OLYMPUS XCHF TYPE B180Y1

K080586 · Olympus Medical Systems Corporation · FBN · May 6, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080586
• Device Name: OLYMPUS XCHF TYPE B180Y1
• Applicant: Olympus Medical Systems Corporation
• Product Code: FBN · Gastroenterology, Urology
• Decision Date: May 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, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS DUODENOSCOPE with an instrument channel with a minimum diameter of @4.2mm.

Device Story

Flexible video choledochoscope; used for visualization and endoscopic surgery within biliary tract and pancreatic duct. Inputs: optical images captured via distal CCD sensor. Transformation: CCD converts optical signals to electronic video signals for display on external monitor. Output: real-time endoscopic video feed. Used in clinical settings by physicians; requires integration with Olympus video system center, light source, and ancillary equipment (e.g., biopsy forceps). Output allows physician to navigate ducts, visualize pathology, and perform therapeutic interventions. Benefits: enables minimally invasive diagnostic and surgical access to biliary and pancreatic systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance specifications compared to the predicate device.

Technological Characteristics

Flexible video endoscope; CCD-based optical system; 90° field of view; 0° forward viewing; 2-50mm depth of field; 3.4mm distal end diameter; 3.8mm insertion tube diameter; 2000mm working length; 1.2mm instrument channel; 70° up/down angulation. Connectivity: requires external video system center and light source.

Indications for Use

Indicated for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct, used in conjunction with an EVIS duodenoscope with a minimum 4.2mm instrument channel.

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

• CHOLEDOCHOSCOPE XCHF-BP160F (K051886)

Reference Devices

• XCH-LR160F (K051806)

Submission Summary (Full Text)

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K080586
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MAY - 6 2008

# 510(k) SUMMARY

# XCHF-B180Y1 Choledochoscope

## 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 |
| Choledochoscope: | Aizu Olympus Co., Ltd.<br>500 Aza-Muranishi, Ooaza-Niidera, Monden-machi,<br>Aizuwakamatsu-shi, Fukushima, Japan 965-8520<br>Establishment Registration No.: 9610595 |
| Date Prepared: | April 30, 2008 |

# 2. Device Identification

| Device Name: | XCHF-B180Y1 Choledochoscope |
|-------------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Choledochoscope |
| Class: | II |
| Regulation Number/Name: | 876.1500 Endoscope and accessories |
| Product Code: | FBN/NWB |
| Classification Panel: | Choledochoscope And Accessories, Flexible/ Rigid<br>Endoscope, accessories, narrow band spectrum |

# olympus medical systems corp.

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

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K080586
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## 3. Legally Marketed Device to which Substantial Equivalence is Claimed

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

## Table 13-1: Primary Component & Predicate Device

| Subject Device<br>(part of this submission) | Predicate Device | 510(k) No. |
|---------------------------------------------|--------------------------------|------------|
| XCHF-B180Y1 Choledochoscope | CHOLEDOCHOSCOPE<br>XCHF-BP160F | K051886 |

## 4. Device Description

The XCHF-B180Y1, is a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct. The XCHF-B180Y1 is basically identical to the predicate device, Olympus XCHF-BP Type 160F Choledochoscope, hereinaffer referred to as XCHF-BP160F in intended use, specifications, performance. The optical system of the XCHF-B180Y1 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 13-1 in intended use, and similar in specifications, performance and materials.

### 5. Indications for Use

### XCHF-B180Y1 Choledochoscope

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 endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS DUODENOSCOPE with an instrument channel with a minimum diameter of @4.2mm.

olympus medical systems corp.

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

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K080586
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## 6. Comparison of Technological Characteristics

The XCHF-B180Y1 is similar to the predicate device XCHF-BP160F in specifications except for the material and optical system. Comparison between the subject and predicate devices is shown below.

| Specifications | Subject Device<br>XCH-B180Y1 | Predicate Device<br>XCH-LR160F<br>(K051806) |
|-----------------------------------------|------------------------------|---------------------------------------------|
| Field of View | 90° | 90° |
| Direction of View | Forward Viewing 0° | Forward Viewing 0° |
| Depth of Field | 2~50mm | 2~50mm |
| Type of CCD Chip | Color CCD | Color CCD |
| Outer Diameter of<br>Distal End | ⌀ 3.4mm | ⌀ 2.8mm |
| Outer Diameter of<br>Insertion Tube | ⌀ 3.8mm | ⌀ 3.7mm |
| Angulation | UP : 70<br>DOWN : 70 | UP : 70<br>DOWN : 70 |
| Working Length | 2000mm | 2000mm |
| Inner Diameter of<br>Instrument Channel | ⌀ 1.2mm | ⌀ 1.2mm |

## Table 13-2. Comparison of Specifications

## 6. Conclusion

When compared to the predicate device, the XCHF-B180Y1 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 [phone], TELEFAX [phone]/3

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## - 6 2008

OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Laura Storms-Tyler Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

Re: K080586

Trade/Device Name: CHOLEDOCHOSCOPE XCHF-B180Y1 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBN Dated: February 28, 2008 Received: March 5, 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 r your we roo be subject to such additional controls. Existing major regulations affecting your Apple 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/3/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. The seal is surrounded by text that reads "U.S. Food & Drug Administration".

Protecting and Promoting Public Health

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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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdri/industry/support/index.html.

Sincerely yours.

Nancy Brogdon

Nancy C. Brogdon 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

510(k) Number (if known): Device Name: CHOLEDOCHOSCOPE XCHF-B180Y1

Indications For Use:

### CHOLEDOCHOSCOPE XCHF-B180Y1

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 endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with the EVIS Duodenoscopes with an instrument channel with a minimum diameter of 04.2mm.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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

510(k) Number

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