(98 days)
Not Found
No
The summary describes a digital video processor and light source for endoscopy/laparoscopy with image processing capabilities (FICE), but there is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML algorithms, or specific AI/ML functionalities. The performance studies focus on compliance with standards and equivalence to a predicate device, not AI/ML performance.
No
The device is described as a "Digital Video Processor with Light Source" used for observation, diagnosis, and image recording during endoscopic/laparoscopic procedures. Its primary function is to process electronic signals and relay images, and it is not explicitly stated to provide any therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used for "diagnosis".
No
The device description explicitly lists hardware components: a Video Processor with Data Keyboard and a Light Source. While it includes software for image processing (FICE), it is not solely software.
Based on the provided information, the EPX-4440FN Digital Video Processor with Light Source is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The EPX-4440FN is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It processes signals from a video endoscope or laparoscope, which are devices inserted directly into the body to visualize internal structures.
- No Sample Analysis: The description does not mention the device analyzing any samples taken from the body. Its function is to process and display images obtained within the body.
Therefore, the EPX-4440FN falls under the category of an endoscopic/laparoscopic imaging and processing system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EPX-4440FN Digital Video Processor with Light Source is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope or laparoscope (a video camera in an endoscope or laparoscope). This product may be used on all patients requiring endoscopic examination or laparoscopic surgical procedures and when using a FUJIFILM medical endoscope or laparoscope, light source, monitor, recorder and various peripheral devices, FICE (Flexible spectral-Imaging Color Enhancement) 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, PEA
Device Description
The EPX-4440FN Digital Video Processor with Light Source is comprised of:
- VP-4440FN Video Processor with DK-4440E Data Keyboard
- XL-4450FN Light Source
The EPX-4440FN Digital Video Processor with Light Source consists of the VP-4440FN Video Processor and the XL-4450FN Light Source. The VP-4440FN Video Processor relays the image from a laparoscope or endoscope to a video monitor. The processor also controls the light projected to the body cavity. The XL-4450FN Light Source employs a Xenon lamp with an emergency back-up Halogen lamp. Brightness control is performed by the user.
Mentions image processing
Yes, "process electronic signals transmitted from a video endoscope or laparoscope" and "The VP-4440FN Video Processor relays the image from a laparoscope or endoscope to a video monitor." Also, "FICE (Flexible spectral-Imaging Color Enhancement) is an adjunctive tool for gastrointestinal endoscopic examination".
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic imaging, Laparoscopic imaging
Anatomical Site
Gastrointestinal (for FICE), general anatomy for endoscopic/laparoscopic observation.
Indicated Patient Age Range
All patients
Intended User / Care Setting
Healthcare professionals
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)
Bench testing was conducted in order to demonstrate compliance with recognized consensus standards:
- ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007: Medical electrical equipment-Part 1-2: General requirements ● for basic safety and essential performance-Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment-Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- ISO 14971:2007, Medical Device Risk Management-Part 1: Application of risk . management to medical devices
- IEC 62471: 2006 Photobiological safety of lamps and lamp systems ●
- AAMI ANSI IEC 62304:2006 Medical device software. Software lifecycle processes. ●
Additionally, performance testing showed that the EPX-4440FN Digital Video Processor with Light Source met all the acceptance criteria.
The conclusions drawn from the non-clinical testing demonstrate that the device is as safe and effective as the legally marketed predicate device.
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/0 description: The image shows 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 consists of 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 24, 2018
FUJIFILM New Development U.S.A., Inc. % Maureen O'Connell President O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, Massachusetts 01864
K180414 Re:
Trade/Device Name: EPX-4440FN Digital Video Processor with Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FET, GCT, PEA Dated: April 9, 2018 Received: April 10, 2018
Dear Maureen O'Connell:
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 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);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known) K180414
Device Name
EPX-4440FN Digital Video Processor with Light Source
Indications for Use (Describe)
The EPX-4440FN Digital Video Processor with Light Source is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope or laparoscope (a video camera in an endoscope or laparoscope). This product may be used on all patients requiring endoscopic examination or laparoscopic surgical procedures and when using a FUJIFILM medical endoscope or laparoscope, light source, monitor, recorder and various peripheral devise. FICE (Flexible spectral-Imaging Color Enhancement) is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathologic sampling as a means of diagnosis.
X 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 New Development U.S.A. Inc. EPX-4440FN Digital Video Processor with Light Source
510(k) Owner
FUJIFILM New Development U.S.A, Inc. 318 Bear Hill Road Waltham, MA 02451 781-860-2463 Phone: Contact Person: Stephen Mariano
Submission Correspondent:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 978-207-1245 Phone:
Date Prepared: February 9, 2018
Trade Name of Device
EPX-4440FN Digital Video Processor with Light Source
Common or Usual Name
Video Processor and Light Source
Regulation Name
Endoscope and Accessories; 21 C.F.R. 876.1500 Class II Product Code: FET, GCT and PEA
Predicate Devices
FUJIFILM New Development U.S.A., Inc. FUJIFILM Surgical System (K162836)
FUJIFILM Corp. EPX-4440HD Digital Video Processor with FICE and Light Source (K140149)
Device Description
The EPX-4440FN Digital Video Processor with Light Source is comprised of:
- o VP-4440FN Video Processor with DK-4440E Data Keyboard
- o XL-4450FN Light Source
The EPX-4440FN Digital Video Processor with Light Source consists of the VP-4440FN Video Processor and the XL-4450FN Light Source. The VP-4440FN Video Processor relays
4
the image from a laparoscope or endoscope to a video monitor. The processor also controls the light projected to the body cavity. The XL-4450FN Light Source employs a Xenon lamp with an emergency back-up Halogen lamp. Brightness control is performed by the user.
Intended Use / Indications for Use
The EPX-4440FN Digital Video Processor with Light Source is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope or laparoscope (a video camera in an endoscope or laparoscope). This product may be used on all patients requiring endoscopic examination or laparoscopic surgical procedures and when using a FUJIFILM medical endoscope or laparoscope, light source, monitor, recorder and various peripheral devices, FICE (Flexible spectral-Imaging Color Enhancement) 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.
Substantial Equivalence
The EPX-4440FN Digital Video Processor with Light Source is substantially equivalent to the FUJIFILM New Development U.S.A., Inc. FUJIFILM Surgical System cleared in K162836 and FujiFilm's EPX-4440 HD Digital Video Processor with FICE and Light Source cleared in K140149 ("the predicate devices"). The intended use of the EPX-4440FN Digital Video Processor with Light Source is for endoscopic or laparoscopic observation, diagnosis, treatment and image recording. The FUJIFILM Surgical System is intended for use in laparoscopic observation, diagnosis, and treatment while the FUJIFILM EPX-4440 HD Digital Video Processor with FICE and Light Source is intended for use in endoscopic observation, diagnosis, treatment, and image processing. All of these devices are prescription devices used by healthcare professionals.
The devices have the same technological characteristics. The EPX-4440FN Digital Video Processor with Light Source is comprised of the VP-4440FN Video Processor, XL-4450FN Light Source and DK-4440E Data Keyboard which are the same components included in the FUJIFILM Surgical System cleared in K162836. The system cleared in K162836 also included a laparoscope while this system is for use with both a laparoscope or an endoscope. The FUJIFILM EPX-4440 HD Digital Video Processor with FICE and Light Source is comprised of the VP-4440 HD Video Processor, the XL-4450 Light Source and the DK-4440E Data Keyboard.
The VP-4440FN Digital Video Processor with XL-4450FN Light Source has the same technological characteristics as the EPX-4440 HD Digital Processor with FICE and Light Source also made by FUJIFILM and cleared in K140149 for use with an endoscope. Both systems have a Xenon lamp as the main lamp with a Halogen lamp as the emergency lamp. All technical specifications relevant to the indications for use of the subject device and predicate device are identical.
Therefore, based on the devices having the same intended use and the same technological characteristics the EPX-4440FN Digital Video Processor with Light Source is substantially equivalent to the predicate devices.
5
Performance Data
Bench testing was conducted in order to demonstrate compliance with recognized consensus standards:
- . ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007: Medical electrical equipment-Part 1-2: General requirements ● for basic safety and essential performance-Collateral standard: Electromagnetic compatibility -Requirements and tests
- . IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment-Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- ISO 14971:2007, Medical Device Risk Management-Part 1: Application of risk . management to medical devices
- IEC 62471: 2006 Photobiological safety of lamps and lamp systems ●
- AAMI ANSI IEC 62304:2006 Medical device software. Software lifecycle processes. ●
Additionally, performance testing showed that the EPX-4440FN Digital Video Processor with Light Source met all the acceptance criteria.
The conclusions drawn from the non-clinical testing demonstrate that the device is as safe and effective as the legally marketed predicate device.