(77 days)
Not Found
No
The device description focuses on standard endoscopic technology (light source, CCD, video processor) and does not mention any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended to provide "therapeutic access to, the Upper Gastrointestinal Tract." Additionally, the 'Device Description' mentions that the instrument contains a working channel through which "biopsy devices, or other devices, may be introduced," and specifies that "the instrument is supplied with two biopsy forceps," which are used for therapeutic purposes.
Yes
The device is described as providing visualization of the upper gastrointestinal tract, which implies observing and identifying abnormalities, a key function of diagnostic devices. Additionally, it mentions therapeutic access, suggesting it can be used for interventions based on diagnostic findings.
No
The device description clearly details hardware components such as a flexible insertion tube, control body, umbilicus, light carrying bundles, CCD, and a working channel. It also mentions a separate Video Processor hardware unit. While the Video Processor is described as "software controlled," the device itself is a physical endoscope with integrated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visualization and therapeutic access to the Upper Gastrointestinal Tract. This is a direct examination of the body, not an analysis of samples taken from the body.
- Device Description: The device is a gastroscope, which is used to directly visualize internal organs. It collects image data from within the body, not from in vitro samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is a medical instrument for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The EG-2940, Video Gastroscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. 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
Not Found
Device Description
The EG-2940, Video Gastroscope, 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/ 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 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 prong. 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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Upper Gastrointestinal Tract (Esophagus, Stomach, Duodenum, and Small Bowel)
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 1988
Image /page/0/Picture/1 description: The image shows the characters "K961564" in a handwritten style. The characters are arranged diagonally from the bottom left to the upper right. The text is in black and the background is white.
510(K) SUMMARY EG-2940, VIDEO GASTROSCOPF DEVICE: -PREPARED BY: PAUL SILVA DATE SUMMARY PREPARED: 06-28-96
1. SUBMITTER INFORMATION: Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962 TEL: (914)-365-0700
2. NAME OF DEVICE:
EG-2940. Video Gastroscone Trade Name: Classification Name: Gastroscope, Gastro- Urology (FDS), 876.1500
3. PREDICATED DEVICE(S) INFORMATION:
| 1. EC-3800L, Video Colonoscope | Pentax | K951574 |
|---|---|---|
| 2. FG-23H, Fiber Gastroscope | Pentax | K850020 |
| 3. EPM-330, Video Processor | Pentax | K934918 |
DEVICE DESCRIPTION: 4.
The EG-2940, Video Gastroscope, 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/ 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 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 prong. 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.
న. INTENDED USE:
The EG-2940, Video Gastroscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. 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 EG-2940 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.