OLYMPUS CHF TYPE V

K081456 · Olympus Medical Systems Corporation · FBN · Nov 6, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K081456
• Device Name: OLYMPUS CHF TYPE V
• Applicant: Olympus Medical Systems Corporation
• Product Code: FBN · Gastroenterology, Urology
• Decision Date: Nov 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.

Device Story

The CHF-V is a flexible choledocho videoscope used for endoscopic diagnosis and treatment within the bile duct. It utilizes a charge-coupled device (CCD) to capture optical images, which are transmitted to an external Olympus video system center and displayed on a monitor for the physician. The device features a 120-degree field of view and 160/130-degree up/down angulation. It is designed for use with ancillary equipment, including light sources and EndoTherapy accessories. The physician operates the scope to visualize the bile duct, facilitating diagnostic or therapeutic interventions. The video output allows for real-time visualization, aiding clinical decision-making during endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Flexible video endoscope with color CCD optical system. Field of view: 120°. Direction of view: 0°. Angulation: 160° up / 130° down. Working length: 380mm. Instrument channel diameter: 2.0mm. Connectivity: Compatible with Olympus video system centers. Sterilization: Not specified.

Indications for Use

Indicated for endoscopic diagnosis and treatment within the bile duct in patients requiring such procedures. Intended for use by clinicians in a professional healthcare setting.

Regulatory Classification

Identification

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

Special Controls

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

Predicate Devices

• OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084)

Submission Summary (Full Text)

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# OLYMPUS

.

# 510(k) SUMMARY

NOV - 6 2008

## 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>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:[e-mail]<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 |
| | Choledocoscope: | | Aizu Olympus Co., Ltd.<br>500 Aza-Muranishi, Ooaza-Iidera, Monden-cho,<br>Aizuwakamatsu-shi, Fukushima, Japan 965-8520<br>Establishment Registration No.: 9610595 |
| ■ | Date Prepared: | April | 2008 |

## 2. Device Identification

:

| • | Device Name: | CHF-V |
|---|-------------------------|-------------------------------------------------------------------------------------------|
| • | Common Name: | CHOLEDOCHO VIDEOSCOPE |
| • | Class: | II |
| • | Regulation Number/Name: | 876.1500 Endoscope and accessories |
| • | Product Code: | NWB - Endoscope, accessories, narrow band spectrum<br>FBN - Choledochoscope, accessories, |
| • | Classification Panel: | Gastroenterology/Urology |

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

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# APUS

# 3. Legally Marketed Device to which Substantial Equivalence is Claimed

The following table shows the subject device and the predicate device to which we clalm substantial equivalence.

#### Table 15-1: Primary Component & Predicate Device

| Subject Device<br>(Part of this submission) | Predicate Device | PD's 610(k) No. |
|---------------------------------------------|----------------------------------------------------|-----------------|
| CHOLEDOCHO VIDEOSCOPE<br>CHF-V | OES Nephroscope / Cystoscope<br>Fiberscope CHF-P10 | K843084 |

## 4. Device Description

The CHF-V choledochoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the bile duct . The CHF-V choledochoscope is basically identical to the predicate device, CHF Type P10 OES Nephroscope/Cystoscope, in intended use, spacifications, performance. The optical system of the CHF-V Is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.

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.

### 5. Indications for Use

#### CHOLEDOCHO VIDEOSCOPE CHF-V

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.

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

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Image /page/2/Picture/1 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The letters are large and black, creating a strong visual impact. A thin line is present underneath the word, emphasizing the brand name.

## 6. Comparison of Technological Characteristics

The CHF-V is similar to the predicate device CHF-P10 in specifications except for the material and optical system. Comparison between the subject and predicate devices is shown below.

| Device: OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084) | | |
|-------------------------------------------------------------------|--------------------------|----------------------------------|
| Specifications | Control Unit (VRC CHF-V) | Rigid Device (CHF-P10) (K843084) |
| Field of View | 120° | 90° |
| Direction of View | 0° | 0° |
| Optical System | Color CCD | Image guide fiber bundle |
| Angulation<br>Up / Down | 160° / 130° | 160° / 130° |
| Working Length | 380mm | 330mm |
| Inner Diameter of<br>Instrument Channel | φ2.0mm | φ2.0mm |

#### Table 15-2. Comparison of Specifications Subject Device: CHOLEDOCHO VIDEOSCOPE CHF-V Predicate

### 6. Conclusion

When compared to the predicate device, the CHF-V 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.

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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Olympus Medical Systems Corp. % Ms. Laura Storms-Tyler, Vice President Regulatory Affairs & Quality Assurance Olympus America Incorporated 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K081456

Trade Name: CHF-V Choledocho Videoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FBN Dated: October 6, 2008 Received: October 7, 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. Iisting 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 (PMA), 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.

NOV - 6 2008

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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 (OS) 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 [phone] or [phone] or at its Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely yours,

loque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

08/456 510(k) Number (if known):

Device Name: CHF-V CHOLEDOCHO VIDEOSCOPE

Indications For Use:

#### CHOLEDOCHO VIDEOSCOPE OLYMPUS CHF TYPE V

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.

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)

Page 1 of 1

Arsuththethy

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K081456