EVIS Exera III Gastrointestinal Videoscope GIF-1TH190

K232997 · Olympus Medical Systems Corporation · FDS · Jun 19, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K232997
• Device Name: EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
• Applicant: Olympus Medical Systems Corporation
• Product Code: FDS · Gastroenterology, Urology
• Decision Date: Jun 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Device Story

Flexible gastrointestinal videoscope; used for visualization and therapeutic intervention in upper digestive tract. Input: optical images captured via distal CCD sensor; light provided by external source via light guides. Operation: physician manipulates control knobs to actuate distal bending section via internal wires; suction and air/water valves managed manually. Output: real-time video feed displayed on external monitor via video system center. Used in clinical settings by physicians. Facilitates biopsy and other endoscopic therapies via instrument channel. Benefits: enables minimally invasive diagnosis and treatment of upper GI conditions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including reprocessing validation, biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (thermal safety, durability, photobiological safety, image quality, and resolution).

Technological Characteristics

Flexible endoscope; distal end polysulfone; stainless steel air/water nozzle; PTFE/ePTFE instrument channel. Features CCD imaging, NBI capability, and manual angulation. Compatible with CV-190 processor, CLV-190 light source, and OEV262H monitor. Sterilization via ethylene oxide gas. Reprocessing via ultrasonic cleaning/detergent and glutaraldehyde/ACECIDE disinfection.

Indications for Use

Indicated for use within the upper digestive tract (esophagus, stomach, duodenum) for endoscopy and endoscopic surgery in patients requiring such procedures.

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

• EVIS EXERA III VIDEO SYSTEM ENDOSCOPIC VIDEO IMAGING SYSTEM (K112680)

Reference Devices

• PENTAX Video Upper G.I. Scopes (EG-3490K) (K131902)

Submission Summary (Full Text)

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June 19, 2024

Olympus Medical Systems Corporation % Darlene Hull Regulatory Program Manager Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581

Re: K232997

Trade/Device Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS. NWB Dated: May 17, 2024 Received: May 17, 2024

Dear Darlene Hull:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).

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Sincerely,

# Shanil P. Haugen -S

Shanil P. Haugen, PhD 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K232997

Device Name EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190

Indications for Use (Describe)

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment. monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Section 5

# 510(k) Summary

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Date Prepared: 09/22/2023

K232997 Pg 2 of 21

# 510(k) Summary

# 1. GENERAL INFORMATION

■ 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan

- Contact Person: Darlene Hull Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: [phone] Email: Darlene.hull(@olympus.com
- . Manufacturing site: Aizu Olympus Co., Ltd. 3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan

# 2. DEVICE IDENTIFICATION

- Device Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190
- Model Name: GIF-1TH190
- Common Name: GASTROINTESTINAL VIDEOSCOPE
- Regulation Number: 21 CFR §876.1500
- Regulation Name: Endoscope and accessories
- Regulatory Class: Class II
- Product Code: FDS, NWB
- Classification Panel: Gastroenterology/Urology

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# 3. PREDICATE DEVICE

#### ■ Predicate device

| Device name | 510(k) Submitter | 510(k) No. |
|-------------------------------------------------------------------|----------------------------------|------------|
| EVIS EXERA III VIDEO SYSTEM<br>ENDOSCOPIC VIDEO IMAGING<br>SYSTEM | OLYMPUS MEDICAL<br>SYSTEMS CORP. | K112680 |

# ■ Reference device

| Device name | 510(k) Submitter | 510(k) No. |
|-----------------------------------------------|---------------------------|------------|
| PENTAX Video Upper G.I. Scopes (EG-<br>3490K) | PENTAX Medical<br>Company | K131902 |

# 4. DEVICE DESCRIPTION

# ■ General Description of the subject device

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

# ■ Principle of Operation

The GIF-1TH190 consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the GIF-1TH190 is identical to that of the primary predicate device (K112680) and reference device (K131902).

# 1. The Control Section

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The UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob on the control section is connected to the tip of the bending section by a series of wires. By operating the UP/DOWN angulation control knob and the RIGHT/LEFT angulation control knob, the bending section at the distal end bends vertically or parallel to guide the distal end for insertion and observation within the upper digestive tract (including the esophagus, stomach, and duodenum).

The endoscope contains a cylinder to attach a suction valve for suction and air/water valve. Depressing the suction valve will allow the physician to use the endoscope to suction any fluids which are obscuring a good view of the tissue. Therapeutic instruments can be passed through the instrument channel for performing endoscopic biopsy and other therapies. Depressing the air/water valve will allow the doctor to feed water through the endoscope for lens washing. It also can be operated to feed air for removing any fluids or debris adhering to the objective lens.

# 2. The Insertion Section

The insertion section has main parts including the CCD, light guides that bring light from the light source through the endoscope, and instrument channel where therapeutic tools can be pushed in and out (also the suction channel).

# 3. The Connector Section

The connector section connects the endoscope with the light source (CLV-190) through the universal cord.

#### List of device components ■

The GIF-1TH190 will be packed and offered components listed in the Table below. These devices can be used with commercially available Olympus devices as described within the Instruction Manual.

| Model No. | Device Name |
|-----------|----------------------|
| MAJ-855 | Auxiliary water tube |

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| MH-946 | Injection tube |
|---------|---------------------------------------|
| MH-856 | Suction cleaning adapter |
| MH-948 | AW channel cleaning adapter |
| MB-156 | ETO cap |
| MH-944 | Channel plug |
| MB-142 | Mouthpiece |
| BW-412T | Single-use combination cleaning brush |

# 5. INDICATIONS FOR USE

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

# 6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The subject device has the same technological characteristics and design as the predicate device except for the following features:

- Outer Diameter of the Insertion Section
- Inner Diameter of the Instrument Channel
- Materials
- Air/Water Nozzle Flow Path
- Suction Connector Design

Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.

A side-by-side comparison of the subject device and the predicate device is provided

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K232997 Pg 6 of 21

below.

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| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Olympus Medical | Olympus Medical | Pentax Medical | - |
| Device Image | Image: Olympus Medical Device | Image: Olympus Medical Device | Image: Pentax Medical Device | - |
| Classification<br>&<br>Regulation # | Class II<br>21 CFR §876.1500 | SAME | SAME | SAME |
| Product Code | FDS - Gastroscope And<br>Accessories, Flexible/Rigid,<br>NWB - Endoscope,<br>Accessories, Narrow Band<br>Spectrum | FDF – Colonoscope And<br>Accessories, Flexible/Rigid<br>FDS - Gastroscope And<br>Accessories, Flexible/Rigid,<br>NWB - Endoscope,<br>Accessories, Narrow Band<br>Spectrum | FDS - Gastroscope And<br>Accessories, Flexible/Rigid | All devices share the same<br>primary product code FDS |
| Intended Use | Intended to be used with an<br>Olympus video system center, | Intended to be used with an<br>Olympus video system center, | Intended to be used with a | All devices share the same<br>indications for use. |
| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
| | light source, documentation | light source, documentation | PENTAX video processor | |
| | equipment, monitor, | equipment, monitor, | (including light source), | |
| | EndoTherapy accessories (such | EndoTherapy accessories (such | documentation equipment, | |
| | as a biopsy forceps), and other | as a biopsy forceps), and other | monitor, Endotherapy | |
| | ancillary equipment for | ancillary equipment for | Device such as a Biopsy | |
| | endoscopy and endoscopic | endoscopy and endoscopic | Forceps, and other ancillary | |
| | surgery. | surgery. | equipment for endoscopy | |
| | The EVIS EXERA III | The EVIS EXERA III | and endoscopic surgery | |
| | GASTROINTESTINAL | GASTROINTESTINAL | within the upper digestive | |
| | VIDEOSCOPE GIF-1TH190 is | VIDEOSCOPE GIF-H190 is | tract including the | |
| | indicated for use within the | indicated for use within the | esophagus, stomach, and | |
| | upper digestive tract (including | upper digestive tract (including | duodenum. | |
| | the esophagus, stomach, and | the esophagus, stomach, and | | |
| | duodenum) | duodenum). | | |
| Optical System Parameters | | | | |
| Field of View | 140° | SAME | SAME | SAME |
| Direction of View | 0° (Forward viewing) | SAME | SAME | SAME |
| Depth of Field | 2-100mm | SAME | 4-100mm | Same as Primary Predicate |
| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
| Optimum<br>Working Distance | 8.4 mm | SAME | Unknown | Same as Primary Predicate |
| | Resolution at each working distance: on-axis | | | |
| • 2 mm | 14.0 lp/mm | SAME | Unknown | |
| • 8 mm | 17.4 lp/mm | SAME | Unknown | Same as Primary Predicate |
| • 100 mm | 1.4 lp/mm | SAME | Unknown | |
| | Resolution at each working distance: off-axis (70% of the maximum image height) | | | |
| • 2 mm | 15.6 lp/mm | SAME | Unknown | |
| • 8 mm | 8.7 lp/mm | SAME | Unknown | Same as Primary Predicate |
| • 100 mm | 0.6 lp/mm | SAME | Unknown | |
| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
| Distortion<br>(at<br>maximum<br>field<br>of<br>view) | Image: Distortion graph | Image: Legend for distortion graph | Unknown | Same as Primary Predicate |
| Imaging System | | | | |
| Type of Chip | Color CCD | SAME | Unknown | Same as Primary Predicate |
| Number of active | 529,731 | SAME | Unknown | Same as Primary Predicate |
| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
| image Pixels | | | | |
| Size of Pixels | 2.1 μm x 2.1 μm | SAME | Unknown | Same as Primary Predicate |
| Number of Image<br>Sensor Chip | 1 | SAME | Unknown | Same as Primary Predicate |
| NBI observation | Available | SAME | Unknown | The Subject device and primary<br>predicate device have the same<br>imaging units (including image<br>sensor and objective lens) and<br>are compatible imaging systems.<br>NBI<br>function<br>depends<br>on<br>image sensor and objective lens<br>factors, so the effectiveness of<br>the NBI feature is the same<br>between subject device and<br>primary predicate. |
| Insertion Section | | | | |
| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
| Insertion Tube<br>Diameter | Distal end: 10.0 mm<br>Insertion tube: 10.9 mm<br>Insertion tube (Maximum):<br>13.0 mm | Distal end: 9.2 mm<br>Insertion tube: 9.2 mm<br>Insertion tube (Maximum):<br>11.2 mm | Distal end: 11.5 mm<br>Insertion tube: 11.6mm<br>Insertion tube<br>(Maximum): 12.85 mm | The subject device has a larger<br>diameter for the instrument<br>channel compared to the<br>predicate device. To ensure that<br>this difference does not affect<br>the safe reprocessing of the<br>subject device, new validation<br>testing was conducted. Please<br>see Section 14 for the details of<br>the reprocessing validation.<br>Additionally, while the diameter<br>of the instrument channel of the<br>subject device is larger when<br>compared to the predicate<br>device, it is smaller than other<br>devices on the market as is<br>shown by the identified |
| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
| | | | | reference device (K131902<br>Pentax EG-3490K scope) |
| Insertion section<br>Working Length | 1030 mm | SAME | 1050 mm | Same as Primary Predicate |
| Distal<br>End<br>Enlarged | Image: Distal end diagram with labels 1-5 | Image: Distal end diagram with labels 1-5 | Unknown | Similar to predicate. |
| | 1 Air/water nozzle<br>2 Light guide lens<br>3 Objective lens<br>4 Instrument channel outlet | 1 Air/water nozzle<br>2 Light guide lens<br>3 Objective lens<br>4 Instrument channel outlet | | |
| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
| | 5 Auxiliary water channel | 5 Auxiliary water channel | | |
| | Instrument Channel | | | |
| Channel<br>inner<br>diameter | ${\text{\O}}$ 3.7 mm | ${\text{\O}}$ 2.8 mm | ${\text{\O}}$ 3.8 mm | The subject device has a larger<br>diameter for the instrument<br>channel compared to the<br>predicate device. To ensure that<br>this difference does not affect<br>the safe reprocessing of the<br>subject device, new validation<br>testing was conducted. Please<br>see Section 14 for the details of<br>the reprocessing validation.<br><br>Additionally, while the diameter<br>of the instrument channel of the<br>subject device is larger when<br>compared to the predicate<br>device, it is smaller than other |
| | SUBJECT DEVICE:<br>EVIS EXERA III GIF-<br>1TH190<br>(This Submission) | PREDICATE DEVICE:<br>EVIS EXERA III GIF-H190<br>(K112680) | REFERENCE DEVICE:<br>Upper G.I. Scope EG-<br>3490K (K131902) | COMMENTS ON<br>DIFFERENCE(S) |
| | | | | devices on the market as is<br>shown by the identified<br>reference device (K131902<br>Pentax EG-3490K scope) |
| Bending Section | | | | |
| Angulation Range | Up 210° / Down 90°<br>Right 100° /Left 100° | SAME | Up 210° / Down 120°<br>Right 120° /Left 120° | Same as Primary Predicate |
| Connection to Light Source | | | | |
| Configuration | Light guide (LG) cable is not<br>detachable | SAME | SAME | Same as Primary Predicate |
| Venting Connector | | | | |
| Position…