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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the OLYMPUS XCHF-B180Y1 Choledochoscope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical study to establish acceptance criteria and performance against those criteria. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them.

Here's a breakdown of why the requested information is absent based on the document:

No acceptance criteria or device performance table: The document's closest equivalent to a performance table is the "Comparison of Specifications" (Table 13-2) which compares the subject device's technical specifications (e.g., Field of View, Depth of Field, Outer Diameter) to a predicate device. This is not a comparison of clinical performance or a statement of acceptance criteria for clinical outcomes.
No mention of a test set, data provenance, experts, or adjudication method: These elements are characteristic of a clinical study designed to evaluate device performance against specific endpoints, which is not what a 510(k) submission typically requires for substantial equivalence. The document is comparing technical specifications and intended use.
No MRMC comparative effectiveness study: The document does not describe any human reader study or any comparison of human readers with or without AI assistance. The device is an endoscope, not an AI-powered diagnostic tool.
No standalone algorithm performance: As stated, this is a physical medical device (an endoscope), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.
No type of ground truth mentioned: Ground truth is established for clinical endpoints, which are not being assessed in this 510(k) comparing technical specifications for substantial equivalence.
No sample size for the training set or how ground truth was established for it: Again, these are concepts relevant to algorithm development and validation, not the submission for a physical endoscope demonstrating substantial equivalence.

In summary, the provided 510(k) document is for a traditional medical device (a choledochoscope) and demonstrates substantial equivalence by comparing its technical specifications and intended use to a legally marketed predicate device. It does not include information about clinical acceptance criteria or a study designed to prove the device meets such criteria.

The core of this 510(k) is found in "Table 13-2. Comparison of Specifications" and the accompanying text: "The XCHF-B180Y1 is similar to the predicate device XCHF-BP160F in specifications except for the material and optical system." and "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." This is the "proof" the device meets the criteria for substantial equivalence, which is the regulatory hurdle for a 510(k), not a direct clinical performance study.

Summary

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K080586
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Image /page/0/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced. There is a horizontal line with a grainy texture below the word. The background is plain and white.

MAY - 6 2008

510(k) SUMMARY

XCHF-B180Y1 Choledochoscope

1. General Information

Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, JapanEstablishment Registration No: 8010047
Official Correspondent:	Laura Storms-TylerRegulatory Affairs & Quality AssuranceOlympus America Inc.3500 Corporate Parkway, PO Box 610Center Valley PA 18034-0610Phone: (484) 896-5688Facsimile: (484) 896-7128Email:Laura.storms-tyler@olympus.comEstablishment 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 961-8061Establishment Registration No: 3002808148
Choledochoscope:	Aizu Olympus Co., Ltd.500 Aza-Muranishi, Ooaza-Niidera, Monden-machi,Aizuwakamatsu-shi, Fukushima, Japan 965-8520Establishment 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/ RigidEndoscope, accessories, narrow band spectrum

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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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(part of this submission)	Predicate Device	510(k) No.
XCHF-B180Y1 Choledochoscope	CHOLEDOCHOSCOPEXCHF-BP160F	K051886

4. Device Description

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

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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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 DeviceXCH-B180Y1	Predicate DeviceXCH-LR160F(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 ofDistal End	⌀ 3.4mm	⌀ 2.8mm
Outer Diameter ofInsertion Tube	⌀ 3.8mm	⌀ 3.7mm
Angulation	UP : 70DOWN : 70	UP : 70DOWN : 70
Working Length	2000mm	2000mm
Inner Diameter ofInstrument 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 +81-426-42-2891, TELEFAX +81-426-42-3174 3/3

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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 (800) 638-2041 or (240) 276-3150 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

Page 1 of __

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.