearly fall outside the scope of an In Vitro Diagnostic device. It is an endoscopic device used for direct internal examination and intervention.
N/A
Intended Use / Indications for Use
The ED-3490TK, Video Duodenoscope is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper Gastrointestinal Tract and Biliary Tract includes but is not limited to, the organs; tissues; and subsystems: Esophogus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Product codes
FDT
Device Description
The ED-3490TK, Video Duodenoscope, must be used with a Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus. The 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 that is focused at the connected video endoscope lighteuide prone. The endoscope light carrying bundles present the light to the body cavity and the CCD collects 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
Not Found
Anatomical Site
Upper Gastrointestinal Tract and Biliary Tract, Esophogus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, Common Bile, Hepatic, and Cystic Ducts.
Indicated Patient Age Range
adult and pediatric 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 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
510(k) Submission Video Duodenoscope, ED-3490TK
Kogzio
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 2009
Name of Device
| Trade Name: | ED-3490TK, Video Duodenoscope |
|---|---|
| Classification Name: | Duedenoscope and Accessories Flexible/Rigid {876.1500} tier 2 |
| Product Code: | FDT |
Predicated Device(s) Information
| Model, Description | Manufacturer | PMN # |
|---|---|---|
| ED-3410, Video Duodenoscope | Pentax Medical Company | K963056 |
| EPK-i, Video Processor | Pentax Medical Company | Jointly Submitted |
Device Description
The ED-3490TK, Video Duodenoscope, must be used with a Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus. The 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 that is focused at the connected video endoscope lighteuide prone. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
Intended Use:
The ED-3490TK, Video Duodenoscope is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper Gastrointestinal Tract and Biliary Tract includes but is not limited to, the organs; tissues; and subsystems: Esophogus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
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 substantial equivalence is not based on an assessment of clinical performance data.
Prepared by: Paul Silva
Signature: Date: 2009.08.26
Control Number: ED-3490TK
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Revision: a
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
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
DEC - 2 2009
Ms. Lisa Lancia Regulatory Affairs Assistant Pentax Medical Company 102 Chestnut Ridge Road MONTVALE NJ 07645-1856
Re: K092710
Trade/Device Name: PENTAX ED-3490TK, Video Duodenoscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT Dated: August 6, 2009 Received: September 3, 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
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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.
Sincerely 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): K092710
Device Name: PENTAX ED-3490TK, Video Duodenoscope
Indications For Use:
The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophogus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.
| Prescription Use | √ |
|---|---|
| ------------------ | --- |
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)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K092710 |
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