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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Olympus Choledochoscope Model XCHF-BP160F. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive original studies.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not typically included in a 510(k) summary for a device like this. The submission primarily relies on the established safety and effectiveness of the predicate devices and demonstrates that the new device does not introduce new risks or questions of effectiveness.

Here's a breakdown based on the information available and the nature of a 510(k) submission for this type of device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly list quantitative acceptance criteria in the format typically seen with performance studies (e.g., minimum sensitivity, specificity, accuracy). Instead, acceptance is based on demonstrating substantial equivalence to predicate devices and adherence to voluntary safety standards.
Reported Device Performance:
- Imaging System: CCD (compared to Optical fiber bundle for primary predicate, and CCD for secondary predicate). This is a technological characteristic, not a performance metric in the traditional sense, but it upgrades the imaging capability.
- Insertion diameter: ϕ 2.9 – 3.7mm (smaller than primary predicate's ϕ 4.5mm).
- Channel diameter: ϕ 1.2mm (smaller than primary predicate's ϕ 1.7mm, same as secondary predicate's ϕ 1.2mm).
- Angulation (U / D): U=70°, D=70° (different from predicates' ranges).
- Compliance with Standards: Meets IEC60601-1:1998+ Amendment 1:1991+Amendment 2:1995, IEC 60601-1-1:2000 and IEC60601-2-18: 1996+ Amendment1:2000.
- Non-clinical Tests Performed: Thermal safety, optical performance, reprocessing, mechanical durability, mechanical safety, risk analysis. (No specific quantitative results are provided in this summary).
- Biocompatibility: Patient contacting materials completed biocompatibility studies with the predicate device.
No specific metrics like sensitivity, specificity, or inter-reader agreement are reported as this is not a diagnostic algorithm.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document states, "Therefore, no clinical tests have been conducted on this device." The evaluation is based on non-clinical tests and comparison to predicate devices, not on a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set or ground truth established by experts for performance evaluation was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a choledochoscope, which is an imaging and interventional tool, not an AI-powered diagnostic device. Therefore, MRMC studies or AI assistance effect sizes are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical instrument, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As no clinical studies were performed for this 510(k) submission, there was no ground truth established using patient data. The "ground truth" for the non-clinical tests would be the established industry standards and manufacturer's specifications for design, materials, and safety.

8. The sample size for the training set

Not applicable. This is a medical instrument, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a medical instrument; there is no training set as understood in the context of AI/ML.

Summary

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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 : 631-844-5688 Facsimile : 631-844-5554 E-mail : Laura Storms-Tyler@olympus.com 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
1. Device Name : OLYMPUS CHOLEDOCHOSCOPE Model XCHF- BP160F

3. Classification Name

AER Number	-------IlassificationName------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------1956	TOOLUCE 'Sode
876 1500al O. .S------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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	holedochosconenexioieCand the first of the country of the county of the county of the county ofCompany of Concess of Concess of Concession of Concession Comparis of Concession Comparis of Concession of Concession of Concession of Concession of Concession of Concession------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		STATUTE OF COLUMN OF CONSULER OF CONSULER OF CONSULER OFFBN

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-scope, CHF type B20	#K904799	Olympus Optical Co.,Ltd	II	KOG
EVIS EXERA Bronchofiber-videoscope BF type XP160F	#K033225	Olympus Optical Co.,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 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(Subject Device)	CHF type B20(Predicate Device)K904799	BF type XP160F(Predicate Device)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 (800) 638-2041 or (301) 443-6597 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 :

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

Regulation Number and Section

§ 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.