EVIS EXERA II 180 SYSTEM

K062049 · Olympus Medical Systems Corporation · NWB · Sep 22, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062049
• Device Name: EVIS EXERA II 180 SYSTEM
• Applicant: Olympus Medical Systems Corporation
• Product Code: NWB · Gastroenterology, Urology
• Decision Date: Sep 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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 source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation. VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, XCYF TYPE VQ These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

Device Story

System comprises xenon light source (CLV-180), video system center (CV-180), and cysto-nephro videoscopes (CYF-V2, CYF-VA2, XCYF-VQ). Inputs: optical signals captured by endoscope CCD. Processing: CV-180 performs video signal processing, image enhancement, and NBI (Narrow Band Imaging) processing. NBI uses optical filter in CLV-180 to narrow white light spectrum, enhancing visualization of mucosal surface structures and capillary patterns. Outputs: endoscopic video displayed on monitors for physician observation. Used in clinical settings by physicians for urological diagnosis and treatment. Scope ID function enables automatic scope recognition and white balance. System provides standard white light and NBI modes, selectable via scope or light source switches. Benefits include improved visual contrast of tissue vasculature.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by comparison of specifications, design, and intended use to predicate devices.

Technological Characteristics

System components: Xenon short-arc lamp (300W), CCD-based video endoscopes. NBI function uses optical filter for spectral narrowing. Connectivity: Scope ID function for automatic recognition. Electrical safety: Class I, Type BF/CF applied parts. Standards: UL60601-1. Dimensions and weight specified for each component. Sterilization: Not specified.

Indications for Use

Indicated for endoscopic diagnosis, treatment, and video observation of the bladder, urethra, ureter, and kidney using Olympus endoscopes and ancillary equipment.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• EVIS EXERA XENON LIGHT SOURCE OLYMPUS CLV-160A (K051645)
• EVIS EXERA VIDEO SYSTEM CENTER OLYMPUS CV-160A (K051645)
• VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V (K021074)
• VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE VA (K021074)

Submission Summary (Full Text)

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K062049
Pag. otto

# OLYMPUS

510(k) SUMMARY

# EVIS EXERA II 180 SYSTEM

SEP 2 2 2006

:

# 1. General Information

| ■ Applicant | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan<br>Establishment Registration No: 8010047 | | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| ■ Official Correspondent | Laura Storms-Tyler<br>Executive Director, Regulatory Affairs & Quality Assurance<br>OLYMPUS AMERICA INC.<br>3500 Corporate Parkway PO Box 610<br>Center Valley PA 18034-0610<br>Phone: [phone]<br>Facsimile: [phone]<br>Email: Laura.storms-tyler @olympus.com<br>Establishment Registration No: 2429304 | | | | |
| ■ Manufacturer | | | | | |
| Light source/Video system center: | SHIRAKAWA OLYMPUS CO., LTD.<br>3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura,<br>Nishishirakawa-gun, Fukushima, Japan 961-8061<br>Establishment Registration No: 3002808148 | | | | |
| Cysto-Nephroscopes: | AIZU OLYMPUS CO., LTD.<br>500 Aza-Muranishi, Ooaza-lidera, Monden-cho,<br>Aizuwakamatsu-shi, Fukushima, Japan<br>965-8520<br>Establishment Registration No: 9610595 | | | | |
| ■ Date Prepared | June 27, 2006 | | | | |
| 2. Device Identification | | | | | |
| ■ Device Name: | EVIS EXERA II 180 SYSTEM | | | | |
| ■ Common Name: | Endoscopic Video Imaging System | | | | |
| ■ Class: | II | | | | |
| ■ Regulation Number/Name: | 876.1500 Endoscope and accessories | | | | |
| ■ Product Code: | NWB and FAJ | | | | |
| ■ Classification Panel: | Gastroenterology/Urology | | | | |
| OLYMPUS MEDICAL SYSTEMS CORP. | | | | | |

2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE [phone], TELEFAX [phone]

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# 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<br>(Part of this Submission) | Predicate Device | PD's<br>510(k) No. |
|--------------------------------------------------------|---------------------------------------------------|--------------------|
| EVIS EXERA II XENON LIGHT SOURCE<br>OLYMPUS CLV-180 | EVIS EXERA XENON LIGHT SOURCE<br>OLYMPUS CLV-160A | K051645 |
| EVIS EXERA II VIDEO SYSTEM CENTER<br>OLYMPUS CV-180 | EVIS EXERA VIDEO SYSTEM CENTER<br>OLYMPUS CV-160A | |
| VISERA CYSTO-NEPHRO VIDEOSCOPE<br>OLYMPUS CYF TYPE V2 | VISERA CYSTOVIDEOSCOPE OLYMPUS<br>CYF TYPE V | |
| VISERA CYSTO-NEPHRO VIDEOSCOPE<br>OLYMPUS CYF TYPE VA2 | VISERA CYSTOVIDEOSCOPE OLYMPUS<br>CYF TYPE VA | K021074 |
| VISERA CYSTO-NEPHRO VIDEOSCOPE<br>OLYMPUS XCYF TYPE VQ | | |

### 4. Device Description

The EVIS EXERA II 180 System consists of Olympus camera heads, endoscopes, video r no ENET and The 100 - , monitors, endo-therapy accessories and other ancillary equipment. This system is intended for endoscopic diagnosis, treatment and video observation of the bladder, urethra, ureter, and kidney.

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

- EVIS EXERA 11 Xenon Light Source Olympus CLV-180, •
- EVIS EXERA II Video System Center Olympus CV-180, .
- VISERA Cysto-Nephro Videoscope Olympus CYF type V2, CYF type VA2, and XCYF . type VQ (hereinafter referred to as CYF-V2, CYF-VA2 and XCYF-VQ)

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. 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-180. In comparison to conventional white light observation, NBI observation provides greater visual contrast of the surface structure 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 endoscopes. The CV-180 Video System Center contains the video signal processing technology which enables the

### OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE [phone], TELEFAX [phone]

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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. The flexible endoscopes which are the subject of this premarket notification are cysto-nephroscope models listed in Table 16-1.

Additionally, when they are combined with the new cysto-nephro videoscopes (CYF-V2, CYF-VA2, and XCYF-VQ ), 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-180; the NBI filter in the CLV-180 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 16-1 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 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 source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

### VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, XCYF TYPE VQ

These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and otherancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

#### OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE [phone], TELEFAX [phone] . 3/6

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# 6. Comparison of Technological Characteristics

Each primary component of the EVIS EXERA II 180 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 16-2 to 16-5.

| Predicate Device: EVIS EXERA Xenon Light Source Olympus CLV-160A (K051645) | | | |
|----------------------------------------------------------------------------|---------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specifications | Subject Device<br>CLV-180 | Predicate Device<br>CLV-160A | |
| Power Supply | 100-120V~±10%, 50/60 Hz±1Hz | 100-240V~±10%,<br>50/60Hz±1Hz | |
| Over-current Protection | Same as PD. | Fuse type | |
| Input Current | Same as PD. | 500VA (at observation) | |
| Size | 383(W)×162(H)×536(D)mm | 381(W) × 162(H) × 536(D)mm | |
| Weight | Same as PD. | 15.4kg | |
| Compatible Endoscopes | Same as PD. | Videoscope, Fiberscope,<br>Rigid scope | |
| Examination Lamp | Same as PD. | Xenon short-arc lamp<br>(ozone-free)300W | |
| Average Lamp Life | Same as PD. | Approximately 500 hours of<br>continuous use | |
| Emergency Lamp | Same as PD. | Halogen lamp 12V 35W | |
| Average Emergency Lamp<br>Life | Same as PD. | Approximately 500 hours | |
| NBI Filter | Same as PD. | Provided. | |
| Brightness Control | Same as PD. | Automatic and Manual | |
| Automatic Exposure | Same as PD. | 17 steps | |
| Photography Function | Same as PD. | Not provided. | |
| Air Feeding | Same as PD. | 4 levels available<br>(off, low, mid, high) | |
| Air Feeding Pump | Same as PD. | Diaphragm type pump | |
| System Connector | Same as PD. | Provided | |
| Foot Switch Connector | Same as PD. | Provided | |
| CV Connector | Same as PD. | Provided | |
| Cooling Air Direction | Same as PD. | Rear | |
| Type of Protection against<br>Electric Shock | Same as PD. | Class I | |
| Degree of Protection<br>against Electric Shock of<br>Applied Part | Same as PD. | TYPE BF or CF applied part<br>(Depend on applied part) | |
| Applicable Standard | Same as PD. | UL60601-1 | |
| Specifications | Subject Device<br>CV-180 | Predicate Device<br>CV-160A | |
| Power Supply | Same as PD. | 100-240V~±10%、50/60Hz±1Hz | |
| Over-current Protection | Same as PD. | Fuse type | |
| Input Current | Same as PD. | 150VA | |
| Size | 382(W)×91(H)×<br>490 (D)mm | 370(W)×91(H)×462 (D)mm | |
| Weight | 10 kg | 10.6 kg | |
| Compatible Endoscopes | Same as PD. | • Fiber/rigid scope via camera head<br>• Videoscope | |
| Observation | Video Signal<br>Output | Same as PD. | RGB:3 Y/C:4 VBS:4 HDTV:1 |
| | Auto White<br>Balance | Same as PD. | Automatically adjusted using the white<br>balance switch.<br>At the time of connection with the<br>scope in which Scope ID is provided,<br>compensation is performed<br>automatically. |
| | Standard Color<br>Chart Output | Same as PD. | Color bar image |
| | Color Tone<br>Adjustment | Same as PD. | R: ±8 steps B: ±8 steps<br>CHROMA : ±8steps |
| | Automatic Gain<br>Control (AGC) | Same as PD. | MAX gain: 18dB |
| | Image<br>Enhancement | Same as PD. | Edge enhancement: [OFF] [Low] [Med]<br>[High] 4 levels available<br>Structure enhancement:[OFF] [Low]<br>[Med] [High] 4 levels available |
| | Iris Mode<br>Selection | Same as PD. | AUTO/PEAK<br>EXPOSURE Electrical shutter |
| | Optical Zoom | Same as PD. | ×1/×1.2/×1.5: 3-Mode |
| | NBI Observation | Same as PD. | NBI function |
| | Picture in<br>Picture | Same as PD. | The image of an external device<br>connected to this instrument is<br>displayed on the main monitor together<br>with the endoscopic image. |
| Communication with Scope | | Same as PD. | Provided |
| Foot Switch Connector | | Same as PD. | Provided |
| Record to Memory Card | | Same as PD. | Provided |
| Type of Protection against<br>Electric Shock | | Same as PD. | Class I |
| Degree of Protection against<br>Electric Shock of Applied Part | | Same as PD. | TYPE BF or CF applied part<br>(Depend on applied part) |
| Applicable Standard | | Same as PD. | UL60601-1 |

#### Table 16-2. Comparison of Specifications Subject Device: EVIS EXERA II Xenon Light Source Olympus CLV-180 FRA Xenon Light Source Olympus CLV-160A (K051645) ﺎ

OLYMPUS MEDICAL SYSTEMS CORP.

2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE [phone], TELEFAX [phone]

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# Table 16-3. Comparison of Specifications Subject Device: EVIS EXERA II Video System Center Olympus CV-180 Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645)

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE [phone], TELEFAX [phone]

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K62049
Fagelbäck

### Table 16-4. Comparison of Specifications Subject Device: VISERA Cysto-Nephro Videoscope Olympus CYF type V2/VA2 Predicate Device: VISERA Cystovideoscope Olympus CYF type VIVA (K021074)

| Specifications | Subject Device<br>CYF-V2/VA2 | | Predicate Device<br>CYF-V/VA | |
|---------------------------------------|------------------------------|----------|------------------------------|----------|
| Field of View | 120° | | 120° | |
| Depth of Field | 3-50 mm | | 3-50 mm | |
| Direction of View | 0° Forward Viewing | | 0° Forward Viewing | |
| Type of CCD Chip | Color | | Color | |
| Outer Diameter of Distal End | φ 4.8 mm bullet-shaped | | φ 5.4 mm | |
| Outer Diameter of Insertion Tube | φ 5.4mm | | φ 5.4 mm | |
| | CYF-V2 | CYF-VA2 | CYF-V | CYF-VA |
| Suction Function | Not Provided | Provided | Not Provided | Provided |
| Bending Section Angulation<br>UP/DOWN | 210° /120° | | 210° /120° | |
| Working Length | 380 mm | | 380 mm | |
| Inner Diameter of Instrument Channel | φ 2.2 mm | | φ 2.2 mm | |

### Table 16-5. Comparison of Specifications Subject Device: VISERA Cysto-Nephro Videoscope Olympus XCYF type VQ Predicate Device: VISERA Cystovideoscope Olympus CYF type VIVA (K021074)

| Specifications | Subject Device<br>XCYF-VQ | Predicate Device<br>CYF-V/VA |
|--------------------------------------|---------------------------|---------------------------------------|
| Field of View | 120° | 120° |
| Depth of Field | 3-20 mm | 3-50 mm |
| Direction of View | 0° Forward Viewing | 0° Forward Viewing |
| Type of CCD Chip | Color | Color |
| Outer Diameter of Distal End | ⌀ 5.9 mm | ⌀ 5.4 mm |
| Outer Diameter of Insertion Tube | ⌀ 5.5 mm | ⌀ 5.4 mm |
| Suction Function | Provided | CYF-V Not Provided<br>CYF-VA Provided |
| Bending Section Angulation UP/DOWN | 210° /120° | 210° /120° |
| Working Length | 380 mm | 380 mm |
| Inner Diameter of Instrument Channel | ⌀ 2.0 mm | ⌀ 2.2 mm |

# 6. Conclusion

When compared to the predicate devices, 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 system.

> OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE [phone], TELEFAX [phone]

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 2 2 2006

Ms. Laura Storms-Tyler Executive Director, Regulatory and Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K062049

> Trade/Device Name: EVIS EXERA II 180 System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: NWB Dated: September 11, 2006 Received: September 13, 2006

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 include requirements 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 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.

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Page 2 -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/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

{8}------------------------------------------------

# Indications for Use

Ko62049

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 source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

### VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE VA2, XCYF TYPE VQ

These instruments have been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, ureter, and kidney.

ANDIOR Prescription Use_V_ (Part 21 CFR 801 Subpart D)

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. Legman

Division of Reproductive, Abdominal. and Radiological Dev 510(k) Number

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