Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T

K143556 · Fujifilm Medical Systems U.S.A, Inc. · FDA · Aug 20, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K143556
• Device Name: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
• Applicant: Fujifilm Medical Systems U.S.A, Inc.
• Product Code: FDA · Gastroenterology, Urology
• Decision Date: Aug 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fujifilm Double Balloon Endoscopes are intended for 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.

Device Story

Fujifilm Double Balloon Endoscopes (EN-530T, EN-580T) are flexible endoscopes used for visualization and treatment of the gastrointestinal tract. The system includes an endoscope, over-tube, balloon, and balloon controller (PB-20). The endoscope features a CCD image sensor, glass fiber illumination, and multiple channels (air/water, suction, balloon, forceps). The balloon controller inflates/deflates balloons on the endoscope and over-tube to facilitate navigation. Used in clinical settings by physicians, the device connects to a video processor and light source to display images on a monitor. The physician uses the visual output to perform diagnostic or therapeutic procedures. The double-balloon mechanism allows for deep enteroscopy, potentially benefiting patients by enabling access to areas of the small intestine otherwise difficult to reach.

Clinical Evidence

Bench testing only. Performance evaluated against consensus standards including ANSI/AAMI ES60601-1, IEC 60601 series, ISO 10993 (biocompatibility), and ISO 8600 (endoscopes). Testing confirmed specifications for inflation time, operating pressure, frictional resistance, field of view, bending capability, flow rates (air/water/suction), and resolution.

Technological Characteristics

Materials: EPDM, Silicone rubber (TSE260-5U), JSR EP21. Sensing: CCD image sensor (1/9.7"). Illumination: Glass fiber bundles. Connectivity: 500 series connector to video processor/light source. Sterilization: Compliant with AAMI/ANSI/ISO 11135-1 and 17665-1. Dimensions: 9.4mm distal end, 9.3mm flexible portion, 3.2mm forceps channel. Energy: 120V 60Hz (balloon controller).

Indications for Use

Indicated for patients requiring visualization, diagnosis, and endoscopic treatment of the upper and lower digestive tracts, including esophagus, stomach, duodenum, small intestine, large intestine, and rectum.

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

• Fujinon, Inc., Double Balloon Enteroscope, Model EN-450P5/20 (K040048)
• Fujinon, Inc., Double Balloon Enteroscope, Model EC-450B15 (K090116)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 20, 2015

Fujifilm Medical Systems, U.S.A., Inc. Mary Moore Senior Director, Regulatory Affairs and Ouality Assurance, Endoscopy 10 High Point Drive Wayne, NJ 07470

Re: K143556

> Trade/Device Name: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDA, FDF Dated: July 13, 2015 Received: July 13, 2015

Dear Mary Moore,

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K143556

#### Device Name

Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T

Indications for Use (Describe)

The Fujifilm Double Balloon Endoscopes are intended for 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## 510(k) SUMMARY

## Fujifilm Double Balloon Endoscope Models EN-530T and EN-580T

Date: December 15, 2014

### Submitter's Information

FUJIFILM Medical Systems U.S.A., Inc., Endoscopy Division 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293

## Contact Person:

Mary K. Moore Senior Director, Requlatory Affairs and Quality Assurance Telephone: [phone] ext. 522498 Facsimile: [phone] E-Mail: [e-mail]

## ldentification of the Subject Device:

| Proprietary/Trade Name: | Fujifilm Double Balloon Endoscopes<br>Models EN-530T and EN-580T |
|-------------------------|------------------------------------------------------------------|
| Common Name: | Enteroscope |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |

#### Classification

Enteroscope and accessories, 21 CFR § 876.1500, Product Codes: FDA, FDF

#### Predicate Devices

- · Fujinon, Inc., Double Balloon Enteroscope, Model EN-450P5/20 (K040048)
- · Fujinon, Inc., Double Balloon Enteroscope, Model EC-450B15 (K090116)

#### Intended Use / Indications for Use

The Fujifilm Double Balloon Endoscopes, Models EN-580T are 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.

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## Device Description

The Fujifilm Double Balloon Endoscopes, Models EN-530T and EN-580T and related accessories consist of double balloon endoscopes (models EN-530T and EN-580T), a hood (model DH-17EN), a balloon (model BS-2), an over-tube (model TS-13140), and a balloon controller (model PB-20).

The endoscopes are comprised of three general sections; an operation section, an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains glass fiber bundles, several channels and a charged couple device (CCD) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the gastrointestinal cavity. This provides adequate light to the CCD image sensor to capture an image and display it on the monitor. The endoscope also contains several channels such as an air/water channel, a suction channel, a balloon channel and a forceps channel. The balloon controller is used to inflate or deflate the balloons on the distal end of the endoscope and on the over-tube through the balloon channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps for endoscopic procedures. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and the light source. The subject models are used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscope accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, and cart). The hood is an optional accessory that is attached to the distal end of the endoscopes and is intended to maintain the field of view during the endoscopic procedure.

The minor modifications to the endoscopes were made for the purpose of overall product enhancement and general technological advancement.

## Technological Characteristics

A comparison of the technological characteristics between the subject and predicate devices is provided in the table below.

| DESCRIPTION | EN-450P5/20<br>(K040048) | EC-450BI5<br>(K090116) | EN-580T | EN-530T |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The device is intended for<br>the Optical visualization<br>of the upper<br>gastrointestinal tract. This<br>includes the esophagus,<br>stomach, duodenum, and<br>small bowel. It is intended<br>for the observation,<br>diagnosis, and<br>endoscopic treatment. | The device is intended<br>for the optical<br>visualization of the<br>gastrointestinal tract.<br>This includes the<br>rectum, large and small<br>intestines. It is intended<br>for observation,<br>diagnosis, and<br>endoscopic treatment. | This device is intended for the visualization of the<br>upper and lower digestive tracts. Specifically, for<br>the observation, diagnosis, and endoscopic<br>treatment of the esophagus, stomach, duodenum,<br>small intestine, large intestine and rectum. | This device is intended for the visualization of the<br>upper and lower digestive tracts. Specifically, for<br>the observation, diagnosis, and endoscopic<br>treatment of the esophagus, stomach, duodenum,<br>small intestine, large intestine and rectum. |
| Insertion route | Per oral | Trans anal | Per oral or trans anal | Per oral or Trans anal |
| CCD Type | 1/6" | 1/6" | 1/9.7" double pixel | 1/9.7" |
| Field of view | 120 degrees | 140 degrees | 140 degrees | 140 degrees |
| Resolution | 0.09mm pitch chart is<br>recognizable.<br>(Distance:5mm) | 0.07mm pitch chart is<br>recognizable.<br>(Distance:4mm) | 0.056mm pitch chart is<br>recognizable.<br>(Distance:4mm) | 0.063mm pitch chart is<br>recognizable.<br>(Distance:4mm) |

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| DESCRIPTION | EN-450P5/20<br>(K040048) | EC-450BI5<br>(K090116) | EN-580T | EN-530T |
|---------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| | 1.6mm pitch chart is<br>recognizable.<br>(Distance:100mm) | 1.25mm pitch chart is<br>recognizable.<br>(Distance:100mm) | 1.6mm pitch chart is<br>recognizable.<br>(Distance:100mm) | 1.4mm pitch chart is<br>recognizable.<br>(Distance:100mm) |
| F number | 6.21 | 7.05 | 7.2 | 7.2 |
| Distal end<br>diameter | 8.5mm | 9.4mm | 9.4mm | 9.4mm |
| Flexible portion<br>diameter | 8.5mm | 9.3mm | 9.3mm | 9.3mm |
| Maximum<br>diameter of<br>insertion portion | 9.0mm | 10mm | 10mm | 10mm |
| Number of Light<br>guide fiber | 900x2 | 1200x2 | 650x2 | 650x2 |
| Forceps channel<br>diameter | 2.2mm | 2.8mm | 3.2mm | 3.2mm |
| Forceps channel<br>length | 2100mm | 1620mm | 2100mm | 2100mm |
| Working length | 2000mm | 1520mm | 2000mm | 2000mm |
| Total length | 2300mm | 1820mm | 2300mm | 2300mm |
| Processor | VP-4400, VP-4400HD,<br>VP-4440HD | VP-4400, VP-4400HD,<br>VP-4440HD | VP-4440HD | VP-4400, VP-4400HD,<br>VP-4440HD |
| LG Connector | 400 series connector | 400 series connector | 500 series connector | 500 series connector |
| Video Connector | 400 series connector | 400 series connector | 500 series connector | 500 series connector |
| Location of<br>Balloon inlet | On the control portion | On the control portion | On the LG connector | On the LG<br>connector |

| DESCRIPTION | PB-10<br>(K040048) | PB-20 |
|----------------------------------------------|-----------------------|------------------------------------------------------------------------------|
| Compatible endoscope | EN-450P5/20 | EC-450BI5, EN-450P5/20, EN-<br>450T5, EN-530T, EN-580T |
| Compatible overtube | TS-12140 | TS-12140,TS-13140,TS-13101 |
| Compatible Balloon | BS-1 | BS-2 |
| Power supply | 120V 60Hz | 120V 60Hz |
| Current consumption | 0.37A | 0.58A |
| Dimensions | W300 x H200 X D300 mm | W350 x H130 X D420 mm |
| Weight | 8.7kg | 10kg |
| Set air supply pressure | 5.6kPa | 5.6kPa |
| Warning pressure | 8.2kPa | 8.2kPa |
| Tubing | TY-01 and TY-02 | TY-06D for use with EN-530T<br>and EN-580T<br>TY-04D for use with 400 Series |
| Trap for preventing fluid to invade the pump | Trap bottle (TP-01) | Membrane filter (for TY-06D,<br>TY-04D) |

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| DESCRIPTION | PB-10<br>(K040048) | PB-20 |
|--------------------------------------------------------------------------------------------------|--------------------|-------|
| Foot switch terminal to connect the optional foot<br>switch FS1. | No | Yes |
| The Video output terminal to the external monitor<br>to graphically show the balloon conditions. | No | Yes |

| DESCRIPTION | DH-14EN<br>(K040048) | DH-17EN | |
|-----------------------------------------|----------------------|----------------|-----------------|
| Outer diameter | 10.8mm | 11.5mm | |
| Maximum diameter of attaching endoscope | 12.5mm | 13.5mm | |
| Total length | 8.0mm | 8.0mm | |
| Distance from the tip | 1.5mm | 1.5mm | |
| Inner diameter of attaching portion | 8.8mm | 9.5mm | |
| Inner diameter of distal end | 7.8mm | 8.5mm | |
| Sterility | Non Sterilized | Non Sterilized | |
| Reuse or single use | Single Use | Single Use | |
| Material | Distal portion | EPDM | Silicone rubber |
| | Attaching portion | JSR EP21 | TSE260-5U |

The subject devices are also used with the company's previously cleared balloon model BS-2 (K090116).

## Substantial Equivalence

The subject and predicate endoscopes have the same intended use/indications for use of visualization of the digestive tracts. Per oral and trans anal insertion routes were already cleared in the company's predicate devices K040048 and K090116, respectively. They also have similar technological characteristics as shown in the table above. Both use the Double Balloon Endoscope system to access the gastrointestinal tracts. Device dimensions and visualization technology are also similar. The technological differences between the subject endoscopes and the predicate devices raise no new questions of safety or effectiveness. Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicates.

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## Performance Data

EMC and electrical safety of the subject devices were evaluated using the following consensus standards: ANSI/AAMI ES60601-1:2005; IEC 60601-1-2:2007; IEC 60601-1-6:2010; and IEC 60601-2-18:2009.

Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009; ISO 10993-5:2009; and ISO 10993-10:2010.

Cleaning, disinfection, and sterilization were evaluated according to the following consensus standards: AAMI TIR30:2011; AAMI TIR12:2010; AAMI/ANSI/ISO 11135-1:2007; and AAMI/ANSI/ISO 17665-1:2006.

Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2013; ISO 8600-3:1997; and ISO 8600-4:1997.

Subject devices met performance specifications of the following additional testing:

- . Time for inflation
- Operating pressure .
- Frictional resistance ●
- Field of view
- Bending capability ●
- Rate of air supply ●
- Rate of water supply ●
- Rate of suction ●
- Viewing direction ●
- . Resolution
- Pump air feed pressure .
- Pump air evacuation pressure ●
- Pump air flow rate .

#### Conclusions

The subject devices are substantially equivalent to the predicates based on intended use/indications for use and technological characteristics. The minor technological differences between the propose endoscopes and its predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicates.