(77 days)
No
The document describes a standard video duodenoscope and its associated video processor. While it mentions image processing for compiling color frames, there is no mention of AI, ML, or any advanced algorithms for image analysis, diagnosis, or other functions typically associated with AI/ML in medical devices. The description focuses on the hardware and basic image processing for display.
Yes
The device’s intended use states it provides "therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract."
Yes
The "Intended Use / Indications for Use" states that the device is "intended to provide visualization...of...the Upper Gastrointestinal Tract and Biliary Tract." Visualization, especially when connected to 'indications consistent with the requirement for the procedure are observed', implies a diagnostic purpose. While it also mentions therapeutic access, the primary role of providing visual information about an internal body part makes it a diagnostic device.
No
The device description clearly details 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 itself is a physical endoscope system.
Based on the provided information, the ED-3440T, Video Duodenoscope, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for visualization and therapeutic access to the Upper Gastrointestinal Tract and Biliary Tract. This involves directly examining internal body structures and potentially performing procedures within the body.
- Device Description: The description details a device that is inserted into the body (flexible insertion tube), illuminates internal cavities, collects image data from within the body, and has a working channel for introducing other devices.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes. The ED-3440T does not examine specimens in vitro (outside the body). It directly visualizes and interacts with structures in vivo (within the body).
Therefore, the ED-3440T is an endoscopic device used for direct visualization and intervention within the body, not an IVD.
N/A
Intended Use / Indications for Use
The ED-3440T, Video Duodenoscope, is intended to provide 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 restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
Product codes
FDT
Device Description
The ED-3440T, Video Duodenoscope, must be used with a Video Processor (a 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/ downl left/ right angulation, air/water delivery, suction, elevator control lever, 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 instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prone. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. 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
Video
Anatomical Site
Upper Gastrointestinal Tract and Biliary Tract (Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct)
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 submission for substantial equivalence was 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
JUL 9
510(K) SUMMARY ED-3440T, VIDEO DUODENOSCOPE DEVICE: --PREPARED BY: PAUL SILVA DATE SUMMARY PREPARED: 06-27-96
1. SUBMITTER INFORMATION: Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962 TEL: (914)-365-0700
2. NAME OF DEVICE:
ED-3440T. Video Duodenoscope Trade Name: Classification Name: Duodenoscope (Esphago Gastro), (FDT),876.1500
3. PREDICATED DEVICE(S) INFORMATION:
| 1. | EC-3800L, Video Colonoscope | Pentax | K951574 |
|---|---|---|---|
| 2. | FD-34A, Fiber Duodenoscope | Pentax | K832006 |
| 3. | EPM-3300 | Pentax | K934918 |
4. DEVICE DESCRIPTION:
The ED-3440T, Video Duodenoscope, must be used with a Video Processor (a 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/ downl left/ right angulation, air/water delivery, suction, elevator control lever, 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 instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prone. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.
5. INTENDED USE:
The ED-3440T, Video Duodenoscope, is intended to provide 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 restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
6. COMPARISON TO PREDICATED DEVICE(S):
The submission for substantial equivalence included ED-3440T literature including specifications, the identification of standard set components, and identification of optional accessories. comparision tables were provided to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.