K143732 · Fujifilm Medical Systems U.S.A, Inc. · FDF · Jul 6, 2015 · Gastroenterology, Urology
Device Facts
Record ID
K143732
Device Name
FUJIFILM Endoscope Models EC-600HL and EC-600LS
Applicant
Fujifilm Medical Systems U.S.A, Inc.
Product Code
FDF · Gastroenterology, Urology
Decision Date
Jul 6, 2015
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The FUJIFILM Endoscope Models EC-600HL and EC-600LS are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Device Story
Flexible video endoscopes (EC-600HL, EC-600LS) designed for lower GI tract visualization. Input: optical images captured via distal CMOS sensor; illumination provided by fiber optic bundles connected to external light source. Operation: physician-controlled angulation of distal tip; insertion into rectum/large intestine. Output: real-time video feed displayed on external monitor via video processor. Forceps channel allows introduction of accessories (e.g., biopsy forceps) for diagnostic/therapeutic procedures. Used in clinical settings by trained physicians. Benefits: enables minimally invasive observation and treatment of colorectal pathology. System integrates with existing FUJIFILM video processors, light sources, and peripheral accessories.
Clinical Evidence
Bench testing only. Evaluated per ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, ISO 10993-1/5/10, AAMI TIR30/TIR12, ISO 11135-1, ISO 17665-1, and ISO 8600-1/3/4. No clinical data provided.
Technological Characteristics
Flexible video endoscope with CMOS image sensor, glass fiber illumination, and working channels. Materials evaluated per ISO 10993. Connectivity: proprietary interface to FUJIFILM video processor/light source. Sterilization: validated per ISO 11135-1 and ISO 17665-1. Field of view: 170°. Distal diameter: 12.8mm (EC-600HL) and 11.5mm (EC-600LS).
Indications for Use
Indicated for visualization of the lower digestive tract, including observation, diagnosis, and endoscopic treatment of the rectum and large intestine in patients requiring colonoscopy.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2015
Fujifilm Medical Systems U.S.A., Inc. Mary Moore Senior Director, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470
K143732 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: May 29, 2015 Received: May 29, 2015
Dear Mary Moore,
Re:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 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/ResourcesforYou/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/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 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/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -
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
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# Indications for Use
510(k) Number (if known) K143732
Device Name
FUJIFILM Endoscope Models EC-600HL and EC-600LS
Indications for Use (Describe)
The FUJIFILM Endoscope Models EC-600HL and EC-600LS are 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)
| <span style="font-size:12pt"> <span style="font-family:Symbol"> </span> </span> 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 Medical Systems U.S.A., Inc.'s FUJIFILM Endoscope Models EC-600HL and EC-600LS
Date: May 29, 2015
#### 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:
Mary K. Moore Senior Director, Regulatory Affairs and Quality Assurance Telephone: (973) 686-2498 Facsimile: (973) 686-2616 E-Mail: mkmoore@fujifilm.com
#### 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 CFR 876.1500 Product Code: FDF
#### Predicate Device
- FUJIFILM 600 Series Endoscope EC-600WL (K132210)
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# Intended Use / Indications for Use
The FUJIFILM Endoscope Models EC-600HL and EC-600LS are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
# Technological Characteristics
The 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 controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor. The qlass 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 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 K132210.
A comparison of the technological characteristics between the subject and predicate devices is provided in the table below.
| Device Description | EC-600WL<br>(Predicate Device) | EC-600HL<br>(Subject Device) | EC-600LS<br>(Subject Device) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | This device is intended for<br>the visualization of the lower<br>digestive tract, specifically<br>for the observation,<br>diagnosis, and endoscopic<br>treatment of the rectum and<br>large intestine. | This device is intended for<br>the visualization of the<br>lower digestive tract,<br>specifically for the<br>observation, diagnosis,<br>and endoscopic treatment<br>of the rectum and large<br>intestine. | This device is intended for<br>the visualization of the<br>lower digestive tract,<br>specifically for the<br>observation, diagnosis,<br>and endoscopic treatment<br>of the rectum and large<br>intestine. |
| Insertion route | Retrograde | Retrograde | Retrograde |
| Viewing direction | Forward/ 0 degree | Forward/ 0 degree | Forward/ 0 degree |
| Observation range | 2-100 nm | 2-100 nm | 2-100 nm |
| Field of view | 140 degrees | 170 degrees | 170 degrees |
| Distal end diameter | 12.0 millimeters | 12.8 millimeters | 11.5 millimeters |
| Flexible portion diameter | 12.0 millimeters | 12.8 millimeters | 11.5 millimeters |
| Maximum diameter of insertion<br>portion | 13.2 millimeters | 14.3 millimeters | 13. 1 millimeters |
| Forceps channel diameter | 3.8 millimeters | 4.2 millimeters | Same as predicate |
| Working length | 1690 millimeters | Same as predicate | Same as predicate |
| Total length | 1990 millimeters | Same as predicate | Same as predicate |
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| Processors and light sources | EPX-4440HD video<br>processor systems (VP-<br>4440HD Video Processor<br>and XL-4450 Light Source,<br>K102466) or EPX-4440HD<br>with FICE systems (VP-<br>4440HD Video Processor<br>with FICE and XL-4450<br>Light Source, K140149), | EPX-4440HD video<br>processor systems (VP-<br>4440HD Video Processor<br>and XL-4450 Light<br>Source, K102466) or<br>EPX-4440HD with FICE<br>systems (VP-4440HD<br>Video Processor with<br>FICE and XL-4450 Light<br>Source, K140149), | EPX-4440HD video<br>processor systems (VP-<br>4440HD Video Processor<br>and XL-4450 Light<br>Source, K102466) or<br>EPX-4440HD with FICE<br>systems (VP-4440HD<br>Video Processor with<br>FICE and XL-4450 Light<br>Source, K140149), |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Accessories | Channel Cleaning Brush<br>WB4321FW2 | Channel Cleaning Brush<br>WB5021FW2 | Channel Cleaning Brush<br>WB5021FW2 |
# Performance Data
EMC and electrical safety of the subject devices were evaluated using the following consensus standards: ANSI/AAMI ES60601-1:2005; IEC 60601-1-2:2007; IEC 60601-1-6:2010; and IEC 60601-2-18:2009.
Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009; ISO 10993-5:2009; and ISO 10993-10:2010.
Cleaning, disinfection, and sterilization were evaluated according to the following consensus standards: AAMI TIR30:2011; AAMI TIR12:2010; AAMI/ANSI/ISO 11135-1:2007; and AAMI/ANSI/ISO 17665-1:2006.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2013; ISO 8600-3:1997; and ISO 8600-4:1997.
# Substantial Equivalence
The Endoscope Models EC-600HL and EC-600LS are as safe and effective as the FUJIFILM 600 Series Endoscope EC-600WL. Endoscope Models EC-600HL and EC-600LS have the same intended uses and similar indications, technological characteristics, and principles of operation as their predicate device. The minor technological differences between the Endoscope Models EC-600HL and EC-600LS and their predicate device were made for the purpose of overall product enhancement and general technological advancement, and raise no new issues of safety or effectiveness. Performance data demonstrate that the Endoscope Models EC-600HL and EC-600LS are as safe and effective as the Endoscope EC-600WL. Thus, the devices are substantially equivalent.
# Conclusions
The Endoscope Models EC-600HL and EC-600LS are substantially equivalent to the cleared predicate based on intended use/indications for use and technological characteristics. The minor technological differences between the subject endoscopes and its predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicate. Thus, the devices are as safe and effective as the predicate.
