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K Number
K100584
Device Name
EVIS EXERAII 180 SYSTEM
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORPORATION
Date Cleared
2010-07-02

(122 days)

Product Code
NWBFDFFDS
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180: This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180: This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N: These instruments have been designed 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 transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II. GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180: These instruments have been designed 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 within the upper digestive tract (including the esophagus, stomach, and duodenum). EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, QLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180Al (Pediatric), These instruments have been designed 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 within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).
Device Description
The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The primary components of the subject system, which are part of this submission, are: - EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 - EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 - EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180 - EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N . - EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 . - EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AI . - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI - . EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (PEDIATRIC) - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AI (PEDIATRIC) - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (PEDIATRIC) - EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (PEDIATRIC) The EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. The EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject gastrointestinal videoscopes and colonovideoscopes. The CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 incorporates Image Enhancement and NBI Observation features.
More Information

K051645

Not Found

No
The summary describes standard video processing and optical filtering techniques (Narrow Band Imaging) for image enhancement, but does not mention any AI or ML algorithms or capabilities.

Yes
Explanation: The device is explicitly stated to be for "endoscopic diagnosis, treatment and video observation" and for "endoscopic surgery," which are therapeutic applications.

Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are designed for "endoscopic diagnosis." The device description also reiterates this purpose.

No

The device description explicitly lists multiple hardware components as the primary components of the system, including light sources, video system centers, and videoscopes. While there is mention of image processing and features like Narrow Band Imaging (NBI), these are described as functions of the hardware components (the light source and video system center), not as a standalone software application.

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

Here's why:

  • Intended Use: The intended use clearly states that the system is for "endoscopic diagnosis, treatment and video observation" within the upper and lower digestive tract. This involves direct visualization and intervention within the body, not the examination of samples taken from the body (which is the core of IVD).
  • Device Description: The description details components like light sources, video system centers, and endoscopes, all of which are used for in-vivo procedures.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on such samples. The focus is on imaging and visualization of internal anatomy.

While the system aids in diagnosis, it does so through direct observation and imaging, not through in vitro testing of biological specimens.

N/A

Intended Use / Indications for Use

EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N
These instruments have been designed 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 transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).

EVIS EXERA II. GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180
These instruments have been designed 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 within the upper digestive tract (including the esophagus, stomach, and duodenum).

EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, QLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180Al (Pediatric), These instruments have been designed 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 within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

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

NWB, FDF, FDS

Device Description

The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.

The primary components of the subject system, which are part of this submission, are:

  • EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
  • EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
  • EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180
  • EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N .
  • EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 .
  • EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 트
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL I
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AI .
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI
  • . EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (PEDIATRIC)
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AI (PEDIATRIC) 1
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (PEDIATRIC) u
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (PEDIATRIC)

The EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is substantially identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. The user can select eihter the standard obsevation mode by pressing the scope switch on the scope or the filter mode switch on the CLV-180. In comparison to conventional white light observation, NBI observation provides the greater contrast of the surface and fine capillary patterns of the mucous membranes.

The EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject gastrointestinal videoscopes and colonovideoscopes. The CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Endoscopic Video Imaging

Anatomical Site

Upper digestive tract (including the esophagus, stomach, and duodenum), Lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

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)

Not Found

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.

K051645

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

§ 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.

0

K100584

JUL-- 2 2010

510(k) SUMMARY

EVIS EXERA II 180 SYSTEM

February 26, 2010

General Information 1

■ Applicant: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047

Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance

Center Valley, PA 18034-0610, USA

Email: stacy.kluesner@olympus.com

Olympus America Inc. 3500 Corporate Parkway

Phone: 484-896-5405 FAX: 484-896-7128

PO Box 610

Official Correspondent: .

월 Manufacturer: Light source/Video system center:

Gastrointestinal videoscope/ Colonovideoscope:

Shirakawa Olympus Co., Ltd. 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishirakawa-gun, Fukushima, Japan 961-8061

Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho. Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595

Establishment Registration No.: 3002808148

2 Device Identification

■ Device Trade Name:

Common Name: 올리

■ Regulation Number:

■ Regulation Name:

를 Regulatory Class:

  • l Classification Panel:
  • Product Code:

EVIS EXERA II 180 SYSTEM

Endoscopic Video Imaging System

21 CFR 876.1500

Endoscope and accessories

II

Gastroenterology/Urology

NWB, FDF, FDS

1

3 Legally Marketed Device to which Substantial Equivalence is Claimed

The following table shows the primary components (part of this submission) of the EVIS EXERA II 180 SYSTEM and each device to which we claim substantial equivalence (predicate device).

Table 16-1 Primary Components & Predicate Devices of the EVIS EXERA II 180 SYSTEM
Subject Device
(Part of this Submission)Predicate DevicePD's
510(k)
No.
EVIS EXERA II XENON LIGHT SOURCE
OLYMPUS CLV-180
(Hereinafter referred to as CLV-180)
(K061313, K062049)EVIS EXERA Xenon Light Source
Olympus CLV-160AK051645
EVIS EXERA II VIDEO SYSTEM
CENTER OLYMPUS CV-180
(Hereinafter referred to as CV-180)
(K061313, K062049)EVIS EXERA Video System Center
Olympus CV-160AK051645
EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GIF TYPE
N180
(Hereinafter referred to as GIF-N180)EVIS EXERA Gastrointestinal
Videoscope XGIF-N160Y2K051645
EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GIF TYPE
XP180N
(Hereinafter referred to as GIF-XP180N)EVIS EXERA Gastrointestinal
Videoscope XGIF-N160Y2K051645
EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GIF TYPE
Q180
(Hereinafter referred to as GIF-Q180)EVIS EXERA Gastrointestinal
Videoscope XGIF-Q160Y5K051645
EVIS EXERA II GASTROINTESTINAL
VIDEOSCOPE OLYMPUS GIF TYPE
H180
(Hereinafter referred to as GIF-H180)EVIS EXERA Gastrointestinal
Videoscope XGIF-H160Y2K051645
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE Q180AL
(Hereinafter referred to as CF-Q180AL)EVIS EXERA Colonovideoscope
XCF-Q160W6LK051645
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE Q180AI
(Hereinafter referred to as CF-Q180AI)EVIS EXERA Colonovideoscope
XCF-Q160W6LK051645
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE H180AL
(Hereinafter referred to as CF-H180AL)EVIS EXERA Colonovideoscope
XCF-H160AY2LK051645
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS CF TYPE H180AI
(Hereinafter referred to as CF-H180AI)EVIS EXERA Colonovideoscope
XCF-H160AY2LK051645
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS PCF TYPE Q180AL
(Hereinafter referred to as PCF-Q180AL)EVIS EXERA Colonovideoscope
XPCF-Q160AY2LK051645
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS PCF TYPE H180AL
(Hereinafter referred to as PCF-H180AL)EVIS EXERA Colonovideoscope
XPCF-Q160AY2LK051645
EVIS EXERA II COLONOVIDEOSCOPE
OLYMPUS PCF TYPE H180AI
(Hereinafter referred to as PCF-H180AI)EVIS EXERA Colonovideoscope
XPCF-Q160AY2LK051645

1 2 . i

2

Device Description ব

The EVIS EXERA II 180 SYSTEM consists of Olympus camera heads, endoscopes, video system center, light source, monitors, EndoTherapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.

The primary components of the subject system, which are part of this submission, are:

  • EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180
  • EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
  • EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180
  • EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE XP180N .
  • EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180 .
  • EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE H180 트
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL I
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AI .
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI
  • . EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AL (PEDIATRIC)
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE Q180AI (PEDIATRIC) 1
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AL (PEDIATRIC) u
  • EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (PEDIATRIC)

The EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 is intended for endoscopic diagnosis, treatment and video observation. The CLV-180 is substantially identical to the predicate device, EVIS EXERA Xenon Light Source CLV-160A cleared under K051645 except that the device size has been slightly changed. The CLV-180 has an optional filter which allows the user to enhance endoscopic white light images by selective processing of green and blue light. This feature, referred to as Narrow Band Imaging (NBI), employs an optical filter to filter the white light spectrum, changing it from a broad band to a narrow band. The user can select eihter the standard obsevation mode by pressing the scope switch on the scope or the filter mode switch on the CLV-180. In comparison to conventional white light observation, NBI observation provides the greater contrast of the surface and fine capillary patterns of the mucous membranes.

The EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 is a video processing system intended for use with Olympus endoscopes such as the subject gastrointestinal videoscopes and colonovideoscopes. The CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.

3

videoscopes and colonovideoscopes. TThe CV-180 contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-180 is identical to the predicate device, EVIS EXERA Video System Center CV-160A, cleared under K051645 except that the device size has been slightly changed.

The CV-180 incorporates the following features:

  1. The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscopes.

  2. The CV-180 processes the NBI image, generated by the CLV-180 light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.

Both the CLV-180 and CV-180 can be used with any specified Olympus flexible and rigid endoscope models, including gastroscopes, ultrasound gastroscopes, duodenoscopes, colonoscopes, sigmoidscopes, choledochoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes for conventional white light endoscopy. TThe subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.

Additionally, when they are combined with the subject endoscopes, both an endoscopic image by white light illumination and that by NBI illumination can be obtained. The user can select either the NBI mode or normal light mode by pressing the scope switch on the scope or the filter mode switch on the CLV-180; the NBI filter in the CLV-180 is inserted on the light axis when the NBI mode is selected.

The subject endoscopes are basically identical to each Olympus predicate device shown in Table 16-1 in intended use, and similar in specifications, performance and materials. The CV-180 identifies an NBI-compatible scope when it is connected by using the Scope ID function provided with the scopes ..

5 Indications for Use

. .

EVIS EXERA II XENON LIGHT SQURCE OLYMPUS CLV-180

This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180

This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N

These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy

4

and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).

EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, OLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180Al (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180AI (Pediatric)

These instruments have been designed 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 within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

Comparison of Technological Characteristics હ

Each primary components of the EVIS EXERA II 180 SYSTEM is basically identical to its predicate device in intended use, and similar in specifications. Comparison between the subject and predicate devices is shown in Table 16-2 to 16-11. The clinical literatures provided in this submission support new sales promotional claims for Barrett's esophagus, colorectal polyp detection and histology prediction.

Table 16-2 Comparison of Specifications

Subject Device: EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180 ~ Predicate Device: EVIS EXERA Xenon Light Source Olympus CLV-160A (K051645)

| Specifications | Subject Device
CLV-180 | Predicate Device
CLV-160A |
|--------------------------------|---------------------------------------|----------------------------------------------|
| Power Supply | 100-120V AC ±10%, 50/60 Hz ±
1Hz | 100-240V AC±10%, 50/60 Hz ±
1Hz |
| Over-current Protection | Identical to the Predicate Device | Fuse type |
| Input Current | Identical to the Predicate
Device. | 500VA (at observation) |
| Size | 383(W)×162(H)×536(D)mm | 381(W)×162(H)×536(D)mm |
| Weight | Identical to the Predicate Device | 15.4kg |
| Compatible Endoscopes | Identical to the Predicate Device | Videoscope
Fiberscope
Rigid scope |
| Examination Lamp | Identical to the Predicate Device | Xenon short-arc lamp
(ozone-free)300W |
| Average Lamp Life | Identical to the Predicate Device | Approximately 500 hours of
continuous use |
| Emergency Lamp | Identical to the Predicate Device | Halogen lamp 12V 35W |
| Average Emergency
Lamp Life | Identical to the Predicate Device | Approximately 500 hours |
| NBI Filter | Identical to the Predicate Device | Provided |
| Brightness Control | Identical to the Predicate Device | Automatic and Manual |
| Automatic Exposure | Identical to the Predicate Device | 17 steps |
| Photography Function | Identical to the Predicate Device | Not provided. |
| Air Feeding | Identical to the Predicate Device | 4 levels available (off, low, mid |

5/12

5

Emergency LampIdentical to the Predicate DeviceHalogen lamp 12V 35W
Average Emergency
Lamp LifeIdentical to the Predicate DeviceApproximately 500 hours
NBI FilterIdentical to the Predicate DeviceProvided
Brightness ControlIdentical to the Predicate DeviceAutomatic and Manual
Automatic ExposureIdentical to the Predicate Device17 steps
Photography FunctionIdentical to the Predicate DeviceNot provided.
Air FeedingIdentical to the Predicate Device4 levels available (off, low, mid, high)
Air Feeding PumpIdentical to the Predicate DeviceDiaphragm type pump
System ConnectorIdentical to the Predicate DeviceProvided
Foot Switch ConnectorIdentical to the Predicate DeviceProvided
CV ConnectorIdentical to the Predicate DeviceProvided
Cooling Air DirectionIdentical to the Predicate DeviceRear
Type of Protection
against Electric ShockIdentical to the Predicate DeviceClass I
Degree of Protection
against Electric Shock of
Applied PartIdentical to the Predicate DeviceTYPE BF or CF applied part
(Depend on applied part)
Applicable StandardIdentical to the Predicate DeviceUL60601-1

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and the comments of the comments of the comments of the comments of

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. - - -

6

Table 16-3 Comparison of Specifications (1/2) Subject Device: EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645)

.

| Specifications | | Subject Device
CV-180 | Predicate Device
CV-160A |
|----------------------------------------------------------------|---------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power Supply | | Identical to the Predicate
Device | 100-240V AC±10%, 50/60 Hz ±
1Hz |
| Over-current Protection | | Identical to the Predicate
Device. | Fuse type |
| Input Current | | Identical to the Predicate
Device. | 150VA |
| Size | | 382(W)×91(H)×490 (D) mm | 370(W)×91(H)×462 (D)mm |
| Weight | | 10 kg | 10.6 kg |
| Compatible Endoscopes | | Identical to the Predicate
Device. | · Fiber/rigid scope via camera
head
· Videoscope |
| | Video Signal
Output | Identical to the Predicate
Device. | RGB:3 Y/C:4 VBS:4
HDTV:1 |
| Observation | Auto White
Balance | Identical to the Predicate
Device. | Automatically adjusted using the
white balance switch.
At the time of connection with
the scope in which Scope ID is
provided, compensation is
performed automatically. |
| | Standard Color
Chart Output | Identical to the Predicate
Device. | Color bar image |
| | Color Tone
Adjustment | Identical to the Predicate
Device. | R: ±8 steps B: ±8 steps
CHROMA: ±8steps |
| | Automatic
Gain
Control (AGC) | Identical to the Predicate
Device. | Provided |
| | Image
Enhancement | Identical to the Predicate
Device. | Edge enhancement: [OFF] [Low]
[Med] [High] 4 levels available
Structure enhancement:[OFF]
[Low] [Med] [High] 4 levels
available |
| | Iris Mode
Selection | Identical to the Predicate
Device. | AUTO/PEAK
EXPOSURE Electrical shutter |
| | Optical Zoom | Identical to the Predicate
Device. | ×1/×1.2 /×1.5: 3-Mode |
| | NBI
Observation | Identical to the Predicate
Device. | NBI function |
| | Picture in
Picture | Identical to the Predicate
Device. | The image of an external device
connected to this instrument is
displayed on the main monitor
together with the endoscopic
image. |
| Communication with Scope | | Identical to the Predicate
Device. | Provided |
| Foot Switch Connector | | Identical to the Predicate
Device. | Provided |
| Specifications | Subject Device
CV-180 | Predicate Device
CV-160A | |
| Record to Memory Card | Identical to the Predicate
Device. | Provided | |
| Type of Protection against
Electric Shock | Identical to the Predicate
Device. | Class I | |
| Degree of Protection against
Electric Shock of Applied Part | Identical to the Predicate
Device. | TYPE BF or CF applied part
(Depend on applied part) | |
| Applicable Standard | Identical to the Predicate
Device. | UL60601-1 | |

.

1000

.

.

.

.

7

Table 16-3 Comparison of Specifications (Continued, 2/2) Subject Device: EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645)

Table 16-4 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-N180

Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 (K051645)

| Specifications | Subject Device
GIF-N180 | Predicate Device
XGIF-N160Y2 |
|-----------------------------------------|-----------------------------------|---------------------------------|
| Field of View | Identical to the Predicate Device | 120° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 4.9mm |
| Outer Diameter of Insertion Tube | Identical to the Predicate Device | 4.9mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 210°
DOWN: 120° |
| Working Length | Identical to the Predicate Device | 1100mm |
| Inner Diameter of Instrument
Channel | Identical to the Predicate Device | 2.0mm |

.

·

.

8

Table 16-5 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-XP180N

| Specifications | Subject Device
GIF-XP180N | Predicate Device
XGIF-N160Y2 |
|-----------------------------------------|----------------------------------------------------|---------------------------------|
| Field of View | Identical to the Predicate Device | 120° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | 5.5mm | 4.9mm |
| Outer Diameter of Insertion Tube | 5.5mm | 4.9mm |
| Bending Section Angulation | UP: 210°
DOWN: 90°
RIGHT: 100°
LFFT: 100° | UP: 210°
DOWN: 120° |
| Working Length | Identical to the Predicate Device | 1100mm |
| Inner Diameter of Instrument
Channel | Identical to the Predicate Device | 2.0mm |

Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 (K051645)

Table 16-6 Comparison of Specifications

Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-Q180 Predicate Device: EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 (K051645)

| Specifications | Subject Device
GIF-Q180 | Predicate Device
XGIF-Q160Y5 |
|-----------------------------------------|-----------------------------------|----------------------------------------------------|
| Field of View | Identical to the Predicate Device | 140° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 8.8mm |
| Outer Diameter of Insertion | Identical to the Predicate Device | 8.8mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 210°
DOWN: 90°
RIGHT: 100°
LEFT: 100° |
| Working Length | Identical to the Predicate Device | 1030mm |
| Inner Diameter of Instrument
Channel | Identical to the Predicate Device | 2.8mm |

. .

9

Table 16-7 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GIF-H180 Predicate Device: EVIS EXERA Gastrointestinalvideoscope XGIF-H160Y2 (K051645)

SpecificationsSubject DevicePredicate Device
GIF-H180XGIF-H160Y2
Field of ViewIdentical to the Predicate Device140°
Depth of FieldIdentical to the Predicate Device2-100mm
Type of CCDIdentical to the Predicate DeviceColor
Outer Diameter of Distal EndIdentical to the Predicate Device9.8mm
Outer Diameter of Insertion TubeIdentical to the Predicate Device9.8mm
Bending Section AngulationIdentical to the Predicate DeviceUP: 210°
DOWN: 90°
RIGHT: 100°
LEFT: 100°
Working LengthIdentical to the Predicate Device1030mm
Inner Diameter of Instrument
ChannelIdentical to the Predicate Device2.8mm

Table 16-8 Comparison of Specifications Subject Device: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE CF-Q180AL, CF-Q180Al

Predicate Device: EVIS EXERA Colonovideoscope XCF-Q160W6L (K051645)

| Specifications | Subject Device
CF-Q180AL, CF-Q180AI | Predicate Device
XCF-Q160W6L |
|-----------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------|
| Field of View | Identical to the Predicate Device | 170° |
| Depth of Field | Identical to the Predicate Device | 3-100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 13.2mm |
| Outer Diameter of Insertion Tube | Identical to the Predicate Device | 12.8mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 180°
DOWN: 180°
RIGHT: 160°
LEFT: 160° |
| Working Length | CF-Q180AL: Identical to the
Predicate Device

CF-Q180AI: 1330mm | 1680mm |
| Inner Diameter of Instrument
Channel | Identical to the Predicate Device | 3.7mm |
| Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. |

.

:

10

Table 16-9 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE CF-H180AL, CF-H180AI Predicate Device: EVIS EXERA Colonovideoscope XCF-H160AY2L (K051645)

| Specifications | Subject Device
CF-H180AL, CF-H180AI | Predicate Device
XCF-H160AY2L |
|-----------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------|
| Field of View | Identical to the Predicate Device | 170° |
| Depth of Field | Identical to the Predicate Device | 2 -100mm |
| Direction of Forward View | Identical to the Predicate Device | 0° |
| Type of CCD | Identical to the Predicate Device | Color |
| Outer Diameter of Distal End | Identical to the Predicate Device | 13.9mm |
| Outer Diameter of Insertion Tube | Identical to the Predicate Device | 12.8mm |
| Bending Section Angulation | Identical to the Predicate Device | UP: 180°
DOWN: 180°
RIGHT: 160°
LEFT: 160° |
| Working Length | CF-H180AL: Identical to the
Predicate Device
CF-H180AI: 1330mm | 1680mm |
| Inner Diameter of Instrument
Channel | Identical to the Predicate Device | 3.7mm |
| Flexibility of Insertion Tube | Identical to the Predicate Device | Adjustable by the user. |

Table 16-10 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE PCF-Q180AL, PCF-Q180AI Predicate Device: EVIS EXERA Colonovideoscope XPCF-Q160AY2L (K051645)

.

..

:
【

.

SpecificationsSubject DevicePredicate Device
PCF-Q180AL, PCF-Q180AIXPCF-Q160Y2L
Field of ViewIdentical to the Predicate Device140°
Depth of FieldIdentical to the Predicate Device3-100mm
Direction of Forward ViewIdentical to the Predicate Device0°
Type of CCDIdentical to the Predicate DeviceColor
Outer Diameter of Distal EndIdentical to the Predicate Device11.3mm
Outer Diameter of Insertion TubeIdentical to the Predicate Device11.5mm
Bending Section AngulationIdentical to the Predicate DeviceUP: 180°
DOWN: 180°
RIGHT: 160°
LEFT: 160°
Working LengthPCF-Q180AL: Identical to the
Predicate Device1680mm
PCF-Q180AI: 1330mm
Inner Diameter of Instrument
ChannelIdentical to the Predicate Device3.2mm
Flexibility of Insertion TubeIdentical to the Predicate DeviceAdjustable by the user.

11

Table 16-11 Comparison of Specifications Subject Device: EVIS EXERA II COLONOVIDEOSCOPE PCF-H180AL, PCF-H180AI Predicate Device: EVIS EXERA Colonovideoscope XPCF-Q160AY2L (K051645)

SpecificationsSubject DevicePredicate Device
PCF-H180AL, PCF-H180AIXPCF-Q160Y2L
Field of ViewIdentical to the Predicate Device140°
Depth of Field2-100mm3-100mm
Direction of Forward ViewIdentical to the Predicate Device0°
Type of CCDIdentical to the Predicate DeviceColor
Outer Diameter of Distal End11.7mm11.3mm
Outer Diameter of Insertion Tube11.8mm11.5mm
Bending Section AngulationIdentical to the Predicate DeviceUP: 180°
DOWN: 180°
RIGHT: 160°
LEFT: 160°
Working LengthPCF-H180AL: Identical to the
Predicate Device
PCF-H180AI: 1330mm1680mm
Inner Diameter of Instrument
ChannelIdentical to the Predicate Device3.2mm
Flexibility of Insertion TubeIdentical to the Predicate DeviceAdjustable by the user.

7 Conclusion

ン

When compared to the predicate device, the EVIS EXERA II 180 SYSTEM does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.

12

Image /page/12/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

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

Olympus Medical Systems Corporation % Ms. Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034-0610

JUL.-2 2010

Re: K100584

Trade/Device Name: EVIS EXERA II 180 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: NWB, FDS, FDF Dated: June 18, 2010 Received: June 22, 2010

Dear Ms. Kluesner:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

13

Page 2 -

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

14

Indications for Use

510(k) Number (if known): Device Name: EVIS EXERA II 180 SYSTEM Indications for Use:

EVIS EXERA II XENON LIGHT SOURCE OLYMPUS CLV-180

This light source has been designed to be used with Olympus endoscopes, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180

This video system center has been designed to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.

Page 1 of

15

Indications for Use

510(k) Number (if known):

Device Name: EVIS EXERA II 180 SYSTEM

Indications for Use:

EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180, OLYMPUS GIF TYPE XP180N

These instruments have been designed 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 transoral or transnasal endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, and duodenum).

EVIS EXERA II. GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE Q180, OLYMPUS GIF TYPE H180

These instruments have been designed 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 within the upper digestive tract (including the esophagus, stomach, and duodenum).

Prescription Use_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

Dhal Lunn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices

510(k) Number.

Page 2 of _ 3

16

Indications for Use

510(k) Number (if known):

Device Name: EVIS EXERA II 180 SYSTEM

Indications for Use:

EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE Q180AL, OLYMPUS CF TYPE Q180AI, OLYMPUS CF TYPE H180AL, QLYMPUS CF TYPE H180AI, OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE Q180AL (Pediatric), OLYMPUS PCF TYPE H180AL (Pediatric), OLYMPUS PCF TYPE H180Al (Pediatric), These instruments have been designed 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 within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

Page 3 of _ 3

Division Sign-Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number