(30 days)
Not Found
No
The summary describes a standard endoscope with ultrasonic imaging capabilities and does not mention any AI or ML components or functions.
No
The device is described as providing images for "observation, diagnosis, and endoscopic treatment" but does not perform the treatment itself. The description states it assists in "delivering air/suction as well as endoscope accessories, such as forceps," implying it is a tool for treatment rather than a therapeutic device in itself.
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 outlines physical hardware components including a control portion, insertion portion with fiber bundles, channels, and a CCD image sensor, and an umbilicus with electronic components. It is used in combination with other hardware like video processors, light sources, and monitors.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide 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 a device with an insertion portion, channels for accessories, and a CCD image sensor, all designed for internal examination and procedures.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform such functions.
The device described is a medical endoscope with ultrasonic capabilities, used for in-vivo (within the living body) procedures.
N/A
Intended Use / Indications for Use
Endoscope Model EG-580UT
FUJIFILM Endoscope Model EG-580UT 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.
Endoscope Model EG-580UR
FUJIFILM Endoscope Model EG-580UR 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 (comma separated list FDA assigned to the subject device)
ODG, FDS, ITX
Device Description
Endoscope Models EG-580UT and EG-580UR are 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 class 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 qlass 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 or diagnostic ultrasound systems, and peripheral devices such as monitor, printer, foot switch, and cart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic images
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)
The proposed devices are adopted into the reprocessing validation of the predicate device, which was conducted in accordance with the FDA guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015.
The proposed devices are adopted into the biocompatibility testing of the predicate device, which was conducted in accordance with ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 and the FDA quidance. 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.
EMC and ultrasonic endoscopic safety of the proposed device were evaluated using following standards: IEC 60601-1-2:2014 and IEC 60601-2-37:2007+A1:2015.
The acoustic output of the proposed devices was evaluated with the ALOKA ARIETTA 850 in accordance with the FDA guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued June 27, 2019.
The proposed devices are adopted into the performance testing of the predicate device, which was conducted in accordance with ISO 8600-1:2015.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resolution:
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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, there 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, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
August 4, 2022
FUJIFILM Corporation % Kotei Aoki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K221952
Trade/Device Name: Endoscope Model EG-580UT and Endoscope Model EG-580UR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, FDS, ITX Dated: June 30, 2022 Received: July 5, 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/cdrl/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
1
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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-devices/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-devices/device-advicecomprehensive-regulatory-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,
for
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) K221952
Device Name Endoscope Model EG-580UT Endoscope Model EG-580UR
Indications for Use (Describe)
Endoscope Model EG-580UT
FUJIFILM Endoscope Model EG-580UT 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.
Endoscope Model EG-580UR
FUJIFILM Endoscope Model EG-580UR 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K221952 Page 1 of 4
510(k) Summary
FUJIFILM Corporation
Endoscope Models EG-580UT and EG-580UR
Date: June 30, 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
ldentification of the Proposed Device:
| Device Name: | Endoscope Models EG-580UT and EG-580UR |
|---|---|
| Common Name: | Endoscope |
| Product Code: | ODG |
| FDS | |
| ITX | |
| Device Class: | II |
| Regulation Number: | 876.1500 (ODG, FDS) |
| 892.1570 (ITX) | |
| Regulation Description: | Endoscopic Ultrasound System, Gastroenterology-Urology |
| Gastroscope And Accessories, Flexible/Rigid | |
| Transducer, Ultrasonic, Diagnostic | |
| Review Panel: | Gastroenterology/Urology |
Predicate Device(s):
- Endoscope Models EG-580UT and EG-580UR (K183433) ●
Intended Use / Indications for Use:
Endoscope Model EG-580UT
FUJIFILM Endoscope Model EG-580UT 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.
Endoscope Model EG-580UR
FUJIFILM Endoscope Model EG-580UR 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.
4
Device Description:
Endoscope Models EG-580UT and EG-580UR are 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 class 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 qlass 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 or diagnostic ultrasound systems, and peripheral devices such as monitor, printer, foot switch, and cart.
Comparison of Technological Characteristics:
A comparison of technological characteristics between the proposed device and the predicate device is provided in the Tables below:
| | | Proposed device
EG-580UT
(to be assigned) | Predicate device
EG-580UT
(K183433) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indications for use (IFU) | FUJIFILM Endoscope Model EG-580UT 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 | 3-100mm | |
| | 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 | 0.7mm | |
| | Image sensors | CCD | |
| | Distal end diameter | 13.9mm | |
| | Insertion portion diameter | 12.4mm | |
| | Maximum insertion diameter | 15.0mm | |
| Bending
capability | Up | 150 degrees | |
| | Down | 150 degrees | |
| | Left | 120 degrees | |
| | Right | 120 degrees | |
| | Forceps channel diameter | 3.8mm | |
| | Working length, Total length | 1250mm, 1550mm | |
| | Operation portion | G7 | |
| | Video processor/Light source | VP-4440HD / XL-4450 | |
| Table 1 Comparison of the proposed device to the predicate device, EG-580UT | |||
|---|---|---|---|
5
| Peripherals | VP-7000 / BL-7000 |
|---|---|
| Water Tank (WT-2, WT-4) | |
| Balloon (B20UT) | |
| Air leak tester (LT-7F) | |
| Forceps valve (FOV-LL2) | |
| Air/Water valve (AW-602) | |
| Suction valve (SB-604) | |
| US waterproof cap (WA-7000) | |
| Accessories | Balloon attachment tool (BA-1) |
| Ventilation Adapter (AD-7) | |
| Cleaning Adapter (CA-608) | |
| Air/Water channel cleaning adapter (CA-609) | |
| Cleaning brushes | |
| (WB11003DV, WB7025DC, WB2221FW2, WB1318DE) | |
| Ultrasound specification | |
| Scanning method | Electronic convex scanning method |
| Scanning direction | Same as the insertion direction of the endoscope |
| Ultrasonic processor | SU-1, SU-1 Platinum |
| Diagnostic ultrasound system | ALOKA ARIETTA 850 (K183456) Not compatible |
Table 2 Comparison of the proposed device to the predicate device, EG-580UR
| | | Proposed device
EG-580UR
(to be assigned) | Predicate device
EG-580UR
(K183433) |
|------------------------------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indications for use (IFU) | | FUJIFILM Endoscope Model EG-580UR 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 | 0 degree (Forward view) | | |
| Observation range | | 3-100mm | |
| Field of view | | 140 degrees | |
| F# of the objective lens | | 4.9 | |
| | | [Acceptance Criteria] | |
| | | At 5mm of working distance: 0.08mm of line pair on
the square wave chart is readable. | |
| Resolution | | 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 | | 0.7mm | |
| Image sensors | | CCD | |
| Distal end diameter | | 11.4mm | |
| Insertion portion diameter | | 11.5mm | |
| Maximum insertion diameter | | 12.7mm | |
| Bending
capability | Up | 190 degrees | |
| | Down | 90 degrees | |
| | Left | 100 degrees | |
| | Right | 100 degrees | |
| Forceps channel diameter | | 2.8mm | |
| Working length, Total length | | 1250mm, 1550mm | |
6
| Operation portion | G7 | |
|---|---|---|
| Video processor/Light source | VP-4440HD / XL-4450 | |
| VP-7000 / BL-7000 | ||
| Peripherals | Water Tank (WT-2, WT-4) | |
| Balloon (B20UR) | ||
| Accessories | Air leak tester (LT-7F) | |
| Forceps Valve (FOV-DV7) | ||
| Air/Water valve (AW-602) | ||
| Suction valve (SB-604) | ||
| US waterproof cap (WA-7000) | ||
| Balloon attachment tool (BA-1) | ||
| Ventilation Adapter (AD-7) | ||
| Cleaning Adapter (CA-608) | ||
| Air/Water channel cleaning adapter (CA-609) | ||
| Cleaning brushes (WB11003DV, WB7025DC, WB2221FW2, WB1318DE) | ||
| Ultrasound specification | ||
| Scanning method | Electrical radial array | |
| Scanning direction | Perpendicular to the insertion direction of the ultrasonic | |
| endoscope | ||
| Ultrasonic processor | SU-1, SU-1 Platinum | |
| Diagnostic ultrasound system | ALOKA ARIETTA 850 (K183456) Not compatible |
Performance Data:
The proposed devices are adopted into the reprocessing validation of the predicate device, which was conducted in accordance with the FDA guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015.
The proposed devices are adopted into the biocompatibility testing of the predicate device, which was conducted in accordance with ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 and the FDA quidance. 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.
EMC and ultrasonic endoscopic safety of the proposed device were evaluated using following standards: IEC 60601-1-2:2014 and IEC 60601-2-37:2007+A1:2015.
The acoustic output of the proposed devices was evaluated with the ALOKA ARIETTA 850 in accordance with the FDA guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued June 27, 2019.
The proposed devices are adopted into the performance testing of the predicate device, which was conducted in accordance with ISO 8600-1:2015.
Conclusions:
The proposed devices share the same intended use, physical characteristics, and principle of operation as the predicate device. The differences have been evaluated for the EMC, ultrasound endoscopic safety, and acoustic output. There remains no new concern regarding the safety and effectiveness of the proposed device. Thus, the proposed devices EG-580UR are substantially equivalent to the predicate devices, Endoscope Models EG-580UT and EG-580UR (K183433).