(27 days)
Not Found
No
The summary describes a standard video colonoscope with minor technological advancements, focusing on hardware components and basic image capture and display. There is no mention of AI, ML, or any advanced image processing or analysis capabilities that would typically indicate the presence of such technology.
No.
The device is described as being for "visualization," "observation," and "diagnosis," as well as for introducing accessories for "endoscopic treatment," but it does not directly perform or lead to a therapeutic effect itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnosis." The "Device Description" also reiterates that the device is intended for "observation, diagnosis, and endoscopic treatment." While it also mentions observation and treatment, the inclusion of "diagnosis" qualifies it as a diagnostic device.
No
The device description clearly outlines physical hardware components including an operation section, insertion portion with glass fiber bundles, CMOS image sensor, channels, and an umbilicus with electronic components. It is a physical endoscope.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a colonoscope used for the visualization of the lower digestive tract inside the body. It's an endoscopic device used for direct observation and treatment within the patient.
The device's function and intended use are entirely focused on in-vivo procedures, not in-vitro analysis of specimens.
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 EC-600WL v2 is comprised of three general 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 glass 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, provide suction, and 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 to the video processor and light source.
The EC-600WL v2 is used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscopic accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, cart).
Mentions image processing
Not Found
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 EC-600WL v2 to ensure that the modified device performs equivalently to the predicate EC-600WL:
- . Field of view
- . Bending capability
- Rate of air supply ●
- Rate of water supply
- Rate of suction
- . Working length
- Diameter of forceps channel ●
- Viewing direction ●
- . 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2016
Fujifilm Medical Systems USA, Inc. % John Smith, MD, JD Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, DC 20004
Re: K160196
Trade/Device Name: Fujifilm Video Colonoscope Model EC-600WL v2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDF Dated: January 27, 2016 Received: January 27, 2016
Dear Dr. Smith,
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 device
1
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.
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,
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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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Indications for Use
510(k) Number (if known) K160196
Device Name
FUJIFILM Video Endoscope Model EC-600WL v2
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-600WL v2
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, 2016
Identification of the Subject Device:
| Proprietary/Trade Name: | Fujifilm Video Colonoscope Model EC-600WL v2 |
|---|---|
| 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 600 series colonoscope EC-600WL (K132210)
Purpose of the Special 510(k) notice.
The EC-600WL v2 is a modification to EC-600WL.
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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Technological Characteristics
The Fujifilm video colonoscope model EC-600WL v2 is a modified version of the legally marketed Fujifilm Colonoscope EC-600WL in K132210. Just like K132210, the proposed EC-600WL v2 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 EC-600WL v2 is comprised of three general 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 glass 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, provide suction, and 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 to the video processor and light source.
The EC-600WL v2 is used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscopic accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, cart).
The minor modifications to the proposed device were made for the purpose of overall product enhancement and general technological advancement.
Performance Data
Fujifilm conducted the following performance testing of the EC-600WL v2 to ensure that the modified device performs equivalently to the predicate EC-600WL:
- . Field of view
- . Bending capability
- Rate of air supply ●
- Rate of water supply
- Rate of suction
- . Working length
- Diameter of forceps channel ●
- Viewing direction ●
- . Resolution
- . LG output
In all cases, the device met the pre-defined acceptance criteria for the test.
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Substantial Equivalence
EC-600WL v2 has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate EC-600WL. The minor differences in the modified device's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the EC-600WL v2 is as safe and effective as EC-600WL. Thus, the EC-600WL v2 is substantially equivalent to its predicate device.