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

Intended 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.

Predicate Devices

• FUJIFILM Double Balloon Endoscope EN-580T (K183683)
• Over-tube TS-13140 (K143556)
• Balloon BS-3 (K213195)
• Tube Kit TY-06D (K143556)

Reference Devices

• Balloon Controller PB-30 (K153483)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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: [e-mail] Telephone: [phone]

# 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 |

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#### 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).