Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
K223295 · Fujifilm Corporaton · FDA · Jan 11, 2023 · Gastroenterology, Urology
Device Facts
Record ID
K223295
Device Name
Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
Applicant
Fujifilm Corporaton
Product Code
FDA · Gastroenterology, Urology
Decision Date
Jan 11, 2023
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Endoscope EN-580T 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-1314B This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities. This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children. Balloon BS-4 This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians. Being attached to the endoscope, this product is inserted into the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane. Do not use this product for any other purposes. This product is not intended for use for any neonates, infants or children. Tube Kit TY-500D This product is the tube kit used in combination with the compatible balloon controller in medical facilities. Do not use this product for any other purpose.
Device Story
System comprises Endoscope EN-580T, Over-tube TS-1314B, Balloon BS-4, and Tube Kit TY-500D. Used in medical facilities by physicians for gastrointestinal visualization and treatment. Endoscope features flexible insertion tube with tip-bending mechanism and forceps channel. Over-tube and balloon are used in combination with endoscope to assist insertion and stabilize distal end against mucous membrane. Tube kit connects over-tube and endoscope to external balloon controller (PB-30). Physician operates endoscope and accessories to navigate digestive tract; visual output viewed via endoscope system. System facilitates endoscopic procedures, potentially improving diagnostic and therapeutic access to small intestine and other GI segments.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing and biocompatibility evaluation. Bench testing included endoscope compatibility, sterility validation (ISO 11135), and material safety assessments per ISO 10993 standards.
Technological Characteristics
Endoscope: flexible tube with bending mechanism. Over-tube/Balloon: Silicone rubber (LSR 2030, ELASTOSIL series), Polyvinylpyrrolidone coating. Sterilization: EO. Connectivity: Mechanical/pneumatic connection to balloon controller. Dimensions: Over-tube 10.8mm/13.2mm/16mm (inner/outer/max); Balloon 35mm OD. Standards: ISO 10993 (biocompatibility), ISO 8600 (endoscopes), ISO 11135 (sterilization).
Indications for Use
Indicated for visualization, observation, diagnosis, and endoscopic treatment of upper and lower digestive tracts (esophagus, stomach, duodenum, small intestine, rectum). Over-tube and balloon accessories assist endoscope insertion and stabilization in digestive tracts. Contraindicated for neonates, infants, or children.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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January 11, 2023
FUJIFILM Corporation % Kotei Aoki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington, MA 02421
K223295 Re:
Trade/Device Name: Endoscope Model EN-580T, Over-Tube TS-1314B, Scope Balloon BS-4, Tube Kit TY-500D Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Codes: FDA, FDF Dated: December 12, 2022 Received: December 12, 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
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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 Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K223295
Device Name Endoscope EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
#### Indications for Use (Describe)
Endoscope EN-580T
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-1314B
This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities.
This product is used to assist with the movement of the scopes inside the upper or lower digestive tract.
Do not use this product for any other purposes.
This product is not intended for use for any neonates, infants or children.
### Balloon BS-4
This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians.
Being attached to the endoscope, this product is inserted into the mouth or anus to stabilize the distal end of the endoscope to the digestive tract's mucous membrane.
Do not use this product for any other purposes.
This product is not intended for use for any neonates, infants or children.
Tube Kit TY-500D
This product is the tube kit used in combination with the compatible balloon controller in medical facilities. Do not use this product for any other purpose.
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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# 510(k) Summary
### FUJIFILM Corporation
### Endoscope EN-580T, Over-tube TS-13140, Balloon BS-3, Tube Kit TY-06D
January 6, 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
# Identification of the Proposed Device:
| Device Names: | Endoscope EN-580T,<br>Over-tube TS-13140, Balloon BS-3, Tube Kit TY-06D |
|-------------------------|-------------------------------------------------------------------------|
| Common Names: | Endoscope, Accessories |
| Product Codes: | FDA, FDF |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Description: | Endoscope and Accessories |
| Review Panel: | Gastroenterology/Urology |
# Predicate Device(s):
- FUJIFILM Double Balloon Endoscope EN-580T (K183683) ●
- Over-tube TS-13140 (K143556) ●
- . Balloon BS-3 (K213195)
- . Tube Kit TY-06D (K143556)
#### Intended Use / Indications for Use:
#### Endoscope EN-580T
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-1314B
This product is used in combination with a FUJIFILM Double Balloon Endoscope to assist the insertion of the Endoscope under the management of physicians in medical facilities.
This product is used to assist with the movement of the scopes inside the upper or lower digestive tract. Do not use this product for any other purposes.
This product is not intended for use for any neonates, infants or children.
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### Balloon BS-4
This product is used in combination with FUJIFILM Double Balloon Endoscopes at medical facilities under the management of physicians.
Being attached to the endoscope, this product is inserted into the digestive tract from the mouth or anus to stabilize the distal end of the endoscope to the digestive tract`s mucous membrane.
Do not use this product for any other purposes.
This product is not intended for use for any neonates, infants or children.
#### Tube Kit TY-500D
This product is the tube kit used in combination with the compatible balloon controller in medical facilities. Do not use this product for any other purpose.
#### Device Description:
The endoscope EN-580T is inserted both perorally and transanally into the gastrointestinal tract during clinical use. The insertion of the device has a mechanism which bends the tip from right to left and up and down, and a flexible tube consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.
The over-tube TS-1314B is introduced in the patient's anatomy with the pairing endoscope. TS-1314B 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-1314B is provided sterile and single-patient use only.
The balloon BS-4 is attached to the balloon-compatible endoscope. The balloon air feed outlet should be contained inside BS-4. The accompanying fixing rubber is used to affix the scope balloon in place. The fixing rubbers are made specifically for BS-4 but should not be mixed with the fixing rubber of other scope balloons. BS-4 is provided sterile and single-patient use only.
The tube kit TY-500D consists of a set of two tubes connects the over-tube to the balloon controller by its air inlet. The other tube connects the same balloon controller to the endoscope by its balloon air feed inlet. TY-500D is only compatible with PB-30, cleared K153483. TY-500D is provided non-sterile. The tubes are not patient-contacting and reusable, but each filter is single-patient use only.
#### Comparison of Technological Characteristics:
The proposed EN-580T differs from the predicate EN-580T in terms of the compatible accessories. The modifications are also proposed in some technical characteristics and the material construction of the said accessories. The proposed device and the predicate device share intended use, principle of operation, and other technical characteristics of the compatible accessories. A summary of modifications is provided below.
A comparison of technological characteristics between the proposed device and the predicate device is provided in Table 1 through Table 6:
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| | Proposed Device<br>Endoscope<br>EN-580T (K223295) | Predicate Device<br>FUJIFILM Double Balloon Endoscope<br>EN-580T (K183683) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is intended for the<br>visualization of the upper and lower<br>digestive tracts, specifically for the<br>observation, diagnosis, and endoscopic<br>treatment of the esophagus, stomach,<br>duodenum, small intestine, large<br>intestine and rectum.<br>Never use this product for any other<br>purposes. | This device is intended for the<br>visualization of the upper and lower<br>digestive tracts. Specifically, for the<br>observation, diagnosis, and endoscopic<br>treatment of the esophagus, stomach,<br>duodenum, small intestine, large<br>intestine, and rectum.<br>Never use this product for any other<br>purposes. |
| Over-tube | TS-13140<br>TS-1314B (proposed) | TS-13140 |
| Scope Balloon | BS-2, BS-3<br>BS-4 (proposed) | BS-2, BS-3 |
| Balloon Controller | PB-30 | PB-20, PB-30 |
| Tube Kit | TY-06D [1]<br>TY-500D (proposed) [2] | TY-06D [1] |
#### Table 1 Comparison of endoscopes – compatible accessories
[1] TY-06D should be paired only with TS-13140.
[2] TY-500D should be paired only with TS-1314B.
# Table 2 Comparison of over-tubes
| Table 2 Comparison of over-tubes | | | |
|--------------------------------------------------------------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Proposed Device<br>Over-tube TS-1314B (K223295) | Predicate Device<br>Over-tube TS-13140 (K143556) |
| Intended Use | | This product is used in combination<br>with a FUJIFILM Double Balloon<br>Endoscope to assist the insertion of<br>the Endoscope under the management<br>of physicians in medical facilities.<br>This product is used to assist with the<br>movement of the scopes inside the<br>upper or lower digestive tract.<br>Do not use this product for any other<br>purposes.<br>This product is not intended for use for<br>any neonates, infants or children. | These sterile Over-tubes are<br>intended to be used as<br>accessories with the<br>FUJINON/FUJIFILM Double<br>Balloon Endoscopes cleared for<br>use with Over-tubes. The Over-<br>tubes are used to assist with the<br>movement of the scopes inside<br>the upper or lower digestive tract.<br>This product is not intended for<br>use for any neonates, infants or<br>children. |
| Working length / Total length | | 1350mm / 1450mm | |
| Insertion portion (diameters)<br>(inner/outer/outer maximum) | | 10.8mm/13.2mm/16mm | |
| Outer diameter of balloon | | 40mm | |
| Working length of balloon | | 50mm | |
| Provided sterile | | Yes, EO Sterilized | |
| Reuse | | No, Single patient use only | |
| Product expiration | | 3 years | 2 years |
| | Water inlet | Luer connector (Female) | |
| Connector type | Air inlet | Luer connector (Male) | Luer connector (Female) |
| Transport and storage<br>Environment | | Temperature: -10 to +60°C<br>Humidity: 30 to 95% (no<br>condensation)<br>Atmosphere: 70 to 106 kPa | Temperature: +10 to +40°C<br>Humidity: 30 to 85% (no<br>condensation)<br>Atmosphere: 70 to 106 kPa |
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# Table 3 Comparison of balloons
| | Proposed Device<br>Balloon BS-4 (K223295) | Predicate Device<br>Balloon BS-3 (K213195) |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This product is used in combination<br>with FUJIFILM Double Balloon<br>Endoscopes at medical facilities under<br>the management of physicians.<br>Being attached to the endoscope, this<br>product is inserted into the digestive<br>tract from the mouth or anus to<br>stabilize the distal end of the<br>endoscope to the digestive tract's<br>mucous membrane.<br>Do not use this product for any other<br>purposes.<br>This product is not intended for use for<br>any neonates, infants or children. | Balloon BS-3 is intended to be<br>used in combination with<br>FUJIFILM double balloon<br>endoscopes to assist with<br>insertion inside the upper or<br>lower digestive tract at medical<br>facilities under the management<br>of physicians.<br>Do not use this product for any<br>other purpose. It is not intended<br>for use for any neonates, infants<br>or children. |
| Outer diameter | 35mm | |
| Thickness | 0.25mm | 0.10mm |
| Working length / Total length | 50mm / 66mm | 40mm / 60mm |
| Provided sterile | Yes, EO Sterilized | |
| Reuse | No, Single patient use only | |
| Product expiration | 3 years | 2 years |
| Transport and storage<br>Environment | Temperature: -10 to +60°C<br>Humidity: 30 to 95% (no<br>condensation)<br>Atmosphere: 70 to 106 kPa | Temperature: +10 to +40°C<br>Humidity: 30 to 85% (no<br>condensation)<br>Atmosphere: 70 to 106 kPa |
# Table 4 Comparison of tube kits
| | | Proposed Device<br>Tube Kit TY-500D (K223295) | Predicate Device<br>Tube Kit TY-06D (K143556) |
|--------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | This product is the tube kit used in<br>combination with the compatible<br>balloon controller in medical facilities.<br>Do not use this product for any other<br>purpose. | This product is the tube kit used in<br>combination with the balloon<br>controller PB-20 in medical facilities.<br>Do not use this product for any other<br>purpose. |
| Working<br>length | Over-tube side | 2050mm | |
| | Scope side | 1300mm | |
| Connector<br>type | Balloon<br>controller side | Luer connector (Female) | |
| | Over-tube side | Luer connector (Female) | Luer connector (Male) |
| | Scope side | Dedicated connector | |
| Provided sterile | | | No |
| Reuse | | Tube: Yes<br>Filter: No, Single patient use only | |
| Transport and storage<br>Environment | | Temperature: -10 to +45°C<br>Humidity: 30 to 95%RH (no dew condensation)<br>Atmosphere: 70 to 106 kPa | |
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| | Proposed Device<br>Over-tube TS-1314B (K223295) | Predicate Device<br>Over-tube TS-13140 (K143556) | Contact<br>type |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------|
| Balloon | Silicone rubber<br>(LSR 2030) | Natural rubber<br>(Fujilatex DPNR)<br>ABSORBO HP | Direct |
| Adhesive potion | Bond: Silicon series adhesive agent<br>Adhesive coat: Silicon series adhesive<br>agent<br>(Compound ratio A:B = 5:1)<br>A) Silicon Rubber (YE3085)<br>B) Silicon Sealing Agent (KE-42-T) | Bond: Silicone compound<br>(KE445B)<br>Adhesive coat: N/A | [1] |
| Tube | Tube: Silicon rubber<br>(ELASTOSIL WS 9802 C)<br>Coating: Polyvinylpyrrolidone<br>(K Value:90) | Tubing: Polyurethane<br>(E380MNAT)<br>Coating: Polyvinylpyrrolidone<br>(Kollidon 30) | Direct |
| Tip Ring | Silicon rubber<br>(Compound ratio C:D = 1:1)<br>C) Silicon Rubber<br>(ELASTOSIL R 401/90 OH)<br>D) Silicon Rubber w/ Barium Sulfate<br>(ELASTOSIL EL 7704) | | Direct |
| Handle | Handle: Silicon rubber<br>(ELASTOSIL WS 9802 C)<br>Coating: Polyvinylpyrrolidone<br>(K Value:90) | | Indirect |
| Check Valve | Silicon rubber<br>(ELASTOSIL WS 9402 C) | | Indirect |
| Water feed inlet | Silicon rubber<br>(ELASTOSIL WS 9802 C) | | Indirect |
| Endoscope<br>Insertion inlet | Silicon rubber<br>(ELASTOSIL WS 9402 C)<br>Polyvinylpyrrolidone<br>(K Value:90) | | Indirect |
Table 5 Material construction comparison of the over-tubes
[1] In the adhesive portion of the predicate device, the bonded portion is not coated and considered "Direct" contact type. On the other hand, the adhesive portion of the proposed device is coated. Consequently, the bonded portion is not patient contacting while the coating over the bonded portion is considered "Direct" contact type.
#### Table 6 Material construction comparison of the balloons
| | Proposed Device<br>Balloon BS-4 (K223295) | Predicate Device<br>Balloon BS-3 (K213195) | Contact<br>type |
|---------------|-------------------------------------------|--------------------------------------------|-----------------|
| Balloon | Silicone rubber<br>(LSR 2030) | Natural rubber<br>(Fujilatex DPNR) | Direct |
| | | ABSORBO HP | Direct |
| Fixing rubber | Silicone rubber<br>(ELASTOSIL WS 9502 C) | Natural rubber<br>(Fujilatex DPNR) | Direct |
| | | ABSORBO HP | Direct |
{8}------------------------------------------------
#### Performance Data:
Sterility of TS-1314B and BS-4 were evaluated using the following consensus standards: ISO 11135:2014. ISO 10993-7:2008/AMD1:2019, ISO 11607-1:2019, ISO 11607-2:2019, ISO 11737-1:2018, and ISO 11138-1:2017.
The new accessories are made of different materials compared to the respective predicate devices. Biocompatibility of each new accessory was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-12:2012. 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.
Endoscope specific testing was conducted according to ISO 8600-1:2015. ISO 8600-3:2019, and ISO 8600-4:2014. Endoscope compatibility with the new accessories was conducted with acceptable results.
#### Conclusions:
The proposed devices Endoscope EN-580T, Over-tube TS-13140, Balloon BS-3, and Tube Kit TY-06D shares the same intended use as the respective predicate devices. The endoscope's compatibility with the new accessories was evaluated. The differences among the accessories and their respective predicate devices have been evaluated for the biocompatibility and bench testing with acceptable results. Thus, the proposed device Endoscope EN-580T, Over-tube TS-13140, Balloon BS-3, and Tube Kit TY-06D are substantially equivalent to the respective predicate devices, FUJIFILM Double Balloon Endoscope EN-580T (K183683), Over-tube TS-13140 (K143556), Balloon BS-3 (K213195), and Tube Kit TY-06D (K143556).
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
