(112 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the FUJIFILM Ultrasonic Endoscope EG-740UT, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Resolution | At 5mm of working distance: 0.08mm of line pair on the square wave chart is readable. | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Resolution") |
| At 100mm of working distance: 1.4mm of line pair on the square wave chart is readable. | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Resolution") | |
| Field of View | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: Field of view") |
| Bending Capability | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: Bending capability") |
| Rate of Air Supply | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of air supply") |
| Rate of Water Supply | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of water supply") |
| Rate of Balloon Water Supply | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of balloon water supply") |
| Rate of Suction | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of suction") |
| Rate of Balloon Suction | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Rate of balloon suction") |
| Diameter of Forceps Channel | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Diameter of forceps channel") |
| Viewing Direction | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Viewing direction") |
| LG Output | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... LG output") |
| Axial Resolution | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Axial resolution") |
| Lateral Resolution | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Lateral resolution") |
| Penetration Depth | (Not explicitly stated as an acceptance criterion in the provided text, but was tested) | Met (implied by "The proposed device met performance specifications in the following additional testing: ... Penetration depth") |
| Biocompatibility | (Implied by ISO 10993 standards and FDA guidance) | Evaluated using ISO 10993-1, ISO 10993-5, ISO 10993-10, and FDA guidance. |
| Electrical Safety & EMC | (Implied by IEC 60601 standards) | Evaluated using ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-37. |
| Laser Safety & Photobiological Safety | (Implied by IEC 60825-1 and IEC 62471 standards) | Evaluated using IEC 60825-1 and IEC 62471. |
| Endoscope Specific Testing | (Implied by ISO 8600-1) | Conducted according to ISO 8600-1:2015. |
| Usability | (Implied by IEC 62366-1 and FDA guidance) | Conducted according to IEC 62366-1:2015 and FDA guidance. |
| Cleaning, Disinfection, and Sterilization | Validation in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" | Validated according to FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a "test set" in the context of clinical data for performance evaluation. The performance data presented are primarily from bench testing and compliance with established standards for various aspects like resolution, biocompatibility, electrical safety, etc. It does not appear to involve human patient data or a clinical study test set in the traditional sense.
Therefore, information on sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or not provided in this document for evaluating device performance against clinical outcomes. The studies cited are for engineering, safety, and reprocessing validations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there's no clinical "test set" with ground truth established by experts for diagnostic performance, this information is not applicable or not provided in this document. The evaluations are against technical specifications and regulatory standards.
4. Adjudication Method for the Test Set
Since there is no clinical "test set" requiring expert judgment for ground truth, an adjudication method is not applicable or not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned in the provided text. The document focuses on the technical performance and safety of the device itself, not on differences in human reader performance with or without AI assistance. Therefore, information on effect size for human readers is not applicable or not provided.
6. Standalone (Algorithm Only) Performance Study
No standalone algorithm performance study is mentioned. The device is an endoscope, a medical instrument, not an AI algorithm. Therefore, this is not applicable or not provided.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation in this document is established by:
- Technical specifications/measurements: For metrics like resolution, field of view, bending capability, flow rates, etc. These are objective measurements against predefined engineering targets.
- Compliance with consensus standards: For biocompatibility (ISO 10993), electrical safety (IEC 60601), laser safety (IEC 60825, IEC 62471), endoscope specifics (ISO 8600-1), usability (IEC 62366-1), and reprocessing (FDA guidance). These standards themselves define the acceptable "truth" for device characteristics and safety.
8. Sample Size for the Training Set
As this is a medical device (endoscope) undergoing 510(k) clearance, and not an AI/ML algorithm, there is no concept of a "training set" in the context of learning data. The device's design and manufacturing are based on established engineering principles and prior device models, not on a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set," this information is not applicable or not provided.
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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.
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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
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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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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
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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 EndoscopeEG-740UT | Ultrasonic EndoscopeEG-580UT | GF TypeUCT180 | EndoscopeModel EG-740N | |
| Indications for use | [This product is] intended to provide ultrasonicimages of submucosal and peripheral organs of theupper gastrointestinal tract for observation, diagnosis,and endoscopic treatment. This product is intendedto be used with a FUJIFILM ultrasonic processor.This product is not intended for use on children andinfants. | ||||
| Endoscopic specification | |||||
| Viewing direction | 40 degrees | ||||
| Observation range | 3-100 mm | ||||
| Field of view | 140 degrees | ||||
| F# of the objectivelens | 4.9 | ||||
| Resolution(AcceptanceCriteria) | At 5mm of working distance: 0.08mm of line pair onthe square wave chart is readable.At 100mm of working distance: 1.4mm of line pair onthe square wave chart is readable. | ||||
| Distortioncharacteristics | Orthogonal Projection | ||||
| Magnification oflens(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 portiondiameter | 12.6 mm | 12.4 mm | 12.6 mm | ||
| Proposed device(to be assigned) | Predicate device(K183433) | Reference 1(K093395) | Reference 2(K182836) | ||
| Instrument channeldiameter | 4.0 mm | 3.8 mm | |||
| Maximum insertiondiameter | 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; VideoConnector | |||
| CPU/Software (forcontact-free ScopeConnector) | 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) |
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Table 1 (continued)
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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).
§ 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.