(29 days)
These devices are intended for the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM Endoscope Models EC-600HL and EC-600LS are lower gastrointestinal endoscopes that capture images when used in combination with a video processor and light source. Light travels from the light source, through the glass fiber bundles in the endoscopes, and out 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.
This document describes the 510(k) premarket notification for the FUJIFILM Endoscope Models EC-600HL and EC-600LS. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K162622). As such, the study performed is a performance testing of the device itself rather than a study on an AI algorithm. Therefore, many of the typical questions for AI/ML study design (e.g., sample size for test/training sets, data provenance, ground truth establishment, MRMC studies) are not applicable in this context.
Here's an analysis of the provided information concerning the device's performance and acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "In all cases, the devices met the pre-defined acceptance criteria for the test." However, the exact quantitative acceptance criteria for each test are not explicitly provided in the submitted text. The performance data section lists the parameters tested, but not the specific thresholds for acceptance.
| Performance Parameter | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Field of view | Not explicitly stated | Met pre-defined acceptance criteria |
| Bending capability | Not explicitly stated | Met pre-defined acceptance criteria |
| Air supply rate | Not explicitly stated | Met pre-defined acceptance criteria |
| Water supply rate | Not explicitly stated | Met pre-defined acceptance criteria |
| Suction rate | Not explicitly stated | Met pre-defined acceptance criteria |
| Working length | Not explicitly stated | Met pre-defined acceptance criteria |
| Forceps channel diameter | Not explicitly stated | Met pre-defined acceptance criteria |
| Viewing direction | Not explicitly stated | Met pre-defined acceptance criteria |
| Resolution | Not explicitly stated | Met pre-defined acceptance criteria |
| LG output (Light Guide output) | Not explicitly stated | Met pre-defined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
This is a physical device performance test rather than an AI/ML algorithm evaluation. The document does not specify the sample size of devices used for testing. It also does not specify data provenance as it's not a data-driven AI study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The performance testing is for physical device characteristics, not for diagnostic accuracy requiring expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as this is not an AI/ML study requiring expert adjudication of results.
5. 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
No. This is a performance evaluation of a physical endoscope, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This approval is for an endoscope as a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" here would be the physical and functional specifications of the endoscope. For example, for "Field of view," the ground truth would be the expected angular range, and the device's measurement would need to fall within the accepted tolerance of that specification. The document implies these are established engineering specifications rather than clinical ground truth (e.g., pathology).
8. The sample size for the training set
Not applicable. There is no AI model or training set involved in this device approval.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved. The ground truth for this device's performance would be engineering and design specifications.
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March 15, 2018
FUJIFILM Corporation % Jeffrey Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470
Re: K180405
Trade/Device Name: FUJIFILM Endoscope Models EC-600HL and EC-600LS Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: February 5, 2018 Received: February 14, 2018
Dear Jeffrey Wan:
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.
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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); 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,
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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
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VI. INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known) K180405
Device Name
FUJIFILM Endoscope Models EC-600HL and EC-600LS
Indications for Use (Describe)
These devices are intended for 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)
区Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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VII. 510(K) SUMMARY
510(k) SUMMARY
FUJIFILM Endoscope Models EC-600HL and EC-600LS
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Jeffrey Wan Specialist, Regulatory Affairs Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division Telephone: (973) 709-2219 Facsimile: (201) 995-2452 E-Mail: jeffrey.wan@fujifilm.com
Date Prepared: February 5, 2018
Identification of the Proposed 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: | Endoscope and accessories, 21 C.F.R. § 876.1500 |
| Product Code: | FDF |
Predicate Device:
Fujifilm Endoscope Models EC-600HL and EC-600LS, Fujifilm Medical Systems U.S.A, K162622
Intended Use / Indications for Use:
These devices are 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:
FUJIFILM Endoscope Models EC-600HL and EC-600LS are lower gastrointestinal endoscopes that capture images when used in combination with a video processor and light source. Light travels from the light source, through the glass fiber bundles in the endoscopes, and out 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.
Technological Characteristics:
A comparison of the technological characteristics between the modified and predicate devices is provided in the table below.
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Device name | EC-600HL | EC-600HL | |
| Common name | Endoscope and accessories | Endoscope and accessories | |
| Manufacturer | FUJIFILM Corporation | FUJIFILM Corporation | |
| 510(k) number | To be assigned | K162622 | |
| Intended | The device is intended for the visualization of the lower | ||
| Use/Indications | Same as K162622 | digestive tract, specifically for the observation, diagnosis, and | |
| for Use | endoscopic treatment of the rectum and large intestine. | ||
| Appearance | Same as K162622 | Image: Endoscope | |
| Viewing direction | Same as K162622 | Forward / 0 degrees | |
| Observationrange | Same as K162622 | 2-100mm | |
| Field of view | Same as K162622 | 170 degrees | |
| F# of the objectivelens | Same as K162622 | 7 | |
| Resolution | Same as K162622 | At 5mm of working distance: 0.056mm of line pair on thesquare wave chart is readable.At 100mm of working distance: 1.25mm of line pair on thesquare wave chart is readable. | |
| Distortioncharacteristics | Same as K162622 | Orthogonal Projection | |
| Magnification oflens(es) | Same as K162622 | 0.3-0.01 | |
| Focal length | Same as K162622 | 0.9mm | |
| Image sensors | Same as K162622 | CMOS | |
| # of Light GuideFiber Bundles | Same as K162622 | 2800 | |
| Proposed Device | Predicate Device | ||
| Distal end diameter | Same as K162622 | 12.8mm | |
| Flexible portion diameter | Same as K162622 | 12.8mm | |
| Maximum insertion diameter | Same as K162622 | 14.3mm | |
| Bending capability | Up | Same as K162622 | 180 degrees |
| Down | Same as K162622 | 180 degrees | |
| Left | Same as K162622 | 160 degrees | |
| Right | Same as K162622 | 160 degrees | |
| Forceps channel diameter | Same as K162622 | 4.2mm | |
| Working length | Same as K162622 | 1690mm | |
| Total length | Same as K162622 | 1990mm | |
| WJ Function | Same as K162622 | available | |
| Location of WJ inlet | Same as K162622 | On the light guide connector | |
| Light source: BL-7000Processor: VP-7000 | |||
| Video Processor | EPX-4440HDLight source: XL-4450Processor: VP-4440HDEPX-4440FNLight source: XL-4450FNProcessor: VP-4440FN | EPX-4440HDLight source: XL-4450Processor: VP-4440HD | |
| Video/Light guide connector | Same as K162622 | 500 Series | |
| Peripherals | Same as K162622 | Water Tank WT-2Water Tank WT-4Endoscopic Accessory (i.e. Forceps)MonitorPrinterElectrosurgical InstrumentsFoot SwitchCart | |
| Accessories | Same as K162622 | Cleaning Brush (WB11002FW2)Cleaning Brush (WB5021FW2)Cleaning Adapter Kit (CA-510/A)Forceps Valve (FOV-DV7)Ventilation Adapter (AD-7)J Tube (JT-500)Air/Water button (AW-500)Suction button (SB-500)Water Jet Inlet cap | |
| Optional Items | Same as K162622 | Air leak tester LT-7F | |
| Electrical Safety Compliance | ANSI AAMI ES 60601-1Edition 3.1 | ANSI AAMI ES 60601-1 Edition 3.0 | |
| Proposed Device | Predicate Device | ||
| Device name | EC-600LS | EC-600LS | |
| Common name | Endoscope and accessories | Endoscope and accessories | |
| Manufacturer | FUJIFILM Corporation | FUJIFILM Corporation | |
| 510(k) number | To be assigned | K162622 | |
| IntendedUse/Indicationsfor Use | Same as K162622 | The device is intended for the visualization of the lowerdigestive tract, specifically for the observation, diagnosis, andendoscopic treatment of the rectum and large intestine. | |
| Appearance | Same as K162622 | Image: Endoscope | |
| Viewing direction | Same as K162622 | Forward / 0 degrees | |
| Observationrange | Same as K162622 | 2-100mm | |
| Field of view | Same as K162622 | 170 degrees | |
| F# of the objectivelens | Same as K162622 | 7 | |
| Resolution | Same as K162622 | At 5mm of working distance: 0.056mm of line pair on thesquare wave chart is readable.At 100mm of working distance: 1.25mm of line pair on thesquare wave chart is readable. | |
| Distortioncharacteristics | Same as K162622 | Orthogonal Projection | |
| Magnification oflens(es) | Same as K162622 | 0.3-0.01 | |
| Focal length | Same as K162622 | 0.9mm | |
| Image sensors | Same as K162622 | CMOS | |
| # of Light GuideFiber Bundles | Same as K162622 | 2800 | |
| Distal enddiameter | Same as K162622 | 11.5mm | |
| Flexible portiondiameter | Same as K162622 | 11.5mm | |
| Maximuminsertion diameter | Same as K162622 | 13.1mm | |
| Up | Same as K162622 | 180 degrees | |
| Bendingcapability | Down | Same as K162622 | 180 degrees |
| Left | Same as K162622 | 160 degrees | |
| Right | Same as K162622 | 160 degrees | |
| Forceps channeldiameter | Same as K162622 | 3.8mm | |
| Working length | Same as K162622 | 1690mm | |
| Total length | Same as K162622 | 1990mm | |
| WJ Function | Same as K162622 | available | |
| Location of WJ inlet | Same as K162622 | On the light guide connector | |
| Video Processor | Light source: BL-7000Processor: VP-7000EPX-4440HDLight source: XL-4450Processor: VP-4440HDEPX-4440FNLight source: XL-4450FNProcessor: VP-4440FN | EPX-4440HDLight source: XL-4450Processor: VP-4440HD | |
| Video/Light guide connector | Same as K162622 | 500 Series | |
| Peripherals | Same as K162622 | Water Tank WT-2Water Tank WT-4Endoscopic Accessory (i.e. Forceps)MonitorPrinterElectrosurgical InstrumentsFoot SwitchCart | |
| Accessories | Same as K162622 | Cleaning Brush (WB11002FW2)Cleaning Brush (WB5021FW2)Cleaning Adapter Kit (CA-510/A)Forceps Valve (FOV-DV7)Ventilation Adapter (AD-7)J Tube (JT-500)Air/Water button (AW-500)Suction button (SB-500)Water Jet Inlet cap | |
| Optional Items | Same as K162622 | Air leak tester LT-7F | |
| Electrical Safety Compliance | ANSI AAMI ES 60601-1 Edition 3.1 | ANSI AAMI ES 60601-1 Edition 3.0 |
Table 7.1 - Comparison Chart for EC-600HL
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Table 7.2 – Comparison Chart for EC-600LS
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Performance Data:
Fujifilm conducted the following performance testing on the proposed devices EC-600HL and EC-600LS to ensure that the modified devices perform equivalently to the predicate devices:
- Field of view .
- Bending capability ●
- Air supply rate .
- Water supply rate .
- Suction rate ●
- Working length ●
- Forceps channel diameter .
- . Viewing direction
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- Resolution ●
- . LG output
In all cases, the devices met the pre-defined acceptance criteria for the test.
Substantial Equivalence:
The company's EC-600HL and EC-600LS has the same intended use, indications for use, technological characteristics, and principles of operation as the previously cleared predicate EC-600HL and EC-600LS (K162622). The minor differences between the proposed devices and their predicate devices do not raise new or additional questions of safety or effectiveness of the proposed devices. Thus, the proposed devices EC-600HL and EC-600LS are substantially equivalent to their predicate devices.
Conclusions:
The modified EC-600HL and EC-600LS are substantially equivalent to the predicate EC-600HL and EC-600LS and conform to applicable medical device safety and performance standards.
§ 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.