EVIS EXERA 160A SYSTEM

• K Number: K051645
• Device Name: EVIS EXERA 160A SYSTEM
• Manufacturer: OLYMPUS MEDICAL SYSTEMS CORPORATION
• Date Cleared: 2005-10-13 ( 115 days)
• Product Code: NWB FDF FDS
• Regulation Number: 876.1500

Intended Use

The EVIS EXERA 160A system consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. EVIS EXERA Xenon Light Source Olympus CLV-160A: 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 Video System Center Olympus CV-160A: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum). EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5, XGIF-H160Y2: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy 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 Colonovideoscope XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy 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 160A System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy 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 Xenon Light Source Olympus CLV-160A, - EVIS EXERA Video System Center Olympus CV-160A, - EVIS EXERA Gastrointestinal Videoscopes XGIF-N160Y2, XGIF-Q160Y5, XGIF-H160Y2. - EVIS EXERA Colonovideoscopes XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L The EVIS EXERA Xenon Light Source Olympus CLV-160A is intended for endoscopic diagnosis, treatment and video observation. The CLV-160A is basically identical to the predicate device, EVIS Universal Light Source CLV-U40, with the exception that the CLV-160A 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. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A. In comparison to conventional white light observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes. The EVIS EXERA Video System Center Olympus CV-160A is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-160A Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images.

Predicate Devices

K954451, K001766, K011151, K001241

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes image processing techniques (Narrow Band Imaging) but does not mention AI or ML.

Therapeutic

Yes
The system is intended for "treatment" and includes "endo-therapy accessories".

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is "intended for endoscopic diagnosis". Several components are also described as being for "endoscopic diagnosis".

SaMD (Software as a Medical Device)

No

The device is described as a system consisting of multiple hardware components including camera heads, endoscopes, a video system center, a light source, monitors, and accessories. While it includes video signal processing, it is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
• Device Function: The EVIS EXERA 160A system is used for direct visualization and intervention within the digestive tract using endoscopes. It processes and displays images obtained in vivo (within the living body).
• Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens collected from the patient. While the system can be used with accessories like biopsy forceps, the system itself is not performing the diagnostic analysis of the biopsy sample. The analysis of the biopsy sample would be a separate process, likely involving laboratory techniques, which would fall under the scope of IVD.

Therefore, the EVIS EXERA 160A system is a medical device used for endoscopic procedures, but it does not meet the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EVIS EXERA 160A system consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract.

EVIS EXERA Xenon Light Source Olympus CLV-160A: 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 Video System Center Olympus CV-160A: This video system center has been designed to be used with Olympus camera heads, endoscopes, light source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5, XGIF-H160Y2: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy 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 Colonovideoscope XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L: These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy 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)

FDS, FDF, KOG, GCT, NWB

Device Description

The EVIS EXERA 160A System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy 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 Xenon Light Source Olympus CLV-160A,
• EVIS EXERA Video System Center Olympus CV-160A,
• EVIS EXERA Gastrointestinal Videoscopes XGIF-N160Y2, XGIF-Q160Y5, XGIF-H160Y2.
• EVIS EXERA Colonovideoscopes XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L

The EVIS EXERA Xenon Light Source Olympus CLV-160A is intended for endoscopic diagnosis, treatment and video observation. The CLV-160A is basically identical to the predicate device, EVIS Universal Light Source CLV-U40, with the exception that the CLV-160A 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. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A. In comparison to conventional white light observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.

The EVIS EXERA Video System Center Olympus CV-160A is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-160A Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-160A Video System Center is equivalent to predicate Olympus devices which have the same basic functionality. Predicate Olympus devices include the EVIS Video System Center CV-140. The Video System Center CV-140 enabled the physician to utilize a variety of Olympus flexible endoscopes, including colonoscopes, gastroscopes, sigmoidscopes, duodenoscopes and bronchoscopes. The EVIS Video System Center CV-140 contains the video signal processor technology which allowed the various endoscopes to illuminate, enhance, view, record, and transmit video data of endoscopic images.

Compared to these predicate devices, the subject CV-160A incorporates the following changes:

1. The CV-160A is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscope.
2. The CV-160A processes the NBI image, generated by the CLV-160A light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.

Both the CLV-160A and CV-160A can be used with any specified Olympus flexible and rigid endoscope models, including gastroscopes, ultrasound gastroscopes, duodenoscopes, colonoscopes, sigmoidscopes, choledochoscopes, bronchoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes for conventional white light endoscopy. The flexible endoscopes which are the subject of this premarket notification are gastroscope and colonoscope models listed in Table 16-2.

Additionally, when they are combined with the new Gastrointestinal Videoscopes (XGIF-N160Y2, XGIF-Q160Y5, XGIF-H160Y2), and Colonovideoscopes (XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L), 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 mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A; the NBI filter in the CLV-160A is inserted on the light axis when the NBI mode is selected.

The new endoscopes are basically identical to each predicate device shown in Table 16-2 in intended use, and similar in specifications, performance and materials. The CV-160A identifies an NB+compatible scope when it is connected by using the Scope ID function provided with the scopes.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Endoscopic Video Imaging

Anatomical Site

Upper and lower digestive tract (including the esophagus, stomach, duodenum, 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)

The clinical literatures provided in this submission supports the safety and efficacy of NBI imaging in endoscopy.

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.

K954451, K001766, K011151, K001241

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

0

K05/645

OCT 1 3 2005

510(k) SUMMARY EVIS EXERA 160A SYSTEM

1. General Information

Applicant	Olympus Medical Systems Corp.
	2951 Ishikawa-cho, Hachioji-shi,
	Tokyo, 192-8507, Japan
	Establishment Registration No.: 8010047

Laura Storms-Tyler I Official Correspondent Executive Director Regulatory Affairs & Quality Assurance Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA Phone: [phone] FAX: [phone] Email: Laura.storms-tyler @olympus.com Establishment Registration No.: 2429304

■ Manufacturer

Light source/Video system center:	Shirakawa Olympus Co., Ltd.
	3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura,
Nishishirakawa-gun, Fukushima, Japan 961-8061
Establishment Registration No.: 3002808148
Gastrointestinal scope/
Colonoscope:	Aizu Olympus Co., Ltd.
	500 Aza-Muranishi, Ooaza-Iidera, Monden-cho,
Aizuwakamatsu-shi, Fukushima, Japan 965-8520
Establishment Registration No.: 9610595

2. Device Identification

Device Name:	EVIS EXERA 160A System
Common Name:	Endoscopic Video Imaging System

• il ■ Class:
• Classification:

Table 16-1. Classification of the EVIS EXERA 160A System

| Regulation

Number	Regulation Name	Product Code	Classification Panel
876.1500	Endoscope and accessories	FDS- Gastroscope, Gastro-Urology
FDF- Colonoscope, Gastro-Urology
KOG- Endoscope and accessories
GCT- Light Source, Endoscope,
Xenon Arc	Gastroenterology &
Urology

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 160A System and each device to which we claim substantial equivalence (predicate device).

| Subject Device

(Part of this Submission)	Predicate Device	PD's 510(k) No.
EVIS EXERA Xenon Light Source
Olympus CLV-160A	EVIS Universal Light Source CLV-U40	K954451
EVIS EXERA Video System Center
Olympus CV-160A	EVIS Video System Center CV-140	K954451
EVIS EXERA Gastrointestinal
Videoscope XGIF-N160Y2	XGIF-N200H
Gastrointestinal Videoscope	K001766
EVIS EXERA Gastrointestinal
Videoscope XGIF-Q160Y5	EVIS EXERA Gastrointestinal
Videoscope
GIF-Q160Z	K011151
EVIS EXERA Gastrointestinal
Videoscope XGIF-H160Y2
EVIS EXERA Colonovideoscope
XCF-Q160W6L	EVIS EXERA Colonoscope CF-
Q160AL
EVIS EXERA Colonovideoscope
XCF-H160AY2L		K001241
EVIS EXERA Colonovideoscope
XPCF-Q160AY2L	EVIS EXERA Colonovideoscope PCF-
160AL

Table 16-2 Primary Components & Predicate Devices of the EVIS EXERA 160A System

4. Device Description

The EVIS EXERA 160A System consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy 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 Xenon Light Source Olympus CLV-160A, •
• EVIS EXERA Video System Center Olympus CV-160A, .
• EVIS EXERA Gastrointestinal Videoscopes XGIF-N160Y2, XGIF-Q160Y5, . XGIF-H160Y2.
• EVIS EXERA Colonovideoscopes XCF-Q160W6L, XCF-H160AY2L, ، XPCF-Q160AY2L

The EVIS EXERA Xenon Light Source Olympus CLV-160A is intended for endoscopic diagnosis, treatment and video observation. The CLV-160A is basically identical to the predicate device, EVIS Universal Light Source CLV-U40, with the exception that the CLV-160A 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. Both an endoscopic image by standard white light illumination and that by NBI illumination can be obtained. The user can select either the standard observation mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A. In comparison to conventional white light observation provides greater visual contrast of the surface structure and fine capillary patterns of the mucous membranes.

2

The EVIS EXERA Video System Center Olympus CV-160A is a video processing system intended for use with Olympus endoscopes such as the subject endoscopes. The CV-160A Video System Center contains the video signal processing technology which enables the endoscope to illuminate, enhance, view, record and transmit video data of endoscopic images. The CV-160A Video System Center is equivalent to predicate Olympusdevices which have the same basic functionality. Predicate Olympus devices include the EVIS Video System Center CV-140. The Video System Center CV-140 enabled the physician to utilize a variety of Olympus flexible endoscopes, including colonoscopes, gastroscopes, sigmoidscopes, duodenoscopes and bronchoscopes. The EVIS Video System Center CV-140 contains the video signal processor technology which allowed the various endoscopes to illuminate, enhance, view, record, and transmit video data of endoscopic images.

Compared to these predicate devices, the subject CV-160A incorporates the following changes: 1. The CV-160A is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscope.

• 2. The CV-160A processes the NBI image, generated by the CLV-160A light source and captured by the endoscope's Charged Coupled Device (CCD), creating an enhanced image of the tissue's vasculature.
     Both the CLV-160A and CV-160A can be used with any specified Olympus flexible and rigid endoscope models, including gastroscopes, ultrasound gastroscopes, duodenoscopes, colonoscopes, sigmoidscopes, choledochoscopes, bronchoscopes, rhino-laryngoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, ureterorenoscopes, laparo-thoracoscopes for conventional white light endoscopy. The flexible endoscopes which are the subject of this premarket notification are gastroscope and colonoscope models listed in Table 16-2.

Additionally, when they are combined with the new Gastrointestinal Videoscopes (XGIF-N160Y2, XGIF-Q160Y5, XGIF-H160Y2), and Colonovideoscopes (XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L), 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 mode by pressing the scope switch on the scope or the NBI mode switch on the CLV-160A; the NBI filter in the CLV-160A is inserted on the light axis when the NBI mode is selected.

The new endoscopes are basically identical to each predicate device shown in Table 16-2 in intended use, and similar in specifications, performance and materials. The CV-160A identifies an NB+compatible scope when it is connected by using the Scope ID function provided with the scopes.

5. Indications for Use

The EVIS EXERA 160A system consists of Olympus camera heads, endoscopes, video system center, light source, monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the upper and lower digestive tract. The indications for use of each primary component are shown below.

EVIS EXERA Xenon Light Source Olympus CLV-160A

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 Video System Center Olympus CV-160A

3

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

EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5, XGIF-H160Y2

These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy 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 Colonovideoscope XCF-Q160W6L, XCF-H160AY2L, XPCF-Q160AY2L

These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy 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).

6. Comparison of Technological Characteristics

Each primary component of the EVIS EXERA160A System is basically identical to its predicate device in intended use, and similar in specifications except for the addition of the NBI function. Comparison between the subject and predicate devices is shown in Table 16-3 to 16-10. The clinical literatures provided in this submission supports the safety and efficacy of NBI imaging in endoscopy.

Specifications	Suject Deve	Predicate Device CLV-U40
Power Supply	100-240V~ ±10%,
50/60Hz ± 1Hz	120V~ ±10%,
50/60Hz ± 1Hz
Over-current Protection	Fuse type	Circuit breaker type
Input Current	500VA (at observation)	6A ( at observation)
8A ( at flash)
Size	381(W) × 162(H) × 536(D)mm	587(W) × 165(H) × 537(D)mm
Weight	15.4kg	20kg
Compatible Endoscopes	Videoscope
Fiberscope
Rigid scope	Videoscope
Fiberscope
Rigid scope

Table 16-3. Comparison of Specifications Subject Device: EVIS EXERA Xenon Light Source Olympus CLV-160A Predicate Device: EVIS Universal Light Source CLV-U40 (K954451)

4

| Examination Lamp | Xenon short-arc lamp
(ozone-free)300W | Xenon short-arc lamp
(ozone-free)300W | |
|-------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Average Lamp Life | Approximately 500 hours of
continuous use | Approximately 500 hours of
continuous use | |
| Emergency Lamp | Halogen lamp 12V 35W | Halogen lamp(without mirror)
24V 150W | |
| Average Emergency Lamp
Life | Approximately 500 hours | Approximately 500 hours | |
| NBI Filter | NBI filter | NA | |
| Brightness Control | Automatic and Manual | Automatic and Manual | |
| Automatic Exposure | 17 steps | 17 steps + F | |
| Photography Function | - | Provided | |
| Air Feeding | 4 levels available
(off, low, mid, high) | 4 levels available
(off, low, mid, high) | |
| Air Feeding Pump | Diaphragm type pump | Linear type pump | |
| System Connector | Provided | Provided | |
| Foot Switch Connector | Provided | Provided | |
| CV Connector | Provided | Provided | |
| Cooling Air Direction | Rear | Left side | |
| Type of Protection against
Electric Shock | Class? | Class? | |
| Degree of Protection
against Electric Shock of
Applied Part | TYPE BF or CF applied part
(Depend on applied part) | TYPE BF applied part | |
| Applicable Standard | UL60601-1 | UL544 | |
| Specifications | Subject device CV 160A | Predicate Device CV-140 | |
| Power Supply | | 100-240V~ ±10%? 50/60Hz ±1Hz | 120V~ ±10%? 50/60Hz ± 1Hz |
| Over-current Protection | | Fuse type | Circuit breaker type |
| Input Current | | 150VA | 0.8A |
| Size | | 370(W) $\times$ 91(H) $\times$ 462 (D)mm | 450(W) $\times$ 72(H) $\times$ 465(D)mm |
| Weight | | 10.6 kg | 10 kg |
| Compatible Endoscopes | | · Fiber/rigid scope via camera
head
· Videoscope | · Gastro/colono/sigmoid/duodeno/
broncho videoscope
· Fiberscope via video converter |
| | Video Signal
Output | RGB:3 Y/C:4 VBS:4 HDTV:1 | RGB:3 Y/C:3 VBS:4 |
| | Auto White
balance | 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. | Automatically adjusted using the
white balance switch |
| Observation | Standard Color
Chart Output | Color bar image | Color bar image
50% white |
| | Color Tone
Adjustment | R: ±8 steps
B: ±8 steps
CHROMA: ±8steps | R control: ±7 steps
B control: ±7steps
HSR control: ±7steps |
| | Automatic
Gain Control
(AGC) | Provided | Provided |
| | Image
Enhancement | Edge enhancement: [OFF] [Low]
[Med] [High] 4 levels available
Structure enhancement:[OFF] [Low]
[Med] [High] 4 levels available | Image enhancement: [Low] [Med]
[High] 3 levels available |
| | Iris Mode
Selection | AUTO/ PEAK EXPOSURE
Electrical shutter | AVE/ PEAK |
| | Optical Zoom | $\times$ 1/ $\times$ 1.2 / $\times$ 1.5: 3-Mode | |
| | NBI
Observation | NBI function | |
| | Picture in
Picture | The image of an external device
connected to this instrument is
displayed on the main monitor
together with the endoscopic image. | The frozen endoscopic image is
displayed on the sub screen when
the freeze mode is selected. |
| Communication with Scope | | Provided | |
| Foot Switch Connector | | Provided | |
| Record to Memory Card | | Provided | |
| Type of Protection against
Electric Shock | | Class? | Class? |
| Degree of Protection against | | TYPE BF or CF applied part
(Depend on applied part) | |
| | Electric Shock of Applied Part | | TYPE BF applied part |
| Applicable Standard | | UL60601-1 | UL544 |

:

・

:

.

5

Table 16-4. Comparison of Specifications Subject Device: EVIS EXERA Video System Center Olympus CV -160A Predicate Device: EVIS Video System Center CV-140 (K954451)

6

Table 16-5. Comparison of Specifications Subject Device: EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2 Predicate Device: XGIF-N200H Gastrointestinal Videoscope (K001766)

| Specifications | Subject Device
XGIF-N160Y2 | Predicate Device
XGIF-N200H |
|-----------------------------------------|-------------------------------|---------------------------------------------------------|
| Field of View | 120 ° | 120 ° |
| Depth of Field | 3-100mm | 3-100mm |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Monochrome |
| Outer Diameter of Distal End | 4.9mm | 6mm |
| Outer Diameter of Insertion Tube | 4.9mm | 6mm |
| Bending Section Angulation | UP: 210 °
DOWN:120 ° | UP: 180 °
DOWN: 180 °
RIGHT: 160 °
LEFT: 160 ° |
| Working Length | 1100mm | 925mm |
| Inner Diameter of Instrument
Channel | 2.0mm | 2.0mm |

Table 16-6. Comparison of Specifications Subject Device: EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y5 Predicate Device: EVIS EXERA Gastrointestinal Videoscope GIF-Q160Z (K011151)

| Specifications | Subject Device
XGIF-Q160Y5 | Predicate Device
GIF-Q160Z |
|-----------------------------------------|----------------------------------------------------|----------------------------------------------------------|
| Field of View | 140 ° | 140 ° (in WIDE position)
75 ° (in TELE position) |
| Depth of Field | 3-100mm | 8-100mm (in WIDE position)
1.5-3mm (in TELE position) |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 8.8mm | 10.8mm |
| Outer Diameter of Insertion Tube | 8.8mm | 10.9mm |
| Bending Section Angulation | UP:210 °
DOWN:90 °
RIGHT:100 °
LEFT:100 ° | UP: 210°
DOWN: 90 °
RIGHT:100 °
LEFT:100 ° |
| Working Length | 1030mm | 1030mm |
| Inner Diameter of Instrument
Channel | 2.8mm | 2.8mm |
| Zoom Magnification Function | No | Yes |

7

Table 16-7. Comparison of Specifications Subject Device: EVIS EXERA Gastrointestinal Videoscope XGIF-H160Y2 Predicate Device: EVIS EXERA Gastrointestinal Videoscope GIF-Q160Z (K011151)

| Specifications | Subject Device
XGIF-H160Y2 | Predicate Device
GIF-Q160Z |
|--------------------------------------|------------------------------------------------------|----------------------------------------------------------|
| Field of View | 140 ° | 140 ° (in WIDE position)
75 ° (in TELE position) |
| Depth of Field | 2-100mm | 8-100mm (in WIDE position)
1.5-3mm (in TELE position) |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 9.8mm | 10.8mm |
| Outer Diameter of Insertion Tube | 9.8mm | 10.9mm |
| Bending Section Angulation | UP: 210 °
DOWN: 90 °
RIGHT:100 °
LEFT:100 ° | UP: 210 °
DOWN: 90 °
RIGHT:100 °
LEFT:100 ° |
| | Working Length | 1030mm |
| Inner Diameter of Instrument Channel | 2.8mm | 2.8mm |
| Zoom Magnification Function | No | Yes |

Table 16-8. Comparison of Specifications Subject Device: EVIS EXERA Colonovideoscope XCF-Q160W6L Predicate Device: EVIS EXERA Colonovideoscope CF-Q160AL (K001241)

| Specifications | Subject Device
XCF-Q160W6L | Predicate Device
CF-Q160AL |
|-----------------------------------------|-------------------------------|-------------------------------|
| Field of View | 170 ° | 140 ° |
| Depth of Field | 3-100mm | 3 -100mm |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 13.2mm | 12.8mm |
| Outer Diameter of Insertion Tube | 12.8mm | 12.8mm |
| Bending Section Angulation | UP: 180 ° | UP: 180 ° |
| | DOWN: 180 ° | DOWN: 180 ° |
| | RIGHT:160 ° | RIGHT:160 ° |
| | LEFT:160 ° | LEFT:160 ° |
| Working Length | 1680mm | 1680mm |
| Inner Diameter of Instrument
Channel | 3.7mm | 3.7mm |
| Flexibility of Insertion Tube | Adjustable by the user. | Adjustable by the user. |

8

Table 16-9. Comparison of Specifications Subject Device: EVIS EXERA Colonovideoscope XCF-H160AY2L Predicate Device: EVIS EXERA Colonovideoscope CF-Q160AL (K001241)

| Specifications | Subject Device
XCF-H160AY2L | Predicate Device
CF-Q160AL |
|-----------------------------------------|------------------------------------------------------|------------------------------------------------------|
| Field of View | 170 ° | 140 ° |
| Depth of Field | 2 -100mm | 3 -100mm |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 13.9mm | 12.8mm |
| Outer Diameter of Insertion Tube | 12.8mm | 12.8mm |
| Bending Section Angulation | UP: 180 °
DOWN:180 °
RIGHT:160 °
LEFT:160 ° | UP: 180 °
DOWN:180 °
RIGHT:160 °
LEFT:160 ° |
| Working Length | 1680mm | 1680mm |
| Inner Diameter of Instrument
Channel | 3.7mm | 3.7mm |
| Flexibility of Insertion Tube | Adjustable by the user. | Adjustable by the user. |

Table 16-10. Comparison of Specifications Subject Device: EVIS EXERA Colonovideoscope XPCF-Q160AY2L Predicate Device: EVIS EXERA Colonovideoscope PCF-160AL (K001241)

| Specifications | Subject Device
XPCF-Q160Y2L | Predicate Device
PCF-160AL |
|-----------------------------------------|--------------------------------|-------------------------------|
| Field of View | 140 ° | 140 ° |
| Depth of Field | 3-100mm | 3-100mm |
| Direction of Forward View | 0 ° | 0 ° |
| Type of CCD | Color | Color |
| Outer Diameter of Distal End | 11.3mm | 11.3mm |
| Outer Diameter of Insertion Tube | 11.5mm | 11.5mm |
| Bending Section Angulation | UP: 180 ° | UP: 180 ° |
| | DOWN: 180 ° | DOWN: 180 ° |
| | RIGHT:160 ° | RIGHT:160 ° |
| | LEFT:160 ° | LEFT:160 ° |
| Working Length | 1680mm | 1680mm |
| Inner Diameter of Instrument
Channel | 3.2mm | 3.2mm |
| Flexibility of Insertion Tube | Adjustable by the user | Adjustable by the user |

6. Conclusion

When compared to the predicate devices, the EVIS EXERA 160A 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 system.

9

Image /page/9/Picture/1 description: The image shows a black and white logo of the Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter of the circle. Inside the circle is a stylized image of a bird with three lines extending from its body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 2005

Ms. Laura Storms-Tyler Executive Director, Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-3157

Re: K051645

Trade/Device Name: EVIS EXERA 160A System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: NWB, FDS and FDF Dated: September 2, 2005 Received: September 6, 2005

Dear Ms. Storms-Tyler:

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 actively subjects to the for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your I tpp. o tal), it 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 I or 's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

10

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins icter with anow you're ought mains of substantial equivalence of your device to a legally prematication. "The I Drivination for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific actifice for your ac ween the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)		240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)		240-276-0115
21 CFR 892.xxxx	(Radiology)		240-276-0120
Other			240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picaso note the regulation entitled, formation on your responsibilities under the Act from the 807.97). Tou may obtain outer general missistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

11

Indications for Use

510(k) Number (if known): Device Name: EVIS EXERA 160A System Indications For Use:

EVIS EXERA Xenon Light Source Olympus CLV-160A

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 Video System Center Olympus CV-160A.

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

EVIS EXERA Gastrointestinal Videoscope XGIF-N160Y2

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for transoral or transnasal observation and surgery within the upper digestive tract (including the esophagus, stomach and duodenum).

Prescription Use_ (Part 21 CFR 801 Subpart D) ANDIOR

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)

of Reproductive, Abdomin and Radiological Dev 510(k) Number

Page 1 of 2_

12

Indications for Use

510(k) Number (if known):

Device Name: EVIS EXERA 160A System

Indications For Use:

EVIS EXERA Gastrointestinal Videoscope XGIF-Q160Y4, XGIF-Q160Y5, XGIF-H160Y1, XGIE-H160Y2

These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy 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_Colonovideoscope_XCF_Q160W3L,_XCF-Q160W6L,_XCF-H160AYL,_XCE-H160AY2L, XPCF-Q160AYL, XPCF-Q160AY2L

These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy 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)

David A. Larson

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device

Page 2 of 2_______________________________________________________________________________________________________________________________________________________________

510(k) Number