(261 days)
Not Found
No
The description details image processing techniques to detect a laser spot and superimpose a scale, but does not mention or imply the use of AI or ML algorithms for this function.
No
The Endoscopy Support Program EW10-VM01 explicitly states, "This software provides no therapeutic or diagnostic function." The endoscope itself is for visualization and observation, diagnosis, and endoscopic treatment, but the question specifically asks about the device described in the input, which includes the software component. While the endoscope is used for treatment, the software component of the described device does not provide therapeutic function.
Yes
The Intended Use/Indications for Use section explicitly states that the FUJIFILM Endoscope Model EC-760S-A/L is intended for "observation, diagnosis, and endoscopic treatment of the rectum and large intestine." This directly indicates a diagnostic function for the endoscope itself.
Yes
The device description explicitly states that "Endoscopy Support Program EW10-VM01 is a software-only device". While it interacts with hardware (endoscope, video processor, PC), the device being described and cleared is the software itself.
Based on the provided information, neither the FUJIFILM Endoscope Model EC-760S-A/L nor the Endoscopy Support Program EW10-VM01 are IVDs (In Vitro Diagnostics).
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 concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
-
Device Function:
- The endoscope is a device used for direct visualization of the lower digestive tract. It captures images in vivo (within the living body).
- The Endoscopy Support Program EW10-VM01 is software that processes these in vivo endoscopic images to provide a virtual scale for size estimation. It explicitly states it provides "no therapeutic or diagnostic function."
-
Lack of Specimen Examination: Neither device involves the examination of specimens in vitro (outside the living body). They are used for direct observation and image processing of the internal body.
Therefore, these devices do not fit the definition of an In Vitro Diagnostic. They are considered medical devices used for visualization and image processing in vivo.
N/A
Intended Use / Indications for Use
FUJIFILM Endoscope Model EC-760S-A/L
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.
Endoscopy Support Program EW10-VM01
This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.
Product codes (comma separated list FDA assigned to the subject device)
FDF, QTH
Device Description
FUJIFILM Endoscope Model EC-760S-A/L is comprised of three general sections; a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor, and laser emitting window in its distal end. 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 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 the Company's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
Endoscopy Support Program EW10-VM01 is a software-only device that detects the laser spot position of the dedicated endoscope in the image obtained via the video processor and displays a superimposed scale ("Virtual Scale") in the endoscopic image (e.g., displayed in a monitor). The Virtual Scale images can be either linear or circular. The virtual scale shows the graduated markings at 5mm, 10mm, and 20mm. EW10-VM01 must be installed on a personal computer (PC) that meets the mandatory system requirements for it to function. When the PC with EW10-VM01 connects to the video processor and the Virtual Scale function is turned ON. EW10-VM01 automatically retrieves the calibration data from the EC-760S-A/L. EW10-VM01 uses the data from the calibration table and detects the relative position of the red laser beam in the endoscopic image. EW10-VM01 superimposes the virtual scale images in the endoscopic image in real-time. The virtual scale acts as the virtual reference for the users to estimate sizes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic image
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
Prescription Use
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)
Accuracy of Virtual Scale images with Endoscopy Support Program EW10-VM01 has been evaluated.
in-vivo performance testing of visualization of laser spot with EW10-VM01 has been evaluated.
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
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September 8, 2023
FUJIFILM Corporation % Kotei Aoki Senior Regulatory Affairs Specialist Fujifilm Healthcare Americas Corporation 81 Hartwell Avenue Suite 300 Lexington, Massachusetts 02421
Re: K223827
Trade/Device Name: FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF, OTH Dated: August 8, 2023 Received: August 8, 2023
Dear Kotei Aoki:
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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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. Assistant 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
2
Indications for Use
510(k) Number (if known) K223827
Device Name
FUJIFILM Endoscope Model EC-760S-A/L Endoscopy Support Program EW10-VM01
Indications for Use (Describe)
FUJIFILM Endoscope Model EC-760S-A/L
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.
Endoscopy Support Program EW10-VM01
This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.
| 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)
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3
510(k) Summary
FUJIFILM Corporation
Endoscope Model EC-760S-A/L with Endoscopy Support Program EW10-VM01
August 7, 2023
Submitter's Information:
FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN
Contact Person:
Kotei Aoki Senior Regulatory Affairs Specialist E-Mail: kotei.aoki@fujifilm.com Telephone: (765) 246-2931
ldentification of the Proposed Device:
| Device Name: | FUJIFILM Endoscope Model EC-760S-A/L |
|---|---|
| Common Name: | Colonoscope |
| Product Code: | FDF |
| Device Class: | Class 2 |
| Regulation Number: | 21 C.F.R 876.1500 |
| Regulation Description: | Colonoscope And Accessories, Flexible/Rigid |
| Review Panel: | Gastroenterology/Urology |
| Device Name: | Endoscopy Support Program EW10-VM01 |
| Common Name: | Virtual Scale |
| Product Code: | QTH |
| Device Class: | Class 2 |
| Regulation Number: | 21 C.F.R 876.1530 |
| Regulation Description: | Endoscopic light-projecting measuring device |
| Review Panel: | Gastroenterology/Urology |
Predicate Device(s):
Intended Use / Indications for Use:
FUJIFILM Endoscope Model EC-760S-A/L
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes.
Endoscopy Support Program EW10-VM01
This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.
4
Device Description:
FUJIFILM Endoscope Model EC-760S-A/L is comprised of three general sections; a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor, and laser emitting window in its distal end. 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 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 the Company's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
Endoscopy Support Program EW10-VM01 is a software-only device that detects the laser spot position of the dedicated endoscope in the image obtained via the video processor and displays a superimposed scale ("Virtual Scale") in the endoscopic image (e.g., displayed in a monitor). The Virtual Scale images can be either linear or circular. The virtual scale shows the graduated markings at 5mm, 10mm, and 20mm. EW10-VM01 must be installed on a personal computer (PC) that meets the mandatory system requirements for it to function. When the PC with EW10-VM01 connects to the video processor and the Virtual Scale function is turned ON. EW10-VM01 automatically retrieves the calibration data from the EC-760S-A/L. EW10-VM01 uses the data from the calibration table and detects the relative position of the red laser beam in the endoscopic image. EW10-VM01 superimposes the virtual scale images in the endoscopic image in real-time. The virtual scale acts as the virtual reference for the users to estimate sizes.
Comparison of Technological Characteristics:
A comparison of technological characteristics between the proposed device and the predicate device is provided in Table 1:
| | Proposed Device
Endoscope Model | Predicate Device
Endoscope Model |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | EC-760S-A/L | EC-760S-V/L (K190649) |
| Indications for Use (IFU) | 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. | |
| Virtual Scale Function | Available | Not available |
| Laser diode | For Virtual
Scale Function | Yes
Wavelength :637nm |
| | For optical
communication | Yes
Wavelength :1310nm |
| Viewing direction | Forward/ 0 degree | |
| Observation range | 2mm - 100mm | |
| Field of view | 170 degrees | |
| Image sensors | CMOS | |
| Distal end diameter | 12.8mm | |
| Flexible portion diameter | 12.8mm | |
| Maximum insertion diameter | 14.3mm | |
| Bending
capability | UP | 180 degrees |
| | Down | 180 degrees |
| | Left | 160 degrees |
| Table 1 Comparison of EC-760S-A/L and EC-760S-V/L (K190649) | |
|---|---|
| ------------------------------------------------------------- | -- |
5
| | Proposed Device
Endoscope Model | Predicate Device
Endoscope Model |
|----------------------------------|------------------------------------|-----------------------------------------------|
| | EC-760S-A/L | EC-760S-V/L (K190649) |
| Right | 160 degrees | |
| Instrument channel diameter | | 3.8mm |
| Working length / Total length | | 1690mm / 2010mm |
| WJ function | | YES |
| Location of WJ Inlet | | On the light guide connector |
| Video/Lightguide Connector | | Scope Connector |
| (Power supply method) | | (Electromagnetic induction) |
| (Communication method) | | (Optical communication) |
| Connector CPU/Software | | Installed |
| Light source/Video processor | | BL-7000/VP-7000 |
| | | Water Tank (WT-603) |
| Compatible accessories | | Endoscopic Accessories |
| | | Electrosurgical Instruments |
| | | Air leak tester (LT-7F) |
| | | Suction Channel Brush (WB7025DC) |
| | | Cylinder/Inlet Brush (WB11003DV) |
| | | Distal End Brush (WB1318DE) |
| | | Cleaning Adapter (CA-610, CA-611) |
| Standard accessories | | Forceps Valve (FOV-DV7) |
| | | Ventilation Adapter (AD-7) |
| | | J Tube (JT-500) |
| | | Air/Water valve (AW-603) |
| | | Suction valve (SB-605) |
| | | Water Jet Inlet Cap |
| Flexibility adjustment mechanism | | Advanced Force Transmission, Adaptive Bending |
| Control portion | | G7 control portion |
| FICE | | Available |
| BLI | | Available |
| BLI-bright | | Available |
| LCI | | Available |
Table 2 Comparison of EW10-VM01 and AccuMeasure™ System (DEN210032)
| Proposed Device | Predicate Device | |
|---|---|---|
| Endoscopy Support Program EW10-VM01 | AccuMeasure ™ System | |
| (DEN210032) | ||
| Intended Use | This software provides image information to | |
| assist the user in estimating the size of an | ||
| object displayed in the endoscopic field of | ||
| view. This software provides no therapeutic or diagnostic function. | The AccuMeasure System is intended | |
| to be used as an accessory in | ||
| conjunction with an endoscope to measure observable anatomy and | ||
| pathology in the gastrointestinal tract. | ||
| The AccuMeasure System provides no | ||
| therapeutic or diagnostic function. | ||
| Product code, | ||
| Device class | QTH, Class II | |
| Review Panel | Gastroenterology/Urology | |
| Physical State | FUJIFILM Endoscope Model EC-760S-A/L is | |
| a dedicated endoscope that can emit a red | ||
| laser beam from the distal end of the | ||
| insertion portion by the laser diode. | The device consists of a measuring | |
| device and a processing unit. The | ||
| measuring device includes a laser | ||
| source at the proximal end and a probe | ||
| at the distal end. The processing unit | ||
| Proposed Device | ||
| Endoscopy Support Program EW10-VM01 | Predicate Device | |
| AccuMeasure™ System | ||
| (DEN210032) | ||
| Endoscopy Support Program EW10-VM01 is a software-only device installed on a personal computer (PC) and it is used in conjunction with an endoscopic video processing system. |
The laser spot from EC-760S-A/L is visible on the tissue surface and appears in the endoscopic image. EW10-VM01 detects the laser spot position by referencing the endoscopic image obtained via the video processor and displays a superimposed scale in the endoscopic image in real-time. The software does not have a measuring function—the software only calibrates the virtual scale (e.g., by the object recognition), and does not estimate the measurement by itself. | includes a medical grade PC, touchscreen monitor, video grabber, and device specific software. |
| Technical
Method | EC-760S-A/L can emit a red laser beam from the distal end of the insertion portion by the laser diode.
EW10-VM01 detects the position of the laser spot emitted from the distal end of the EC-760S-A/L insertion portion that appears in the endoscopic image, which is obtained via the video processor. EW10-VM01 displays a superimposed scale (“virtual scale”) in the endoscopic image (e.g., displayed in a monitor) with the graduated markings along the virtual scale. | The device is an endoscope accessory that is inserted through the instrument channel. During use, the measuring device projects a line over a structure on a mucosal surface. An endoscopic image of the structure is taken and then the user can select any two points along the projected line in the image. The device-based software calculates the distance between the selected points. |
| Measurement
principle | Triangulation principle
Reference point: 1 | Triangulation principle
Reference points: 2 |
| Using laser for
measurement | Red laser (from Endoscope)
Wavelength :637nm | Red laser
Wavelength :650nm |
| Using Laser
pattern, safety
class | One spot laser (from Endoscope)
IEC60825-1 Class 1 | One line laser
IEC60825-1 Class 2 |
| Endoscope
Light source
Video processor | EC-760S-A/L
BL-7000
VP-7000 | The AccuMeasure™ System is compatible with commercially available flexible colonoscopes and gastroscopes having working channels of ≥ 3.2 mm in diameter, and both Standard-Definition and High-Definition endoscopy systems are supported. |
| Type of
illumination
light for
observation | 4 LED light from Light source | Light from Light source
(Includes 4 LED light when used in combination with our company light source BL-7000) |
| Target Area | Mucosal surfaces
Ineffective treatment due to the device providing inaccurate measurements | |
| | Proposed Device
Endoscopy Support Program EW10-VM01 | Predicate Device
AccuMeasure™ System
(DEN210032) |
| Identified Risks
to Health | Device failure/malfunction leading to injury | |
| | Device failure due to interference with other devices[1] | |
| | Adverse tissue reaction[1] | |
| | Extended procedure time leading to increased adverse events[1] | |
| | Infection[1] | |
6
7
[1] Evaluated with FUJIFILM Endoscope Model EC-760S-A/L. Endoscopy Support Program EW10-VM01 is software-only device.
Performance Data:
EC-760S-A/L is supplied non-sterile and must be properly reprocessed prior to use in accordance with the reprocessing instructions. 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, issued March 17, 2015.
EC-760S-A/L contains patient contacting material. Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1, ISO 10993-10. Biocompatibility testing was performed in accordance with FDA's guidance, Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', issued September 4, 2020.
EC-760S-A/L contains electronic components. Electromagnetic compatibility, electrical safety, and thermal safety were evaluated using following standards: IEC 60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-2-18:2009.
Laser safety and photobiological safety of Endoscope Model EC-760S-A/L were evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.
Software of EC-760S-A/L and EW10-VM01 were evaluated using IEC 62304:2015 and in accordance with FDA's quidance, Guidance for the Content of Premarket Submissions for Software in Medical Devices, issued May 11, 2005, and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014.
Endoscope specific testing was conducted according to ISO 8600-1:2015.
Accuracy of Virtual Scale images with Endoscopy Support Program EW10-VM01 has been evaluated.
in-vivo performance testing of visualization of laser spot with EW10-VM01 has been evaluated.
Conclusions:
The proposed device FUJIFILM Endoscope Model EC-760S-A/L and Endoscopy Support Program EW10-VM01 share the intended use and indications for use as the respective predicate device. EC-760S-A/L is additionally similar in technological characteristics and principle of operation to EC-760S-V/L (K190649). The differences have been evaluated for the biocompatibility, electrical safety, EMC, software, laser safety, photobiological safety, and bench testing. There remains no new concern regarding the safety and effectiveness of the proposed devices compared to the predicate devices. Thus, FUJIFILM Endoscope Model EC-760S-A/L and Endoscopy Support Program EW10-VM01 are substantially equivalent to the respective predicate device, Endoscope Model EC-760S-V/L (K190649) and AccuMeasure™ System (DEN210032).