(253 days)
Not Found
No
The summary describes image processing techniques (BLI, LCI, FICE) which are spectral and structural enhancements achieved through proprietary software, but does not mention AI or ML.
No
The device is described as an endoscopic processor that provides illumination, processes signals from an endoscope, enables image recording, and supplies air for visualization. Its stated intended use is for "endoscopic observation, diagnosis and treatment," but the "treatment" aspect is not further elaborated or described as a therapeutic function of the device itself. The device's primary functions are related to imaging and visualization for diagnostic purposes.
Yes
The "Intended Use / Indications for Use" section states that the product is "used for endoscopic observation, diagnosis and treatment," and that BLI, LCI, and FICE are "adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy," indicating its role in diagnostic procedures.
No
The device description clearly states it is a "FUJIFILM Video Processor EP-6000" which is a physical hardware unit housed in a steel-polycarbonate case, incorporates LED lamps for light transmission, and is AC operated. While it utilizes proprietary software for image processing, it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EP-6000 is an endoscopic processor. Its primary function is to process signals from a video endoscope, provide illumination, and enable image recording for direct visualization of internal body cavities. It works with an endoscope inserted into the body.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the body. The device processes signals from the endoscope, which is observing the internal anatomy directly.
- Intended Use: The intended use clearly states it's for "endoscopic observation, diagnosis and treatment" and "gastrointestinal endoscopic examinations." These are procedures performed in vivo (within the living body).
While the device is used for diagnosis, it achieves this through direct visualization and image processing of the internal anatomy, not through the analysis of in vitro samples.
N/A
Intended Use / Indications for Use
The EP-6000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment.
BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis. BLI, LCI, and FICE are not intended for bronchoscopic examination.
Product codes
FET, NTN, NWB, PEA, EOQ
Device Description
FUJIFILM Video Processor EP-6000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor incorporates internal or external digital storage capacity. The processor employs fiber bundles to transmit light from three LED lamps, with a total power of 59.5W, to the body cavity. Brightness control is performed by the user. The processor provides for optional structural enhancement through user modes FICE, BLI, BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/2.0-1.1A. The processor is housed in a steel-polycarbonate case measuring 395x210x485mm.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
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)
Electrical, laser, and photobiological safety of the subject device was evaluated using the following standards: ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-2-18:2009, IEC 60825-1:2007, and IEC 62471:2006.
Software validation was evaluated in accordance with ANSI/AAMI/IEC 62304:2006 and the FDA guidance, "Guidance for the Content of Premarket Submissions for Software in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.
Functional testing of the various image processing modes included Color Reproduction and Color Contrast Enhancement. All testing criteria were met, and the device functioned as intended in all instances.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2020
FUJIFILM Corporation % Candace Alva Director, Quality Management Systems FuiiFilm Medical Systems U.S.A., Inc. 81 Hartwell Avenue Lexington, MA 02421
Re: K192286
Trade/Device Name: FUJIFILM EP-6000 Video Processor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, NTN, NWB, PEA, EOQ Dated: August 20, 2019 Received: August 22, 2019
Dear Candace Alva:
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,
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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K192286 |
|---|---|
| Device Name | FUJIFILM Video Processor EP-6000 |
| Indications for Use ( Describe ) | The EP-6000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment. |
| BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis. BLI, LCI, and FICE are not intended for bronchoscopic examination. | |
| 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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3
510(k) SUMMARY
FUJIFILM Corporation's FUJIFILM Video Processor EP-6000
Date: April 30, 2020
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Candace Alva Director, Quality Management Systems Telephone: (828) 638-5240 E-Mail: candace.alva@fujifilm.com
Identification of the Proposed Devices:
| Proprietary/Trade Name: | FUJIFILM Video Processor EP-6000 |
|---|---|
| Common Name: | Endoscopic Video Imaging System |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Endoscope and accessories | 21 CFR 876.1500 | FET, NTN, NWB, PEA, EOQ |
Predicate Device:
- . FUJIFILM Video Processor VP-7000 and Light Source BL-7000 (K163675)
Intended Use / Indications for Use
The EP-6000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording. This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals. It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment.
4
BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis. BLI, LCI, and FICE are not intended for bronchoscopic examination.
Device Description
FUJIFILM Video Processor EP-6000 relays the image from an endoscope to a video monitor. The projection can be either analog or digital at the user's preference. The processor incorporates internal or external digital storage capacity. The processor employs fiber bundles to transmit light from three LED lamps, with a total power of 59.5W, to the body cavity. Brightness control is performed by the user. The processor provides for optional structural enhancement through user modes FICE, BLI, BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/2.0-1.1A. The processor is housed in a steel-polycarbonate case measuring 395x210x485mm.
Comparison of Technological Characteristics
FUJIFILM Video Processor EP-6000 differs from the predicate devices VP-7000 and BL-7000 in terms of technological characteristics. The subject and predicate devices share the same mode of operation and intended use.
A summary of major differences between the subject device EP-6000 and the predicate devices VP-7000 and BL-7000 is provided as follows:
- One unit that provides both video processing and light sourcing functions
- . Number of LED lamps used for light transmission
Performance Data
Electrical, laser, and photobiological safety of the subject device was evaluated using the following standards: ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-2-18:2009, IEC 60825-1:2007, and IEC 62471:2006.
Software validation was evaluated in accordance with ANSI/AAMI/IEC 62304:2006 and the FDA guidance, "Guidance for the Content of Premarket Submissions for Software in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.
Functional testing of the various image processing modes included Color Reproduction and Color Contrast Enhancement. All testing criteria were met, and the device functioned as intended in all instances.
5
Substantial Equivalence
The subject device FUJIFILM Video Processor EP-6000 is substantially equivalent to the predicate devices, FUJIFILM Video Processor VP-7000 and Light Source BL-7000 (K163675). The subject and predicate devices share the same intended use and substantially similar indications. Bench testing demonstrates that the differences in technological characteristics raise no new issues of safety or effectiveness. Thus, EP-6000 is substantially equivalent to the predicate devices.
Conclusions
The subject device FUJIFILM Video Processor EP-6000 is substantially equivalent to the predicate devices based on the same intended use, similar indications for use, and similar technological characteristics.