(241 days)
No
The summary describes a standard endoscope with a CCD image sensor and channels for accessories. There is no mention of AI, ML, image processing beyond basic capture, or any performance studies related to algorithmic analysis of images.
Yes.
The device is intended for "endoscopic treatment," which indicates a therapeutic purpose in addition to observation and diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment" of the upper and lower digestive tracts.
No
The device description clearly outlines physical components such as a control portion, insertion portion with glass fiber bundles, channels, a CCD image sensor, and an umbilicus. It also mentions being used in combination with a video processor, light sources, and peripheral devices, indicating it is a hardware device.
Based on the provided information, the FUJIFILM Endoscope Model EI-740D/S is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the observation, diagnosis, and endoscopic treatment of the upper and lower digestive tracts. This involves direct visualization and intervention within the body.
- Device Description: The description details the physical components of an endoscope used for internal examination and procedures. It mentions channels for accessories and light for illumination, all consistent with an in-vivo imaging and treatment device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro). IVD devices typically analyze biological samples like blood, urine, tissue, etc., in a laboratory setting.
Therefore, the FUJIFILM Endoscope Model EI-740D/S is an in-vivo medical device used for direct examination and treatment within the patient's body, not an IVD device.
N/A
Intended Use / Indications for Use
FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Never use this product for any other purposes.
Product codes
FDS, FAM
Device Description
FUJIFILM Endoscope Model EI-740D/S is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) 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 CCD 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 processor, FUJIFILM's 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
upper digestive tract (esophagus, stomach, and duodenum), lower digestive tract (rectum and sigmoid colon)
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)
- The proposed device was adopted into the cleaning, disinfection, and sterilization of the predicate device.
- Validation of the delayed reprocessing instructions was performed in accordance with the FDA's guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015.
- The proposed device was adopted into the StO2 measurement (in OXEI mode) testing performed on the EX-0 Oxygen Saturation Image Processor paired with the Endoscope Model EG-740N (K203717).
- EMC and Electrical safety of the proposed device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-2-18:2009.
- Photobiological safety of the proposed device were evaluated using the following standard: IEC 62471:2006.
- No modification has been proposed in the material construction, patient contact type/duration, or other technological characteristics. The proposed device FUJIFILM Endoscope Model El-740D/S can be adopted into the biocompatibility and the performance testing of the Endoscope Model El-740D/S (K210162).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Endoscope Model El-740D/S (K210162)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
January 27, 2023
FUJIFILM Corporation % Kotei Aoki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K221551
Trade/Device Name: FUJIFILM Endoscope Model EI-740D/S Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS, FAM Dated: December 22, 2022 Received: December 22, 2022
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.
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
1
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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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
2
Indications for Use
510(k) Number (if known)
K221551
Device Name FUJIFILM Endoscope Model EI-740D/S
Indications for Use (Describe)
FUJIFILM Endoscope Model El-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Never use this product for any other purposes.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K221551 Page 1 of 3
510(k) Summary
FUJIFILM Corporation
FUJIFILM Endoscope Model El-740D/S
Date: May 25, 2022
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 EI-740D/S |
|---|---|
| Common Name: | Endoscope |
| Product Code: | FDS, FAM |
| Device Class: | II |
| Regulation Number: | 876.1500 |
| Regulation Description: | Endoscope and accessories |
| Review Panel: | Gastroenterology/Urology |
Predicate Device(s):
- Endoscope Model El-740D/S (K210162) .
Intended Use / Indications for Use:
FUJIFILM Endoscope Model EI-740D/S is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Never use this product for any other purposes
Device Description:
FUJIFILM Endoscope Model EI-740D/S is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) 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 CCD image sensor to capture an image and display it on the monitor. The umbilicus
4
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 processor, FUJIFILM's light sources and peripheral devices such as monitor, printer, foot switch, and cart.
Comparison of Technological Characteristics:
A comparison of technological characteristics between the proposed device and the predicate device is provided in Table 1:
| | | Proposed Device
FUJIFILM Endoscope
Model El-740D/S
(To be assigned) | Predicate Device
FUJIFILM Endoscope
Model El-740D/S
(K210162) |
|--------------------------------------|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Indications for Use (IFU) | | FUJIFILM Endoscope Model El-740D/S 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 device is also intended for the visualization of the lower digestive
tract, specifically for the observation, diagnosis, and endoscopic | |
| | | treatment of the rectum and sigmoid colon.
Never use this product for any other purposes. | |
| Light Source/Video Processor | | BL-7000/VP-7000
BL-7000X/VP-7000
EP-6000 | BL-7000/VP-7000
EP-6000 |
| Oxygen Saturation Image
Processor | | EX-0 | Not Available |
| Delayed Reprocessing | | Yes | No |
| Viewing direction | | Forward/ 0 degree | |
| Observation range | | 3mm-100mm | |
| Field of View | | 140 degrees | |
| Distal end diameter | | 12.8mm | |
| Flexible portion diameter | | 12.8mm | |
| Maximum insertion diameter | | 14.3mm | |
| Bending
capability | Up | 210 degrees | |
| | Down | 90 degrees | |
| | Right | 100 degrees | |
| | Left | 100 degrees | |
| Forceps channel diameter | | (1st Channel) 3.2mm
(2nd Channel) 3.7mm | |
| Working length | | 1030mm | |
| Total length | | 1330mm | |
| FICE | | Available | |
| BLI | | Available | |
| BLI-bright | | Available | |
| LCI | | Available | |
| OXEI mode | | Available | Not Available |
Table 1 Comparison of the features
Performance Data:
The proposed device was adopted into the cleaning, disinfection, and sterilization of the predicate device. Validation of the delayed reprocessing instructions was performed in accordance with
5
the FDA's guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015.
The proposed device was adopted into the StO2 measurement (in OXEI mode) testing performed on the EX-0 Oxygen Saturation Image Processor paired with the Endoscope Model EG-740N (K203717).
EMC and Electrical safety of the proposed device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-2-18:2009.
Photobiological safety of the proposed device were evaluated using the following standard: IEC 62471:2006.
No modification has been proposed in the material construction, patient contact type/duration, or other technological characteristics. The proposed device FUJIFILM Endoscope Model El-740D/S can be adopted into the biocompatibility and the performance testing of the Endoscope Model El-740D/S (K210162).
Conclusions:
The proposed device FUJIFILM Endoscope Model EI-740D/S shares the same intended use and indications, materials of construction, and electrical components as the predicate device. The reprocessing validation demonstrates that the proposed device can be cleaned as effective as the predicate device. Thus, FUJIFILM Endoscope Model El-740D/S is substantially equivalent to the predicate device, Endoscope Model EI-740D/S (K210162).