(151 days)
Not Found
No
The document describes standard video processing techniques (Narrow Band Imaging) and does not mention any AI or ML algorithms.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the system is designed for "endoscopic diagnosis, treatment and video observation." "Treatment" indicates a therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the devices are "intended for endoscopic diagnosis".
No
The device description explicitly lists multiple hardware components including a light source, video system center, endoscopes, camera heads, and monitors. While there is mention of image processing software, the device is clearly a system of hardware and software, not software-only.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopic diagnosis, treatment and video observation" within specific anatomical sites (bladder, urethra, ureter, and kidney). This involves direct visualization and intervention within the body.
- Device Description: The description reinforces the use of endoscopes and associated equipment for internal examination and procedures.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This system does not involve the analysis of such specimens.
While the system involves diagnosis, it is through direct visualization and imaging within the body, not through the analysis of samples outside the body. The image processing mentioned is for enhancing the visual information obtained during the endoscopic procedure, not for analyzing biological samples.
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 source, monitors, endo-therapy accessories and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
VISERA URETERO-RENO VIDEOSCOPE OLYMPUS XURF TYPE V: This instrument has 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.
Product codes (comma separated list FDA assigned to the subject device)
NWB, FGB
Device Description
The EVIS EXERA II 180 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.
The primary components of the subject system, are:
- EVIS EXERA II Xenon Light Source Olympus CLV-180
- EVIS EXERA II Video System Center Olympus CV-180
The endoscope to be added for the system, is:
- VISERA Uretero-Reno Videoscope Olympus XURF type V (hereinafter referred to as XURF-V)
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 lmaging (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 endoscope to illuminate, enhance view, record and transmit video data of endoscopic images.
The CV-180 incorporates the following features:
- The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscopes.
- The CV-180 processes both standard white light and NBI images, generated by the CLV-180 light source and captured by the endoscope's Charged Coupled Device (CCD). NBI images create 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, bronchoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, 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 15-1.
Additionally, when they are combined with the new uretero-reno videoscope XURF-V, 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 white light mode by pressing 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 new endoscope is basically identical to each predicate device shown in Table 15-1 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic Video Imaging
Anatomical Site
bladder, urethra, ureter, and kidney
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.
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
Image /page/0/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the frame.
510(k) SUMMARY
EVIS EXERA II 180 SYSTEM
1. General Information
MAR 1 8 2008
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951-Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan
Establishment Registration No: 8010047 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Laura Storms-Tyler
Vice President
Regulatory Affairs & Quality Assurance
Olympus Medical Equipment Services America
3500 Corporate Parkway, PO Box 610
Center Valley PA 18034-0610
Phone: (484) 896-5688
Facsimile: (484) 896-7128
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 |
| Ureteroscope: | OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant
34-3 Hirai Hinode-machi, Nishitama-gun,
Tokyo, Japan 190-0182
Establishment Registration No: 3003637092 |
| Date Prepared: | June 30, 2007 |
| 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 – Endoscope, accessories, narrow band spectrum
FGB – Ureteroscope |
| Classification Panel: | Gastroenterology/Urology |
OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174
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3. Legally Marketed Device to which Substantial Equivalence is Claimed
The following table shows the primary components of the EVIS-EXERATII 180 System and each device to which we claim substantial equivalence (predicate device).
Table 15-1: Primary Components & Predicate Devices of the EVIS EXERA II 180 System
| Subject Device | Predicate Device | 510(k) NO. |
|---|---|---|
| VISERA URETERO-RENO VIDEOSCOPE | ||
| OLYMPUS XURF TYPE V | ||
| (Part of this submission) | OES URETERORENOFIBERSCOPE/ | |
| CHOLEDOCHOFIBERSCOPE | ||
| OLYMPUS URF TYPE P2 | K912120 | |
| VISERA CYSTO-NEPHRO | ||
| VIDEOSCOPES | ||
| OLYMPUS CYF TYPE V2 | K062049 | |
| EVIS EXERA II XENON LIGHT SOURCE | ||
| OLYMPUS CLV-180 (K062049) | EVIS EXERA XENON LIGHT SOURCE | |
| OLYMPUS CLV-160A | ||
| EVIS EXERA II VIDEO SYSTEM CENTER | ||
| OLYMPUS CV-180 (K062049) | EVIS EXERA VIDEO SYSTEM CENTER | |
| OLYMPUS CV-160A | K051645 |
4. Device Description
The EVIS EXERA II 180 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.
The primary components of the subject system, are:
- EVIS EXERA II Xenon Light Source Olympus CLV-180
- EVIS EXERA II Video System Center Olympus CV-180
The endoscope to be added for the system, is:
- VISERA Uretero-Reno Videoscope Olympus XURF type V (hereinafter referred to as XURF-V)
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 lmaging (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.
OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174
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Image /page/2/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the frame. The background is white.
23ER32P
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 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:
- The CV-180 is compatible with any specified Olympus flexible, both video and fiberoptic, and rigid endoscopes.
The CV-180 processes both standard white light and NBI images, generated by the CLV-180 light 2. source and captured by the endoscope's Charged Coupled Device (CCD). NBI images create 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, bronchoscopes, tracheal intubation scopes, transnasal esophago scopes, hysteroscopes, cystoscopes, 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 15-1.
Additionally, when they are combined with the new uretero-reno videoscope XURF-V, 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 white light mode by pressing 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 new endoscope is basically identical to each predicate device shown in Table 15-1 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 (K062049)
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 (K062049)
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 URETERO-RENO VIDEOSCOPE OLYMPUS XURF TYPE V
This instrument has 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.
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in bold, black letters. The font is sans-serif and the letters are tightly spaced. The word is centered and takes up most of the frame. The background is plain white.
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 NBI function. Comparison between the subject and predicate devices is shown in Table 15-2 to 15-5.
Table 15-2. 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)
| Specification | Compliance Value | |
|---|---|---|
| Power Supply | 100-120V~±10%, 50/60 Hz±1Hz | 100-240V~±10%, |
| 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, |
| Rigid scope | ||
| Examination Lamp | Same as PD. | Xenon short-arc lamp |
| (ozone-free)300W | ||
| Average Lamp Life | Same as PD. | Approximately 500 hours of |
| continuous use | ||
| Emergency Lamp | Same as PD. | Halogen lamp 12V 35W |
| Average Emergency Lamp | ||
| 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 |
| (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 | ||
| Electric Shock | Same as PD. | Class I |
| Degree of Protection | ||
| against Electric Shock of | ||
| Applied Part | Same as PD. | TYPE BF or CF applied part |
| (Depend on applied part) |
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174 4/6
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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced together. Below the word, there is a thin line of smaller text that is difficult to read due to its size and resolution.
Table 15-3. Comparison of Specifications
Subject-Dovice: EVIS EXERA-Il-Video-System-Genter-Olympus-GV-180-Predicate Device: EVIS EXERA Video System Center Olympus CV-160A (K051645) STARS (Spicifican Station) 1. 2014 Regal since at Page . 10:10 11 - 14 - 14 - 14 - 14 - 11 -2017 11:00:00 169,314 13191 Same as PD. 100-240V~±10%、50/60Hz土1Hz Power Supply Over-current Protection Same as PD. Fuse type Same as PD. 15076 Input Current 382(W)×91(H)× 370(W)×91(H)×462 (D)mm Size 490 (D)mm Weight 10 kg -------10.6 kg · Fiber/rigid scope via camera head Same as PD. Compatible Endoscopes · Videoscope Video Signal RGB:3 YIC:4 VBS:4 HDTV:1 Same as PD. Output Automatically adjusted using the white balance switch. At the time of connection with the Auto White Same as PD. scope in which Scope ID is provided, Balance compensation ાંડ performed automatically. Standard Color Color bar image Same as PD. Chart Output R: ±8 steps B: ±8 steps Color Tone Same as PD. CHROMA : ±8steps Adiustment Observation Automatic Gain Same as PD. MAX gain: 18dB Control (AGC) Edge enhancement: [OFF] [Low] [Med] [High] 4 levels available lmage Same as PD. Structure enhancement:[OFF] [Low] Enhancement [Med] [High] 4 levels available Iris Mode AUTO/PEAK Same as PD. EXPOSURE Electrical shutter Selection × 1/× 1.2 /× 1.5: 3-Mode Optical Zoom Same as PD. NBI function NB1 Observation Same as PD. The image of an external device instrument connected to this is Picture in Same as PD. displayed on the main monitor together Picture with the endoscopic image. Same as PD. Provided Communication with Scope Provided Foot Switch Connector Same as PD. Provided Same as PD. Record to Memory Card of Protection Type against Same as PD. Class I Electric Shock TYPE BF or CF applied part Degree of Protection against Same as PD. (Depend on applied part) Electric Shock of Applied Part UL60601-1 Same as PD. Applicable Standard
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174 કાદ
5
Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced. Below the word, there is a thin, horizontal line that spans the width of the word. The background is white.
The XURF-V is similar to the predicate device URF-P2 in specifications except for the optical system. As-for-the optical system, the XURF-V-is-similar-to-the-predicate-device-GYF-V2-Gomparison-betweenthe subject and predicate devices is shown below.
| Field of View | 90° | 90° | 120° |
|---|---|---|---|
| Direction of View | 0° (Forward Viewing) | 0° (Forward Viewing) | 0°(Forward viewing) |
| Depth of Field | 2-50 mm | 1-50 mm | 3-50mm |
| Optical System | Color CCD | Image guide fiber bundle | Color CCD |
| Outer Diameter of | |||
| Distal End | 8.5 Fr (bullet-shape) | 9.3 Fr (φ3.1 mm) | 12.9 Fr (bullet-shaped) |
| Outer Diameter of | |||
| Insertion Tube | φ3.3mm | φ3.3mm | φ5.4mm |
| φ6.7mm (Max.) | |||
| Bending Section | |||
| Angulation | Up: 180°/ Down: 275° | Up: 180°/ Down: 100° | Up: 210°/ Down: 120° |
| Working Length | 670 mm | 700 mm | 380mm |
| Inner Diameter of | |||
| Instrument Channel | φ1.2 mm | φ1.2 mm | φ2.2mm |
Table 15-4. Comparison of Specifications
6. Conclusion
1 - 1
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.
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-426-42-2891, TELEFAX +81-426-42-3174 ରାଚ
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Olympus Medical Systems Corporation % Ms. Laura Storms-Tyler Regulatory Affairs & Ouality Assurance Olympus America, Incorporated 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
MAR 1 8 2008
Re: K072957
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 and FGB Dated: February 20, 2008 Received: February 21, 2008
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.
Image /page/6/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a circular border with text that is difficult to read due to the image quality.
Protecting and Promoting Public Health
7
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
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
510(k) Number (if known):
Device Name: EVIS EXERA II 180 S
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 URETERO-RENO VIDEOSCOPE OLYMPUS XURF TYPE V
This instrument has 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.
Prescription Use V AND/OR (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)
oncurrence of CDRH, Office of Device Evaluation (ODE)
Hub Lema
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number K072957
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