(62 days)
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No
The description focuses on standard video processing and hardware components without mentioning any AI/ML algorithms for image analysis, diagnosis, or other functions.
Yes
The intended use states that the device provides "therapeutic access to, the Lower Gastrointestinal Tract" and mentions the provision of a working channel through which therapeutic devices (such as biopsy forceps, which are supplied) can be introduced.
Yes
Explanation: The device, a video sigmoidoscope, is intended to provide visualization of the lower gastrointestinal tract, which allows for observation and examination of the internal organs. This process of visual examination is a form of diagnosis, as it helps identify conditions or abnormalities. Therapeutic access is also mentioned, but the primary function for visualization classifies it as a diagnostic device.
No
The device description clearly outlines hardware components such as a flexible insertion tube, umbilicus, control body with physical controls, light carrying bundles, a CCD, a working channel, and a video processor with a xenon lamp and color wheel. While the video processor is described as "software controlled," the device itself is a physical instrument with integrated hardware.
Based on the provided information, the ES-3840, Video Sigmoidoscope, is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide visualization and therapeutic access to the Lower Gastrointestinal Tract in vivo (within the living body). IVDs are used to examine specimens in vitro (outside the living body), such as blood, urine, or tissue samples, to diagnose or monitor a condition.
- Device Description: The device is a sigmoidoscope, which is an instrument inserted into the body for direct visualization. It uses light and a CCD to capture images of the internal anatomy. This is a direct imaging device used on a living patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside the body.
Therefore, the ES-3840, Video Sigmoidoscope, is a medical device used for in vivo examination and therapeutic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ES-3840, Video Sigmoidoscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Rectum and Sigmoid Colon. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.
Product codes
FAM
Device Description
The ES-3840, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, 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, Forward Water Jet, 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
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Anatomical Site
Lower Gastrointestinal Tract, Rectum and Sigmoid Colon
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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) SUMMARY JUN 2 4 1996 ES-3840, VIDEO SIGMOIDOSCOPE DEVICE: PAUL SILVA DATE SUMMARY PREPARED: 06-14-96 PREPARED BY:
1. SUBMITTER INFORMATION: Pentax Precision Instrument Corporation 30 Ramland Road Orangeburg, NY, 10962
TEL: (914)-365-0700
2. NAME OF DEVICE:
Trade Name: ES-3840. Video Sigmoidoscope Classification Name: Sigmoidoscope, flexible (FAM), 876.1500
3. PREDICATED DEVICE(S) INFORMATION:
| 1. EC-3800L, Video Colonoscope | Pentax | K951574 |
|---|---|---|
| 2. EPM-3300, Video Processor | Pentax | K934918 |
4. DEVICE DESCRIPTION:
The ES-3840, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, 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, Forward Water Jet, 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.
INTENDED USE: ട.
The ES-3840, Video Sigmoidoscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Rectum and Sigmoid Colon. The instrument is introduced per rectally 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 ES-3840 literature including specifications, the identification of standard set components, and identification of optional accessories, comparison 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.