(189 days)
Not Found
No
The summary describes a standard endoscope with image capture capabilities and mentions no features or components related to AI or ML. The performance studies focus on safety, biocompatibility, and cleaning, not algorithmic performance.
Yes
The intended use states "endoscopic treatment," and the device description mentions a "forceps channel... to introduce endoscope accessories such as biopsy forceps during the procedure." While visualization is diagnostic, the capability for endoscopic treatment using accessories makes it a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment."
No
The device description clearly outlines physical hardware components including an operation section, insertion portion with glass fiber bundles and a CMOS image sensor, and an umbilicus with electronic components. It also mentions being used in combination with other hardware like a video processor and light source.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The FUJIFILM Endoscope Models EC-600HL and EC-600LS are used for the direct visualization of the lower digestive tract within the body. They capture images of the internal anatomy.
- Lack of Specimen Examination: The device does not examine specimens outside of the body. It is used for in-vivo procedures.
The description clearly states its purpose is for "visualization of the lower digestive tract" and "observation, diagnosis, and endoscopic treatment of the rectum and large intestine." This is an in-vivo diagnostic and therapeutic tool, not an in-vitro diagnostic.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
FDF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower digestive tract, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
FUJIFILM 600 Series Endoscope EC-600WL (K132210)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads representing the department's focus on health, human services, and the well-being of the nation.
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
1
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
2
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)
| 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 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)
4
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
(Predicate Device) | EC-600HL
(Subject Device) | EC-600LS
(Subject Device) |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | 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. |
| 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
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 |
5
| Processors and light sources | EPX-4440HD video
processor systems (VP-
4440HD Video Processor
and XL-4450 Light Source,
K102466) or EPX-4440HD
with FICE systems (VP-
4440HD Video Processor
with FICE and XL-4450
Light Source, K140149), | EPX-4440HD video
processor systems (VP-
4440HD Video Processor
and XL-4450 Light
Source, K102466) or
EPX-4440HD with FICE
systems (VP-4440HD
Video Processor with
FICE and XL-4450 Light
Source, K140149), | EPX-4440HD video
processor systems (VP-
4440HD Video Processor
and XL-4450 Light
Source, K102466) or
EPX-4440HD with FICE
systems (VP-4440HD
Video Processor with
FICE and XL-4450 Light
Source, K140149), |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Accessories | Channel Cleaning Brush
WB4321FW2 | Channel Cleaning Brush
WB5021FW2 | Channel Cleaning Brush
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.