(112 days)
No
The device description and performance studies focus on the physical and functional aspects of the endoscope and its components, with no mention of AI or ML for image analysis or other functions.
Yes
The intended use states that the device is 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 tool.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing ultrasonic images of internal organs for observation, diagnosis, and endoscopic treatment. This involves direct interaction with the patient's body.
- Device Description: The description details an endoscope with an insertion portion, channels for accessories, and a CCD image sensor. This is consistent with a device used for internal examination and procedures, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro (outside the living organism).
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.
This product is not intended for use on children and infants.
Product codes
ODG, FDS, ITX
Device Description
FUJIFILM Ultrasonic Endoscope EG-740UT 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 contains glass fiber bundles, several channels and a 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 into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors, and peripheral devices such as monitor, printer, foot switch, and cart.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic images, CCD image sensor
Anatomical Site
upper gastrointestinal tract
Indicated Patient Age Range
Not intended for use on children and infants.
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)
Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's quidance. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, published March 17, 2015.
Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2018, 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 September 4, 2020.
Electrical safety and EMC of the proposed device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-2-18:2009, and IEC 60601-2-37:2015.
Laser safety and photobiological safety of the proposed device was evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.
Endoscope specific testing was conducted according to ISO 8600-1: 2015.
The proposed device met performance specifications in the following additional testing:
- Field of view
- Bending capability
- Rate of air supply
- Rate of water supply
- Rate of balloon water supply
- Rate of suction
- Rate of balloon suction
- Diameter of forceps channel
- Viewing direction
- Resolution
- LG output
- Axial resolution
- Lateral resolution
- Penetration depth
Usability testing was conducted according to IEC 62366-1:2015 and the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, issued February 3, 2016.
Key Results: The testing demonstrates that the proposed device remains as safe and effective as the predicate device and there remains no new concern regarding the safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
FUJIFILM Ultrasonic Endoscope EG-580UT (K183433)
Reference Device(s)
Olympus GF Type UCT180 (K093395), FUJIFILM Endoscope Model EG-740N (K182836)
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 19, 2022
FUJIFILM Corporation % Kotei Aoki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K221238
Trade/Device Name: FUJIFILM Ultrasonic Endoscope EG-740UT Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, FDS, ITX Dated: July 20, 2022 Received: July 20, 2022
Dear Kotei Aoki:
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.
1
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 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.
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
2
Indications for Use
510(k) Number (if known)
K221238
Device Name FUJIFILM Ultrasonic Endoscope EG-740UT
Indications for Use (Describe)
FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.
This product is not intended for use on children and infants.
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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3
510(k) Summary
FUJIFILM Corporation
FUJIFILM Ultrasonic Endoscope EG-740UT
Date: April 28, 2022
Submitter's Information:
FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN
Contact Person:
Kotei Aoki Senior Regulatory Affairs Specialist E-Mail: kotei.aoki@fujifilm.com Telephone: (765) 246-2931
Identification of the Proposed Device:
| Device Name: | FUJIFILM Ultrasonic Endoscope EG-740UT |
|---|---|
| Common Name: | Ultrasonic Endoscope |
| Product Code: | ODG; FDS, ITX |
| Device Class: | II |
| Regulation Number: | 21 CFR 876.1500; 21 CFR 892.1570 |
| Regulation Description: | Endoscope and accessories; Diagnostic ultrasonic transducer |
| Review Panel: | Gastroenterology/Urology |
Predicate Device:
- . FUJIFILM Ultrasonic Endoscope EG-580UT (K183433)
Reference Devices:
Intended Use / Indications for Use:
FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.
This product is not intended for use on children and infants.
Device Description:
FUJIFILM Ultrasonic Endoscope EG-740UT 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 contains glass fiber bundles, several channels and a 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
4
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 into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors, and peripheral devices such as monitor, printer, foot switch, and cart.
Comparison of Technological Characteristics:
The comparison is presented in Table 1.
Table 1
| | Proposed device
(to be assigned) | Predicate device
(K183433) | Reference 1
(K182836) | Reference 2
(K093395) | |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------|--------------------------------|--------------------------|
| Device name | Ultrasonic Endoscope
EG-740UT | Ultrasonic Endoscope
EG-580UT | GF Type
UCT180 | Endoscope
Model EG-
740N | |
| Indications for use | [This product is] intended to provide ultrasonic
images of submucosal and peripheral organs of the
upper gastrointestinal tract for observation, diagnosis,
and endoscopic treatment. This product is intended
to be used with a FUJIFILM ultrasonic processor.
This product is not intended for use on children and
infants. | | | | |
| Endoscopic specification | | | | | |
| Viewing direction | 40 degrees | | | | |
| Observation range | 3-100 mm | | | | |
| Field of view | 140 degrees | | | | |
| F# of the objective
lens | 4.9 | | | | |
| Resolution
(Acceptance
Criteria) | At 5mm of working distance: 0.08mm of line pair on
the square wave chart is readable.
At 100mm of working distance: 1.4mm of line pair on
the square wave chart is readable. | | | | |
| Distortion
characteristics | Orthogonal Projection | | | | |
| Magnification of
lens(es) | 0.2-0.01 | | | | |
| Focal length | 0.7 mm | | | | |
| Image sensors | CCD | | | | |
| Distal end diameter | 14.5 mm | 13.9 mm | 14.6 mm | | |
| Insertion portion
diameter | 12.6 mm | 12.4 mm | 12.6 mm | | |
| | | Proposed device
(to be assigned) | Predicate device
(K183433) | Reference 1
(K093395) | Reference 2
(K182836) |
| Instrument channel
diameter | | 4.0 mm | 3.8 mm | | |
| Maximum insertion
diameter | | 15.6 mm | 15.0 mm | 15.85 mm | |
| Working length | | | 1250mm | | |
| | Up | 150 degrees | | | |
| Bending | Down | 100 degrees | 150 degrees | 90 degrees | |
| capability | Left | 100 degrees | 120 degrees | 90 degrees | |
| | Right | 100 degrees | 120 degrees | 90 degrees | |
| | Control portion | | G7 | | |
| Scope Connector | | One Step Connector | LG Connector; Video
Connector | | |
| CPU/Software (for
contact-free Scope
Connector) | | Installed | N/A | | Installed |
| Ultrasound specification | | | | | |
| Scanning method | | | Electrical convex scanning method | | |
| Scanning direction | | | Same as the insertion direction of the endoscope | | |
| | | Compatible Peripherals and Standard Accessories | | | |
| | | Video processing system
(VP-7000, BL-7000) | Video processing system
(EPX-4440HD, EPX-
7000) | | |
| | | Water Tank (WT-603) | Water Tank (WT-2, WT-4) | | |
| | | Balloon (BS-102) | Balloon (B20UT) | | |
| Compatible | | Ultrasonic cable (UC-01) | Not included | | |
| Peripherals | | | Air leak tester (LT-7F) | | |
| | | | Suction Unit[1] | | |
| | | Mouthpiece (MPC-ST) | | | |
| | | Foot Switch (FS1) | | | |
| | | Electrosurgical instruments | | | |
| | | Monitor, Printer, Cart | | | |
| | | Ultrasonic processors (SU-1, SU-1 PLATINUM) | | | |
| | | Forceps valve (FV-002) | Forceps valve (FOV-LL2) | | |
| | | Built in the scope | US waterproof cap (WA- | | |
| | | connector | 7000) | | |
| | | Balloon attachment tool | Balloon attachment tool | | |
| | | (BA-03) | (BA-1) | | |
| | | Balloon channel brush
(WB2517DC) | Balloon channel brush
(WB2221FW2) | | |
| Standard | | | | | |
| Accessories | | | | | |
| | | Air/Water valve (AW-602)
Suction valve (SB-604) | | | |
| | | Air/Water channel cleaning adapter (CA-609) | | | |
| | | Cleaning adapter (CA-608) | | | |
| | | Ventilation adapter (AD-7) | | | |
| | | Cleaning brushes | | | |
| | | (WB11003DV, WB7025DC, WB1318DE) | | | |
5
Table 1 (continued)
6
Performance Data:
Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's quidance. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, published March 17, 2015.
Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2018, 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 September 4, 2020.
Electrical safety and EMC of the proposed device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-2-18:2009, and IEC 60601-2-37:2015.
Laser safety and photobiological safety of the proposed device was evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.
Endoscope specific testing was conducted according to ISO 8600-1: 2015.
The proposed device met performance specifications in the following additional testing:
- Field of view
- Bending capability ●
- Bonuing Supability Rate of air supply ●
- Rate of water supply ●
- Rate of balloon water supply ●
- . Rate of suction
- Rate of Suction
Rate of balloon suction . - .
- Diameter of forceps channel ●
- Viewing direction .
- Resolution ●
- LG output
- Axial resolution ●
- Lateral resolution ●
- Penetration depth .
Usability testing was conducted according to IEC 62366-1:2015 and the FDA guidance, Applying Human Factors and Usability Engineering to Medical Devices, issued February 3, 2016.
Conclusion:
The proposed device, FUJIFILM Ultrasonic Endoscope EG-740UT, share intended use and indications for use as, similar technological characteristics to, the same principles of operation as, and similar materials to the predicate device and the reference devices. The differences in technological characteristics and materials have been validated through the biocompatibility, the electrical safety, the EMC testing, and the bench testing. The testing demonstrates that the proposed device remains as safe and effective as the predicate device and there remains no new concern regarding the safety and effectiveness. FUJIFILM Ultrasonic Endoscope EG-740UT is substantially equivalent to the predicate device, FUJIFILM Ultrasonic Endoscope EG-580UT (K183433).