(230 days)
Not Found
No
The summary describes a standard endoscope with mechanical controls and a CMOS image sensor for visualization. There is no mention of AI, ML, or advanced image processing beyond basic capture. The performance studies focus on electrical safety, biocompatibility, endoscope-specific functions, and software validation according to IEC 62304, which is a general standard for medical device software, not specific to AI/ML.
Yes
The device is intended for "endoscopic treatment" and has a "forceps channel" for inserting "surgical instruments" and "biopsy forceps and other endoscopic accessories," indicating its use in performing therapeutic procedures.
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 clearly details physical components like an insertion portion, bending mechanism, flexible tube, forceps channel, distal end with imaging section, objective lens, nozzles, light guide, and control portion. While software is mentioned as being tested, the core functionality and description are centered around hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum." This involves directly viewing and interacting with internal body structures.
- Device Description: The description details the physical components of an endoscope designed for insertion into the body to provide optical visualization and facilitate procedures.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests on samples. It is a tool for direct observation and intervention within the body.
The device is an endoscope, which is a type of medical device used for in-vivo (within the living body) procedures, not in-vitro (in glass/outside the body) diagnostics.
N/A
Intended Use / Indications for Use
FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally. Never use this product for any other purposes.
Product codes
FDS
Device Description
The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion with a knob which controls the bending portion. The forceps channel which runs through the the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle (Except EG-840N), Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.
The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.
The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper digestive tract, esophagus, stomach, 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/AAMI ES 60601-1-2012, IEC 60601-1-6:2020, and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: 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 8600-3:1997, and ISO 8600-4:2014.
Software specific testing was conducted using the following consensus standard: IEC 62304:2015. The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Validation of the cleaning, disinilization instructions was performed in accordance with FDA's quidance, "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 suction
- Working length
- Diameter of forceps channel
- Resolution
- LG output
- Uneven illumination
- Viewing direction
- Color reproducibility
The subject devices FUJFILM Endoscope Model EG-840T, EG-840TP are 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 and predicate devices raise of safety or effectiveness. Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the difference in materials between subject and predicate devices has been validated through biocompatibility testing. Thus, the subject devices FUJ/FILM Endoscope Models EG-840N, EG-840T are substantially equivalent to the predicate devices, FUJ/FLM Endoscope Models EG-740CT(K183572).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K183572, K182836, K172916, K183032
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 4, 2024
Fujifilm Corporation % Chaitrali Kulkarni Sr. Regulatory Affairs Specialist Fujifilm Healthcare Americas Corporation 81 Hartwell Ave, Suite 300 Lexington, Massachusetts 02421
Re: K240142
Trade/Device Name: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDS Dated: August 5, 2024 Received: August 5, 2024
Dear Chaitrali Kulkarni:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. 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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T;
FUJIFILM Endoscope Model EG-840TP
Indications for Use (Describe)
FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophaqus, stomach, and duodenum.
FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally. Never use this product for any other purposes.
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
Prepared on: 2024-02-07
Contact Details 21 CFR 807 92(a)(1) Fujifilm Corporation Applicant Name 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN KANAGAWA Applicant Address 258-8538 Japan Applicant Contact Telephone 704-517-4886 Ms. Chaitrali Kulkarni Applicant Contact Applicant Contact Email hcusregulatoryaffairs@fujifilm.com Correspondent Name Fujifilm Healthcare Americas Corporation Correspondent Address 81 Hartwell Ave, Suite 300 Lexington MA 02421 United States Correspondent Contact Telephone 704-517-4886 Correspondent Contact Ms. Chaitrali Kulkarni Correspondent Contact Email hcusregulatoryaffairs@fujifilm.com Device Name 21 CFR 807.92(a)(2) FUJIFILM Endoscope Model EG-840N; Device Trade Name FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP Common Name Endoscope and accessories Classification Name Gastroscope And Accessories, Flexible/Rigid Regulation Number 876.1500 FDS Product Code Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K183572 FUJIFILM Endoscope Model EG-760CT FDS K182836 FUJIFILM Endoscope Model EG-740N FDS FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-VIL K172916 FDS K183032 FUJIFILM Double Balloon Endoscope El-580BT FDA Device Description Summary 21 CFR 807.92(a)(4)
A. Intended Use/indications for Use
5
FUJIFILM Endoscope Model EG-840T, EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Endoscope Model EG-840N is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally. Never use this product for any other purposes.
B. Technological Characteristics
The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion with a knob which controls the bending portion. The forceps channel which runs through the the tip is arranged inside the insertion portion for inserting the surgical instrument. The insertion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle (Except EG-840N), Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.
The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.
The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source.
C. Principles of Operation
The Endoscope Model EG-840T, and EG-840TP function on the same principles of operation as the predicate device. EG-840N, EG-840T, and EG-840TP are endoscopes for observation, diagnosis, and treatment of the upper digestive tract. After connecting to the light source and video processor, the devices guide the fiber bundles situated inside the insertion portion of the device. The light that emits from the distal end of the insertion portion reflects from the target region and forms an image on the CMOS image sensor through a group of object lenses placed at the distal end of the devices. An electric signal from the image sensor is transmitted to the video processor connected to the device. The video processor converts the electric signal and displays an image on a monitor.
Intended Use/Indications for Use
FUJIFILM Endoscope Models EG-840T and EG-840TP is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Endoscope Model EG-840N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally. Never use this product for any other purposes.
Indications for Use Comparison
The indication for use for the proposed device and the predicate devices are same.
Technological Comparison
Proposed device models come with optical characteristics compared to predicate devices. Although the differences in the optical characteristics have been tested through Bench testing and no new concern for safety or efficacy was seen.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807 92(a)(5)
6
Proposed device models EG-840T have differences in insertion diameter and bending capability. Bench testing data demonstrated that the proposed devices are substantially equivalent in performance to the predicate devices. The dimensions of the proposed device models are smaller than the dimensions of the predicate device there are no new concerns for safety or efficacy.
The proposed device models have differences in materials in comparison to the differences in the materials have been tested through biocompatibility testing and no new concern for safety or efficacy was seen.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Electrical safety of the subject device was evaluated using following standards: ANSI/AAMI ES 60601-1-2012, IEC 60601-1-6:2020, and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: 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 8600-3:1997, and ISO 8600-4:2014.
Software specific testing was conducted using the following consensus standard: IEC 62304:2015. The software validation activities were performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Validation of the cleaning, disinilization instructions was performed in accordance with FDA's quidance, "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 suction
- · Working length
-
· Diameter of forceps channel
· Resolution
- · LG output
· Uneven illumination
· Viewing direction
· Color reproducibility
-
Resolution
-
The subject devices FUJFILM Endoscope Model EG-840T, EG-840TP are 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 and predicate devices raise of safety or effectiveness. Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the difference in materials
between subject and predicate devices has been validated through biocompatibility testing. Thus, the subject devices FUJ/FILM Endoscope Models EG-840N, EG-840T are substantially equivalent to the predicate devices, FUJ/FLM Endoscope Models EG-740CT(K183572).