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 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.

AI/ML Overview

This 510(k) summary describes an endoscopic device, and as such, it does not fit the typical format for AI/ML device evaluations. Therefore, many of the requested bullet points, such as MRMC studies, effect size, and specific ground truth details for AI models, are not applicable.

However, based on the provided document, I can extract the following information about the device's performance evaluation against established criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance specifications that were tested, comparing the subject devices (EN-530T and EN-580T) to predicate devices (EN-450P5/20 and EC-450BI5). The statement "Subject devices met performance specifications of the following additional testing" implies that the new devices achieved acceptable performance for each listed criterion.

Acceptance Criteria / Performance Metric	Predicate Device (EN-450P5/20) Performance	Predicate Device (EC-450BI5) Performance	Subject Device (EN-580T) Performance	Subject Device (EN-530T) Performance
Resolution (Distance: 5mm/4mm)	0.09mm pitch chart recognizable (5mm)	0.07mm pitch chart recognizable (4mm)	0.056mm pitch chart recognizable (4mm)	0.063mm pitch chart recognizable (4mm)
Resolution (Distance: 100mm)	1.6mm pitch chart recognizable (100mm)	1.25mm pitch chart recognizable (100mm)	1.6mm pitch chart recognizable (100mm)	1.4mm pitch chart recognizable (100mm)
Field of View	120 degrees	140 degrees	140 degrees	140 degrees
F number	6.21	7.05	7.2	7.2
Distal end diameter	8.5mm	9.4mm	9.4mm	9.4mm
Flexible portion diameter	8.5mm	9.3mm	9.3mm	9.3mm
Max diameter of insertion portion	9.0mm	10mm	10mm	10mm
Number of Light guide fiber	900x2	1200x2	650x2	650x2
Forceps channel diameter	2.2mm	2.8mm	3.2mm	3.2mm
Forceps channel length	2100mm	1620mm	2100mm	2100mm
Working length	2000mm	1520mm	2000mm	2000mm
Total length	2300mm	1820mm	2300mm	2300mm
Processor	VP-4400, VP-4400HD, VP-4440HD	VP-4400, VP-4400HD, VP-4440HD	VP-4440HD	VP-4400, VP-4400HD, 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 Balloon inlet	On the control portion	On the control portion	On the LG connector	On the LG connector

Additional Performance Tests for which "Subject devices met performance specifications":

Time for inflation
Operating pressure
Frictional resistance
Bending capability
Rate of air supply
Rate of water supply
Rate of suction
Viewing direction
Pump air feed pressure
Pump air evacuation pressure
Pump air flow rate

2. Sample size used for the test set and the data provenance:

The document states that "Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicates." However, it does not specify the sample size for this bench testing.
The data provenance is internal bench testing conducted by the manufacturer, Fujifilm Medical Systems, U.S.A., Inc. It is retrospective in the sense that it's testing against established specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The performance tests appear to be objective measurements based on engineering and performance specifications, rather than expert interpretation of images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided and is generally not applicable to bench testing of endoscopic devices which relies on objective measurements against engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the device is an endoscope and not an AI/ML-driven diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is an endoscope and not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance specifications is based on pre-defined engineering and functional specifications and measurements as outlined by relevant consensus standards (e.g., ISO 8600 series) and the manufacturer's internal criteria. For example, resolution is measured by recognizing a pitch chart at a specific distance.

8. The sample size for the training set:

This is not applicable as this is not an AI/ML device requiring a training set in that context.

9. How the ground truth for the training set was established:

This is not applicable as this is not an AI/ML device requiring a training set.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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: (800) 385-4666 ext. 522498 Facsimile: (973) 686-2616 E-Mail: mkmoore@fujifilm.com

ldentification of the Subject Device:

Proprietary/Trade Name:	Fujifilm Double Balloon EndoscopesModels 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 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(K040048)	EC-450BI5(K090116)	EN-580T	EN-530T
Indications for Use	The device is intended forthe Optical visualizationof the uppergastrointestinal tract. Thisincludes the esophagus,stomach, duodenum, andsmall bowel. It is intendedfor the observation,diagnosis, andendoscopic treatment.	The device is intendedfor the opticalvisualization of thegastrointestinal tract.This includes therectum, large and smallintestines. It is intendedfor observation,diagnosis, andendoscopic treatment.	This device is intended for the visualization of theupper and lower digestive tracts. Specifically, forthe observation, diagnosis, and endoscopictreatment of the esophagus, stomach, duodenum,small intestine, large intestine and rectum.	This device is intended for the visualization of theupper and lower digestive tracts. Specifically, forthe observation, diagnosis, and endoscopictreatment of the esophagus, stomach, duodenum,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 isrecognizable.(Distance:5mm)	0.07mm pitch chart isrecognizable.(Distance:4mm)	0.056mm pitch chart isrecognizable.(Distance:4mm)	0.063mm pitch chart isrecognizable.(Distance:4mm)

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DESCRIPTION	EN-450P5/20(K040048)	EC-450BI5(K090116)	EN-580T	EN-530T
	1.6mm pitch chart isrecognizable.(Distance:100mm)	1.25mm pitch chart isrecognizable.(Distance:100mm)	1.6mm pitch chart isrecognizable.(Distance:100mm)	1.4mm pitch chart isrecognizable.(Distance:100mm)
F number	6.21	7.05	7.2	7.2
Distal enddiameter	8.5mm	9.4mm	9.4mm	9.4mm
Flexible portiondiameter	8.5mm	9.3mm	9.3mm	9.3mm
Maximumdiameter ofinsertion portion	9.0mm	10mm	10mm	10mm
Number of Lightguide fiber	900x2	1200x2	650x2	650x2
Forceps channeldiameter	2.2mm	2.8mm	3.2mm	3.2mm
Forceps channellength	2100mm	1620mm	2100mm	2100mm
Working length	2000mm	1520mm	2000mm	2000mm
Total length	2300mm	1820mm	2300mm	2300mm
Processor	VP-4400, VP-4400HD,VP-4440HD	VP-4400, VP-4400HD,VP-4440HD	VP-4440HD	VP-4400, VP-4400HD,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 ofBalloon inlet	On the control portion	On the control portion	On the LG connector	On the LGconnector

DESCRIPTION	PB-10(K040048)	PB-20
Compatible endoscope	EN-450P5/20	EC-450BI5, EN-450P5/20, EN-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-530Tand EN-580TTY-04D for use with 400 Series
Trap for preventing fluid to invade the pump	Trap bottle (TP-01)	Membrane filter (for TY-06D,TY-04D)

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DESCRIPTION	PB-10(K040048)	PB-20
Foot switch terminal to connect the optional footswitch FS1.	No	Yes
The Video output terminal to the external monitorto graphically show the balloon conditions.	No	Yes

DESCRIPTION	DH-14EN(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.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.