(207 days)
No
The summary describes a standard endoscope with image capture capabilities and mechanical controls. There is no mention of AI, ML, or any advanced image processing that would suggest the use of such technologies. The performance studies focus on physical and functional aspects of the device.
Yes
The device is intended for "endoscopic treatment" of the esophagus, stomach, duodenum, rectum, and large intestine, indicating a therapeutic function beyond just observation or diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the endoscope is intended for "observation, diagnosis, and endoscopic treatment" of the digestive tract.
No
The device description clearly outlines physical components including a control portion, insertion portion with glass fiber bundles, channels, and image sensors (CMOS or CCD), and an umbilicus with electronic components. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that the FUJIFILM Endoscope Models are used for the direct visualization of the digestive tract. They are inserted into the body to observe, diagnose, and perform endoscopic treatments.
- No Specimen Analysis: There is no mention of the device analyzing any specimens taken from the patient. The device's primary function is to capture images of the internal anatomy.
Therefore, these endoscopes fall under the category of medical devices used for direct visualization and intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
FUJIFILM Endoscope Model EG-760CT is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Endoscope Models EC-760P-V/L and EC-740T/L are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Product codes
FDF, FDS
Device Description
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and either a complementary metal-oxide-semiconductor (CMOS, in 760 series models) or charged-coupled device (CCD, in EC-740T/L) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS or CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor and the light source. The endoscopes are used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K172916.
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.
lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
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 of the subject device was evaluated using following standards: ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was conducted in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
Software specific testing was conducted using the following consensus standard: ANSI/AAM//EC 62304:2006. The software validation activities were performed in accordance with the FDA Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Cleaning, high-level disinfection, and sterilization of the subject device were evaluated according to the following consensus standards: AAMI TIR12:2010, AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
Bench testing was conducted on EC-760P-V/L and EC-740T/L to validate the Advanced Force Transmission and Adaptive Bending features. Comparative bench testing was conducted on the subject device EG-760CT and the predicate device EG-760R to evaluate the rate of suction.
The subject device met performance specifications in the following additional testing:
- Field of view
- Bending capability ●
- . Rate of air supply
- Rate of water supply
- Rate of suction
- Working length ●
- Diameter of forceps channel
- Viewing direction
- Resolution
- LG output
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
July 16, 2019
FUJIFILM Corporation % Jeffrey Wan Specialist. Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 419 West Ave Stamford, CT 06902
Re: K183572
Trade/Device Name: FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDF, FDS Dated: June 20, 2019 Received: June 21, 2019
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 may, 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 aware 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
1
statutes and regulations administered by other Federal agencies. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shanil Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183572
Device Name
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
Indications for Use (Describe)
FUJIFILM Endoscope Model EG-760CT is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Endoscope Models EC-760P-V/L and EC-740T/L are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
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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510(k) SUMMARY
FUJIFILM Corporation's FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L, and EC-740T/L
Date: July 15, 2019
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Jeffrey Wan Senior Regulatory Affairs Specialist Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
ldentification of the Proposed Devices:
| Proprietary/Trade Name: | FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and |
|---|---|
| EC-740T/L | |
| Common Name: | Endoscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Endoscope and accessories | 21 CFR 876.1500 | FDS, FDF |
Predicate Devices:
- . FUJIFILM Endoscope Models EG-760R and EC-760R-V/L (K172916)
Intended Use / Indications for Use
FUJIFILM Endoscope Model EG-760CT is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
4
FUJIFILM Endoscope Models EC-760P-V/L and EC-740T/L are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Device Description
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and either a complementary metal-oxide-semiconductor (CMOS, in 760 series models) or charged-coupled device (CCD, in EC-740T/L) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS or CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor and the light source. The endoscopes are used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K172916.
Comparison of Technological Characteristics
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L differ from the predicate devices EG-760R and EC-760R-V/L in terms of technological characteristics and materials. The subject and predicate devices share mode of operation and intended use.
A summary of differences between the subject devices EG-760CT, EC-760P-V/L and EC-740T/L and the predicate devices EG-760R and EC-760R-V/L is provided as follows:
- . Introduction of new features, "Advanced Force Transmission" and "Adaptive Bending" for EC-760P-V/L and EC-740T/L
- . Dimensional changes to the insertion portion and instrument channel
- . Material changes to the insertion portion, instrument channel, and water jet channel
Performance Data
Electrical safety of the subject device was evaluated using following standards: ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was conducted in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016.
5
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
Software specific testing was conducted using the following consensus standard: ANSI/AAM//EC 62304:2006. The software validation activities were performed in accordance with the FDA Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Cleaning, high-level disinfection, and sterilization of the subject device were evaluated according to the following consensus standards: AAMI TIR12:2010, AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
Bench testing was conducted on EC-760P-V/L and EC-740T/L to validate the Advanced Force Transmission and Adaptive Bending features. Comparative bench testing was conducted on the subject device EG-760CT and the predicate device EG-760R to evaluate the rate of suction.
The subject device met performance specifications in the following additional testing:
- Field of view
- Bending capability ●
- . Rate of air supply
- Rate of water supply
- Rate of suction
- Working length ●
- Diameter of forceps channel
- Viewing direction
- Resolution
- LG output
Substantial Equivalence
The subject devices FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are substantially equivalent to the predicate devices, FUJIFILM Endoscope Models EG-760R and EC-760R-V/L (K172916). The subject devices have the same intended use/indications for use and substantially similar technological characteristics and principles of operation as that of the predicate devices. Material changes to the predicate devices have been validated through biocompatibility testing. Thus, the subject devices FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are substantially equivalent to the predicate devices.
Conclusions
The subject devices FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are substantially equivalent to the predicate devices based on the same intended use, indications for
6
use, similar technological characteristics and materials. The differences in technological characteristics and materials between the subject and predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the predicate devices. The difference in materials between subject and predicate devices has been validated through biocompatibility testing. Thus, the subject devices FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are substantially equivalent to the predicate devices, FUJIFILM Endoscope Models EG-760R and EC-760R-V/L (K172916).