OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F

K051886 · Olympus Medical Systems Corporation · FBN · Nov 14, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051886
• Device Name: OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
• Applicant: Olympus Medical Systems Corporation
• Product Code: FBN · Gastroenterology, Urology
• Decision Date: Nov 14, 2005
• 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 endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of ¢ 4.2mm.

Device Story

The XCHF-BP160F is a choledochoscope designed for biliary and pancreatic duct visualization and surgery. It functions as a hybrid device, utilizing a fiber bundle for image transmission and a high-resolution CCD in the control section to convert images into video signals for display on a monitor. The device is inserted through the instrument channel of a compatible duodenoscope (e.g., TJF series) to reach the Papilla of Vater. It is operated by a physician in a clinical setting. The output provides real-time visualization of the biliary and pancreatic tracts, facilitating diagnostic and therapeutic procedures such as biopsy. The device benefits patients by enabling minimally invasive access to these ducts for endoscopic surgery.

Clinical Evidence

No clinical data. Bench testing only, including thermal safety, optical performance, reprocessing, mechanical durability, mechanical safety, and risk analysis. Biocompatibility was confirmed via comparison to predicate devices.

Technological Characteristics

Hybrid imaging system using fiber bundle and CCD. Insertion diameter 2.9–3.7mm; channel diameter 1.2mm. Complies with IEC 60601-1, IEC 60601-1-1, and IEC 60601-2-18. Patient-contacting materials are biocompatible.

Indications for Use

Indicated for endoscopic observation and surgery within the biliary tract and pancreatic duct. Used in conjunction with a duodenoscope having an instrument channel of at least 4.2mm diameter.

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 Transduodenal Choledochoscope, CHF type B20 (K904799)
• EVIS EXERA Bronchofiber-videoscope BF type XP160F (K033225)

Submission Summary (Full Text)

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NOV I 4 2005

K051886
pg 1 of 3
June .27. 2005

# SMDA 510(k) SUMMARY

# "Olympus Choledochoscope Model XCHF- BP160F"

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.

#### A. General Information 1. Applicant : Olympus Medical Systems Corp. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Registration number : 8010047 2. Official Correspondent : Laura Storms-Tvler Executive Director, Regulatory Affairs and Quality Assurance Olympus America Inc. Two Corporate Center Drive, Melville, NY 11747-9058, USA Telephone : [phone] Facsimile : 631-844-5554 E-mail : Laura [e-mail] Registration number : 2429304 3. Manufacturer : Aizu Olympus Co., Ltd. 500 Aza Muranishi Ooaza, Niidera, Monden-machi, Aizuwakamatsu-shi, Fukushima, 965-8520 Japan Registration number : 9610595

#### B. Device Identification

- 1. Common/Usual Name : Choledochoscope
- 2. Device Name : OLYMPUS CHOLEDOCHOSCOPE Model XCHF- BP160F

#### 3. Classification Name

| AER Number<br> | -------<br>I<br>lassification<br>Name<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1956 | TOOLUCE '<br>Sode |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| 876 1500<br>al O. .<br>S<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A . Production of the company of the company of the company of the company of the comments of the country of the country of the country of the country of the country of the c | holedochoscone<br>nexioie<br>C<br>and the first of the country of the county of the county of the county of<br>Company of Concess of Concess of Concession of Concession Comparis of Concession Comparis of Concession of Concession of Concession of Concession of Concession of Concession<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | STATUTE OF COLUMN OF CONSULER OF CONSULER OF CONSULER OF<br>FBN |

# C. Identification of the predicate or legally marketed device(s)

The following listed devices are the predicate medical devices;

| Model | 510(k)# | Manufacturer | Class | P-code |
|-------------------------------------------------------|----------|-----------------------------|-------|--------|
| OES Transduodenal Choledocho-<br>scope, CHF type B20 | #K904799 | Olympus Optical Co.,<br>Ltd | II | KOG |
| EVIS EXERA Bronchofiber-<br>videoscope BF type XP160F | #k033225 | Olympus Optical Co.,<br>Ltd | II | EOQ |

#### D. General Description

This instrument has been designed to be used with Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories and other ancillary equipment for endoscopy and endoendoscopic surgery within the biliary tract and pancreatic duct in conjunction with the TJF-duodenoscope.

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Ko51886

pg 2 of 3

#### E. Device Description

The XCHF-BP160F Choledochoscope is basically identical to the predicate device, OES Transduodenal Choledochofiberscope CHF type B20 except that the subject device is equipped with the high resolution CCD in the control section, in addition to the fiber bundle in the insertion tube. Images are transmitted through the fiber bundle and converted by the CCD in the control section to video signals. This is a hybrid technology and substantially equivalent to another Olympus predicate device, Olympus bronchoscope, model BF type XP160F(K033225).

The XCHF-BP160F Choledochoscope is used in conjunction with the TJF-duodenoscope with an instrument channel with a minimum diameter of ¢ 4.2mm, such as Olympus TJF type 100. TJF type 140, TJF type 160F/VF and TJF type M20 duodenoscopes. The XCHF-BP160F Choledochoscope is safety and effectively delivered through the upper gastrointestinal (G) tract to the Papilla of Vater) by traveling through the instrument channel of the TJF-duodenoscopes. At this point, XCHF-BP160F Choledochoscope can directly observe the billiary tract or pancreatic duct.

The technique of using a TJF-duodenoscope to introduce a Choledochoscope, such as the subject device, into the common bile duct is similar to the method commonly used to introduce catheters, stents and other accessories into the biliary tract and pancreatic duct.

#### F. Summary

In summary, the new Choledochoscope, XCHF-BP160F is basically identical to the predicate device in intended use, similar in specification, performance and materials. The subject device differs in that the indication for use have been expanded to include observation of the pancreatic duct, and the high resolution CCD is installed in the control section.

#### G. Design

The Choledochoscope XCHF-BP160F has been designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirement of IEC60601-1:1998+ Amendment 1:1991+Amendment 2:1995, IEC 60601-1-1:2000 and IEC60601-2-18: 1996+ Amendment1:2000.

#### H. Intended use of the device

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 biopsy forceps) and ancillary equipment or endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of ¢ 4.2mm.

#### I. Comparison Technological Characteristics

Comparison between the subject device and predicate device is as follow:

| Items | XCHF-BP160F<br>(Subject Device) | CHF type B20<br>(Predicate Device)<br>K904799 | BF type XP160F<br>(Predicate Device)<br>K033225 |
|--------------------|---------------------------------|-----------------------------------------------|-------------------------------------------------|
| Imaging system | CCD | Optical fiber bundle | CCD |
| Insertion diameter | $\phi$ 2.9 – 3.7mm | $\phi$ 4.5mm | $\phi$ 2.8mm |
| Channel diameter | $\phi$ 1.2mm | $\phi$ 1.7mm | $\phi$ 1.2mm |
| Angulation (U / D) | U=70°, D=70° | U=160°, D=100° | U=180°, D=130° |

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Kc51886
pg 3 of 3

### J. Conclusion

Olympus Medical Systems Corp. has performed non-clinical tests such as thermal safety, optical performance, reprocessing, mechanical durability, mechanical safety and risk analysis to confirm the safety or effectiveness of the XCHF-BP160F Choledochoscope. In addition, EMC standard and electric safety will be performed before we market it.

Furthermore, all patient contacting materials used in the device have completed biocompatibility studies with the predicate device.

When compared to the predicate devices, the XCHF-BP160F Choledochoscope does not incorporate any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness. Therefore, no clinical tests have been conducted on this device.

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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. The central symbol is a stylized depiction of a bird or abstract shape, composed of three curved lines that suggest movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2005

Ms. Laura Storms-Tyler Executive Director Regulatory Affairs and Quality Assurance Olympus America, Inc. Two Corporate Center Drive MELVILLE NY 11747-9058

Re: K051886

Trade/Device Name: Choledochoscope, XCHF-BP160F Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBN Dated: September 29, 2005 Received: October 4, 2005

Dear Ms. Storms-Tyler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act 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.

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin manieling of substantial equivalence of your device to a legally prematication. The I Dri mailig of outs.
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 If you desire specific advice for your de roo on the following numbers, based on the regulation number at the top of this letter:

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation entitled, formation on your responsibilities under the Act from the 807.77). I ou may obtain only Echolai missistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. hogdon

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

Enclosure

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# Indication for Use Statement

510(k) Number (if known) : Device Name: Choledochoscope, XCHF- BP160F Indications for 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 endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of ¢ 4.2mm.

Prescription Use (Per 21 CFR 801 Subpart D)

AND I OR

Over-The-Counter Use_

( 21 CFR 801 Subpart C)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lagermann

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

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