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, 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 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 (K120446) and EB-530US (K121035) 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.

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, is used to control operational features of the SU-1 PLATINUM or SU-1 ultrasonic processor.

The Fuifilm 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, Pulse Doppler, 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

This is a device that processes ultrasound images, not an AI / ML device. Hence most of the questions are not applicable to the context.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:

The document describes a medical device submission (K153206) for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1. It is a 510(k) submission, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, not by proving efficacy through a comprehensive clinical trial.

Therefore, there is no mention of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," or "how ground truth for training set was established" in the context of an AI/ML device or a traditional clinical study with outcome-based performance metrics.

Instead, the document focuses on demonstrating substantial equivalence through:

Comparing technological characteristics.
Compliance with recognized performance and safety standards.
Bench testing.

Here's an attempt to extract relevant information given the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a typical AI/ML or clinical study format (e.g., target sensitivity/specificity). Instead, equivalence is demonstrated by meeting technical specifications and safety standards.

Acceptance "Criteria" (Derived from Predicate Comparison & Standards)	Reported Device Performance (as stated in the document)
Intended Use / Indications for Use: Similar to predicate (SU-8000), with expanded applications for trachea, bronchial tree, surrounding organs due to compatibility with EB-530US.	The SU-1 PLATINUM and SU-1 are intended to be used with Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices 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.
Technological Characteristics: Substantially similar to predicate (SU-8000), including compatible endoscopes, probe type, scanning method, image modes (with addition of Elastography for SU-1 PLATINUM), frequency, display range, data format, measuring functions.	All technological characteristics are stated to be "Same as the predicate device" or are explicitly listed as an enhancement (Elastography). Bench testing data demonstrated that the subject ultrasonic processors have substantially equivalent performance and safety to their predicate.
Safety and Performance Standards Compliance: Conformance to relevant IEC, ANSI/AAMI, and NEMA standards (listed in the "Performance Data" section).	All predetermined testing criteria were met, and the device functioned in all instances (as stated on page 6).
Attenuation Spatial Peak Temporal Average Intensity (Ispta.3): ≤ 720mW/cm²	Same as the predicate device (≤ 720mW/cm²)
Mechanical Index (MI): 1.9 or less	Same as the predicate device (1.9 or less)
Thermal Index (TI): 1.0 or less	Same as the predicate device (1.0 or less)

2. 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 applicable in the context of clinical data for performance evaluation. The "Performance Data" section refers to software validation and EMC safety/performance testing. These are engineering/device-level tests, not imaging-data-based performance studies with a "test set" of patient data.
Data Provenance: Not applicable. The "Performance Data" section describes engineering and safety testing of the device hardware and software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving expert readers and establishing ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This device is an ultrasonic processor, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm, but a hardware device with embedded software for image processing.

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

Not applicable. The "ground truth" here pertains to the device meeting engineering specifications and safety standards, confirmed through various tests (e.g., electrical safety, electromagnetic compatibility, software validation).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that undergoes training on a dataset.

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side and top of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 3, 2016

Fujifilm Medical System USA, Inc. Shraddha More Specialist, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470

Re: K153206 Trade/Device Name: Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Codes: FDS, IYN, IYO, ITX Dated: January 27, 2016 Received: January 28, 2016

Dear Shraddha More,

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

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) K153206

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 Medical Systems U.S.A., Inc.'s SU-1 and SU-1 PLATINUM

Submitter's Information:

Fujifilm Medical Systems U.S.A., Inc., Endoscopy Division 10 High Point Drive Wavne, NJ 07470 USA FDA Establishment Registration Number: 2431293

Contact Persons:

Shraddha More Specialist, Regulatory Affairs and Quality Assurance Telephone: (973)-686-2627 Ext. 522627 Facsimile: (973)-633-8818 E-Mail: smore@fujifilm.com

Aaron Ge Regulatory Manager, Regulatory Affairs and Quality Assurance Telephone: (973) 686-2636 Facsimile: (973) 686-2616 E-Mail: age@fujifilm.com

Date Prepared: November 4, 2015

ldentification of the Proposed Device:

Proprietary/Trade Name: Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1 Common Name: Ultrasonic Processor

Device Class: Class II

Classification Information:

Classification Name	CFR Section	Product Codes
Gastroscope and accessories, flexible/rigid	21 CFR 876.1500	FDS
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 Devices

Fujinon Ultrasonic Processor SU-8000 (K111243)

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Intended Use / Indications for Use

Device Description

Technological Characteristics

	Fujinon Ultrasonic ProcessorSU-8000(Predicate Device K111243)	Fujifilm Ultrasonic Processor SU-1/SU-1 PLATINUM (Subject Device)
IntendedUse/Indicationsfor Use	The Fujinon ultrasonic processor SU-8000 isintended to be used in combination withFujinon/Fujifilm ultrasonic endoscope, videoprocessor, light source, monitor, recorder, andvarious peripheral devices. The product isintended to provide ultrasonic images ofsubmucosal and peripheral organs of theupper gastrointestinal tract for observation,recording and to aid in diagnosis duringendoscopic evaluation.	The FUJIFILM ultrasonic processors SU-1PLATINUM and SU-1 are intended to beused in combination with FUJIFILMultrasonic endoscope, video processor, lightsource, monitor, recorder, and variousperipheral devices. The product is intendedto provide ultrasonic images of the trachea,bronchial tree and surrounding organs, orsubmucosal and peripheral organs of theupper gastrointestinal tract for observation,
	Fujinon Ultrasonic ProcessorSU-8000(Predicate Device K111243)	Fujifilm Ultrasonic Processor SU-1/SU-1 PLATINUM (Subject Device)
Appearance	Image: Ultrasonic Processor SU-8000	Image: Ultrasonic Processor SU-1
CompatibleEndoscopes	EG-530UR/UR2 (Radial probe)EG-530UT/UT2 (Convex probe)	EG-530UR2 (Radial probe)EG-530UT2 (Convex probe)EB-530US (Convex probe)
Probe Type	Radial scanConvex scan	Same as the predicate device
ScanningMethod	Electronic scan	Same as the predicate device
Image Mode	B-mode,M-mode,Color Doppler/Power Doppler,Pulsed Wave Doppler,THIDual/Duplex/Triplex	B-mode,M-mode,Color Doppler/Power Doppler,Pulsed Wave Doppler,THIDual/Duplex/TriplexElastography (SU-1 PLATINUM only)
Frequency	5MHz/7.5MHz/10MHz/12MHz	Same as the predicate device
Display Range	EG-530UR/UR2: 15-120mmEG-530UT/UT2: 15-120mmDisplay depth:120mm (max)	EG-530UR2: 15mm-120mmEG-530UT2: 15mm-120mmEB-530US: 15mm-120mmDisplay depth:120mm (max)
Data Format	Data can be saved inJPEG formatTIFF formatDICOM format	Same as the predicate device
Measuringfunctions	DepthDistanceCircumference Length/AreaVolumeFlow VelocityAccelerationA/B Ratio	Same as the predicate device
Compliancewith MedicalElectrical SafetyandPerformanceStandard	IEC60601-1,IEC60601-1-1,IEC60601-1-2,IEC60601-2-18,IEC60601-2-37	ANSI/AAMI ES60601-1,IEC60601-1-2,IEC60601-2-18,IEC60601-2-37
	Fujinon Ultrasonic ProcessorSU-8000(Predicate Device K111243)	Fujifilm Ultrasonic Processor SU-1/SU-1 PLATINUM (Subject Device)
AttenuationSpatial PeakTemporalAverageIntensity(Ispta.3)	$I_{spta.3} \leq 720mW/cm^2$	Same as the predicate device
MechanicalIndex (MI)	1.9 or less	Same as the predicate device
Thermal Index(TI)	1.0 or less	Same as the predicate device
Dimensions(mm)	375(W) x 445(D) x 215(H)	390(W) x 485(D) x 135(H)
Weight	14Kg	13Kg
Control	Using Keyboard CP-8000	Using Keyboard CP-1
PowerRequirements	AC120V	AC100-240V
Otherequipmentwhich can beused with thedevice	Video ProcessorLight SourceCartMonitorRecorderColor or Black & White PrinterFoot Switch	Same as the predicate device

A comparison of the technological characteristics between the subject and predicate devices is provided in the table below.

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Performance Data

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 are non-sterile and has no potential for patient contact. Testing of the SU-1 PLATINUM and SU-1 consisted of software validation in accordance with IEC 62304. Additionally, the devices were tested for EMC safety and performance in accordance to the requirements of the following standards and applicable quality system regulations: All predetermined testing criteria were met, and the device functioned in all instances.

StandardsNo.	StandardsOrganization	Standards Title	Date
ES60601-1	ANSI/AAMI	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance	2010
60601-1-2	IEC	Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic compatibility Requirements and tests	2007
60601-1-6	IEC	Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability	2010
60601-2-18	IEC	Medical electrical equipment - Part 2-18: Particular requirementsfor the basic safety and essential performance of endoscopicequipment	2009
60601-2-37	IEC	Medical electrical equipment - part 2-37: particular requirementsfor the basic safety and essential performance of ultrasonic	2007

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StandardsNo.	StandardsOrganization	Standards Title	Date
		medical diagnostic and monitoring equipment.
62304	IEC	Medical device software - Software life-cycle processes	2006
62366	IEC	Medical devices -Application of usability engineering to medicaldevices	2007
62359	IEC	Ultrasonics - Field characterization - Test methods for thedetermination of thermal and mechanical indices related tomedical diagnostic ultrasonic fields	2005
UD2	NEMA	Acoustic output measurement standard for diagnostic ultrasoundequipment	2004

Substantial Equivalence

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is comparable with and substantially equivalent to the predicate, Fujinon Ultrasonic Processor SU-8000. The SU-1 PLATINUM and SU-1 has the same intended use, and substantially similar indications for use, technological characteristics, and principles of operation as their predicate device SU-8000. The key differences between the SU-1 PLATINUM and SU-1 and their predicate device are expanded indications for use and the addition of the elastography function in the SU-1 Platinum.

The indications for use have been expanded to include additional clinical applications such as the trachea, bronchial tree, and surrounding organs to accommodate the use of the SU-1 and SU-1 Platinum with Fujifilm's currently marketed ultrasonic bronchoscope EB-530US (K121035) which is cleared for these same clinical applications. Additionally, the SU-1 PLATINUM offers a feature, known as elastrography imaging, which is not present in the SU-8000 predicate, but is supported by a substantially similar elastography imaging feature in the Olympus EU-Y0008 (also known as EU-ME2 premier plus) (K130058) which is cited as a reference device.

These differences in indications for use and technology of the SU-1 PLATINUM and SU-1 and their predicate device SU-8000 do not raise new concerns regarding safety or effectiveness. Bench testing data demonstrated that the subject ultrasonic processors have substantially equivalent performance and safety to their predicate.

Conclusions

The SU-1 PLATINUM and SU-1 are substantially equivalent to the similar legally marketed device SU-8000, and conform 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.