The FUJIFILM ultrasonic processors SU-1 PLATINUM and SU-1 are intended to be used in combination with FUJIFILM ultrasonic endoscope, Video processor, light source, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peribheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.

Device Description

The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 are used with previously cleared ultrasonic endoscopes, EG-530UR2 & EG-530UT2 (K181763), EB-530US (K182825), EG-580UR and EG-580UT (K183433).

The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 consist of two components, Processor and Keyboard, which are used in conjunction with one another. The SU-1 PLATINUM or SU-1 ultrasonic processors connect to an ultrasonic endoscope and transmit ultrasound waves into the body cavity by driving the transducer installed on the ultrasonic endoscope. The SU-1 PLATINUM or SU-1 ultrasonic processors process the reflected ultrasound signals received by the ultrasonic transducer in the body cavity and convert the electrical signals into image or video signals. The signals are displayed on the monitor or printer as ultrasonic images. The Keyboard, CP-1/CP-1TB, is used to control operational features of the SU-1 PLATINUM or SU-1 ultrasonic processor. Furthermore, the SU-1 PLATINUM and SU-1 system can be expanded by connecting additional devices. The system can optionally be used with a previously cleared FUJIFILM Ultrasonic Processor SP-900 (K171207).

The Fujifilm ultrasonic processor SU-1 PLATINUM and SU-1 can acquire and display real-time ultrasound data in different modes such as M, B, Color Doppler, F-Flow, Duplex and Triplex.

Additionally, SU-1 PLATINUM offers a feature/mode known as Elastrography, which is a medical imaging modality that maps the elastic properties of the target organs. Relative stiffness of the tissue is visualized as a color distribution map by a way of calculating the distortion of the tissue caused by external compression of inner vibration, and displaying disparities in stiffness levels as different colors.

AI/ML Overview

The provided text describes a 510(k) summary for the Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Electrical safety standards met: ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-6:2013, IEC 60601-1-2:2014, IEC 60601-2-37:2015, and IEC 60601-2-18:2009	The device met these electrical safety standards.
Software validation in accordance with IEC 62304:2015 and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005)	Software validation was evaluated and presumably met these criteria (implied by overall SE conclusion).
Cybersecurity controls developed according to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2, 2014)	Cybersecurity controls were developed according to this guidance (implied by overall SE conclusion).
Doppler sensitivity for F-Flow mode performance must meet pre-defined acceptance criteria, exhibiting equivalence to the predicate device.	The device met the pre-defined acceptance criteria for the test.

2. Sample size used for the test set and the data provenance:

The document mentions "Doppler sensitivity for F-Flow mode performance testing" was conducted on the proposed device. However, it does not specify the sample size for this test.
Data provenance is not explicitly stated. Given that it's a 510(k) submission by FUJIFILM Corporation, headquartered in Japan, and the submission is to the FDA for a device to be marketed in the US, the testing was likely conducted by the manufacturer, but the location of the test (e.g., country of origin of the data) is not detailed. The nature of the study (retrospective or prospective) is also not specified, though performance testing is typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The document focuses on technical performance testing rather than studies involving human expert interpretation.

4. Adjudication method for the test set:

This information is not provided. As the testing appears to be technical performance testing (e.g., Doppler sensitivity), an adjudication method for ground truth establishment by experts is likely not applicable or was not part of this submission's provided details.

5. 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:

No MRMC comparative effectiveness study was done or reported. The submission describes modifications to an existing ultrasonic processor (software update for a new view mode, F-Flow, and compatibility with new endoscopes) and focuses on demonstrating equivalence through technical performance tests. There is no mention of AI assistance; the device is an ultrasonic processor.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The document describes performance testing for the "Doppler sensitivity for F-Flow mode." This is a standalone technical performance test of the device's imaging capability. However, it's a device that produces images for human interpretation, not an algorithm that makes diagnostic recommendations on its own.
The "standalone" performance here refers to the device's ability to acquire and process signals as intended for the new F-Flow mode.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "Doppler sensitivity for F-Flow mode performance testing," the ground truth would likely be technical measurements against a known standard or phantom, as part of validating the physical performance of the Doppler functionality, rather than a clinical ground truth like pathology or expert consensus. The description implies a technical verification of the device's output against expected performance for a particular imaging mode.

8. The sample size for the training set:

This information is not applicable/not provided. The device is an ultrasonic processor, not a machine learning algorithm that requires a training set in the typical sense. The software updates mentioned relate to a new view mode and compatibility, not a trainable AI component.

9. How the ground truth for the training set was established:

This information is not applicable/not provided for the same reason as point 8.

Summary

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July 6, 2020

FUJIFILM Corporation % Kamila Sak Regulatory Affairs Specialist FUJIFILM Medical System U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421

Re: K200850

Trade/Device Name: Fujifilm Ultrasonic Processor, Model SU-1 Platinum and SU-1 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, IYN, IYO, ITX Dated: June 15, 2020 Received: June 16, 2020

Dear Kamila Sak:

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.

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

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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 (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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200850 Device Name

FUJIFILM Ultrasonic Processors SU-1 PLATINUM and SU-1

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1

Date: June 15, 2020

Submitter's Information:

FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928

Contact Person:

Kamila Sak Regulatory Affairs Specialist Telephone: (347) 577-2309 E-Mail: kamila.sak@fujifilm.com Regulatory Affairs Specialist

Identification of the Proposed Device:

Device Name:	Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1
Common Name:	Ultrasonic Processor
Classification Number:	21 C.F.R. § 876.1500
Classification Name:	Endoscope and accessories
Regulatory Class:	Class II
Device Panel:	Gastroenterology/Urology

Product Code Information:

Product Code Name	CFR Section	Product Codes
Gastroscope and accessories, flexible/rigid	21 CFR 876.1500	FDS (Primary Product Code)
Ultrasonic Doppler Imaging System	21 CFR 892.1550	IYN
Ultrasonic Pulsed Echo Imaging System	21 CFR 892.1560	IYO
Diagnostic Ultrasonic Transducer	21 CFR 892.1570	ITX

Predicate Device:

Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1 (K153206)

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Intended Use / Indications for Use:

SU-1 PLATINUM and SU-1 are intended to be used in combination with FUJIFILM ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.

Device Description:

The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 are used with previously cleared ultrasonic endoscopes, EG-530UR2 & EG-530UT2 (K181763), EB-530US (K182825), EG-580UR and EG-580UT (K183433).

The Fujifilm ultrasonic processor SU-1 PLATINUM and SU-1 can acquire and display real-time ultrasound data in different modes such as M, B, Color Doppler, F-Flow, Duplex and Triplex.

Technological Characteristics:

The proposed device SU-1 PLATINUM and SU-1 differs from the predicate device in the following minor modifications:

Software version update to v1.17 to include view mode: F-Flow, which is a modification of power doppler mode
. Addition of two compatible endoscopes: EG-580UR (Radial probe) and EG-580UT (Convex probe) previously cleared in K183433

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Performance Data:

Electrical safety of the proposed device was evaluated using the following standards: ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-6:2013, IEC 60601-1-2:2014, IEC 60601-2-37:2015, and IEC 60601-2-18:2009.

Software validation was evaluated in accordance with IEC 62304:2015 and the FDA quidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA quidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.

Fujifilm conducted Doppler sensitivity for F-Flow mode performance testing on the proposed device SU-1 PLATINUM and SU-1 to ensure that the modified device performs equivalently to the predicate device. The device met the pre-defined acceptance criteria for the test.

Substantial Equivalence:

The company's SU-1 PLATINUM and SU-1 has the same intended use and indications for use as the previously cleared predicate SU-1 PLATINUM and SU-1 (K153206). In addition, the proposed device has similar technological characteristics and principles of operation as the predicate. The minor differences between the proposed and predicate devices do not raise new or additional questions of safety or effectiveness of the proposed devices. Thus, the proposed device SU-1 PLATINUM and SU-1 is substantially equivalent to the predicate device.

Conclusions:

The modified SU-1 PLATINUM and SU-1 is substantially equivalent to the predicate and conforms to applicable medical device safety and performance standards.

Regulation Number and Section

§ 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.