(71 days)
No
The description focuses on standard video endoscopy technology and a video processor that compiles color frames. There is no mention of AI, ML, or any advanced image analysis beyond basic processing for display.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "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 it is "supplied with two biopsy forceps," indicating its use for therapeutic procedures like biopsies.
No
Explanation: The device is described as providing optical visualization and therapeutic access to the Upper Gastrointestinal Tract, and includes functions like air/water delivery, suction, and a working channel for biopsy devices. While it visualizes, it doesn't state that it analyzes or interprets medical data to derive a diagnosis. Its primary function is visualization and access for therapeutic procedures.
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 software-controlled, the device itself is a physical instrument with multiple hardware elements.
Based on the provided information, the EG-3400, Video Gastroscope, is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide optical visualization and therapeutic access to the Upper Gastrointestinal Tract within the patient's body. IVD devices are used to examine specimens taken from the human body (e.g., blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an endoscope that is inserted into the body. It uses light and a CCD to capture images of internal organs. This is a direct visualization tool, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside the body.
The device is a medical device used for direct visualization and therapeutic procedures within the body, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The EG-3400, Video Gastroscope, is intended to provide optical visualization (vja a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not limited 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 procedure(s) are observed in Adult and Pediatric patient populations.
Product codes
78FDS
Device Description
The EG-3400, 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical visualization
Anatomical Site
Upper Gastrointestinal Tract including Esophagus, Stomach, Duodenum, and Small Bowel.
Indicated Patient Age Range
Adult and Pediatric
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
K 962897
DOCUMENT NUMBER: KS031.B7 DATE PREPARED: 07-23-96
PAGE 1 OF 1 PREPARED BY: PAUL SILVA
510(K) SUMMARY
EG-3400, VIDEO GASTROSCOPE DEVICE:
OCT ** 4 1996
1. SUBMITTER INFORMATION:
Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962 TEL: (914)-365-0700
2. NAME OF DEVICE:
- Trade Name: EG-3400. Video Gastroscope Classification Name: Gastroscope, Gastro- Urology (78FDS), 876.1500
PREDICATED DEVICE(S) INFORMATION: 3.
| 1. FG-23H, Fiber Gastroscope | Pentax | K850020 |
|---|---|---|
| 2. EC-3800L, Video Colonoscope | Pentax | K951574 |
| 3. EPM-3300, Video Processor | Pentax | K934918 |
4. DEVICE DESCRIPTION:
The EG-3400, 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.
న్న INTENDED USE:
The EG-3400, Video Gastroscope, is intended to provide optical visualization (vja a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not limited 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 procedure(s) are observed in Adult and Pediatric patient populations.
COMPARISON TO PREDICATED DEVICE(S): 6.
The submission for substantial equivalence included EG-3400 literature including specifications, the identification of standard set components, and identification of optional accessories, comparision tables were provides to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.