(235 days)
No
The description focuses on the hardware components and basic image capture/display, with no mention of AI/ML or advanced image processing beyond simple visualization.
Yes
The intended use statement explicitly mentions "endoscopic treatment" in addition to observation and 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 CCD 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.
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 and endoscopic treatment of the digestive tract. This involves directly observing the internal anatomy and potentially performing procedures within the body.
- Device Description: The description details an endoscope, which is a device used to look inside the body. It mentions components like a CCD image sensor, light source, and channels for accessories like forceps and balloons. These are all characteristic of an in-vivo (within the living body) diagnostic and therapeutic device, not an in-vitro (outside the living body) diagnostic device.
- Anatomical Site: The device is used within the digestive tract, which is inside the patient's body. IVD devices typically analyze samples taken from the body (like blood, urine, tissue).
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device operates directly within the body for visualization and intervention.
N/A
Intended Use / Indications for Use
This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, and rectum.
Product codes
FDA, FDF, FDS
Device Description
FUJIFILM Double Balloon Endoscope EI-580BT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion contains components to control 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 Charge-Coupled Device (CCD) image sensor in its distal end. The channels in the insertion assist in delivering air/suction as well as endoscope accessories, such as forceps and balloons. 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 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 processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K143556 and K172916.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, and rectum.
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 subject device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2006.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
Cleaning, high-level disinfection, and sterilization of the subject device were evaluated according to the following consensus standards: AAMI TIR12:2010 and AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
Usability testing was conducted according to IEC 62366-1:2015.
Bench testing was conducted on the subject device to validate the Advanced Force Transmission and Adaptive Bending features.
The subject device met performance specifications in the following additional testing:
- Field of view
- Bending capability
- Rate of air supply
- Rate of water supply
- Rate of suction
- Working length
- Diameter of forceps channel
- Viewing direction
- Resolution
- LG output
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 24, 2019
FUJIFILM Corporation % Jeffrey Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
Re: K183032
Trade/Device Name: FUJIFILM Double Balloon Endoscope EI-580BT Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDA, FDF, FDS Dated: May 10, 2019 Received: May 13, 2019
Dear Jeffrey Wan:
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-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-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,
for
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183032
Device Name
FUJIFILM Double Balloon Endoscope EI-580BT
Indications for Use (Describe)
This device is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, and rectum.
| 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
K183032 Page 1 of 3
510(k) SUMMARY
FUJIFILM Corporation's FUJIFILM Double Balloon Endoscope El-580BT
Date: October 31, 2018
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Jeffrey Wan Specialist, Regulatory Affairs Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
ldentification of the Proposed Device:
| Proprietary/Trade Name: | FUJIFILM Double Balloon Endoscope EI-580BT |
|---|---|
| Common Name: | Endoscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Enteroscope And Accessories | 21 CFR 876.1500 | FDA |
| Colonoscope And Accessories, Flexible/Rigid | 21 CFR 876.1500 | FDF |
| Gastroscope And Accessories, Flexible/Rigid | 21 CFR 876.1500 | FDS |
Predicate Device:
FUJIFILM Double Balloon Endoscope Model EN-580T (K143556)
Reference Devices:
FUJIFILM Endoscope Model EC-760R-V/L (K172916)
4
Intended Use / Indications for Use
FUJIFILM Double Balloon Endoscope EI-580BT is intended for the visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment of the esophaqus, stomach, duodenum, small intestine, and rectum.
Device Description
FUJIFILM Double Balloon Endoscope EI-580BT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control 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 Charge-Coupled Device (CCD) image sensor in its distal end. The channels in the insertion assist in delivering air/suction as well as endoscope accessories, such as forceps and balloons. 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 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 processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K143556 and K172916.
FUJIFILM Double Balloon Endoscope EI-580BT differs from the predicate device EN-580T in terms of technological characteristics and materials. The reference device EC-760R-V/L supports substantial equivalence with respect to some of these differences. Furthermore, the subject device and predicate device share the same mode of operation and intended use.
Comparison of Technological Characteristics
A summary of major differences between the subject device El-580BT and the predicate device EN-580T is provided as follows:
- . Use of the "G7" control portion, which has previously been cleared under K172916.
- . Introduction of new features, "Advanced Force Transmission" and "Adaptive Bending"
- . Compatibility with different video processors, light sources, over-tubes, and other accessories
Performance Data
Electrical safety of the subject device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2006.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
5
Cleaning, high-level disinfection, and sterilization of the subject device were evaluated according to the following consensus standards: AAMI TIR12:2010 and AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
Usability testing was conducted according to IEC 62366-1:2015.
Bench testing was conducted on the subject device to validate the Advanced Force Transmission and Adaptive Bending features.
The subject device met performance specifications in the following additional testing:
- Field of view
- Bending capability ●
- Rate of air supply
- Rate of water supply
- Rate of suction
- Working length
- Diameter of forceps channel ●
- Viewing direction ●
- Resolution ●
- LG output ●
Substantial Equivalence
The subject device FUJIFILM Double Balloon Endoscope EI-580BT is substantially equivalent to the predicate device, FUJIFILM Double Balloon Endoscope Model EN-580T (K143556). The subject device has the same intended use, indications, similar technological characteristics and principles of operation as that of the predicate device.
Technological changes to the predicate device EN-580T have previously been cleared for the reference device EC-760R-V/L. Material changes were validated through biocompatibility testing. Thus, the subject device EI-580BT is substantially equivalent to the predicate device.
Conclusions
The subject device Double Balloon Endoscope El-580BT is substantially equivalent to the predicate device based on the same intended use, indications for use, similar technological characteristics and materials. The differences in technological characteristics and materials between the subject and predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject device is substantially equivalent in performance to the predicate device. Material changes made to the subject device were validated through biocompatibility testing. Thus, the subject device FUJIFILM Double Balloon Endoscope EI-580BT is substantially equivalent to the predicate device, FUJIFILM Double Balloon Endoscope EN-580T (K143556).