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 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.

AI/ML Overview

The provided document is a 510(k) summary for the OLYMPUS CHF-V CHOLEDOCHO VIDEOSCOPE. It establishes substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics. Therefore, detailed information requested in the prompt's points 1-9 is largely not available in this type of submission.

Here's an analysis based on the provided text for each requested point:

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

Not Applicable (N/A). This 510(k) submission does not present specific acceptance criteria or performance metrics in a table. It asserts substantial equivalence to a predicate device based on similar intended use and technological characteristics, particularly in comparison to the OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084). The document compares specifications in Table 15-2 but does not provide quantitative performance data against predefined acceptance criteria.

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

Not Applicable (N/A). The submission does not describe a clinical performance study with a test set. This is a premarket notification asserting substantial equivalence, not a report on a clinical trial or performance evaluation study.

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 (N/A). As no test set from a clinical performance study is described, there's no mention of experts establishing ground truth.

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

Not Applicable (N/A). No test set or associated adjudication method is described.

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 (N/A). This document concerns a video endoscope for direct visualization, not an AI-assisted diagnostic tool. No MRMC study or AI-related effectiveness is discussed.

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

Not Applicable (N/A). The device is a video endoscope, which is a human-operated medical instrument. There is no "algorithm only" performance that would be applicable to this device.

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

Not Applicable (N/A). As there is no described clinical performance study, there's no mention of a ground truth type.

8. The sample size for the training set

Not Applicable (N/A). This submission is for a medical device (endoscope), not a machine learning algorithm that requires a training set.

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

Not Applicable (N/A). This submission does not involve a training set as it's not a machine learning device.

Summary of the Study (as per the 510(k) submission):

The "study" presented in this document is a substantial equivalence comparison to a legally marketed predicate device, the OES Nephroscope / Cystoscope Fiberscope CHF-P10 (K843084).

Acceptance Criteria and Device Performance: The primary "acceptance criterion" for this 510(k) is demonstrating that the CHF-V Choledocho Videoscope is substantially equivalent to the predicate device in terms of intended use, specifications, performance, and materials, and that it does not incorporate any significant changes that could affect safety or effectiveness. The device's performance is implicitly accepted by its similarity to the predicate device, which has a history of safe and effective use.
- Table of (Implied) Acceptance Criteria & Reported Performance (based on comparison to predicate):

Feature	Predicate Device (CHF-P10) "Acceptance"	Subject Device (CHF-V) "Performance"
Intended Use	Endoscopic diagnosis and treatment	Endoscopic diagnosis and treatment
Field of View	90°	120°
Direction of View	0°	0°
Optical System	Image guide fiber bundle	Color CCD
Angulation (Up/Down)	160° / 130°	160° / 130°
Working Length	330mm	380mm
Inst. Channel ID	φ2.0mm	φ2.0mm

Conclusion: The submission concludes that "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." The primary differences highlighted are the Field of View (120° vs 90°), Working Length (380mm vs 330mm), and the Optical System (Color CCD vs. Image guide fiber bundle). These differences are presented without specific performance metrics against a clinical standard, but rather as design differences from the predicate device that are deemed not to raise new questions of safety or effectiveness.

Summary

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OLYMPUS

510(k) SUMMARY

NOV - 6 2008

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-muraNishishirakawa-gun, Fukushima, Japan 961-8061Establishment Registration No: 3002808148
	Choledocoscope:		Aizu Olympus Co., Ltd.500 Aza-Muranishi, Ooaza-Iidera, Monden-cho,Aizuwakamatsu-shi, Fukushima, Japan 965-8520Establishment 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 spectrumFBN - Choledochoscope, accessories,
•	Classification Panel:	Gastroenterology/Urology

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-42-642-2694, TELÉFAX +81-42-642-2307

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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(Part of this submission)	Predicate Device	PD's 610(k) No.
CHOLEDOCHO VIDEOSCOPECHF-V	OES Nephroscope / CystoscopeFiberscope CHF-P10	K843084

4. Device Description

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

OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji-shi Tokyo, 192-8507 JAPAN TELEPHONE +81-42-642-2694, TELEFAX +81-42-642-2307

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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
AngulationUp / Down	160° / 130°	160° / 130°
Working Length	380mm	330mm
Inner Diameter ofInstrument 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 (800) 638-2041 or (240) 276-3150 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

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

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.