The FUJIFILM Ultrasonic Processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation.

PB2020-M:

This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities.

Device Description

The FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M consists of five components: 1) processor (SP-900), 2) probe (PB2020-M), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. The SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in the PB2020-M, which is inserted through the forceps channel of an endoscope. The SP-900 processes the reflected ultrasound signals which the PB2020-M receives in the body cavity and further converts the processed electrical signals into video signals to relay to a monitoring system. The SP-900 can acquire and display real-time ultrasound data in B-mode. The CP-900 is used to control operational features of the RS-900 provides the mechanical scanning for acquiring a two-dimensional image. The power cord supplies power to the SP-900.

AI/ML Overview

The provided document is a 510(k) summary for the FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or performance efficacy study with a test set, ground truth, or expert readers.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not present in this document. The document outlines bench testing to ensure the device functions as intended and meets established specifications, particularly regarding image quality and performance, but it does not describe a study involving human readers or a defined set of diagnostic tasks.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for diagnostic accuracy (e.g., sensitivity, specificity) against a ground truth. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (Olympus EU-ME2 and UM-S20-17S). The "performance" reported is primarily the device's conformance to safety and performance standards, and its ability to produce images and function as intended during bench testing.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Safety and Essential Performance:
Compliance with IEC 60601-1	Met (listed as compliant in the "Performance Data" section)
Compliance with IEC 60601-1-1	Met (listed as compliant)
Compliance with IEC 60601-1-2 (EMC)	Met (listed as compliant, states "All predetermined testing criteria were met, and the device functioned as intended in all instances.")
Compliance with IEC 60601-2-37	Met (listed as compliant)
Compliance with IEC 62359 (Acoustic Output)	Met (listed as compliant, and specific values for ISPTA.3, MI, and TI are provided and noted as less than or equal to predicate device's values, implying meeting safety limits.)
Image Quality and Performance:
Meeting internally established specifications (for image quality and performance)	Tested and met ("Testing was conducted on the SP-900 in combination with PB2020-M to ensure that the image quality and performance met all internally established specifications.")
Functional equivalence to predicate device	Demonstrated through comparison of technological characteristics (frequency, scanning method, display range, measuring functions, etc.), with an assertion that differences do not raise new safety/effectiveness concerns.
Software Validation:
Compliance with IEC 62304	Met ("Testing of the SP-900 consisted of software validation in accordance with IEC 62304.")
Biocompatibility:
Compliance with ISO 10993 (for PB2020-M)	Tested and met ("Ultrasonic Probe PB2020-M was tested for biocompatibility according to ISO 10993.")
Cleaning, Disinfection, Sterilization:	Evaluated ("Cleaning, disinfection, and sterilization were also evaluated.") No specific acceptance criterion or outcome from this evaluation is provided beyond the statement of evaluation.

Study Details (Based on available information):

Sample size used for the test set and the data provenance:
This document describes bench testing and software validation, not a clinical or performance study with a "test set" of patient data in the typical sense for evaluating diagnostic accuracy. No sample size for a patient data test set is mentioned. The data provenance is not applicable in the context of device function testing rather than diagnostic performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No "ground truth" establishment for diagnostic accuracy is described, as the evaluation was of device functionality and safety, not diagnostic performance on patient cases.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There was no test set requiring expert adjudication for diagnostic ground truth.
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. This document does not mention any MRMC study or AI assistance. The device is an ultrasonic processor and probe, not an AI-powered diagnostic tool requiring human-in-the-loop performance studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is hardware (ultrasonic processor and probe), not an algorithm that performs standalone diagnostic functions. Its performance was tested as a system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth for diagnostic accuracy was used. The "ground truth" for the engineering tests would be the established performance specifications and safety standards defined in the relevant IEC and ISO standards (e.g., acoustic output limits, electromagnetic compatibility, software integrity).
The sample size for the training set:
Not applicable. There is no mention of machine learning or an AI model requiring a training set.
How the ground truth for the training set was established:
Not applicable, as there was no training set for an AI/ML model.

In summary: This 510(k) summary focuses on demonstrating the substantial equivalence of a new ultrasonic imaging device to existing legally marketed devices, primarily through engineering and safety testing. It attests that the device meets relevant performance and safety standards and its functionality is comparable to its predicate. It does not include details about clinical performance studies, diagnostic accuracy, or human reader involvement, as these types of studies are typically required for devices with more subjective or interpretative outputs, or for AI-based diagnostic tools.

Summary

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January 11, 2018

FUJIFILM Medical Systems U.S.A., Inc. Jeffrey Wan Specialist, Regulatory Affairs 10 High Point Drive Wayne, NJ 07470

Re: K171207

Trade/Device Name: FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODG, IYO, ITX Dated: November 30, 2017 Received: December 1, 2017

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 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Joyce M. Whang -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K171207

Device Name

FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M

Indications for Use (Describe)

SP-900:

PB2020-M:

Type of Use (Select one or both, as applicable)

区Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801

Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) SUMMARY

FUJIFILM Medical Systems, U.S.A., Inc.'s

FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. Endoscopy Division 10 Highpoint Drive Wayne, NJ 07470 FDA Establishment Registration Number: 2431293

Contact Person:

Jeffrey Wan Specialist, Regulatory Affairs Telephone: (973) 709-2219 Facsimile: (973) 686-8818 E-Mail: jeffrey.wan@fujifilm.com

Date Prepared: January 9, 2018

Identification of the Proposed Device:

Trade/Device Name:	FUJIFILM Ultrasonic Processor SP-900, FUJIFILM Ultrasonic ProbePB2020-M
Regulation Number:	21 CFR 876.1500
Regulation Name:	Endoscope and Accessories
Regulation Class:	Class II
Product Codes:	ODG, IYO, ITX

Predicate Device:

Endoscopic Ultrasound Center EU-Y0008 (marketed as EU-ME2), Olympus Medical Systems Corp., K130058

Intended Use / Indications for Use:

SP-900:

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PB2020-M:

Device Description:

Technological Characteristics:

A comparison of the technological characteristics between the subject and predicate device is provided in the table below. The predicate device is specified as the EU-ME2 connected to UM-S20-17S ultrasonic probe.

	Proposed Device	Predicate Device
Device name	SP-900	EU-ME2
Common name	Ultrasonic processor	Ultrasonic processor
Manufacturer	FUJIFILM Medical Systems U.S.A., Inc.	Olympus Medical Systems Corp.
510(k) number	To be assigned	K130058
IntendedUse/Indicationsfor Use	The FUJIFILM Ultrasonic Processor SP-900is intended to be used in combination withFUJIFILM Ultrasonic Probe, video processor,light source, monitor, recorder, and variousperipheral devices. The product is intendedto provide ultrasonic images of thegastrointestinal tract, biliary and pancreaticducts and surrounding organs, airways andtracheobronchial tree for observation,recording and to aid in diagnosis duringendoscopic evaluation.	This ultrasound center is intended to beused with Olympus ultrasound endoscopes,Olympus ultrasound probes or Olympusesophageal ultrasound probes to observeand to store real-time ultrasound imagesand indicated for use within thegastrointestinal (GI) tract, biliary andpancreatic ducts and surrounding organs,airways and tracheobronchial tree, andurinary tract.
Appearance	Image: FUJIFILM SP-900	Image: Olympus EU-ME2
Compatibletransducer	PB2020-M	UM-S20-17S
Probe type	Radial scan	Radial scan
Scanningmethod	Mechanical scan	Mechanical scan
Image mode	B-mode	B-mode
Frequency	20MHz	20MHz
Display range	20mm, 30mm, 40mm, 60mm, 90mm, 120mmdiameter	20mm, 30mm, 40mm, 60mm, 90mm,120mm diameter
Data format	JPEG, TIFF	JPEG, BMP
Measuringfunctions	DistanceCircumference Length/Area	DistanceCircumference Length/Area
Compliance withMedicalElectrical Safetyand PerformanceStandard	IEC 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-2-37	IEC 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-2-37
AttenuationSpatial PeakTemporalAverageIntensity	ISPTA.3≤ 720mW/cm2	ISPTA.3≤ 720mW/cm
Mechanical Index(MI)	Less than 1.0	Less than 1.0
Thermal Index(TI)	Less than 1.0	Less than 1.0
Dimensions(mm)	377(W) x 480(D) x 80(H)	371(W) x 480(D) x 175(H)
Weight (kg)	8.0	22.5
Control	CP-900	MAJ-1995
Mechanical drive	RS-900	MAJ-935
Powerrequirements	AC100-240V	AC100-240V
Other equipmentwhich can beused with thedevice	Video ProcessorLight SourceCartMonitorRecorderColor or Black & White PrinterFoot SwitchUSB MemoryUltrasonic Processor	Video ProcessorLight SourceCartMonitorRecorderColor or Black & White PrinterFoot SwitchUSB Memory

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	Proposed Device	Predicate Device
Device name	PB2020-M	UM-S20-17S
Common name	Ultrasonic probe	Ultrasonic probe
Manufacturer	FUJIFILM Medical Systems U.S.A., Inc.	Olympus Medical Systems Corp.
510(k) number	To be assigned	K130058

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IntendedUse/Indicationsfor Use	This product is a medical ultrasonicprobe. It is intended for the observationand diagnosis of the gastrointestinaltract, biliary and pancreatic ducts andsurrounding organs, airways andtracheobronchial tree under themanagement of physicians at medicalfacilities.	UM-S20-17S is designed for use with incombination with Olympus endoscopic ultrasoundsystem for intraluminal sonographic imaging ofgastrointestinal tract wall; biliary (common bile,cystic, intrahepatic); pancreatic ducts; surroundingorgans and upper airways and tracheobronchialtree.
Appearance	Image: Endoscopic ultrasound probe	Image: Endoscopic ultrasound probe
Diameter ofinsertionportion	1.4-1.9mm	1.4-1.7mm
Maximumdiameter ofinsertionportion	2.0mm	1.8mm
Working length	2150mm	2150mm
EOGSterilization	Applicable	Applicable
Applicablesystem	FUJIFILM SP-900	Olympus EU-ME2
Applicablescope	Endoscopes that meet the followingconditions:Channel diameter ≥ 2.0mmWorking length ≤ 1330mmEndoscope types:- Bronchoscope- Upper gastrointestinalendoscope- Large intestine endoscope- Duodenoscope	Olympus flexible endoscopes without guide sheaththat meet the following conditions:Channel diameter ≥ 2.0mmWorking length ≤ 1330mmEndoscope types:- Bronchoscope- Gastroscope- Colonoscope- Duodenoscope- Choledochoscope
Scanningmethod	Mechanical radial	Mechanical radial
Ultrasonicfrequency	20MHz	20MHz

Performance Data:

FUJIFILM Ultrasonic Processor SP-900 is non-sterile and has no potential for patient contact. Testing of the SP-900 consisted of software validation in accordance with IEC 62304.

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Ultrasonic Probe PB2020-M was tested for biocompatibility according to ISO 10993. Cleaning, disinfection, and sterilization were also evaluated.

Testing was conducted on the SP-900 in combination with PB2020-M to ensure that the image quality and performance met all internally established specifications.

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 as intended in all instances.

StandardsNo.	StandardsOrganization	Standards Title	Date
ES60601-1	ANSI/AAMI	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance	2012
60601-1-2	IEC	Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -Requirements and tests	2007
60601-1-6	IEC	Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance -Collateral standard: Usability	2013
60601-2-37	IEC	Medical electrical equipment - Part 2-37: particularrequirements for the basic safety and essentialperformance of ultrasonic medical diagnostic andmonitoring equipment	2007
62304	IEC	Medical device software - Software life-cycle processes	2006
62359	IEC	Ultrasonics – Field characterization – Test methods for thedetermination of thermal and mechanical indices related tomedical diagnostic ultrasound fields	2010
62366	IEC	Medical devices - Application of usability engineering tomedical devices	2014
10993-5	ISO	Biological evaluation of medical devices - Part 5: Tests forin vitro cytotoxicity.	2009
10993-10	ISO	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization.	2010
14971	ISO	Medical devices - Application of risk management tomedical devices	2007
UD2	NEMA	Acoustic output measurement standard for diagnosticultrasound equipment	2009

Substantial Equivalence:

FUJIFILM Ultrasonic Processor SP-900 is comparable with and substantially equivalent to the predicate, Endoscopic Ultrasound Center EU-Y0008 (K130058), which is marketed as the EU-ME2.

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The proposed device has the same general intended use and similar indications, technological characteristics, and principles of operation as the predicate device. The key difference between the proposed and predicate devices is the expanded indications in the predicate device that are not found in the subject device.

The SP-900 is intended for use with the Ultrasonic Probe PB2020-M, which is not intended for use with the EU-ME2. However, the PB2020-M is substantially equivalent to the UM-S20-17S, which is intended for use with the EU-ME2. The PB2020-M has the same general intended use and similar indications, technological characteristics, and principles of operation as the UM-S20-17S.

The differences in indications and technological characteristics between the subject and predicate devices do not raise new concerns regarding safety and effectiveness. Bench testing data demonstrates that the SP-900 with PB2020-M is substantially equivalent to the EU-ME2 with UM-S20-17S in safety and effectiveness.

Conclusions:

The SP-900 and PB2020-M are substantially equivalent to the similar legally marketed devices EU-ME2 and UM-S20-17S 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.