(28 days)
No
The device description focuses on the physical components and basic functions of an endoscope (light, image capture, channels for tools). There is no mention of any software or processing capabilities that would suggest AI/ML is used for image analysis, diagnosis, or any other function. The performance studies listed are also focused on basic physical and optical parameters, not algorithmic performance.
Yes.
The device is intended for "endoscopic treatment of the rectum and large intestine," which indicates a therapeutic purpose in addition to observation and diagnosis.
Yes
The Intended Use/Indications for Use section explicitly states that the device is intended for "diagnosis."
No
The device description clearly outlines physical components like an operation section, insertion portion with fiber bundles, CMOS sensor, channels, and an umbilicus, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body. The intended use of this device is for the visualization and treatment of the lower digestive tract within the body.
- The device description focuses on the physical components and functions for internal examination and intervention. It describes light transmission, image capture, and channels for air/water, suction, and accessories like biopsy forceps. These are all related to direct interaction with the internal anatomy.
- There is no mention of analyzing biological samples or performing tests on specimens. The device is used for direct observation and treatment, not for laboratory analysis of bodily fluids or tissues.
Therefore, this device falls under the category of an endoscope used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Product codes
FDF
Device Description
The modified Fujifilm Endoscope Models EC-600HL and EC-600LS are comprised of three main sections: an operation section, an insertion portion, and an umbilicus. The Table 5-1 describes the insertion and non-insertion portions of the devices. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains class fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water and provide suction, as well as a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The Figure 10-1 below shows main components of the endoscopes.
The subject device is used in combination with FUJIFILM's video processor, light source and peripheral devices such as water tank, endoscope accessories, monitor, printer, electrosurgical instruments, foot switch, and cart. All of these were previously cleared in K143732.
Mentions image processing
This provides enough light to the CMOS image sensor to capture an image and display it on the monitor.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
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
Fujifilm conducted the following performance testing of the modified EC-600HL and EC-600LS to ensure that the modified device performs equivalently to the predicate EC-600HL and EC-600LS:
- Field of view .
- Bending capability .
- Rate of air supply .
- Rate of water supply .
- . Rate of suction
- . Working length
- . Diameter of forceps channel
- . Viewing direction
- Maximum insertion portion width .
- Resolution ●
- . LG output
In all cases, the device met the pre-defined acceptance criteria for the test.
Key Metrics
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
Fujifilm Medical Systems USA, Inc. Shraddha Morc Specialist, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, New Jerscy 07470
Re: K162622
Trade/Device Name: Fujifilm Endoscope Models EC-600HL and EC-600LS Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDF Dated: September 19, 2016 Received: September 20, 2016
Dear Shraddha Morc:
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, labcling, 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 mislcading.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Shraddha Morc
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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/Resourcesfor You/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/McdicalDcvices/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/Industrv/default.htm.
Sinccrely,
For Division
Douglas Silverstein -S 2016.10.18 13:53:51 -04'00'
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) K162622
Device Name
Fujifilm Endoscope Models EC-600HL and EC-600LS
Indications for Use (Describe)
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
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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3
510(k) SUMMARY
Fujifilm's EC-600HL and EC-600LS
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 Person:
Shraddha More Specialist, Regulatory Affairs and Quality Assurance Telephone: (973) 686-2627 Ext. 522627 Facsimile: (973) 633-8818 E-Mail: smore@fujifilm.com
Date Prepared: January 27, 2017
ldentification of the Subject Device:
| Proprietary/Trade Name: | Fujifilm Endoscope Models EC-600HL and EC-600LS |
|---|---|
| Common Name: | Video Endoscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Classification Information:
Colonoscope and Accessories (Flexible/Rigid), 21 C.F.R. § 876.1500 Product Code: FDF
Primary Predicate
Fujifilm Endoscope Models EC-600HL and EC-600LS (K143732)
Purpose of the Special 510(k) notice
The EC-600HL and EC-600LS are modifications of predicate EC-600HL and EC-600LS respectively
Intended Use
This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
4
Device Description
The modified Fujifilm Endoscope Models EC-600HL and EC-600LS are comprised of three main sections: an operation section, an insertion portion, and an umbilicus. The Table 5-1 describes the insertion and non-insertion portions of the devices. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains class fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water and provide suction, as well as a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The Figure 10-1 below shows main components of the endoscopes.
The subject device is used in combination with FUJIFILM's video processor, light source and peripheral devices such as water tank, endoscope accessories, monitor, printer, electrosurgical instruments, foot switch, and cart. All of these were previously cleared in K143732.
Image /page/4/Figure/4 description: The image shows a diagram of a system with various components and labels. The diagram includes pipes, valves, and other mechanical parts, all interconnected. The labels provide information about the function and purpose of each component within the system. The diagram appears to be technical in nature, possibly related to engineering or mechanics.
Figure 10-1: Components of the Endoscope EC-600HL and EC-600LS
5
Technological Characteristics
| Table 10-1: Comparison between technological characteristics of EC-600HL and its predicate | |
|---|---|
| | | Predicate Device Model
EC-600HL | Proposed Device Model
EC-600HL |
|-------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Device Name | | Fujifilm Video Endoscope
EC-600HL | Fujifilm Video Endoscope
EC-600HL |
| 510(k) Number | | K143732 | Pending |
| Indications for Use
(IFU) | | This device is intended for the visualization
of the lower digestive tract, specifically for
the observation, diagnosis, and
endoscopic treatment of the rectum and
large intestine. | Same as K143732 |
| Viewing direction | | Forward/ 0 degree | Same as K143732 |
| Observation range | | 2-100mm | Same as K143732 |
| Field of View | | 170 degrees | Same as K143732 |
| Distortion
characteristics | | Orthogonal Projection | Same as K143732 |
| Image sensors | | CMOS | Same as K143732 |
| Distal end diameter | | 12.8mm | Same as K143732 |
| Flexible portion
diameter | | 12.8mm | Same as K143732 |
| Maximum insertion
diameter | | 14.3mm | Same as K143732 |
| | Up | 180 degrees | Same as K143732 |
| Bending | Down | 180 degrees | Same as K143732 |
| capability | Left | 160 degrees | Same as K143732 |
| | Right | 160 degrees | Same as K143732 |
| Forceps channel
diameter | | 4.2mm | Same as K143732 |
| Working length | | 1690mm | Same as K143732 |
| Total length | | 1990mm | Same as K143732 |
| WJ Function | | c | Same as K143732 |
| Location of WJ inlet | | On the light guide connector | Same as K143732 |
| Video Processor | | EPX-4440HD
- Light Source:XL-4450
- Processor:VP-4440HD | Same as K143732 |
| Peripherals | | Water Tank WT-2
Water Tank, WT-4 | Same as K143732 |
| | | Endoscopic Accessory(i.e. Forceps) | Same as K143732 |
| | | Monitor | Same as K143732 |
| | | Printer | Same as K143732 |
| | | None | Same as K143732 |
| | | Electrosurgical Instruments | Same as K143732 |
| | | Foot Switch | Same as K143732 |
| | | Cart | Same as K143732 |
| | Predicate Device Model
EC-600HL | Proposed Device Model
EC-600HL | |
| Accessories | Cleaning Brush WB11002FW2 | Same as K143732 | |
| | Channel Cleaning Brush
WB5021FW2 | Same as K143732 | |
| | Forceps Valve
(FOV-DV7) | Same as K143732 | |
| | Ventilation Adapter
(AD-7) | Same as K143732 | |
| | Cleaning Adapter Kit (CA-510/A)
Image: Cleaning Adapter Kit | Same as K143732 | |
| | J Tube (JT-500)
Image: J Tube | Same as K143732 | |
| | Air/Water button
(AW-500) | Minor material and design modifications | |
| | Suction button (SB-500) | Minor material and design modifications | |
| Optional items | Water Jet Inlet cap | Same as K143732 | |
| | Air leak tester LT-7F | Same as K143732 | |
6
7
| | | Predicate Device Model
EC-600LS | Proposed Device Model
EC-600LS |
|-------------------------------|-------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Device Name | | Fujifilm Video Endoscope | Fujifilm Video Endoscope |
| | | EC-600LS | EC-600LS |
| 510(k) Number | | K143732 | Pending |
| Indications for Use
(IFU) | | This device is intended for the visualization
of the lower digestive tract, specifically for
the observation, diagnosis, and endoscopic
treatment of the rectum and large intestine. | Same as K143732 |
| Viewing direction | | Forward/ 0 degree | Same as K143732 |
| Observation range | | 2-100mm | Same as K143732 |
| Field of View | | 170 degrees | Same as K143732 |
| Distortion
characteristics | | Orthogonal Projection | Same as K143732 |
| Image sensors | | CMOS | Same as K143732 |
| Distal end diameter | | 11.5mm | Same as K143732 |
| Flexible portion
diameter | | 11.5mm | Same as K143732 |
| Maximum insertion
diameter | | 13.1mm | Same as K143732 |
| Bending
capability | Up | 180 degrees | Same as K143732 |
| | Down | 180 degrees | Same as K143732 |
| | Left | 160 degrees | Same as K143732 |
| | Right | 160 degrees | Same as K143732 |
| Forceps channel
diameter | | 3.8mm | Same as K143732 |
| Working length | | 1690mm | Same as K143732 |
| Total length | | 1990mm | Same as K143732 |
| WJ Function | | Yes | Same as K143732 |
| Location of WJ inlet | | On the light guide connector | Same as K143732 |
| Video Processor | | EPX-4440HD
Light Source: XL-4450
Processor:VP-4440HD | Same as K143732 |
| | | Water Tank WT-2
Water Tank, WT-4 | Same as K143732 |
| | | Endoscopic Accessory(i.e. Forceps) | Same as K143732 |
| Peripherals | | Monitor | Same as K143732 |
| | | Printer | Same as K143732 |
| | | None | Same as K143732 |
| | | Electrosurgical Instruments | Same as K143732 |
| | | Foot Switch | Same as K143732 |
| | | Cart | Same as K143732 |
Table 10-2: Comparison between technological characteristics of EC-600LS and its predicate
8
| | Predicate Device Model
EC-600HL | Proposed Device Model
EC-600HL |
|----------------|------------------------------------------------------------------|-----------------------------------------|
| Accessories | Cleaning brush WB11002FW2 | Same as K143732 |
| | Cleaning brush WB11002FW2 | Same as K143732 |
| | Channel Cleaning Brush
WB5021FW2 | Same as K143732 |
| | Cleaning Adapter Kit (CA-510/A)
Image: [Cleaning Adapter Kit] | Same as K143732 |
| | Forceps Valve
(FOV-DV7)
Ventilation Adapter
(AD-7) | Same as K143732 |
| | J Tube (JT-500)
Image: [J Tube] | Same as K143732 |
| Optional items | Air/Water button
(AW-500) | Minor material and design modifications |
| | Suction button (SB-500) | Minor material and design modifications |
| | Water Jet Inlet cap
Air leak tester LT-7F | Same as K143732 |
Principles of Operation
The principles of operation of the FUJIFILM Endoscope Models EC-600HL and EC-600LS are identical to those of the predicate device, FUJIFILM 600 Series Endoscope EC-600HL and EC-600LS (K132210). All three devices utilize a retrograde approach for visualization of the areas of the lower digestive tracts.
9
Summary of the Design Modifications
The proposed devices have been modified from their corresponding predicate devices in their materials. A new epoxy resin will be used in modified devices instead of the current epoxy resin during their manufacturing. Both epoxy resins will be used for the repair of predicate as well as subject devices.
This material change does not affect the intended use or fundamental scientific technology of the proposed endoscopes; therefore the intended use and fundamental scientific technology of the proposed endoscopes remain the same as the legally marketed EC-600HL and EC-600LS (K143732). See Table 10-1 and Table 10-2 for a detailed similarities and differences comparison between the technological characteristics of proposed device and the legally marketed device.
Performance Data
Fujifilm conducted the following performance testing of the modified EC-600HL and EC-600LS to ensure that the modified device performs equivalently to the predicate EC-600HL and EC-600LS:
- Field of view .
- Bending capability .
- Rate of air supply .
- Rate of water supply .
- . Rate of suction
- . Working length
- . Diameter of forceps channel
- . Viewing direction
- Maximum insertion portion width .
- Resolution ●
- . LG output
In all cases, the device met the pre-defined acceptance criteria for the test.
Substantial Equivalence
EC-600HL and EC-600LS has the same intended use and similar indications, principles of operation, and technological characteristics as their predicate devices EC-600HL and EC-600LS. The minor differences in the modified devices technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the EC-600HL and EC-600LS are as safe and effective as their predicate devices EC-600HL and EC-600LS respectively. Thus, the modified EC-600HL and EC-600LS are substantially equivalent to their respective predicate devices.