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 through a percutaneous route and/or intraoperatively.

Device Description

The CHF-Y0003 choledochoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the bile duct through a percutaneous route and/or intraoperatively, utilized with the EVIS EXERA II 180 System. The CHF-Y0003 choledochoscope is basically identical to the predicate device, CHF Type V, in specifications, performance, and optical system.

The differences of the subject CHF-Y0003 from the predicate device CHF-V are as follows:

The material of the bending rubber in the bending section is different.
Indication for use has been changed to include a percutaneous route and/or intraoperatively use to specify the applied part.

AI/ML Overview

Acceptance Criteria and Study for CHF-Y0003 CHOLEDOCHO VIDEOSCOPE

Based on the provided 510(k) summary, the CHF-Y0003 CHOLEDOCHO VIDEOSCOPE is deemed substantially equivalent to its predicate device, the CHF-V. This submission focuses on demonstrating substantial equivalence rather than fulfilling specific performance acceptance criteria for a novel device. The primary "study" presented is a comparison between the new device and the predicate device, supported by clinical literature and biocompatibility testing for a material change.

Key takeaway: This 510(k) relies on the substantial equivalence pathway, meaning it aims to show the new device is as safe and effective as a legally marketed predicate, rather than meeting novel performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission demonstrating substantial equivalence to a predicate device, specific quantitative "acceptance criteria" in the traditional sense (e.g., minimum sensitivity/specificity for an AI algorithm) are not explicitly stated or met. Instead, the "acceptance criteria" are implied to be "identical in specifications except for material, and comparable in intended use, method of operation, and design, such that safety and effectiveness are maintained."

The "reported device performance" is essentially the evidence presented to support this substantial equivalence.

Aspect of Comparison	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Evidence Presented)
Intended Use	Comparable to predicate device.	Changed to include "percutaneous route and/or intraoperatively use" – supported by clinical literature. Remainder identical.
Specifications	Identical to predicate device.	"Basically identical" in specifications, performance, and optical system.
Optical System	Identical to predicate device.	"Basically identical".
Performance	Identical to predicate device.	"Basically identical".
Material	Safety and effectiveness maintained despite changes.	Material of bending rubber in bending section is different. Supported by biocompatibility testing.
Method of Operation	No significant changes that affect safety/effectiveness.	No significant changes mentioned.
Design	No significant changes that affect safety/effectiveness.	No significant changes mentioned.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of this 510(k) summary. There is no discreet "test set" of patient data used to evaluate the device's diagnostic or therapeutic performance in a quantified manner. The evaluation is based on a comparison to the predicate device and specific tests for the changed component.
Data Provenance:
- Clinical Literature: Used to support the new indications for use (percutaneous route and/or intraoperatively). The summary does not specify the country of origin or whether these were retrospective or prospective studies, only that "clinical literatures provided in this submission supports the safety and efficacy of the choledochoscope used in a percutaneous route and/or intraoperatively."
- Biocompatibility Testing: Performed on the new material for the bending rubber. This is typically pre-clinical (in vitro or in vivo animal) testing, not human patient data. The summary does not specify the provenance of this testing data beyond "Test data...provided in this submission supports the safety and efficacy of the new material."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a medical instrument (videoscope), not an AI-powered diagnostic system requiring expert consensus for ground truth on a specific image or patient outcome. The evaluation is based on engineering specifications, material safety, and comparison to an existing device.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" of patient cases requiring interpretation or diagnosis, no adjudication method was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a medical device, not an AI or imaging diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.

6. Standalone (Algorithm Only) Performance Study

No. This is a medical device (a videoscope), not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

Engineering Specifications: The primary "ground truth" for showing substantial equivalence relies on comparing the new device's physical and functional specifications to those of the predicate device (CHF-V).
Material Biocompatibility Standards: The "ground truth" for the new bending rubber material is its compliance with recognized biocompatibility standards and test results proving it is safe for patient contact.
Clinical Evidence (Literature Review): For the expanded indications for use, the "ground truth" is established through existing clinical literature supporting the safe and effective use of choledochoscopes in percutaneous and intraoperative settings.

8. Sample Size for the Training Set

Not applicable. This is a medical instrument, not an AI or machine learning model. Therefore, no training set was used.

9. How Ground Truth for the Training Set Was Established

Not applicable. As no training set was used for an algorithm, no ground truth was established for one.

Summary

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510(k) SUMMARY

K0935°7

CHF-Y0003 CHOLEDOCHO VIDEOSCOPE

November 6, 2009

MAR 1 0 2010

General Information 1

OLYMPUS MEDICAL SYSTEMS CORP. 1 Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Official Correspondent: 0

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

Olympus Medical Systems Corp. Manufacturer: Hinode Plant 34-3 Hirai, Hinode-cho, Nishitama-gun, Tokyo 190-0182, Tokyo, 192-8507, Japan

Device Identification 2

Device Trade Name:	CHF-Y0003
Common Name:	CHOLEDOCHO VIDEOSCOPE
Regulation Number:	21 CFR 876.1500
Regulation Name:	Endoscope and accessories
Regulatory Class:	II
Classification Panel:	Gastroenterology/Urology
Product Code:	FBN - Choledochoscope, accessoriesNWB - Endoscope, accessories, narrow band spectrum

Predicate Device Information 3
CHF-V Device Name:

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Ko 93507
py 208r

CHOLEDOCHO VIDEOSCOPE 0 Common Name:
Aizu Olympus Co., Ltd. Manufacturer: 1 500 Aza-Muranishi, Ooaza-Iidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595
510(k) No. 1 K081456

Device Description ব

The differences of the subject CHF-Y0003 from the predicate device CHF-V are as follows:

The material of the bending rubber in the bending section is different. ェ
Indication for use has been changed to include a percutaneous route and/or intraoperatively use to specify the applied part.

ന Indications for Use

Comparison Between the Predicate Device 6

The CHF-Y0003 is basically identical to the predicate device in intended use, except the addition of a percutaneous route and/or intraoperatively use, and identical in specifications except the material. The clinical literatures provided in this submission supports the safety and efficacy of the choledochoscope used in a percutaneous route and/or intraoperatively. Test data of the biocompatibility testing provided in this submission supports the safety and efficacy of the new material.

ﺣ Conclusion

When compared to the predicate device, the CHF-Y0003 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/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the top of the circle. The seal is black and white.

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

Olympus Medical System Corp. % Stacy Abbatiello Kluesner Project Manager Olympus America Inc. 3500 Corporate Parkway PO Box 610 CENTER VALLEY PA 18034-0610

Re: K093507

Trade/Device Name: CHF-Y0003 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBN, NWB Dated: November 6, 2009 Received: November 13, 2009

MAR 1 0 2010

Dear Ms. Kluesner:

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. Isting 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 of medical device-related

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Page 2 -

adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

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

510(k) Number (if known): Device Name: CHF-Y0003 Indications For Use:

This instrument has been designed to be used with an Olympus video system documentation equipment, monitor, center, light source, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within through a percutaneous the bile duct route and/or intraoperatively.

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 CBRH, Office of Device Evaluation (ODE)

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

Page 1 of _ 1

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.