(97 days)
No
The summary describes standard ultrasonic image processing and display functionalities, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No
The device is described as an ultrasonic processor intended for observation, recording, and aiding in diagnosis by providing ultrasonic images. It processes reflected ultrasound signals into images but does not actively treat or alter the body, which is characteristic of therapeutic devices.
Yes
The intended use explicitly states that the product is "intended to provide ultrasonic images ... to aid in diagnosis during endoscopic evaluation," which is the function of a diagnostic device.
No
The device description clearly states that the device consists of two hardware components, a Processor and a Keyboard, which are used in conjunction with an ultrasonic endoscope. It processes electrical signals into image or video signals and displays them on a monitor or printer, indicating a physical output.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide ultrasonic images of internal body structures (trachea, bronchial tree, upper gastrointestinal tract) for observation, recording, and to aid in diagnosis during endoscopic evaluation. This involves imaging within the body, not testing samples taken from the body.
- Device Description: The description details how the device works by transmitting and receiving ultrasound waves within the body cavity and processing these signals into images. This is consistent with in-vivo imaging, not in-vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body.
Therefore, the device is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
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, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peribheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
Product codes (comma separated list FDA assigned to the subject device)
FDS, IYN, IYO, ITX
Device Description
The Fujifilm ultrasonic processors SU-1 PLATINUM and SU-1 are used with previously cleared ultrasonic endoscopes, EG-530UR2 & EG-530UT2 (K181763), EB-530US (K182825), EG-580UR and EG-580UT (K183433).
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/CP-1TB, is used to control operational features of the SU-1 PLATINUM or SU-1 ultrasonic processor. Furthermore, the SU-1 PLATINUM and SU-1 system can be expanded by connecting additional devices. The system can optionally be used with a previously cleared FUJIFILM Ultrasonic Processor SP-900 (K171207).
The Fujifilm 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, F-Flow, 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Imaging
Anatomical Site
trachea, bronchial tree and surrounding organs, or submucosal and peripheral organs of the upper gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Fujifilm conducted Doppler sensitivity for F-Flow mode performance testing on the proposed device SU-1 PLATINUM and SU-1 to ensure that the modified device performs equivalently to the predicate device. The device met the pre-defined acceptance criteria for the test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K181763, K182825, K183433, K171207
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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July 6, 2020
FUJIFILM Corporation % Kamila Sak Regulatory Affairs Specialist FUJIFILM Medical System U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K200850
Trade/Device Name: Fujifilm Ultrasonic Processor, Model SU-1 Platinum and SU-1 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, IYN, IYO, ITX Dated: June 15, 2020 Received: June 16, 2020
Dear Kamila Sak:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality 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: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200850 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, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or submucosal and peribheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) SUMMARY Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1
Date: June 15, 2020
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Kamila Sak Regulatory Affairs Specialist Telephone: (347) 577-2309 E-Mail: kamila.sak@fujifilm.com Regulatory Affairs Specialist
Identification of the Proposed Device:
| Device Name: | Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1 |
|---|---|
| Common Name: | Ultrasonic Processor |
| Classification Number: | 21 C.F.R. § 876.1500 |
| Classification Name: | Endoscope and accessories |
| Regulatory Class: | Class II |
| Device Panel: | Gastroenterology/Urology |
Product Code Information:
| Product Code Name | CFR Section | Product Codes |
|---|---|---|
| Gastroscope and accessories, flexible/rigid | 21 CFR 876.1500 | FDS (Primary Product Code) |
| 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 Device:
Fujifilm Ultrasonic Processor, Model SU-1 PLATINUM and SU-1 (K153206)
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Intended Use / Indications for Use:
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 (K181763), EB-530US (K182825), EG-580UR and EG-580UT (K183433).
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/CP-1TB, is used to control operational features of the SU-1 PLATINUM or SU-1 ultrasonic processor. Furthermore, the SU-1 PLATINUM and SU-1 system can be expanded by connecting additional devices. The system can optionally be used with a previously cleared FUJIFILM Ultrasonic Processor SP-900 (K171207).
The Fujifilm 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, F-Flow, 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:
The proposed device SU-1 PLATINUM and SU-1 differs from the predicate device in the following minor modifications:
- Software version update to v1.17 to include view mode: F-Flow, which is a modification of power doppler mode
- . Addition of two compatible endoscopes: EG-580UR (Radial probe) and EG-580UT (Convex probe) previously cleared in K183433
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Performance Data:
Electrical safety of the proposed device was evaluated using the following standards: ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-6:2013, IEC 60601-1-2:2014, IEC 60601-2-37:2015, and IEC 60601-2-18:2009.
Software validation was evaluated in accordance with IEC 62304:2015 and the FDA quidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA quidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.
Fujifilm conducted Doppler sensitivity for F-Flow mode performance testing on the proposed device SU-1 PLATINUM and SU-1 to ensure that the modified device performs equivalently to the predicate device. The device met the pre-defined acceptance criteria for the test.
Substantial Equivalence:
The company's SU-1 PLATINUM and SU-1 has the same intended use and indications for use as the previously cleared predicate SU-1 PLATINUM and SU-1 (K153206). In addition, the proposed device has similar technological characteristics and principles of operation as the predicate. The minor differences between the proposed and predicate devices do not raise new or additional questions of safety or effectiveness of the proposed devices. Thus, the proposed device SU-1 PLATINUM and SU-1 is substantially equivalent to the predicate device.
Conclusions:
The modified SU-1 PLATINUM and SU-1 is substantially equivalent to the predicate and conforms to applicable medical device safety and performance standards.