(244 days)
No
The summary describes image processing technology (FICE) and structural/spectral enhancements achieved through proprietary software, but there is no mention of AI, ML, or related concepts like neural networks or training data. The performance studies focus on standard image quality metrics and electrical safety, not AI/ML performance evaluation.
No
The device is described as processing electronic signals from a video endoscope for observation, diagnosis, and recording, but not for direct therapeutic intervention. FICE is an adjunctive diagnostic tool.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for endoscopic observation, diagnosis, treatment, and image recording." It also mentions "FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy."
No
The device description clearly outlines multiple hardware components (Video Processor, Light Source, Keyboard) that are integral to the device's function, in addition to the software.
Based on the provided information, 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 EPX-4400 and EPX-4400HD Digital Video Processors with FICE are used for endoscopic observation, diagnosis, treatment, and image recording within the body. They process electronic signals from a video endoscope inserted into the body.
- Intended Use: The intended use clearly states it's for endoscopic examination and processing signals from a video endoscope. While it aids in diagnosis, it does so through direct visualization and image processing of internal structures, not through testing samples taken from the body.
- FICE as an adjunctive tool: The description of FICE as an "adjunctive tool for gastrointestinal endoscopic examination" further reinforces its role in enhancing visualization during an internal procedure, not as a standalone diagnostic test on a sample.
Therefore, the device falls under the category of medical devices used for internal examination and imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The EPX-4400 and EPX-4400HD Digital Video Processors with FICE are used for endoscopic observation, diagnosis, treatment, and image recording. The devices are intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). The devices may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.
Product codes
FET, GCT
Device Description
The EPX-4400 and EPX-4400HD Digital Video Processor with FICE and light source consist of three components used in conjunction with one another:
The VP-4400/4400HD Video Processor: The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software.
The XL-4400/4400HD Light Source: The Fujinon/FUJIFILM endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user.
The DK-4400E Keyboard: The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc.) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4400/4400HD Processor.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video endoscope
Anatomical Site
gastrointestinal
Indicated Patient Age Range
all patients
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)
The EPX-4400/4440HD Digital Video Processor is non-sterile and has no potential for patient contact. Testing of the VP-44000/4400HD with FICE consisted of software validation in accordance with IEC 62304 and electrical safety in accordance with IEC 60601 requirements. FUJIFILM has performed the same testing that was used to fully characterize the FICE feature as part of clearance with use with the EPX-4440HD system in K140149. All predetermined testing criteria were met, and in all instances the device functioned as intended. These tests include:
- Contrast Enhancement
- Resolution
- Noise
- Artifact
- Color Reproduction
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.
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Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of interconnected shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2015
Fujifilm Medical System U.S.A., Inc. Mary Moore Senior Director, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470
Re: K150221 Trade/Device Name: EPX-4440HD and EPX-4400 HD with FICE Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, GCT Dated: August 19, 2015 Received: August 19, 2015
Dear Mary Moore,
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
Benjamin R. Fisher, Ph.D. for 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) K150221
Device Name EPX-4400 and EPX-4400 HD with FICE
Indications for Use (Describe)
The EPX-4400 and EPX-4400HD Digital Video Processors with FICE are used for endoscopic observation, diagnosis. treatment, and image recording. The devices are intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). The devices may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.
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) |
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510(k) SUMMARY
FUJIFILM Medical Systems U.S.A., Inc.'s EPX-4400 and EPX-4400 HD with FICE
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc., Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293
Contact Persons:
Marv K. Moore Senior Director, Regulatory Affairs and Quality Assurance Telephone: (800) 385-4666 ext. 522498 Facsimile: (973) 686-2616 E-Mail: mkmoore@fujifilm.com
Date Prepared: January 30, 2015
Identification of the Proposed Device:
Proprietary/Trade Name: FUJIFILM EPX-4440HD and EPX-4400 HD with FICE Common Name: Endoscopic Video Processor
Classification Information:
| Classification Name | CFR Section | Product Code |
|---|---|---|
| Endoscopic Video Imaging System/ | 21 CFR 876.1500 | FET, GCT |
| Component, Gastroenterology- | ||
| Urology | ||
Predicate Devices
FUJIFILM Medical Systems U.S.A., Inc.'s EPX-4440 HD Digital Video Processor with FICE (K140149)
Intended Use / Indications for Use
The EPX-4400 and EPX-4400HD Digital Video Processors with FICE are used for endoscopic observation, diagnosis, treatment, and image recording. The devices are intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). The devices may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.
4
Technological Characteristics
This subject device is intended to be used in conjunction with Fujinon/FUJIFILM endoscopes to provide illumination, visual display and data storage during endoscopic procedures. The EPX-4400 and EPX-4400HD Digital Video Processor with FICE and light source consist of three components used in conjunction with one another:
The VP-4400/4400HD Video Processor: The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software.
The XL-4400/4400HD Light Source: The Fujinon/FUJIFILM endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user.
The DK-4400E Keyboard: The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc.) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4400/4400HD Processor.
Both EPX-4400 and EPX-4400HD contain FICE which is an image processing technology. A licensed medical practitioner (user) can utilize FICE, as an adjunctive tool, to supplement the white light endoscopic examination. FICE extracts spectral images of specific wavelength components from the original full spectral (white light) image through an image processing algorithm that, assigns a spectral wavelength component in the Red (R), Green (G) spectrum and displays the enhanced color image. FICE may enhance color contrast to improve visibility of the selected structures, borders of areas of interests.
Performance Data
The EPX-4400/4440HD Digital Video Processor is non-sterile and has no potential for patient contact. Testing of the VP-44000/4400HD with FICE consisted of software validation in accordance with IEC 62304 and electrical safety in accordance with IEC 60601 requirements. FUJIFILM has performed the same testing that was used to fully characterize the FICE feature as part of clearance with use with the EPX-4440HD system in K140149. All predetermined testing criteria were met, and in all instances the device functioned as intended. These tests include:
-
- Contrast Enhancement
-
- Resolution
-
- Noise
-
- Artifact
-
- Color Reproduction
5
EMC and electrical safety of the subject devices were evaluated using the following consensus standards: ANSI/AAMI ES60601-1:2005; IEC 60601-1-2:2007; IEC 60601-1-6:2010; and IEC 60601-2-18:2009.
Substantial Equivalence
The EPX-4400 and EPX-4400HD with FICE are as safe and effective as the EPX-4440HD Digital Video Processor with FICE. The EPX-4400 and EPX-4400HD with FICE have the same intended uses and similar indications, technological characteristics, and principles of operation as their predicate device. The minor technological differences between the EPX-4400 and EPX-4400HD with FICE and their predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the EPX-4400 and EPX-4400HD with FICE are as safe and effective as the EPX-4440HD Digital Video Processor with FICE. Thus, the EPX-4400/4000HD with FICE are substantially equivalent to EPX-4440HD with FICE.
Conclusions
The EPX-4400 and EPX-4400HD with FICE are substantially equivalent to similar legally marketed devices and conforms to applicable medical device safety and performance standards.