(268 days)
No
The document describes standard video processing and enhancement features, but there is no mention of AI or ML technologies. The software mentioned is for proprietary spectral and structural enhancements, which are not necessarily AI/ML.
No
The device aids in observation and diagnosis, and facilitates treatment by providing illumination and visualization, but it does not directly perform a therapeutic action or deliver a therapeutic agent.
Yes
The "Intended Use / Indications for Use" section explicitly states that the VP-4440HD unit and the XL-4450 light source are "used for endoscopic observation, diagnosis, treatment, and image recording." This directly indicates a diagnostic purpose. The description also mentions assisting in obtaining "clear visualization to facilitate diagnostic examination."
No
The device description clearly outlines three hardware components: a Video Processor, a Light Source, and a Keyboard. While the Video Processor utilizes proprietary software for image enhancement, the device as a whole is a system of interconnected hardware and software, not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device (VP-4440HD and XL-4450) is used for endoscopic observation, diagnosis, treatment, and image recording. It processes signals from a video endoscope and provides illumination and air for visualization inside the body.
- No Specimen Analysis: The device does not analyze any specimens taken from the body. It directly visualizes and processes images from within the body cavity.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices.
The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.
Product codes
FET, GCT
Device Description
This system is intended to be used in conjunction with Fujinon endoscopes to provide illumination, visual display and data storage during endoscopic procedures.
The EPX-4440HD Digital Video Processor consists of three components used in conjunction with one another:
The VP-440HD 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 also incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor also provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60MzJO.8A. The Processor is housed in a steel-polycarbonate case measuring 390X105X460mm.
The XL-4450 Light Source: The Fujinon 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 device is AC operated at a power setting of 120V/60MzJ3.3A. The Processor is housed in a steel-polycarbonate case measuring 390X155X485mm.
The DK-440E 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-4440HD Processor. The Keyboard resembles a standard computer keyboard in size and shape.
Mentions image processing
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope).
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video endoscope
Anatomical Site
Not Found
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
Non-clinical testing: The EPX-4440HD Digital Video Processor is non-sterile and has no potential for patient contact. Testing of the VP-4440HD consisted of software validation electrical safety in accordance with IEC 60601 requirements and performance testing using physician evaluators. All testing criteria were met.
Non-clinical testing of the subject device consisted of electrical testing in accordance with IEC 60601 requirements, software validation in accordance with IEC 62304 requirements and physician evaluation of the spectral enhancement capability. Functional testing consisting of visual comparison tests were conducted using physician evaluators. In all cases they passed the required testing regimens. The sponsor believes that the testing regimen demonstrates the continued safety of the subject device.
Clinical testing: NA
Key Metrics
Not Found
Predicate Device(s)
Fujinon 400 Series (K944620)
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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510(k) Summary -
Fuiinon EPX-4440 HD Digital Video Processor
MAY 25 2011
Date Prepared: May 25, 2011
Sponsor:
Fujinon, Inc. 10 High Point Drive Wavne, NJ 07474
Contact:
Gina Walljasper Director, Quality and Regulatory Compliance Tel: (973) 633-5600 Fax: (973) 633-8818 E-mail: gina walljasper@fujinon.com
Trade name: Fujinon EPX-4440HD Video Processor and Light Source
Common name: Endoscopic Video Processor and Light Source
Classification name:
- Endoscopic Video Imaging System/Component, Gastroenterology-Urology (Product Code FET) and Light Source, Endoscope, Xenon Arc (Product Code GCT)
- Both product codes are covered under 21 CFR 876.1500
- Predicate device(s): Fujinon 400 Series (K944620)
Device description:
This system is intended to be used in conjunction with Fujinon endoscopes to provide illumination, visual display and data storage during endoscopic procedures.
The EPX-4440HD Digital Video Processor consists of three components used in conjunction with one another:
The VP-440HD 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
1
preference. The Processor also incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor also provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60MzJO.8A. The Processor is housed in a steel-polycarbonate case measuring 390X105X460mm.
The XL-4450 Light Source: The Fujinon 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 device is AC operated at a power setting of 120V/60MzJ3.3A. The Processor is housed in a steel-polycarbonate case measuring 390X155X485mm.
The DK-440E 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-4440HD Processor. The Keyboard resembles a standard computer keyboard in size and shape.
Intended Use(s):
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope. light source, monitor, recorder and various peripherals.
The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, digital video processor, monitor, recorder and various peripherals.
Technological characteristics: The subject device is a modification of the current Fujinon Video Processor. Basic technological characteristics have not changed. The Video Processor, Light Source and Keyboard remain essentially unchanged from the predicate device with the exception of additional cabling connections. The processor has been updated to allow for both digital and analog outputs. Previously these outputs were analog only with no digital storage capacity. Digital storage capability can be achieved by on-site storage (internal or CF card) or off-site (Ethernet).
2
The Processor now incorporates a new connector for the 500 series of Fujinon endoscopes as well as the original series 400 scopes. The above changes were made for the purposes of user preference and general technological advancement: they were not the result of product recalls or · adverse events.
Non-clinical testing:
The EPX-4440HD Digital Video Processor is non-sterile and has no potential for patient contact. Testing of the VP-4440HD consisted of software validation electrical safety in accordance with IEC 60601 requirements and performance testing using physician evaluators. All testing criteria were met.
Non-clinical testing of the subject device consisted of electrical testing in accordance with IEC 60601 requirements, software validation in accordance with IEC 62304 requirements and physician evaluation of the spectral enhancement capability. Functional testing consisting of visual comparison tests were conducted using physician evaluators. In all cases they passed the required testing regimens. The sponsor believes that the testing regimen demonstrates the continued safety of the subject device.
Clinical testing:
NA
Conclusions:
Modifications to the predicate device consisted of:
Software additions: Allowing for either digital or analog outputs Addition of optional digital memory storage Adding an additional port for acceptance of newer generation endoscopes
Changes to the endoscopes were made for purposes of ergonomics and user, preferences. The changes were not made for reasons of product safety or adverse events.
Testing was performed to demonstrate the continued electrical safety of the device and the reliability of the software. The sponsor believes that the modified device maintains the same safety and performance levels as the previous generation processor while adding additional features for user convenience.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Fujinon, Inc. c/o Robert Schiff, Ph.D., RAC, CQA, FRAPS Regulatory Affairs Consultant Schiff & Company, Inc. 1129 Bloomfield Avenue WEST CALDWELL NJ 07006
MAY 25 2011
Re: K102466
Trade/Device Name: Fujinon EPX-4440HD Digital Processor and Light Source Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET and GCT Dated: May 19, 2011 Received: May 20, 2011
Dear Dr. Schiff:
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
4
Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Michael Lemon MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use Statement
510(k) Number (If known): K102466
EPX-4440HD Digital Video Processor and Light Source Device Name:
Indications for Use (VP-4440HD):
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, light source, monitor, recorder and various peripheral devices.
Indications for Use (XL-4450):
The XL-4450 light source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using Fujinon medical Endoscope, video processor, monitor, recorder and various peripheral devices.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102466