Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

K153206 · Fujifilm Medical System U.S.A., Inc. · FDS · Mar 3, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153206
• Device Name: Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: FDS · Gastroenterology, Urology
• Decision Date: Mar 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 to aid in diagnosis during endoscopic evaluation.

Device Story

Ultrasonic processors (SU-1/SU-1 PLATINUM) used with ultrasonic endoscopes, video processors, and monitors; system drives transducer in endoscope to transmit ultrasound waves into body cavities; processes reflected signals into electrical signals for display as real-time ultrasound images (B, M, Color/Pulse Doppler, Duplex, Triplex modes). SU-1 PLATINUM includes elastography for mapping tissue elastic properties via color distribution based on stiffness. Operated by clinicians in endoscopic settings; output used for observation, recording, and diagnostic support. Benefits include real-time visualization of internal structures and tissue stiffness assessment.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included software validation (IEC 62304), EMC safety, and performance testing per IEC 60601-1, 60601-1-2, 60601-2-18, 60601-2-37, and NEMA UD2. All predetermined criteria met.

Technological Characteristics

Ultrasonic processor with keyboard (CP-1); electronic scanning; supports B, M, Color/Pulse Doppler, Duplex, Triplex, and Elastography (PLATINUM only). Frequencies: 5/7.5/10/12 MHz. Connectivity: DICOM, JPEG, TIFF. Power: AC100-240V. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 62359, NEMA UD2.

Indications for Use

Indicated for providing ultrasonic images of the trachea, bronchial tree, surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording, and diagnostic aid during endoscopic evaluation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Fujinon Ultrasonic Processor SU-8000 (K111243)

Reference Devices

• Olympus EU-Y0008 (EU-ME2 premier plus) (K130058)
• EG-530UR2 & EG-530UT2 (K120446)
• EB-530US (K121035)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: [phone] Ext. 522627 Facsimile: (973)-633-8818 E-Mail: [e-mail]

Aaron Ge Regulatory Manager, Regulatory Affairs and Quality Assurance Telephone: [phone] Facsimile: [phone] E-Mail: [e-mail]

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

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 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 (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.

# Technological Characteristics

| | Fujinon Ultrasonic Processor<br>SU-8000<br>(Predicate Device K111243) | Fujifilm Ultrasonic Processor SU-1/<br>SU-1 PLATINUM (Subject Device) |
|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications<br>for Use | The Fujinon ultrasonic processor SU-8000 is<br>intended to be used in combination with<br>Fujinon/Fujifilm ultrasonic endoscope, video<br>processor, light source, monitor, recorder, and<br>various peripheral devices. The product is<br>intended to provide ultrasonic images of<br>submucosal and peripheral organs of the<br>upper gastrointestinal tract for observation,<br>recording and to aid in diagnosis during<br>endoscopic evaluation. | The FUJIFILM ultrasonic processors SU-1<br>PLATINUM and SU-1 are intended to be<br>used in combination with FUJIFILM<br>ultrasonic endoscope, video processor, light<br>source, monitor, recorder, and various<br>peripheral devices. The product is intended<br>to provide ultrasonic images of the trachea,<br>bronchial tree and surrounding organs, or<br>submucosal and peripheral organs of the<br>upper gastrointestinal tract for observation, |
| | Fujinon Ultrasonic Processor<br>SU-8000<br>(Predicate Device K111243) | Fujifilm Ultrasonic Processor SU-1/<br>SU-1 PLATINUM (Subject Device) |
| Appearance | Image: Ultrasonic Processor SU-8000 | Image: Ultrasonic Processor SU-1 |
| Compatible<br>Endoscopes | EG-530UR/UR2 (Radial probe)<br>EG-530UT/UT2 (Convex probe) | EG-530UR2 (Radial probe)<br>EG-530UT2 (Convex probe)<br>EB-530US (Convex probe) |
| Probe Type | Radial scan<br>Convex scan | Same as the predicate device |
| Scanning<br>Method | Electronic scan | Same as the predicate device |
| Image Mode | B-mode,<br>M-mode,<br>Color Doppler/Power Doppler,<br>Pulsed Wave Doppler,<br>THI<br>Dual/Duplex/Triplex | B-mode,<br>M-mode,<br>Color Doppler/Power Doppler,<br>Pulsed Wave Doppler,<br>THI<br>Dual/Duplex/Triplex<br>Elastography (SU-1 PLATINUM only) |
| Frequency | 5MHz/7.5MHz/10MHz/12MHz | Same as the predicate device |
| Display Range | EG-530UR/UR2: 15-120mm<br>EG-530UT/UT2: 15-120mm<br>Display depth:120mm (max) | EG-530UR2: 15mm-120mm<br>EG-530UT2: 15mm-120mm<br>EB-530US: 15mm-120mm<br>Display depth:120mm (max) |
| Data Format | Data can be saved in<br>JPEG format<br>TIFF format<br>DICOM format | Same as the predicate device |
| Measuring<br>functions | Depth<br>Distance<br>Circumference Length/Area<br>Volume<br>Flow Velocity<br>Acceleration<br>A/B Ratio | Same as the predicate device |
| Compliance<br>with Medical<br>Electrical Safety<br>and<br>Performance<br>Standard | IEC60601-1,<br>IEC60601-1-1,<br>IEC60601-1-2,<br>IEC60601-2-18,<br>IEC60601-2-37 | ANSI/AAMI ES60601-1,<br>IEC60601-1-2,<br>IEC60601-2-18,<br>IEC60601-2-37 |
| | Fujinon Ultrasonic Processor<br>SU-8000<br>(Predicate Device K111243) | Fujifilm Ultrasonic Processor SU-1/<br>SU-1 PLATINUM (Subject Device) |
| Attenuation<br>Spatial Peak<br>Temporal<br>Average<br>Intensity<br>(Ispta.3) | $I_{spta.3} \leq 720mW/cm^2$ | Same as the predicate device |
| Mechanical<br>Index (MI) | 1.9 or less | Same as the predicate device |
| Thermal Index<br>(TI) | 1.0 or less | Same as the predicate device |
| Dimensions<br>(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 |
| Power<br>Requirements | AC120V | AC100-240V |
| Other<br>equipment<br>which can be<br>used with the<br>device | Video Processor<br>Light Source<br>Cart<br>Monitor<br>Recorder<br>Color or Black & White Printer<br>Foot 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.

| Standards<br>No. | Standards<br>Organization | Standards Title | Date |
|------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ES60601-1 | ANSI/AAMI | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance | 2010 |
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic compatibility Requirements and tests | 2007 |
| 60601-1-6 | IEC | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability | 2010 |
| 60601-2-18 | IEC | Medical electrical equipment - Part 2-18: Particular requirements<br>for the basic safety and essential performance of endoscopic<br>equipment | 2009 |
| 60601-2-37 | IEC | Medical electrical equipment - part 2-37: particular requirements<br>for the basic safety and essential performance of ultrasonic | 2007 |

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| Standards<br>No. | Standards<br>Organization | 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 medical<br>devices | 2007 |
| 62359 | IEC | Ultrasonics - Field characterization - Test methods for the<br>determination of thermal and mechanical indices related to<br>medical diagnostic ultrasonic fields | 2005 |
| UD2 | NEMA | Acoustic output measurement standard for diagnostic ultrasound<br>equipment | 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.