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

K171207 · Fujifilm Medical Systems U.S.A, Inc. · ODG · Jan 11, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K171207
• Device Name: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
• Applicant: Fujifilm Medical Systems U.S.A, Inc.
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Jan 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

SP-900: 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 Story

System comprises SP-900 ultrasonic processor, PB2020-M ultrasonic probe, CP-900 control pad, and RS-900 scanner. Probe inserts through endoscope forceps channel; processor drives transducer to generate ultrasound waves into body cavity. Reflected signals processed and converted to B-mode real-time video signals for display on monitoring system. Used in clinical settings by physicians for endoscopic evaluation. Output aids diagnosis via visualization of GI tract, biliary/pancreatic ducts, and airways. System supports measurement functions (distance, circumference, length/area). Benefits include real-time imaging for diagnostic guidance during endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data. Testing included software validation (IEC 62304), biocompatibility (ISO 10993), EMC safety, and performance testing against established specifications. All predetermined criteria met.

Technological Characteristics

Mechanical radial scanning ultrasonic system. Frequency: 20MHz. Imaging mode: B-mode. Processor dimensions: 377x480x80mm. Probe diameter: 1.4-1.9mm. Connectivity: Video processor, light source, monitor, recorder, USB. Sterilization: EOG (probe). Software: IEC 62304 compliant. Safety standards: IEC 60601-1, 60601-1-2, 60601-2-37, IEC 62359, NEMA UD2.

Indications for Use

Indicated for observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts, surrounding organs, airways, and tracheobronchial tree in patients undergoing endoscopic evaluation, managed by physicians at medical facilities.

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

• Endoscopic Ultrasound Center EU-Y0008 (marketed as EU-ME2) (K130058)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

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.

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.

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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: [phone] Facsimile: [phone] E-Mail: [e-mail]

Date Prepared: January 9, 2018

### Identification of the Proposed Device:

| Trade/Device Name: | FUJIFILM Ultrasonic Processor SP-900, FUJIFILM Ultrasonic Probe<br>PB2020-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:

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.

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# 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.

# 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 |
| Intended<br>Use/Indications<br>for Use | The FUJIFILM Ultrasonic Processor SP-900<br>is intended to be used in combination with<br>FUJIFILM Ultrasonic Probe, video processor,<br>light source, monitor, recorder, and various<br>peripheral devices. The product is intended<br>to provide ultrasonic images of the<br>gastrointestinal tract, biliary and pancreatic<br>ducts and surrounding organs, airways and<br>tracheobronchial tree for observation,<br>recording and to aid in diagnosis during<br>endoscopic evaluation. | This ultrasound center is intended to be<br>used with Olympus ultrasound endoscopes,<br>Olympus ultrasound probes or Olympus<br>esophageal ultrasound probes to observe<br>and to store real-time ultrasound images<br>and indicated for use within the<br>gastrointestinal (GI) tract, biliary and<br>pancreatic ducts and surrounding organs,<br>airways and tracheobronchial tree, and<br>urinary tract. |
| Appearance | Image: FUJIFILM SP-900 | Image: Olympus EU-ME2 |
| Compatible<br>transducer | PB2020-M | UM-S20-17S |
| Probe type | Radial scan | Radial scan |
| Scanning<br>method | Mechanical scan | Mechanical scan |
| Image mode | B-mode | B-mode |
| Frequency | 20MHz | 20MHz |
| Display range | 20mm, 30mm, 40mm, 60mm, 90mm, 120mm<br>diameter | 20mm, 30mm, 40mm, 60mm, 90mm,<br>120mm diameter |
| Data format | JPEG, TIFF | JPEG, BMP |
| Measuring<br>functions | Distance<br>Circumference Length/Area | Distance<br>Circumference Length/Area |
| Compliance with<br>Medical<br>Electrical Safety<br>and Performance<br>Standard | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-2-37 | IEC 60601-1<br>IEC 60601-1-1<br>IEC 60601-1-2<br>IEC 60601-2-37 |
| Attenuation<br>Spatial Peak<br>Temporal<br>Average<br>Intensity | ISPTA.3≤ 720mW/cm2 | ISPTA.3≤ 720mW/cm |
| Mechanical Index<br>(MI) | Less than 1.0 | Less than 1.0 |
| Thermal Index<br>(TI) | Less than 1.0 | Less than 1.0 |
| Dimensions<br>(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 |
| Power<br>requirements | AC100-240V | AC100-240V |
| Other 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<br>USB Memory<br>Ultrasonic Processor | Video Processor<br>Light Source<br>Cart<br>Monitor<br>Recorder<br>Color or Black & White Printer<br>Foot Switch<br>USB 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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| Intended<br>Use/Indications<br>for Use | This product is a medical ultrasonic<br>probe. It is intended for the observation<br>and diagnosis of the gastrointestinal<br>tract, biliary and pancreatic ducts and<br>surrounding organs, airways and<br>tracheobronchial tree under the<br>management of physicians at medical<br>facilities. | UM-S20-17S is designed for use with in<br>combination with Olympus endoscopic ultrasound<br>system for intraluminal sonographic imaging of<br>gastrointestinal tract wall; biliary (common bile,<br>cystic, intrahepatic); pancreatic ducts; surrounding<br>organs and upper airways and tracheobronchial<br>tree. |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appearance | Image: Endoscopic ultrasound probe | Image: Endoscopic ultrasound probe |
| Diameter of<br>insertion<br>portion | 1.4-1.9mm | 1.4-1.7mm |
| Maximum<br>diameter of<br>insertion<br>portion | 2.0mm | 1.8mm |
| Working length | 2150mm | 2150mm |
| EOG<br>Sterilization | Applicable | Applicable |
| Applicable<br>system | FUJIFILM SP-900 | Olympus EU-ME2 |
| Applicable<br>scope | Endoscopes that meet the following<br>conditions:<br>Channel diameter ≥ 2.0mm<br>Working length ≤ 1330mm<br>Endoscope types:<br>- Bronchoscope<br>- Upper gastrointestinal<br>endoscope<br>- Large intestine endoscope<br>- Duodenoscope | Olympus flexible endoscopes without guide sheath<br>that meet the following conditions:<br>Channel diameter ≥ 2.0mm<br>Working length ≤ 1330mm<br>Endoscope types:<br>- Bronchoscope<br>- Gastroscope<br>- Colonoscope<br>- Duodenoscope<br>- Choledochoscope |
| Scanning<br>method | Mechanical radial | Mechanical radial |
| Ultrasonic<br>frequency | 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.

| Standards<br>No. | Standards<br>Organization | Standards Title | Date |
|------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| ES60601-1 | ANSI/AAMI | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance | 2012 |
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Electromagnetic compatibility -<br>Requirements and tests | 2007 |
| 60601-1-6 | IEC | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Usability | 2013 |
| 60601-2-37 | IEC | Medical electrical equipment - Part 2-37: particular<br>requirements for the basic safety and essential<br>performance of ultrasonic medical diagnostic and<br>monitoring equipment | 2007 |
| 62304 | IEC | Medical device software - Software life-cycle processes | 2006 |
| 62359 | IEC | Ultrasonics – Field characterization – Test methods for the<br>determination of thermal and mechanical indices related to<br>medical diagnostic ultrasound fields | 2010 |
| 62366 | IEC | Medical devices - Application of usability engineering to<br>medical devices | 2014 |
| 10993-5 | ISO | Biological evaluation of medical devices - Part 5: Tests for<br><i>in vitro</i> cytotoxicity. | 2009 |
| 10993-10 | ISO | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization. | 2010 |
| 14971 | ISO | Medical devices - Application of risk management to<br>medical devices | 2007 |
| UD2 | NEMA | Acoustic output measurement standard for diagnostic<br>ultrasound 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.