(178 days)
No
The document describes a standard endoscope with image capture capabilities and mentions no features related to AI or ML for image analysis, diagnosis, or treatment. The modifications are described as "minor" for "overall product enhancement and general technological advancement," which typically refers to hardware improvements, not AI/ML integration.
Yes
The device is described as being used for "endoscopic treatment," which implies a therapeutic function beyond just observation and diagnosis. Additionally, it mentions the use of a "forceps channel" for introducing accessories like "biopsy forceps during the procedure," which can be used for tissue removal (a therapeutic act).
Yes
The "Intended Use / Indications for Use" section explicitly states that the endoscopes are intended for "diagnosis" of the lower and upper digestive tracts.
No
The device description clearly outlines physical components like an operation section, insertion portion with glass fiber bundles and a CMOS image sensor, channels for air/water/suction/forceps, and an umbilicus with electronic components. It also mentions being used in combination with a video processor, light source, and other peripheral hardware. This indicates it is a hardware device with potential software control, not a software-only device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Device Function: The Fujifilm 600 Series Endoscopes and Water Tank are used for direct visualization of the internal digestive tract. They are inserted into the body to allow a physician to observe, diagnose, and treat conditions in vivo (within the living body).
- Intended Use: The intended use clearly states "visualization," "observation," "diagnosis," and "endoscopic treatment" of the digestive tract. This involves direct examination of the body, not testing of specimens outside the body.
- Device Description: The description details components like image sensors, light sources, and channels for air/water and instruments, all of which are consistent with an endoscope used for internal examination.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or performing tests on samples taken from the patient.
Therefore, the Fujifilm 600 Series Endoscopes and Water Tank are considered medical devices used for internal visualization and procedures, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Fujifilm 600 Series Endoscope EC-600WL: 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.
Fujifilm 600 Series Endoscope EG-600WR: The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Fujifilm 600 Series (Water Tank, WT-4): The device is intended for use in combination with Fuiinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FDS
Device Description
Fuiifilm 600 Series Endoscopes, EC-600WL and EG-600WR, are modified versions of the legally marketed Fujinon Colonoscopes EC-530HL2 and EC-530LS2 in K112391, and Fujinon G5 Gastroscope EG-450WR5 in K042043 respectively. Just like K112391, the proposed EC-600WL 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 proposed EG-600WR is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum, this is similar to K042043.
The endoscopes are comprised of three general sections: an operation section, an insertion portion and an umbilicus. The operation section controls the anqulation (up/down/left/right) of the distal end of the endoscope. The insertion portion 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 proposed models are 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 intended use, scientific fundamental technology and operating principle of the Water Tank WT-4 accessory, remains the same as the legally marketed Water Tank WT-2.
The minor modifications to the proposed devices were made for the purpose of overall product enhancement and general technological advancement.
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.
upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
management of a physician in medical facilities.
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)
The proposed devices have been subjected to and passed electrical safety and EMC test requirements.
Fuiifilm 600 Series Endoscopes, EC-600WL and EG-600WR, and Water Tank WT-4 were evaluated in accordance with the following safety and performance requirements in addition to the applicable quality regulations:
ANSI/AAMI ES60601-1*** Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC60601-1-2*** Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Compatibility - Requirements and tests
IEC60601-2-18*** Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
ISO10993-1* Biological evaluation of medical devices
ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO8600-1** Optics and photonics - Medical endoscopes and endotherapy devices
ISO8600-3 Optics and Optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics
ISO8600-4 Optics and Optical instruments - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
*Evaluation to ISO 10993-1 (Tested per ISO10993-5 and ISO-10993-10) was conducted for patient contact materials for 600 Series Endoscopes (direct and indirect) and Water Tank WT-4 (indirect only).
**Evaluation to ISO 8600-1 (Tested per ISO 8600-3 and ISO 8600-4) was conducted for 600 Series Endoscopes.
***Evaluation to ANSI/AAMI ES60601-1, IEC60601-1-2 and IEC60601-2-18 were conducted for 600 Series Endoscopes.
The reprocessing instructions were updated and validated. No clinical testing was conducted.
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.
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
FUJ!FILM
Date: January 9, 2014
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293
Contact Persons:
Gina Walljasper Director, Quality and Requlatory Compliance Telephone: (973) 686-2636 Facsimile: (973) 686-2616 E-Mail: qwalliasper@fujifilm.com
Identification of the Proposed Devices:
Proprietary/Trade Name: Fujifilm 600 Series Endoscopes EC-600WL and · EG-600WR Water Tank WT-4 Common Name: Video Endoscope Device Class: Class II Review Panel: Gastroenterology/Urology Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Colonoscope and Accessories (Flexible/Rigid) | 21 CFR 876.1500 | FDF |
| Gastroscope and Accessories (Flexible/Rigid) | 21 CFR 876.1500 | FDS |
I. INDICATIONS FOR USE
Fujifilm 600 Series Endoscope EC-600WL: 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.
Fujifilm 600 Series Endoscope EG-600WR: The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
JAN 1 0 2014
1
FUJIFILM
Fujifilm 600 Series (Water Tank, WT-4): The device is intended for use in combination with Fuiinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.
II. DEVICE DESCRIPTION
Fuiifilm 600 Series Endoscopes, EC-600WL and EG-600WR, are modified versions of the legally marketed Fujinon Colonoscopes EC-530HL2 and EC-530LS2 in K112391, and Fujinon G5 Gastroscope EG-450WR5 in K042043 respectively. Just like K112391, the proposed EC-600WL 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 proposed EG-600WR is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum, this is similar to K042043.
The endoscopes are comprised of three general sections: an operation section, an insertion portion and an umbilicus. The operation section controls the anqulation (up/down/left/right) of the distal end of the endoscope. The insertion portion 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 proposed models are 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 intended use, scientific fundamental technology and operating principle of the Water Tank WT-4 accessory, remains the same as the legally marketed Water Tank WT-2.
The minor modifications to the proposed devices were made for the purpose of overall product enhancement and general technological advancement.
2
FUJIFILM
.
SUMMARY OF STUDIES III.
The proposed devices have been subjected to and passed electrical safety and EMC test requirements.
Fuiifilm 600 Series Endoscopes, EC-600WL and EG-600WR, and Water Tank WT-4 were evaluated in accordance with the following safety and performance requirements in addition to the applicable quality regulations:
| ANSI/AAMI ES60601-1*** | Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC60601-1-2*** | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
Compatibility - Requirements and tests |
| IEC60601-2-18*** | Medical electrical equipment - Part 2-18: Particular
requirements for the safety of endoscopic equipment |
| ISO10993-1* | Biological evaluation of medical devices |
| ISO10993-5 | Biological evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity |
| ISO10993-10 | Biological evaluation of medical devices - Part 10:
Tests for irritation and skin sensitization |
| ISO8600-1** | Optics and photonics - Medical endoscopes and
endotherapy devices |
| ISO8600-3 | Optics and Optical instruments - Medical endoscopes
and endoscopic accessories - Part 3: Determination
of field of view and direction of view of endoscopes
with optics |
| ISO8600-4 | Optics and Optical instruments - Medical endoscopes
and certain accessories - Part 4: Determination of
maximum width of insertion portion |
*Evaluation to ISO 10993-1 (Tested per ISO10993-5 and ISO-10993-10) was conducted for patient contact materials for 600 Series Endoscopes (direct and indirect) and Water Tank WT-4 (indirect only).
**Evaluation to ISO 8600-1 (Tested per ISO 8600-3 and ISO 8600-4) was conducted for 600 Series Endoscopes.
***Evaluation to ANSI/AAMI ES60601-1, IEC60601-1-2 and IEC60601-2-18 were conducted for 600 Series Endoscopes.
The reprocessing instructions were updated and validated. No clinical testing was conducted.
3
FUJIFILM
IV. SUBSTANTIAL EQUIVALENCE
Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, and Water Tank WT-4 are substantially equivalent to the following devices:
| Proposed Device | Legally Marketed Device(s) | 510(k) # |
|---|---|---|
| Fujifilm 600 Series | ||
| Endoscope EC-600WL | Fujinon Colonoscopes, EC-530HL2 | |
| and EC-530LS2 | K112391 | |
| Fujifilm 600 Series | ||
| Endoscope EG-600WR | Fujinon G5 Gastroscope EG-450WR5 | K042043 |
| Water Tank WT-4 | Water Tank WT-2 | K944620 |
V. CONCLUSION
Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, and Water Tank WT-4 are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping, curved lines, which is the official symbol of the department.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2014
FUJIFILM Medical Systems U.S.A., Inc. Gina Walliasper Director, Quality and Regulatory Compliance 10 High Point Drive Wayne, NJ 07470
- Re: K132210
Trade/Device Name: Fujifilm 600 Series Endoscopes EC-600WL and EG-600WR Fujifilm 600 Series (Water Tank, WT-4) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FDS Dated: December 20, 2013 Received: December 23, 2013
Dear Gina Walljasper,
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.
5
Page 2 - Gina Walljasper
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 forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Image /page/5/Picture/7 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters "Herbert" and "Lerner" are clear and distinct. The "P." is smaller and has a slightly pixelated appearance. The "-S" is also in bold and is separated from "Lerner" by a space and a hyphen.
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
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132210
Device Name Fujifilm 600 Series (Water Tank, WT-4)
Indications for Use (Describe)
This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities.
Do not use this product for any other purpose.
Type of Use (Select one or both, as applicable)
[X] 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 Radiclogical Health (CDRH) (Signature)
Herbert P. Le 2014.01.10 12: 00'
FORM FDA 3881 (9/13)
Page Lotz
CONFIDENTIAL and PROPRIETARY
K132210 - FUJIFILM 600 Series Endoscopes
7
Indications for Use
510(k) Number (if known): K 132210
Device Name: Fujifilm 600 Series Endoscopes EC-600WL and EG-600WR
Indications for Use:
Fujifilm 600 Series Endoscope EC-600WL: 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.
Fujifilm 600 Series Endoscope EG-600WR: The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S 2014.01.10 10:26:44 -05'00'
FUJIFILM 600 Series Endoscopes (EC-600WL and EG-600WR)