(24 days)
EG-530UT2 and EG-530UR2 are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. The product is intended to be used with a Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 are upper gastrointestinal endoscopes that emit ultrasound waves and scan the reflected signals to provide ultrasonic images when used in combination with an ultrasonic processor.
The provided text describes a 510(k) premarket notification for FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a new AI/software device meets specific performance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria for an AI/software device and a study to prove it meets them cannot be fully extracted from this document. The document lists performance tests for the physical endoscopic devices (e.g., field of view, bending capability, resolution, air/water supply rates), but these are for hardware performance, not AI/software performance.
However, I can extract the information related to the device performance and acceptance criteria for the physical endoscopy device as described in the document.
Here's a breakdown of what can be extracted and what cannot be, based on the provided text:
What Can Be Extracted (for the physical endoscope device):
-
A table of acceptance criteria and the reported device performance:
The document states: "Fujifilm conducted the following performance testing on the proposed devices EG-530UT2 and EG-530UR2 to ensure that the modified devices perform equivalently to the predicate devices:- Field of view
- Viewing direction
- Bending capability
- Resolution
- Air supply rate
- Water supply rate
- Axial resolution
- LG output
- Suction rate
- Working length
- Lateral resolution
- Penetration depth
- Forceps channel diameter
In all cases, the devices met the pre-defined acceptance criteria for the test."
Therefore, the table would look like this (specific values are not provided in the document, only the claim of meeting criteria):
Acceptance Criteria (Measured Parameter) Reported Device Performance Field of view Met pre-defined criteria Viewing direction Met pre-defined criteria Bending capability Met pre-defined criteria Resolution Met pre-defined criteria Air supply rate Met pre-defined criteria Water supply rate Met pre-defined criteria Axial resolution Met pre-defined criteria LG output Met pre-defined criteria Suction rate Met pre-defined criteria Working length Met pre-defined criteria Lateral resolution Met pre-defined criteria Penetration depth Met pre-defined criteria Forceps channel diameter Met pre-defined criteria -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for each performance test. The document refers to "the proposed devices EG-530UT2 and EG-530UR2" performing these tests, suggesting testing on the physical devices themselves rather than a separate dataset of patient cases.
- Data Provenance: Not specified. This is a pre-market submission, and the tests are likely internal lab/bench testing of the device hardware.
What Cannot Be Extracted (as it's not an AI/software performance study):
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance typically comes from engineering specifications and measurements, not expert human interpretation of medical images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe an AI-assisted diagnostic device or an MRMC study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/software context. Ground truth for physical device specs (like resolution, field of view) is based on engineering measurements against design specifications.
- The sample size for the training set: Not applicable. This document is not about AI training.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided FDA 510(k) clearance document for FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 pertains to demonstrating substantial equivalence of a physical medical device (endoscope) to a predicate, primarily through engineering performance testing (e.g., field of view, bending capability, resolution, fluid rates), electrical safety, and biocompatibility. It is not a document describing the validation of an AI/software device, and therefore the specific criteria related to AI performance studies cannot be found within it.
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July 27, 2018
FUJIFILM Corporation % Jeffrey Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470
Re: K181763
Trade/Device Name: FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDS, ITX Dated: July 2, 2018 Received: July 3, 2018
Dear Jeffrey Wan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows the FDA logo on the left side. On the right side, the text "Jeffrey W. Co" is present, followed by the date "2018.07.27 1" and the time zone "-04'00'".
Jeffrey W. Cooper -S 2018.07.27 18:59:10
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181763
Device Name
FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2
Indications for Use (Describe)
EG-530UT2 and EG-530UR2 are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. The 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 Ultrasonic Endoscopes EG-530UT2 and EG-530UR2
Date: July 2, 2018
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Jeffrey Wan Specialist, Regulatory Affairs Telephone: (973) 709-2219 Facsimile: (201) 995-2452 E-Mail: jeffrey.wan@fujifilm.com
Identification of the Proposed Device:
| Proprietary/Trade Name: | FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 |
|---|---|
| Common Name: | Video Endoscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Classification: | Endoscope and accessories, 21 C.F.R. § 876.1500Diagnostic ultrasonic transducer, 21 C.F.R. § 892.1570 |
| Product Code: | FDS, ITX |
Predicate Device:
Fujifilm Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 (K120446)
Reference Device:
Fujifilm Video Colonoscope Model EC-600WL v2 (K160196)
Intended Use / Indications for Use:
EG-530UT2 and EG-530UR2 are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. The product is intended to be used with a Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
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Device Description:
FUJIFILM Ultrasonic Endoscopes EG-530UT2 and EG-530UR2 are upper gastrointestinal endoscopes that emit ultrasound waves and scan the reflected signals to provide ultrasonic images when used in combination with an ultrasonic processor.
Technoloqical Characteristics:
The proposed devices EG-530UT2 and EG-530UR2 differ from the predicate devices in the following minor modifications:
- . Compatibility with Video Processor VP-7000 and Light Source BL-7000 (K163675).
- Compatibility with Ultrasonic Processor SU-1 (K153206). ●
- Compliance to IEC60601-1 edition 3.1 and IEC60601-2-37 edition 2.1 to support . compatibility with VP-7000, BL-7000, and SU-1.
- . Expansion of transport and storage conditions to a temperature range of -20°C to 60°C and a humidity range of 10 to 85% RH.
- . Use of a new epoxy resin in the manufacturing process. Both the new and original epoxy resins can be used for repair.
- Other minor material changes .
Performance Data:
Electrical safety of the proposed devices was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, IEC 60601-2-18:2009, and IEC 60601-2-37:2015.
The proposed devices EG-530UR2 and EG-530UR2 were adopted into biocompatibility testing conducted on reference device EC-600WL v2 using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
Storage and transportation testing was conducted on the proposed devices EG-530UT2 and EG-530UR2 to validate the expanded storage and transportation conditions.
Fujifilm conducted the following performance testing on the proposed devices EG-530UT2 and EG-530UR2 to ensure that the modified devices perform equivalently to the predicate devices:
- Field of view
- Viewing direction ●
- . Bending capability
- Resolution .
●
- . Air supply rate
- . Water supply rate
- Axial resolution ●
LG output
- . Suction rate
- Working length
- Lateral resolution .
- ●
- . Penetration depth
- Forceps channel diameter ●
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In all cases, the devices met the pre-defined acceptance criteria for the test.
Substantial Equivalence:
The company's EG-530UT2 and EG-530UR2 has the same intended use and indications for use as the previously cleared predicates EG-530UT2 and EG-530UR2 (K120446). In addition, the proposed devices have similar technological characteristics and principles of operation as their predicates. The minor differences between the proposed devices and their predicate devices do not raise new or additional questions of safety or effectiveness of the proposed devices. Thus, the proposed devices EG-530UT2 and EG-530UR2 are substantially equivalent to their predicate devices.
Conclusions:
The modified EG-530UT2 and EG-530UR2 are substantially equivalent to the predicate EG-530UT2 and EG-530UR2 and conform to applicable medical device safety and performance standards.
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K181763
Page 4 of 4
§ 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.