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

• K Number: K143556
• Device Name: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
• Manufacturer: FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
• Date Cleared: 2015-08-20 ( 248 days)
• Product Code: FDA FDF
• Regulation Number: 876.1500

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 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.

Predicate Devices

K040048, K090116

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard endoscope with mechanical and optical components, and the performance studies focus on physical and electrical characteristics, not algorithmic performance. There is no mention of AI, ML, or image processing beyond basic capture and display.

Therapeutic

Yes
The device is described as being used for "endoscopic treatment," and it includes a "forceps channel... to introduce endoscope accessories such as biopsy forceps for endoscopic procedures," which indicates its use in therapeutic interventions beyond just diagnosis or observation.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment."

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including endoscopes, a hood, balloons, an over-tube, and a balloon controller, along with their physical functions and interactions.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for "observation, diagnosis, and endoscopic treatment" of the digestive tract. This involves direct visualization and intervention within the body.
• Device Description: The description details an endoscope with optical components, channels for procedures (biopsy, suction, etc.), and mechanical controls. This is consistent with a device used for direct examination and intervention in vivo.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue samples, or other bodily fluids. IVDs are designed to analyze these types of samples to provide diagnostic information.

The device is an endoscope, which is a medical device used for internal examination and procedures, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

FDA, FDF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

esophagus, stomach, duodenum, small intestine, large intestine, and rectum

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicates.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K040048, K090116

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

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

1

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)
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: [phone] ext. 522498 Facsimile: [phone] E-Mail: [e-mail]

ldentification of the Subject Device:

| Proprietary/Trade Name: | Fujifilm Double Balloon Endoscopes
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.

4

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
(K040048) | EC-450BI5
(K090116) | EN-580T | EN-530T |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The device is intended for
the Optical visualization
of the upper
gastrointestinal tract. This
includes the esophagus,
stomach, duodenum, and
small bowel. It is intended
for the observation,
diagnosis, and
endoscopic treatment. | The device is intended
for the optical
visualization of the
gastrointestinal tract.
This includes the
rectum, large and small
intestines. It is intended
for observation,
diagnosis, and
endoscopic treatment. | 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. | 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. |
| 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
recognizable.
(Distance:5mm) | 0.07mm pitch chart is
recognizable.
(Distance:4mm) | 0.056mm pitch chart is
recognizable.
(Distance:4mm) | 0.063mm pitch chart is
recognizable.
(Distance:4mm) |

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| DESCRIPTION | EN-450P5/20
(K040048) | EC-450BI5
(K090116) | EN-580T | EN-530T |
|---------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| | 1.6mm pitch chart is
recognizable.
(Distance:100mm) | 1.25mm pitch chart is
recognizable.
(Distance:100mm) | 1.6mm pitch chart is
recognizable.
(Distance:100mm) | 1.4mm pitch chart is
recognizable.
(Distance:100mm) |
| 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 |
| Maximum
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 |

| 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-530T
and EN-580T
TY-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 foot
switch FS1. | No | Yes |
| The Video output terminal to the external monitor
to 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.