This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment. This instrument is intended to be used without DUODENOSCOPE.

The CHOLEDOCHO VIDEOSCOPE CHF-Y0005 is indicated for endoscopy and endoscopic surgery within the biliary tract and the duodenum.

Device Description

The CHF-Y0005 is designed as a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and the duodenum.

The CHF-Y0005 is modified from the predicate XCHF TYPE T160 as it has two bending sections, a gas feeding function when connected to an Endoscopic CO2 regulation unit, Narrow Band Imaging observation and is now compatible with specified electrosurgical units and electrosurgical accessories.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the CHOLEDOCHO VIDEOSCOPE CHF-Y0005, and focuses on its substantial equivalence to predicate devices, rather than an independent performance study with clinical endpoints. Therefore, detailed information about acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial report, is not present.

However, based on the Summary of Non-Clinical Testing section, we can infer some aspects related to acceptance criteria and the nature of the evaluation.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document mentions that non-clinical tests were performed and design verification tests and their acceptance criteria were identified and performed as a result of their risk analysis assessment. However, it does not provide a table with specific performance metrics and their corresponding acceptance criteria or actual reported device performance values. Instead, it refers to compliance with general safety and performance standards.

Acceptance Criteria Category	Reported Device Performance
Device Safety & Performance	Demonstrated compliance with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-18 standards.
Mechanical & Functional Performance	Verification and comparison studies conducted, concluding equivalence to predicate devices.
Risk Analysis	Carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. Design verification tests and their acceptance criteria were identified and performed based on risk analysis.
Substantial Equivalence (Overall)	Noted that the device does not incorporate any significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness, thus determined substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance

The document describes non-clinical tests, verification and comparison studies, and design verification tests. These are typically engineering or benchtop tests rather than tests on human subjects. Therefore, the concept of "sample size for the test set" in the context of clinical data (e.g., patient images, patient outcomes) is not applicable here.

Test Set Sample Size: Not applicable (non-clinical, benchtop testing).
Data Provenance: Not applicable. The tests are described as non-clinical and in-house (e.g., "established in-house acceptance criteria").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. Given that the testing described is non-clinical/benchtop, the establishment of "ground truth" by clinical experts (like radiologists) for a test set is not relevant to the described studies.

4. Adjudication method for the test set

This information is not provided. As the studies are non-clinical, an adjudication method for clinical test outcomes would not be relevant.

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

No such study was mentioned or performed. This submission is for a medical device (endoscope), not an AI algorithm, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant to this filing.

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

No such study was mentioned or performed. This submission is for a physical medical device (endoscope), not a standalone algorithm.

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

For the non-clinical and design verification tests, the "ground truth" would be established by engineering specifications, calibration standards, and validated measurement techniques, as dictated by the referenced international standards (e.g., IEC, ISO, ASTM). This is not equivalent to clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is an endoscope and does not employ a training set as would be required for an AI/machine learning algorithm.

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

Not applicable, as there is no training set for this device.

Summary

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K113120 page 1 of 4

SEP 25 2012

510(k) SUMMARY

CHOLEDOCHO VIDEOSCOPE CHF-Y0005

General Information 1

. ।

트 Applicant:
.
트 Official Correspondent:
OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047

Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy.kluesner@olympus.com

Aizu Olympus Co., Ltd. 500 Aza-Muranishi, Ooaza-lidera, Monden-cho; Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No.: 9610595

Device Identification 2

i Device Trade Name:
Manufacturer:
Common Name:
Regulation Number:
Regulation Name:
I Regulatory Class:
Classification Panel: .
Product Code: E

CHF-Y0005

CHOLEDOCHO VIDEOSCOPE

21 CFR 876.1500 .

Endoscope and accessories

Choledochoscope And Accessories, Flexible Endoscope, Accessories, Narrow Band Spectrum

FBN, NWB

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Predicate Device Information 3

Subject Device(Part of this Submission)	Predicate Device	PD's510(k)No.
CHOLEDOCHO VIDEOSCOPECHF-Y0005(Hereinafter referredto asCHF-Y0005)	VIDEOSCOPE OLYMPUS XCHF TYPE T160(XCHF-T160)	K082576
	GASTROINTESTINALVIDEOSCOPEXGIF-Q140M (XGIF-Q140M)	K032177
	CHOLEDOCHOSCOPE OLYMPUS XCHFTYPE B180Y1 (XCHF-B180Y1)	K080586
	EVIS EXERA II GASTROINTESTINALVIDEOSCOPE OLYMPUS GIF TYPE N180(GIF-N180)	K100584

Device Description ব

The CHF-Y0005 is designed as a flexible video endoscope used for endoscopy and endoscopic surgery within the biliary tract and the duodenum.

Indications for Use 5

The CHOLEDOCHO VIDEOSCOPE CHF-Y0005 is indicated for endoscopy and endoscopic surgery within the biliary tract and the duodenum.

Comparison of Technological Characteristics 6

The CHF-Y0005 is basically identical to the predicate devices in intended use, and similar in specifications.

When compared to the predicate devices the subject device has the similar technological features such as the depth of field, direction of forward view and bending section angulation. The differences include two bending sections, a gas feeding function when connected to an

{2}------------------------------------------------

Endoscopic CO2 regulation unit, Narrow Band Imaging observation and is now compatible with specified electrosurgical units and electrosurgical accessories.

Substantially Equivalent Discussion 7

The indications for use, principles of operation and fundamental technology of the CHF-Y0005 are similar to the predicate devices.

The major differences from the predicate devices are as follows:

Bending Section:

When compared with predicate XCHF-T160 device (K082576), the predicate XCHF-T160 device has one bending section with four bending directions (Up/Down/Right/Left).

The predicate device XGIF-Q140M (K032177) also has two bending sections. The first bending section has four bending directions (Up/Down/Right/Left) while the second bending section passively bends in 4 directions (Up/Down/Left/Right).

As the CHF-Y0005 has the same degree of movement as the predicate XCHF-T160.

Gas Feeding:

The gas feeding function was added to allow for insufflations with CO2 which aids in the insertion of the choleodocho scope through the GI tract.

The predicate XCHF-T160 device (K082576) does not have a gas feeding function. However, the predicate XGIF-Q140M (K032177) does have a gas feeding function.

Narrow Band Imaging:

The predicate XCHF-B180Y1 device (K080586) which has similar indications for use to the subject device, was cleared with NBI observation mode.

Compatibility with electrosurgical units:

The distal end of the subject CHF-Y0005 is equivalent to the predicate XGIF-Q140M (K032177) and therefore is compatible with the specified electrosurgical units

The above functions have been confirmed that the safety and effectiveness are equivalent as compared with the predicate devices. The CHF-Y0005 is similar or identical in the method of operation, materials and design as the predicate devices.

Summary of Non-Clinical Testing 8

The following non-clinical tests were performed.

Basic safety and performance testing was performed in accordance with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-2-18. In addition, verification and comparison studies were conducted to evaluate the mechanical and functional performance.

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The following standards were used during the design and validation of the subject devices.

IEC 60601-1: 1988, A1: 1991, A2: 1995
IEC 60601-1-1: 2000, 3) IEC 60601-1-2: 2001, A1: 2004
IEC 60601-2-18: 1996, A1: 2000
ISO 14971: 2007
ASTM E1837-96: 2007
ANSI/AAMI/ISO 11135-1: 2007
ISO 10993-7: 2008

The risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of their risk analysis assessment.

Conclusion 9

When compared to the predicate device, the subject CHF-Y0005 device 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. Therefore, the CHF-Y0005 is substantially equivalent to the identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OLYMPUS MEDICAL SYSTEMS CORP. % Ms. Sheri Musgnung Associate Manager, Regulatory Affairs Olympus America Inc. 3500 Corporate Parkway, P.O. Box 610 CENTER VALLEY PA 18034-0610

SEP 25 2012

Re: K113120

Trade/Device Name: CHOLEDOCHO VIDEOSCOPE CHF-Y0005 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBN, NWB Dated: September 14, 2012 Received: September 17, 2012

Dear Ms. Musgnung:

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

{5}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse evones) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regardines (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s and the many of the comments of any connect off and complised on the II you desire specific advice for your ac neves contracts offices/ucm115809.html for go to inter.har.gov/rtbound Drives Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radioregiven on premarket notification' (21CFR Path note the regulation entitled, "Misoranding of references of promises
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the I ou may obtain other general mornational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

(600) 050-2011 of (2011 of (201) industry/default.html

Sincerely yours,

Benjamin K. Evans

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological 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: CHOLEDOCHO VIDEOSCOPE CHF-Y0005 Indications For Use:

The CHOLEDOCHO VIDEOSCOPE CHF-Y0005 is indicated for endoscopy and endoscopic surgery within the biliary tract and the duodenum.

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)

Aogui mrz

Page 1 of ﺎ ﻟﻢ

Castro-Rena

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.