(175 days)
No
The description focuses on the mechanical and optical components of the endoscope and does not mention any software features related to AI or ML for image analysis or diagnosis. The performance studies listed are related to electrical safety, biocompatibility, and basic endoscope functionality, not AI/ML performance metrics.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is intended for "endoscopic treatment."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment." The inclusion of "diagnosis" clearly indicates its function as a diagnostic device.
No
The device description clearly outlines physical hardware components including a control portion, insertion portion with glass fiber bundles, channels, and a CCD image sensor, and an umbilicus with electronic components. It also mentions being used in combination with other hardware like video processors, light sources, and monitors. While software testing is mentioned, the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the observation, diagnosis, and endoscopic treatment of the upper digestive tract. This involves direct visualization and intervention within the body.
- Device Description: The description details a device that is inserted into the body to capture images and facilitate procedures. It does not describe a device that analyzes samples (like blood, urine, or tissue) in vitro (outside the body).
- 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.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This endoscope is a medical device used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
FUJIFILM Endoscope Model EG-740N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophaqus, stomach, and duodenum. The device can be inserted orally or transnasally.
Product codes
FDS
Device Description
FUJIFILM Endoscope Model EG-740N is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion 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 a complementary Charge-Coupled Device (CCD) 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 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 in to the video processor and the light source. The endoscope is 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 K163675 and 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
Comparative bench testing was conducted on the subject and primary predicate device to evaluate the rate of suction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FUJIFILM Endoscope Model EG-530N (K063316), FUJIFILM Endoscope Model EG-760R (K172916)
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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April 2, 2019
FUJIFILM Corporation % Jeffrey Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT 06902
Re: K182836
Trade/Device Name: FUJIFILM Endoscope Model EG-740N Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDS Dated: February 28, 2019 Received: March 1, 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 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 and Part 809; 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,
Mark J. Antonino -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182836
Device Name
FUJIFILM Endoscope Model EG-740N
Indications for Use (Describe)
FUJIFILM Endoscope Model EG-740N is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. The device can be inserted orally or transnasally.
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 Model EG-740N
Date: March 29, 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 Specialist, Regulatory Affairs Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
Identification of the Proposed Device:
| Proprietary/Trade Name: | FUJIFILM Endoscope Model EG-740N |
|---|---|
| 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 |
Predicate Devices:
- Primary - FUJIFILM Endoscope Model EG-530N (K063316)
- . Secondary - FUJIFILM Endoscope Model EG-760R (K172916)
Intended Use / Indications for Use
FUJIFILM Endoscope Model EG-740N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophaqus, stomach, and duodenum. The device can be inserted orally or transnasally.
4
Device Description
FUJIFILM Endoscope Model EG-740N is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion 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 a complementary Charge-Coupled Device (CCD) 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 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 in to the video processor and the light source. The endoscope is 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 K163675 and K172916.
FUJIFILM Endoscope Model EG-740N differs from the primary predicate device EG-530N in terms of technological characteristics and materials. The secondary predicate device EG-760R supports substantial equivalence with respect to several of these differences. Furthermore, the subject device and predicate devices share the same mode of operation and intended use.
Comparison of Technological Characteristics
A summary of major differences between the subject device EG-740N and the primary predicate device EG-530N is provided as follows:
- . The Scope Connector has updated technological characteristics for power supply and optical communication. These technological characteristics have been previously cleared by the secondary predicate device.
- CPU software has been installed in the subject device to support the modified scope connector. Similar software has been previously cleared by the secondary predicate device.
- . Compatibility with different video processors, light sources, and other accessories
- . Minor material changes to the insertion portion, instrument channel and air/water channel due to supplier availability.
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 Mav 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.
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 ●
Comparative bench testing was conducted on the subject and primary predicate device to evaluate the rate of suction.
Substantial Equivalence
The subject device FUJIFILM Endoscope Model EG-740N is substantially equivalent to the predicate devices, FUJIFILM Endoscope Model EG-530N (K063316) and FUJIFILM Endoscope Model EG-760R (K172916). The subject device has the same intended use and substantially similar indications, technological characteristics, and principles of operation as that of the previously cleared predicate devices.
Technological changes to the primary predicate device EG-530N have previously been cleared for the secondary predicate device EG-760R. Material changes to the primary predicate device have been validated through biocompatibility testing. Thus, the subject device EG-740N is substantially equivalent to the predicate devices.
6
Conclusions
The subject device FUJIFILM Endoscope Model EG-740N is substantially equivalent to the predicate devices based on the same intended use, indications for use, similar technological characteristics and materials. The differences in technological characteristics and materials between the subject device and the predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject device is 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 device FUJIFILM Endoscope Model EG-740N is substantially equivalent to the predicate devices, FUJIFILM Endoscope Model EG-530N (K063316) and FUJIFILM Endoscope Model EG-760R (K172916).