(186 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description and intended use are typical for a standard endoscopic system.
Yes
The intended use explicitly states "treatment" as a function of the device, indicating it has a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "specifically designed for endoscopic diagnosis."
No
The device description explicitly states it includes the "Olympus EVIS 140 System, associated endoscope, and ancillary equipment and endoscopic accessories," indicating hardware components are part of the system.
Based on the provided information, the Olympus EVIS 140 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopic diagnosis, treatment, and photo and video documentation" within the body (upper and lower digestive tract). IVDs are used to examine specimens outside the body (in vitro).
- Device Description: The description mentions the system, endoscope, and accessories, all of which are used for internal examination and procedures.
- Anatomical Site: The specified anatomical sites are all internal organs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The EVIS 140 System is an endoscopic system used for direct visualization and intervention within the body, which falls under the category of medical devices used for internal examination and procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EVIS 140 System is specifically designed for endoscopic diagnosis, treatment, and photo and video documentation in combination with Olympus endoscopes, various accessories and ancillary equipment within the upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliary duct, duodenum, small intestine, rectum and colon.
The intended use of EVIS 140 System and associated endoscopes are identical to the currently marketed EVS System which was cleared for marketing in the 510(k) # K853585. Both systems are used for observation, photo and video documentation of the images within the upper and lower GI tract. Thus, when compared to the predicate device, Olympus EVIS 140 System does not raise any questions regarding the safety of the subject device.
Product codes
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Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliary duct, duodenum, small intestine, rectum and colon.
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
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
1.754451
MAR 2 9 1996
510 (k) SUMMARY
OLYMPUS EVIS 140 VIDEO ENDOSCOPY SYSTEM
| Device Name: | Olympus EVIS 140 System, associated endoscope,
and ancillary equipment and endoscopic accessories |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Olympus EVIS 140 System |
| Classification Name: | Endoscope and Accessories |
| Predicate Devices: | Olympus EVS Video Endoscopy System (K853585)
Olympus EVIS 200 System - Bronchoscopy (K931154)
Refer to Subsection I-A for additional list of predicate
devices. |
| Submitted By:
(Contact Person) | Mr. Barry Sands
Olympus America Inc.
Endoscope Division
Two Corporate Center Drive
Melville, New York 11747-3157
(516) 844-5474 |
| Summary Preparation Date: | January 16, 1996 |
Statement of Intended Use
The EVIS 140 System is specifically designed for endoscopic diagnosis, treatment, and photo and video documentation in combination with Olympus endoscopes, various accessories and ancillary equipment within the upper and lower digestive tract including esophagus, stomach, pancreatic duct, biliary duct, duodenum, small intestine, rectum and colon.
The intended use of EVIS 140 System and associated endoscopes are identical to the currently marketed EVS System which was cleared for marketing in the 510(k) # K853585. Both systems are used for observation, photo and video documentation of the images within the upper and lower GI tract. Thus, when compared to the predicate device, Olympus EVIS 140 System does not raise any questions regarding the safety of the subject device.