(177 days)
No
The summary describes a standard endoscope with image capture capabilities and does not mention any AI/ML components or image processing beyond basic visualization.
No
The primary intended use of the device is "visualization," "observation," and "diagnosis," with the capability for "endoscopic treatment." While it facilitates treatment, its core function is diagnostic, making it not solely a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment."
No
The device description explicitly states it is an "upper gastrointestinal endoscope" that captures images using a CMOS image sensor and relies on a video processor and light source. The performance studies also detail testing on the physical endoscope device (electrical safety, biocompatibility, endoscopic performance, cleaning/disinfection/sterilization, storage/transportation, and various physical performance metrics). This indicates it is a hardware device with associated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum." This involves directly observing internal body structures.
- Device Description: The description details an endoscope that captures images of the body cavity using light and a CMOS sensor. This is a device used in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used in vitro (outside the living body).
This device is an endoscope, which is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Product codes
FDS
Device Description
FUJIFILM 600 Series Endoscope EG-600WR v2 is an upper gastrointestinal endoscope that captures images when used in combination with a video processor and light source. Light travels from the light source, through the glass fiber bundles in the endoscope, and out the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
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
Electrical safety testing was conducted on the proposed device EG-600WR v2 using the following consensus standards: ANSI/AAMI ES60601-1:2005+AMD1:2012 CSV, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
The proposed device EG-600WR v2 was adopted into biocompatibility testing conducted on the reference device EC-600WL v2 using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
Endoscopic performance testing was conducted on the proposed device EG-600WR v2 according to the consensus standard ISO 8600-1:2015.
Cleaning, high-level disinfection, and sterilization testing was conducted on the proposed device EG-600WR v2 in accordance with the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015).
The proposed device EG-600WR v2 was adopted into storage and transportation validation testing conducted on the reference devices EC-600HL/LS.
Fujifilm conducted the following performance testing on the proposed device EG-600WR v2 to ensure that the modified device performs equivalently to the predicate device:
- Field of view
- Bending capability
- Air supply rate
- Water supply rate
- Suction rate
- Working length
- Forceps channel diameter
- Viewing direction
- Resolution
- LG output
In all cases, the device met the pre-defined acceptance criteria for the test.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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August 3, 2018
FUJIFILM Corporation % Jeffrey Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470
Re: K180341
Trade/Device Name: FUJIFILM 600 Series Endoscope EG-600WR v2 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDS Dated: July 5, 2018 Received: July 6, 2018
Dear Jeffrey Wan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Glenn B. Bell -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180341
Device Name
FUJIFILM 600 Series Endoscope EG-600WR v2
Indications for Use (Describe)
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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K180341 Page 1 of 5
510(k) SUMMARY
FUJIFILM 600 Series Endoscope EG-600WR v2
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Jeffrey Wan Specialist, Regulatory Affairs Fujifilm Medical Systems U.S.A., Inc. Telephone: (973) 709-2219 Facsimile: (201) 995-2452 E-Mail: jeffrey.wan@fujifilm.com
Date Prepared: July 5th, 2018
Identification of the Proposed Device:
| Proprietary/Trade Name: | FUJIFILM 600 Series Endoscope EG-600WR v2 |
|---|---|
| Common Name: | Video Endoscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Classification: | Endoscope and accessories, 21 C.F.R. § 876.150 |
| Product Code: | FDS |
Predicate Device:
Fujifilm 600 Series Endoscopes EC-600WL and EG-600WR, Fujifilm Medical Systems U.S.A, K132210
Reference Devices:
-
- Fujifilm Video Colonoscope Model EC-600WLv2, FUJIFILM Medical Systems U.S.A., K160196
-
- Fujifilm Endoscope Models EC-600HL and EC-600LS, FUJIFILM Medical Systems U.S.A., K162622
4
Intended Use / Indications for Use:
The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Device Description:
FUJIFILM 600 Series Endoscope EG-600WR v2 is an upper gastrointestinal endoscope that captures images when used in combination with a video processor and light source. Light travels from the light source, through the glass fiber bundles in the endoscope, and out the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor.
Technoloqical Characteristics:
The proposed device EG-600WR v2 differs from the predicate device in the following minor modifications:
- o Use of a new epoxy resin in the manufacturing process instead of the original epoxy resin. Both the new and original epoxy resins can be used for repair.
- Minor design changes to the optical fiber, distal end cap, and air/water nozzle .
- Addition of VP/BL-7000 (K163675) and VP-4440FN/XL-4450FN (K162836) as compatible . video processors and light sources.
- Expansion of transport and storage conditions
- Use of an improved Air/Water button AW-500 and Suction button SB-500 ●
- Continued compatibility with an improved Water Tank WT-4 ●
- o J Tube JT-500 is changed from a mandatory accessory to an optional accessory.
A comparison of the technological characteristics between the modified and predicate devices is provided in the table below.
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Device name | EG-600WR v2 | EG-600WR | |
| Common name | Same as K132210 | Endoscope and accessories | |
| Manufacturer | Same as K132210 | FUJIFILM Corporation | |
| 510(k) number | Same as K132210 | K132210 | |
| Intended | |||
| Use/Indications | |||
| for Use | Same as K132210 | The device is intended for the visualization of the | |
| upper digestive tract, specifically for the observation, | |||
| diagnosis, and endoscopic treatment of the | |||
| esophagus, stomach, and duodenum. | |||
| Appearance | Same as K132210 | Image: Endoscope | |
| Viewing direction | Same as K132210 | Forward / 0 degrees | |
| Observation | |||
| range | Same as K132210 | 2-100mm | |
| Field of view | Same as K132210 | 140 degrees | |
| F# of the objective | |||
| lens | Same as K132210 | 9.1 | |
| Resolution | Same as K132210 | At 5mm of working distance: 0.07mm of line pair on | |
| the square wave chart is readable. | |||
| At 100mm of working distance: 0.9mm of line pair on | |||
| the square wave chart is readable. | |||
| Distortion | |||
| characteristics | Same as K132210 | Orthogonal Projection | |
| Magnification of | |||
| lens(es) | Same as K132210 | 0.48-0.01 | |
| Focal length | Same as K132210 | 1.2mm | |
| Image sensors | Same as K132210 | CMOS | |
| # of Light Guide | |||
| Fiber Bundles | Same as K132210 | 2800 | |
| Distal end | |||
| diameter | Same as K132210 | 9.2mm | |
| Flexible portion | |||
| diameter | Same as K132210 | 9.3mm | |
| Maximum | |||
| insertion diameter | Same as K132210 | 10.7mm | |
| Bending | Up | Same as K132210 | 210 degrees |
| capability | Down | Same as K132210 | 90 degrees |
| Left | Same as K132210 | 100 degrees | |
| Right | Same as K132210 | 100 degrees | |
| Forceps channel | |||
| diameter | Same as K132210 | 2.8mm | |
| Working length | Same as K132210 | 1100mm | |
| Total length | Same as K132210 | 1400mm | |
| WJ Function | Same as K132210 | ? | |
| Location of WJ | |||
| inlet | Same as K132210 | On the light guide connector | |
| Video Processor | Light source: BL-7000 | ||
| Processor: VP-7000 | EPX-4440HD | ||
| Light source: XL-4450 | |||
| Processor: VP-4440HD | |||
| EPX-4440HD | |||
| Light source: XL-4450 | |||
| Processor: VP-4440HD | EPX-4440FN | ||
| Light source: XL-4450FN | |||
| Processor: VP-4440FN | 500 Series | ||
| Video/Light guide connector | Same as K132210 | ||
| Peripherals | Same as K132210 | Water Tank WT-2 | |
| Water Tank WT-4 | |||
| Monitor | |||
| Printer | |||
| Electrosurgical Instruments | |||
| Foot Switch | |||
| Cart | |||
| Accessories | Cleaning Brush (WB11002FW2) | Cleaning Brush (WB11002FW2) | |
| Cleaning Brush (WB4321FW2) | Cleaning Brush (WB4321FW2) | ||
| Cleaning Adapter Kit (CA-510/A) | Cleaning Adapter Kit (CA-510/A) | ||
| Forceps Valve (FOV-DV7) | Forceps Valve (FOV-DV7) | ||
| Ventilation Adapter (AD-7) | Ventilation Adapter (AD-7) | ||
| Air/Water button (AW-500) | J Tube (JT-500) | ||
| Suction button (SB-500) | Air/Water button (AW-500) | ||
| Water Jet Inlet cap | Suction button (SB-500) | ||
| Water Jet Inlet cap | |||
| Optional Items | Air leak tester LT-7F | Air leak tester LT-7F | |
| J Tube (JT-500) | |||
| Electrical Safety Compliance | ANSI AAMI ES60601-1 Edition 3.1 | ANSI AAMI ES60601-1 Edition 3.0 |
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6
Substantial equivalence was determined based on the performance testing described below.
Performance Data:
Electrical safety testing was conducted on the proposed device EG-600WR v2 using the following consensus standards: ANSI/AAMI ES60601-1:2005+AMD1:2012 CSV, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
The proposed device EG-600WR v2 was adopted into biocompatibility testing conducted on the reference device EC-600WL v2 using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
Endoscopic performance testing was conducted on the proposed device EG-600WR v2 according to the consensus standard ISO 8600-1:2015.
Cleaning, high-level disinfection, and sterilization testing was conducted on the proposed device EG-600WR v2 in accordance with the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015).
The proposed device EG-600WR v2 was adopted into storage and transportation validation testing conducted on the reference devices EC-600HL/LS.
7
Fujifilm conducted the following performance testing on the proposed device EG-600WR v2 to ensure that the modified device performs equivalently to the predicate device:
- . Field of view
- Bending capability
- Air supply rate
- Water supply rate
- Suction rate
- o Working length
- Forceps channel diameter
- Viewing direction ●
- o Resolution
- LG output
In all cases, the device met the pre-defined acceptance criteria for the test.
Substantial Equivalence:
The company's EG-600WR v2 has the same intended use as the previously cleared predicate EG-600WR (K132210). In addition, the proposed device EG-600WR v2 has similar indications for use, technological characteristics, and principles of operation as its predicate. The minor differences between the proposed device and its predicate device do not raise new or additional questions of safety or effectiveness of the proposed device. Thus, the proposed device EG-600WR v2 is substantially equivalent to its predicate device.
Conclusions:
The modified EG-600WR v2 is substantially equivalent to the predicate EG-600WR and conforms to applicable medical device safety and performance standards.