(28 days)
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.
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 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 provided text is a 510(k) summary for the Fujifilm Endoscope Models EC-600HL and EC-600LS. This document describes modifications to existing devices and asserts substantial equivalence to predicate devices, rather than presenting a study for a novel device to meet specific acceptance criteria for a new clinical indication. Therefore, much of the requested information (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study results, standalone performance) is not applicable or not provided in this regulatory submission for device modifications.
Here's the available information based on your request:
Acceptance Criteria and Reported Device Performance
The submission states that performance testing was conducted for the modified devices to "ensure that the modified device performs equivalently to the predicate EC-600HL and EC-600LS." The acceptance criterion for each test was that "the device met the pre-defined acceptance criteria for the test," implying equivalence to the predicate device's performance specifications.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Field of view | Met pre-defined acceptance criteria |
| Bending capability | Met pre-defined acceptance criteria |
| Rate of air supply | Met pre-defined acceptance criteria |
| Rate of water supply | Met pre-defined acceptance criteria |
| Rate of suction | Met pre-defined acceptance criteria |
| Working length | Met pre-defined acceptance criteria |
| Diameter of forceps channel | Met pre-defined acceptance criteria |
| Viewing direction | Met pre-defined acceptance criteria |
| Maximum insertion portion width | Met pre-defined acceptance criteria |
| Resolution | Met pre-defined acceptance criteria |
| LG output (Light Guide output) | Met pre-defined acceptance criteria |
(Note: The document only states that the device 'met pre-defined acceptance criteria' for each test. It does not provide the specific numerical criteria or the measured performance values. The acceptance criteria are implicitly based on the performance characteristics of the predicate device.)
Other Requested Information:
- Sample size used for the test set and the data provenance: Not explicitly stated. The performance data seems to be based on engineering and bench testing, not clinical studies with human subjects or retrospective data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for this type of engineering performance testing. Ground truth for these tests would likely be established through calibrated measurement equipment and established engineering standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of engineering performance testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This submission is for modifications to an endoscope, not an AI-powered diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the performance characteristics listed, the ground truth would typically be established through physical measurements, calibration, and engineering specifications, rather than clinical outcomes or expert consensus.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
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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
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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
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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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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.
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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
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Technological Characteristics
| Table 10-1: Comparison between technological characteristics of EC-600HL and its predicate | |
|---|---|
| Predicate Device ModelEC-600HL | Proposed Device ModelEC-600HL | ||
|---|---|---|---|
| Device Name | Fujifilm Video EndoscopeEC-600HL | Fujifilm Video EndoscopeEC-600HL | |
| 510(k) Number | K143732 | Pending | |
| Indications for Use(IFU) | This device is intended for the visualizationof the lower digestive tract, specifically forthe observation, diagnosis, andendoscopic treatment of the rectum andlarge 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 | |
| Distortioncharacteristics | Orthogonal Projection | Same as K143732 | |
| Image sensors | CMOS | Same as K143732 | |
| Distal end diameter | 12.8mm | Same as K143732 | |
| Flexible portiondiameter | 12.8mm | Same as K143732 | |
| Maximum insertiondiameter | 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 channeldiameter | 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-2Water 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 ModelEC-600HL | Proposed Device ModelEC-600HL | ||
| Accessories | Cleaning Brush WB11002FW2 | Same as K143732 | |
| Channel Cleaning BrushWB5021FW2 | 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 |
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| Predicate Device ModelEC-600LS | Proposed Device ModelEC-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 visualizationof the lower digestive tract, specifically forthe observation, diagnosis, and endoscopictreatment 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 | |
| Distortioncharacteristics | Orthogonal Projection | Same as K143732 | |
| Image sensors | CMOS | Same as K143732 | |
| Distal end diameter | 11.5mm | Same as K143732 | |
| Flexible portiondiameter | 11.5mm | Same as K143732 | |
| Maximum insertiondiameter | 13.1mm | Same as K143732 | |
| Bendingcapability | 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 channeldiameter | 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-4440HDLight Source: XL-4450Processor:VP-4440HD | Same as K143732 | |
| Water Tank WT-2Water 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
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| Predicate Device ModelEC-600HL | Proposed Device ModelEC-600HL | |
|---|---|---|
| Accessories | Cleaning brush WB11002FW2 | Same as K143732 |
| Cleaning brush WB11002FW2 | Same as K143732 | |
| Channel Cleaning BrushWB5021FW2 | 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 capAir 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.
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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.
§ 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.