These instruments have been designed 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.

Use the EVIS EXERA II COLONOVIDEOSCOPE CF-Y0023-L/I for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

Device Description

The CF-Y0023-L/I Colonovideoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the colon. The CF-Y0023-L/I Colonovideoscope is basically identical to the predicate device, Olympus XCF-H160AY2L Colonovideoscope, hereinafter referred to as XCF-H160AY2L in intended use, specifications, performance. The optical system of the CF-Y0023-L/I is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.

The major differences of the subject CF-Y0023-L/I Colonovideoscope from the predicate XCF-H160AY2L device are as follows:

-The number of objective lens and the width of the field of view for the subject and predicate devices differ. ( CF-Y0023-L/l:140° (forward view) and 141- 233° (side view), XCF-H160AY2L: 170° (forward view))

-The shape of distal ends differ.

-The layout of the light guide lens differ.

-The number of air/water nozzles differ.( CF-Y0023-L/I:n=3, XCF-H160AY2L:n=1)

The new colonovideoscope CF-Y0023-L/I has both 140 degree forward view and 141-233 degree side view. Both forward view and side view are focused on one CCD, and the user can observe both 140 degree forward view and 141-233 degree side view at once.

AI/ML Overview

The provided text is a 510(k) summary for the OLYMPUS MEDICAL SYSTEMS CORP. COLONOVIDEOSCOPE CF-Y0023-L/I. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel medical device like an AI algorithm.

Therefore, many of the requested elements (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods) are not applicable or not present in this type of submission.

The 510(k) summary primarily compares the technological characteristics of the new device (CF-Y0023-L/I) to a predicate device (XCF-H160AY2L) to argue that it does not raise new questions of safety or effectiveness.

Here's how the available information relates to your request:

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

Not Applicable. This document does not establish performance criteria for a diagnostic or AI-driven device with specific metrics like sensitivity, specificity, or accuracy. The comparison is based on technical specifications.

Acceptance Criteria (N/A for this type of device)	Reported Device Performance (Comparison to Predicate)
N/A	Field of View: - Subject Device: forward view: 140°, side view: 141°~233° - Predicate Device: 170°
N/A	Depth of Field: - Subject Device: forward view: 3.1~~100mm, side view: 0~~60mm - Predicate Device: 2-100mm
N/A	Direction of View: - Subject Device: forward view: 0°, side view: 93.5° - Predicate Device: forward viewing: 0°
N/A	Type of CCD: - Subject Device: Color - Predicate Device: Color
N/A	Outer Diameter of Distal End: - Subject Device: φ13.9mm - Predicate Device: φ13.9mm
N/A	Outer Diameter of Insertion Tube: - Subject Device: φ12.8mm - Predicate Device: φ12.8mm
N/A	Bending Section Angulation UP/DOWN: - Subject Device: UP:180°, DOWN:180° - Predicate Device: UP: 180°, DOWN:180°
N/A	Working Length: - Subject Device: CF-Y0023-L=1680mm, CF-Y0023-I=1330mm - Predicate Device: 1680mm
N/A	Inner Diameter of Instrument Channel: - Subject Device: φ3.7mm - Predicate Device: φ3.7mm

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. This document describes a medical device, not an AI or diagnostic algorithm tested with a dataset. It's a review of the physical characteristics and intended use in comparison to an existing device.

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 ground truth establishment by experts for a test set is mentioned.

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

Not Applicable. No test set or 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. This device is a colonovideoscope, not an AI system designed to assist human readers.

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

Not Applicable. This device is a manual colonovideoscope, not an algorithm.

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

Not Applicable. No ground truth is mentioned as this is a physical device submission.

8. The sample size for the training set

Not Applicable. No training set for an algorithm is mentioned.

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

Not Applicable. No ground truth for a training set is mentioned.

Summary

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JUL 1 4 2010

K 10 10 53

510(k) SUMMARY

Pg 1 of 3

April 9, 2010

General Information ﻠﺴﻨﺎ

।

OLYMPUS MEDICAL SYSTEMS CORP. 그 Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507 Establishment Registration No: 8010047
Stacy Abbatiello Kluesner, M.S., RAC 1 Official Requiatory Affairs & Quality Assurance Correspondent: 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. Manufacturer: 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595

Device Identification 2

CF-Y0023-L/I D Device Trade Name:
COLONOVIDEOSCOPE 홍 Common Name:
21 CFR 876.1500 B Regulation Number:
1 Endoscope and accessories Regulation Name:

일반 Regulatory Class:
Classification Panel: FDF: Colonoscope and Accessories, Flexible/Rigid L NWB: Endoscope, Accessories, Narrow Band Spectrum
Product Code: Gastroenterology and urology 1

1/3

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K101053
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Predicate Device Information 3

XCF-H160AY2L Device Name: 그
COLONOVIDEOSCOPE Common Name: 행
Aizu Olympus Co., Ltd. Manufacturer: I 500 Aza-Muranishi, Ooaza-lidera, Monden-cho, Aizuwakamatsu-shi, Fukushima, Japan 965-8520 Establishment Registration No .: 9610595
. .

K051645 510(k) No.

Device Description 4

The CF-Y0023-L/I Colonovideoscope is a flexible video endoscope used for endoscopic diagnosis and treatment within the colon . The CF-Y0023-L/I Colonovideoscope is basically identical to the predicate device, Olympus XCF-H160AY2L Colonovideoscope, hereinafter referred to as XCF-H160AY2L in intended use, specifications, performance. The optical system of the CF-Y0023-L/I is a charge coupled device (CCD) based system, allowing endoscopic image display on a video monitor.

The major differences of the subject CF-Y0023-L/I Colonovideoscope from the predicate XCF-H160AY2L device are as follows:

-The shape of distal ends differ.

-The layout of the light guide lens differ.

-The number of air/water nozzles differ.( CF-Y0023-L/I:n=3, XCF-H160AY2L:n=1)

5 Indications for Use

Use the EVIS EXERA II COLONOVIDEOSCOPE CF-Y0023-L/I for

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K101053
pg 3 of 3

endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

6 Comparison of Technological Characteristics

The CF-Y0023-L/I is basically identical to the predicate device in intended The Of - 10020 LT 15 backeding is. There main difference are having a wider doe, and a different shape of the distal end. Comparison between the subject and predicate devices is shown in Table 7.

Specifications	Subject DeviceCF-Y0023-L/I	Predicate DeviceXCF-H160AY2L
Field of View	forward view : 140°side view : 141°~233°	170°
Depth of Field	forward view : 3.1~~100mmside view : 0~~60mm	2-100mm
Direction of View	forward view : 0°side view : 93.5°	forward viewing : 0°
Type of CCD	Color	Color
Outer Diameter ofDistal End	φ13.9mm	φ13.9mm
Outer Diameter ofInsertion Tube	φ12.8mm	φ12.8mm
Bending SectionAngulationUP/DOWN	UP:180°DOWN:180°	UP: 180°DOWN:180°
Working Length	CF-Y0023-L=1680mmCF-Y0023-I=1330mm	1680mm
Inner Diameter ofInstrument Channel	φ3.7mm	φ3.7mm

Comparison of Specifications Table 7.

7 Conclusion

When compared to the predicate device, the CF-Y0023-L/1 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.

ਤੇ ਤੇ

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G66 Silver Spring, MD 20993-0002

OLYMPUS MEDICAL SYSTEMS CORP. c/o Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. . . . . 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610

JUL 1 4 2010

Re: K101053

Trade/Device Name: COLONOVIDEOSCOPE CF-Y0023-L/I Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: April 9, 2010. Received: April 15, 2010

Dear Ms. Kluesner:

We have reviewed your Section 510(k) prematket 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. 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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adverse events) (21 CFR 803); 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.

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/CDRH/CDRHOffices/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

K101053 510(k) Number (if known): Device Name: COLONOVIDEOSCOPE CF-Y0023-L/I Indications For Use:

Use the EVIS EXERA II COLONOVIDEOSCOPE CF-Y0023-L/I for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, and ileocecal valve).

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.