(55 days)
Not Found
No
The summary describes a standard endoscope with image capture capabilities and mechanical controls. There is no mention of AI, ML, image processing beyond basic capture, or any data analysis features that would suggest the use of AI/ML. The performance studies focus on safety, biocompatibility, reprocessing, and basic functional parameters of the endoscope.
Yes
The device is intended for "endoscopic treatment of the rectum and large intestine," indicating a therapeutic function beyond just visualization or diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnosis."
No
The device description clearly outlines physical components such as a control portion, 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 hardware like video processors, light sources, monitors, printers, foot switches, and carts. The performance studies also include testing related to electrical safety, biocompatibility, and reprocessing, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the visualization, diagnosis, and endoscopic treatment of the lower digestive tract. This involves direct observation and intervention within the body.
- Device Description: The description details a physical endoscope with components for visualization, manipulation, and delivering accessories. It does not describe a device that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or performing tests on samples outside the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This endoscope is a medical device used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
EC-760S-V/L 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 (comma separated list FDA assigned to the subject device)
FDF
Device Description
FUJIFILM Endoscope Model EC-760S-V/L is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the anqulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. 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 umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety of the proposed device was evaluated using the following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
The proposed device EC-760S-V/L was adopted into the reprocessing validation of the predicate device EC-760R-V/L using the following consensus standards: AAMI TIR12:2010, AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
The proposed device EC-760S-V/L was adopted into the photobiological safety testing of the predicate device EC-760R-V/L in accordance with IEC 62471:2006.
Bench testing was conducted on the subject device to validate the Advanced Force Transmission, Adaptive Bending features.
Fujifilm conducted the following performance testing on the proposed device EC-760S-V/L to ensure that the modified device performs equivalently to the predicate device:
- Field of view
- Bending capability
- Rate of air supply
- Rate of water supply
- Suction rate
- Working length
- Forceps channel diameter
- Viewing direction
- Resolution
- LG output
In all cases, the device met the pre-defined acceptance criteria for the test.
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 Endoscope Model EC-760R-V/L (K172916)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 7, 2019
FUJIFILM Corporation % Liza Dejesa-Jamanila Director, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K190649
Trade/Device Name: FUJIFILM Endoscope Model EC-760S-V/L Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: March 12, 2019 Received: March 13, 2019
Dear Liza Dejesa-Jamanila:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190649
Device Name
FUJIFILM Endoscope Model EC-760S-V/L
Indications for Use (Describe)
EC-760S-V/L 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 Endoscope Model EC-760S-V/L
Date: March 12, 2019
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Liza Dejesa-Jamanila Director, Regulatory Affairs Telephone: (520) 414-6641 E-Mail: liza.dejesa-jamanila@fujifilm.com
Identification of the Proposed Device:
| Proprietary/Trade Name: | FUJIFILM Endoscope Model EC-760S-V/L |
|---|---|
| Common Name: | Colonoscope |
| 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 Model EC-760R-V/L (K172916)
Intended Use / Indications for Use:
EC-760S-V/L is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Device Description:
FUJIFILM Endoscope Model EC-760S-V/L is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the anqulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as
4
endoscope accessories, such as forceps. 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 umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
Technological Characteristics:
The proposed device EC-760S-V/L differs from the predicate device in the following minor modifications:
- . Dimensional and material changes to the insertion portion
- . Introduction of the "Advanced Force Transmission" and "Adaptive Bending" features
Performance Data:
Electrical safety of the proposed device was evaluated using the following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
The proposed device EC-760S-V/L was adopted into the reprocessing validation of the predicate device EC-760R-V/L using the following consensus standards: AAMI TIR12:2010, AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
The proposed device EC-760S-V/L was adopted into the photobiological safety testing of the predicate device EC-760R-V/L in accordance with IEC 62471:2006.
Bench testing was conducted on the subject device to validate the Advanced Force Transmission, Adaptive Bending features.
Fujifilm conducted the following performance testing on the proposed device EC-760S-V/L to ensure that the modified device performs equivalently to the predicate device:
- . Field of view
- Bending capability
- . Rate of air supply
- Rate of water supply
- Suction rate
- Working length
5
- Forceps channel diameter
- . Viewing direction
- Resolution
- . LG output
In all cases, the device met the pre-defined acceptance criteria for the test.
Substantial Equivalence:
The company's EC-760S-V/L has the same intended use and indications for use as the previously cleared predicate EC-760R-V/L (K172916). In addition, the proposed device has similar technological characteristics and principles of operation as the predicate. The minor differences between the proposed and predicate devices do not raise new or additional questions of safety or effectiveness of the proposed devices. Thus, the proposed device EC-760S-V/L is substantially equivalent to the predicate device.
Conclusions:
The modified EC-760S-V/L is substantially equivalent to the predicate EC-760R-V/L and conforms to applicable medical device safety and performance standards.