(258 days)
Not Found
No
The device description focuses on the mechanical and optical components of the endoscope and over-tube. While it mentions image processing for display, there is no indication of AI/ML being used for analysis, diagnosis, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The Intended Use / Indications for Use explicitly states that the device is intended for "endoscopic treatment" in addition to observation and diagnosis.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the Double Balloon Endoscope Model EN-840T is intended for "observation, diagnosis, and endoscopic treatment" of the digestive tracts.
No
The device description clearly outlines physical hardware components such as the insertion portion, bending portion, control portion, objective lens, light guide, forceps channel, and a CMOS image sensor. It also describes an over-tube accessory, which is a physical device. While there is mention of a video processor converting an electrical signal to a video signal, this is part of a larger hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "visualization of the upper and lower digestive tracts, specifically for the observation, diagnosis, and endoscopic treatment". This involves direct examination of the body's internal structures.
- Device Description: The description details the physical components of an endoscope and an over-tube, designed for insertion into the body.
- Mechanism of Action: The device works by providing optical imaging of the digestive tract and allowing for the introduction of instruments for treatment.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens (like blood, tissue, or urine) outside of the body to obtain diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (inside the body).
N/A
Intended Use / Indications for Use
Double Balloon Endoscope Model EN-840T
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, large intestine and rectum.
Never use this product for any other purposes.
Over-Tube TS-1214C
This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube is used to assist with the movement of the scope inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
Product codes (comma separated list FDA assigned to the subject device)
FDA
Device Description
a. Double Balloon Endoscope Model EN-840T
Technological characteristics
The insertion portion of the device has a mechanism (hereinafter "the bends the tip from right to left and up and down, and a flexible tube (hereinafter") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the tip is arranged inside the insertion portion for inserting the surgical instrument.
The insertion portion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Balloon air feed outlet , Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide.
The bending portion is controlled by knobs on the control portion section to angulate the distal end to certain angles.
The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles alow light to travel through the body cavity, thereby providing enough light to the CMOS sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.
The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connects the endoscopes to the light source.
b. Over-tube TS-1214C
The over-tube TS-1214C is introduced in the patient's anatomy with the pairing endoscope. TS-1214C is assembled over the outer diameter of endoscope. The endoscope and the over-tube are not advanced both at the same time, but alternatingly and successively. TS-1214C is provided sterile and single-patient use only. This accessory is a Class 2 device.
Principles of Operation
a. Double Balloon Endoscope Model EN-840T
The Double Balloon Endoscope Model EN-840T function on the same principles of operation as the predicate device. EN-840T is a gastrointestinal endoscope for observation, diagnosis, and treatment of the upper and lower digestive tract. After connecting to the light source, the devices guide the light through the fiber bundles situated inside the insertion of the device. The light that emits from the distal end of the insertion portion reflects from the target region and forms an image on through a group of object lenses placed at the distal end of the devices. An electric signal from the image sensor is transmitted to the video processor connected to the device. The video processor converts the electric signal into a video signal and displays an image on a monitor.
b. Over-tube TS-1214C
An over-tube is attached to the insertion of the endoscope, and then the scope balloon is mounted to the distal end of the endoscope using the specified setting tool.
By inflating the balloon at distal end of the balloon at the distal end of the endoscope, the distal end of the over-tube and the distal end of the endoscope are maintained in the body cavity.
By inserting an over-tube after the endoscope, it is possible to correct the hollow viscera. And then by inflating a balloon attached to the distal end of the over-tube, the distal end consequently stronger straightening of the hollow viscera can be obtained.
Mentions image processing
Yes, "An electric signal from the image sensor is transmitted to the video processor connected to the device. The video processor converts the electric signal into a video signal and displays an image on a monitor."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light through fiber bundles; CMOS image sensor
Anatomical Site
esophagus, stomach, duodenum, small intestine, large intestine and rectum (upper and lower digestive tracts)
Indicated Patient Age Range
The Over-Tube TS-1214C product is not intended for use for any neonates, infants or children.
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)
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
EMC and Electrical safety of the subject device was evaluated using following standards: ANS/AAM ES ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010(R)2012 (Consolidated Text), IEC 60601-1-6:2013, and IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-52009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's quidance, 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.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-3:1997, and ISO 8600-4:2014.
The proposed EN-840T is provided non-sterile and must be reprocessed prior to each use. Sterility of the other new accessories TS-13148 and BS-4 were evaluated using the following consensus standards: ISO 11135:2014, ISO 11607-1:2019, ISO 11607-2:2019, ISO 11737-1:2018, and ISO 1:2017. Sterilization was performed in accordance with FDA's guidance, Submission and Review of Sterility Information in Premarket Notification for Devices Labeled as Sterile, issued January 21, 2016.
The subject device met performance specifications in the following additional testing: Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Viewing direction, Resolution, LG output.
Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the predicate devices. The difference in materials between subject and predicate devices has been validated through biocompatibility testing.
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.
K143556, K221551, K183032, K223295
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 13, 2024
FUJIFILM Healthcare Americas Corporation Chaitrali Kulkarni Sr. Regulatory Affairs Specialist 81 Hartwell Avenue Suite 300 Lexington, Massachusetts 02421
Re: K233321
Trade/Device Name: Double Balloon Endoscope EN-840T, Over-tube TS-1214C Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDA Dated: May 14, 2024 Received: May 14, 2024
Dear Chaitrali Kulkarni:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Double Balloon Endoscope EN-840T; Over-tube TS-1214C
Indications for Use (Describe)
Double Balloon Endoscope Model EN-840T
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, large intestine and rectum.
Never use this product for any other purposes.
Over-Tube TS-1214C
This product is intended to be used as an accessory with the FUJIFILM Double Balloon Endoscope cleared for use with an Over-tube is used to assist with the movement of the scope inside the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
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
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| | K233321
Page 1 of 3 | | |
|-----------------------------------------------------------|-------------------------------------------------------------|--------------|-----|
| 510(k) #: | K233321 | | |
| | 510(k) Summary | | |
| | Prepared on: 2024-06-12 | | |
| Contact Details | 21 CFR 807.92(a)(1) | | |
| Applicant Name | Fujifilm Healthcare Americas Corporation | | |
| Applicant Address | 81 Hartwell ave Suite 300 Lexington MA 02421 United States | | |
| Applicant Contact Telephone | 704-517-4886 | | |
| Applicant Contact | Ms. Chaitrali Kulkarni | | |
| Applicant Contact Email | chaitrali.kulkarni@fujifilm.com | | |
| Device Name | 21 CFR 807.92(a)(2) | | |
| Device Trade Name | Double Balloon Endoscope EN-840T;
Over-tube TS-1214C | | |
| Common Name | Endoscope and accessories | | |
| Classification Name | Enteroscope And Accessories | | |
| Regulation Number | 876.1500 | | |
| Product Code | FDA | | |
| Legally Marketed Predicate Devices
21 CFR 807.92(a)(3) | | | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-58 | FDA | |
| K221551 | FUJIFILM Endoscope Model El-740D/S | | FDS |
| K183032 | FUJIFILM Double Balloon Endoscope El-580BT | | FDA |
| K223295 | Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4 | | FDA |
| Device Description Summary
21 CFR 807.92(a)(4) | | | |
| Technological characteristics | | | |
a. Double Balloon Endoscope Model EN-840T
Technological characteristics
The insertion portion of the device has a mechanism (hereinafter "the bends the tip from right to left and up and down, and a flexible tube (hereinafter") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the tip is arranged inside the insertion portion for inserting the surgical instrument.
The insertion portion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Balloon air feed outlet , Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide.
The bending portion is controlled by knobs on the control portion section to angulate the distal end to certain angles.
5
The Flexible portion refers to the long insertion area between the Control portion (a part of Non-insertion portion). This portion contains light guides), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The class fiber bundles alow light to travel through the body cavity, thereby providing enough light to the CMOS sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.
The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connects the endoscopes to the light source.
b. Over-tube TS-1214C
The over-tube TS-1214C is introduced in the patient's anatomy with the pairing endoscope. TS-1214C is assembled over the outer diameter of endoscope. The endoscope and the over-tube are not advanced both at the same time, but alternatingly and successively. TS-1214C is provided sterile and single-patient use only. This accessory is a Class 2 device.
Principles of Operation
a. Double Balloon Endoscope Model EN-840T
The Double Balloon Endoscope Model EN-840T function on the same principles of operation as the predicate device. EN-840T is a gastrointestinal endoscope for observation, diagnosis, and treatment of the upper and lower digestive tract. After connecting to the light source, the devices guide the light through the fiber bundles situated inside the insertion of the device. The light that emits from the distal end of the insertion portion reflects from the target region and forms an image on through a group of object lenses placed at the distal end of the devices. An electric signal from the image sensor is transmitted to the video processor connected to the device. The video processor converts the electric signal into a video signal and displays an image on a monitor.
b. Over-tube TS-1214C
An over-tube is attached to the insertion of the endoscope, and then the scope balloon is mounted to the distal end of the endoscope using the specified setting tool.
By inflating the balloon at distal end of the balloon at the distal end of the endoscope, the distal end of the over-tube and the distal end of the endoscope are maintained in the body cavity.
By inserting an over-tube after the endoscope, it is possible to correct the hollow viscera. And then by inflating a balloon attached to the distal end of the over-tube, the distal end consequently stronger straightening of the hollow viscera can be obtained.
Intended Use/Indications for Use
Double Balloon Endoscope Model EN-840T
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. Never use this product for any other purposes.
Over-Tube TS-1214C
This product is intended to be used as an accessory with the FUJIFLM Double Balloon Endoscope cleared for use with an Over-tube. The Over-tube is used to assist with the movement of the upper or lower digestive tract. This product is not intended for use for any neonates, infants or children.
Indications for Use Comparison
The proposed overtube and double balloon have the same intended use as the predicate devices.
Technological Comparison
The proposed Over-tube has two side holes on the insertion portion. The holes were added to be able to discharge air trapped between
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
6
the Over-tube and the body cavity from the endoscope insertion inlet to the body. The addition of the two side holes does not affect the safety or efficacy of the device.
The proposed Over-tube has an additional compatible endoscope to use in combination with the over-tube. The endoscope has been tested to be compatible with the over-tube and there are no new concerns for safety or efficacy.
The balloon material on the proposed Over-tube is different than the predicate devices. Biocompatibility testing has been conducted, there are no new concerns for safety or efficacy.
The proposed endoscope has a CMOS image sensor, the predicate devices have CCD. The difference in the image sensor does not affect the safety or efficacy of the proposed endoscope.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
EMC and Electrical safety of the subject device was evaluated using following standards: ANS/AAM ES ES60601-1:2005/(R)2012 and A1:2012 C1:2009/(R)2012 and A2:2010(R)2012 (Consolidated Text), IEC 60601-1-6:2013, and IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-52009, and ISO 10993-10:2010. Biocompatibility testing was performed in accordance with FDA's quidance, 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.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-3:1997, and ISO 8600-4:2014.
The proposed EN-840T is provided non-sterile and must be reprocessed prior to each use. Sterility of the other new accessories TS-13148 and BS-4 were evaluated using the following consensus standards: ISO 11135:2014, ISO 11607-1:2019, ISO 11607-2:2019, ISO 11737-1:2018, and ISO 1:2017. Sterilization was performed in accordance with FDA's guidance, Submission and Review of Sterility Information in Premarket Notification for Devices Labeled as Sterile, issued January 21, 2016.
The subject device met performance specifications in the following additional testing:
| • Field of view | • Bending capability | • Rate of suction | • Working length |
|---|---|---|---|
| • Diameter of forceps channel | • Viewing direction | • Resolution | • LG output |
The subject devices Double Balloon Endoscope EN-840T and Over-tube TS-1214C are substantially equivalent to the predicate devices based on the same intended use, indiar technological characteristics and materials. The differences in technological characteristics and materials between the subject and predicate devices rafety or effectiveness. Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the difference in materials between subject and predicate devices has been validated through biocompatibility testing. Thus, Double Balloon Endoscope EN-840T and Over-tube TS-1214C the subject devices are substantially equivalent to the predicate devices, Fujifilm Double Balloon Endoscope Model EN-580T and Over-tube TS1314B (K223295).