FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

K214089 · Fujifilm Corporation · ODG · Jun 3, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K214089
• Device Name: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
• Applicant: Fujifilm Corporation
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Jun 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

FUJIFILM Ultrasonic Processor 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. Modes of Operation: B-mode FUJIFILM Ultrasonic Probe PB2020-M2 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. Modes of Operation: B-mode

Device Story

System comprises ultrasonic processor (SP-900), ultrasonic probe (PB2020-M2), control pad (CP-900), and mechanical scanner (RS-900). Probe inserts through endoscope forceps channel; processor drives transducer to emit ultrasound waves into body cavity. Reflected signals processed to generate real-time B-mode ultrasound images for display on external monitor. Used in clinical settings by physicians for observation and diagnosis of GI tract, biliary/pancreatic ducts, and airways. Output aids clinical decision-making during endoscopic procedures. Benefits include enhanced visualization of internal structures and surrounding organs.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-1, -5, -10), electrical safety (ANSI/AAMI ES60601-1, IEC 60601-2-37), electromagnetic compatibility (IEC 60601-1-2), and software validation (IEC 62304). Reprocessing validation performed for cleaning, high-level disinfection, and STERRAD sterilization.

Technological Characteristics

Mechanical radial scanning ultrasonic system. Operating frequency: 20 MHz. B-mode imaging. Dimensions: 377x480x80mm. Power: 100-240V AC. Connectivity: Peripheral support via video processor/monitor. Reprocessing: Manual cleaning, HLD, EOG, and STERRAD sterilization. Software: IEC 62304 compliant.

Indications for Use

Indicated for patients requiring endoscopic ultrasound imaging of the gastrointestinal tract, biliary/pancreatic ducts, surrounding organs, and airways/tracheobronchial tree. Used under physician management in 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

• FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (K171207)

Submission Summary (Full Text)

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June 3, 2022

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The U.S. Food & Drug Administration logo is on the right and features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Fujifilm Corporation % Kotei Aoki Senior Regulatory Affairs Specialist Fujifilm Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421

Re: K214089

Trade/Device Name: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: ODG, IYO, ITX Dated: May 2, 2022 Received: May 3, 2022

Dear Kotei Aoki:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K214089

#### Device Name

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

Indications for Use (Describe)

FUJIFILM Ultrasonic Processor 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.

Modes of Operation: B-mode

FUJIFILM Ultrasonic Probe PB2020-M2

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.

Modes of Operation: B-mode

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

| <span style="font-size:10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary - K214089

## FUJIFILM Corporation

# FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

Date: December 27, 2021

## Submitter's Information:

FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN

## Contact Person:

Kotei Aoki Senior Requlatory Affairs Specialist E-Mail: [e-mail] Telephone: [phone]

#### ldentification of the Subject Device:

| Device Name | FUJIFILM Ultrasonic Processor<br>SP-900 | FUJIFILM Ultrasonic Probe<br>PB2020-M2 |
|------------------------|---------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Common Name | Ultrasonic Processor | Ultrasonic Probe |
| Product Code | • ODG<br>• IYO | • ITX |
| Device Class | Class 2 | Class 2 |
| Regulation Number | • 876.1500<br>• 892.1560 | • 892.1570 |
| Regulation Description | • Endoscopic Ultrasound System,<br>Gastroenterology-Urology;<br>• System, Imaging, Pulsed Echo,<br>Ultrasonic | • Transducer, Ultrasonic,<br>Diagnostic |
| Review Panel | • Gastroenterology/Urology<br>• Radiology | • Radiology |

## Predicate Device(s):

- FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (K171207) ●
## Intended Use / Indications for Use:

FUJIFILM Ultrasonic Processor 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. Modes of Operation: B-mode

FUJIFILM Ultrasonic Probe PB2020-M2

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. Modes of Operation: B-mode

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# Device Description:

The FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 consists of five components: 1) processor (SP-900), 2) probe (PB2020-M2), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in PB2020-M2, which is inserted through the forceps channel of an endoscope. SP-900 processes the reflected ultrasound signals which PB2020-M2 receives in the body cavity and further converts the processed electrical signals to relay to a monitoring system. SP-900 can acquire and display real-time ultrasound data in B-mode. CP-900 is used to control operational features of SP-900. RS-900 provides the mechanical scanning for acquiring a twodimensional image. The power cord supplies power to SP-900.

# Comparison of Technological Characteristics:

Comparisons of technological characteristics between the subject devices and the predicate devices are provided in the tables below:

| | Subject device model<br>SP-900 | Predicate device model<br>SP-900 | Remark |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------|
| Device name | Ultrasonic processor | Ultrasonic processor | |
| 510(k) number | K214089 | K171207 | |
| Indications for use (IFU) | The FUJIFILM Ultrasonic Processor SP-900 is intended to be used<br>in combination with FUJIFILM Ultrasonic Probe, video processor,<br>light source, monitor, recorder, and various peripheral devices. The<br>product is intended to provide ultrasonic images of the<br>gastrointestinal tract, biliary and pancreatic ducts and surrounding<br>organs, airways and tracheobronchial tree for observation,<br>recording and to aid in diagnosis during endoscopic evaluation.<br>Modes of Operation: B-mode | | Same |
| Compatible transducer | PB2020-M2, PB2020-M | PB2020-M | |
| Physical specification | | | |
| Size (mm) | 377(W) x 480(D) x 80(H) | | Same |
| Weight (kg) | 8.0 | | Same |
| Power requirements (V) | AC 100-240 | | Same |
| Scan specification | | | |
| Probe type | Radial scan | | Same |
| Scanning method | Mechanical scan | | Same |
| Image mode | B-mode | | Same |
| Frequency (Mhz) | 20 | | Same |
| Measuring functions | Distance; Circumference Length/Area | | Same |
| Output specification | | | |
| Display range (mm) | 20, 30, 40, 60, 90, 120 in diameter | | Same |
| Data format | JPEG, TIFF | | Same |
| Electrical Safety | | | |
| Spatial Peak Temporal<br>Average Intensity | ≤ 720 mW/cm² | | Same |
| Mechanical Index | < 1.0 | | Same |
| Thermal Index | < 1.0 | | Same |
| Compatible Peripherals | | | |
| Control | | CP-900 | Same |
| Mechanical drive | | RS-900 | Same |
| Other compatible<br>peripherals | Video Processor, Light Source, Cart, Monitor, Recorder, Printer,<br>Foot Switch, USB Memory | | Same |

Table 1

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# Table 2

| | Subject device model<br>PB2020-M2 | Predicate device model<br>PB2020-M | Remark |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device name | Ultrasonic probe | Ultrasonic probe | |
| 510(k) number | K214089 | K171207 | |
| Indications for use (IFU) | This product is a medical ultrasonic probe. It is intended for the<br>observation and diagnosis of the gastrointestinal tract, biliary and<br>pancreatic ducts and surrounding organs, airways and<br>tracheobronchial tree under the management of physicians at<br>medical facilities.<br>Modes of Operation: B-mode | | Same |
| Probe specification | | | |
| Diameter of insertion<br>portion (mm) | 1.4~1.9 | | Same |
| Working length (mm) | 2150 | | Same |
| Maximum outer diameter<br>of insertion portion (mm) | 1.98 | 2.0 | |
| Reprocessing method | | | |
| Manual cleaning | Applicable | | Same |
| High-Level Disinfection | Applicable | Applicable | Same |
| EOG Sterilization | Applicable | | Same |
| STERRAD Sterilization | Applicable | Not applicable | |
| Compatibility | | | |
| Applicable system | | SP-900 | Same |
| Applicable scope | FUJIFILM endoscopes that<br>meet the following conditions<br>• Channel diameter: ≥2.0mm<br>• Working length: ≤1330mm<br>• Any of the following types of<br>endoscope<br>o Bronchoscope<br>o Upper gastrointestinal<br>endoscope<br>o Lower gastrointestinal<br>endoscope<br>o Duodenoscope | FUJIFILM endoscopes that<br>meet the following conditions<br>• Channel diameter: ≥2.0mm<br>• Working length: ≤1330mm<br>• Any of the following types of<br>endoscope<br>o Bronchoscope<br>o Upper gastrointestinal<br>endoscope<br>o Large intestine<br>endoscope<br>o Duodenoscope | Same |
| Ultrasound specification | | | |
| Scanning method | | Mechanical radial | Same |
| Acoustic operating<br>frequency (Mhz) | 20 | | Same |
| Resolution (mm) | Axial: ≤ 2.0<br>Lateral: ≤ 2.0 | | Same |
| Penetration depth (mm) | 7.0 | | Same |

# Performance Data:

FUJIFILM Ultrasonic Processor SP-900 is supplied non-sterile but has no potential for patient contact. FUJIFILM Ultrasonic Probe PB2020-M2 is also supplied non-sterile and must be properly reprocessed prior to each use in accordance with its reprocessing instructions. The cleaning, disinfection, and sterilization were validated on PB2020-M2. The STERRAD sterilization was also conducted.

The biocompatibility was evaluated in accordance with FDA's guidance, Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk

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management process", issued September 4, 2020. The cytotoxicity was evaluated according to ISO 10993-5. The sensitization and irritation testing were conducted according to ISO 10993-10.

The subject devices SP-900 and PB2020-M2 contain electronic components. The subject device SP-900 has the same electrical components and can be adopted into electrical safety of the predicate device SP-900. Meanwhile, the software validation for the SP-900 was conducted in accordance with IEC 62304. The testing was conducted to ensure the electrical safety of the subject device PB2020-M2 according to ANSI/AAMI ES60601-1 and IEC 60601-2-37:2007. The subject devices SP-900 and PB2020-M2 were evaluated for the electromagnetic compatibility according to IEC 60601-1-2:2014.

# Conclusions:

The subject device FUJIFILM Ultrasonic Processor SP-900 is intended to be used with the FUJIFILM Ultrasonic Probe PB2020-M2. The subject devices share intended use and indications, technological characteristics, principles of operation, and reprocessing methods as the respective predicate devices. The key differences are the modification to the materials of construction in PB2020-M2 and the addition of STERRAD sterilization method for reprocessing PB2020-M2. The validation and test results demonstrate that the key differences between the subject devices and the predicate devices do not raise new concerns regarding safety and effectiveness.

The subject devices FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 are substantially equivalent to the respective predicate devices FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Processor PB2020-M (K171207).