These instruments have been designed to be used with an Olympus Light Source, Documentation Equipment, Display Monitor, Suction Pump, Endo-Therapy Accessories, elecrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, and kidneys.

Do not use this instrument for any purpose other than its intended use.

Device Description

The Olympus XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE has been specifically designed to be used with an Olympus Light Source, documentation, equipment, and display monitor. The XCYF-1T3 is equipped with a large Instrument Channel of bright optical quality compared to the predicate device, XCYF-1T3. These characteristics facilitate operation under endoscopic-surgery including high-frequency treatment within the bladder, urethra and kidnev.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Olympus XCYF-1T3 OES Cystofiberscope/Nephrofiberscope) and does not contain the detailed information required to fill out a table of acceptance criteria, reported device performance, or specific study details often found in clinical trial reports or validation studies.

Here's why and what information can be extracted:

510(k) Purpose: A 510(k) submission primarily aims to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It's not a direct submission of clinical trial results proving specific performance metrics against an acceptance criterion in the same way a PMA (Premarket Approval) or a clinical study report would.

Therefore, most of the requested information regarding detailed acceptance criteria, study specifics, and performance metrics is not available in this document.

However, I can extract and state what is present:

Key Information from the Document:

Device Name: Olympus XCYF-1T3 OES Cystofiberscope/Nephrofiberscope, accessories and ancillary equipment.
Intended Use: Endoscopic diagnosis and treatment within the bladder, urethra, and kidneys, to be used with an Olympus Light Source, Documentation Equipment, Display Monitor, Suction Pump, Endo-Therapy Accessories, electrosurgical Unit, and other ancillary equipment.
Predicate Devices: K843084 Olympus Nephroscope/Cystoscope and K904940 Infant Resectoscope & Accessories.
Safety Standards: The device is manufactured and tested according to voluntary safety standards IEC60601-1 and IEC60601-2-18.

Why specific details are missing:

Acceptance Criteria & Reported Performance: The document states that the new device has a "large Instrument Channel of bright optical quality compared to the predicate device, XCYF-1T3" and "facilitate operation under endoscopic-surgery including high-frequency treatment." However, it does not provide quantitative acceptance criteria (e.g., "optical clarity must be >X lumens") or specific performance values (e.g., "achieved Y lumens"). The comparison to the predicate device is implicit rather than a formal side-by-side performance table.
Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Study, Training Set, Training Ground Truth: These are all aspects associated with detailed performance evaluation studies, especially for AI/algorithm-driven devices or clinical trials. This document pertains to a medical device (fiber optic endoscope) and does not describe such studies. Its substantial equivalence argument relies on comparing the design and materials to a predicate, and adherence to performance standards, rather than complex clinical outcome studies for this classification of device at the 510(k) stage. The mention of "electrosurgical treatment" being a new feature compared to the predicate "Nephroscope/Cystoscope Model CHF-P10" is a key difference being addressed, and the safety standards (IEC60601-1 and IEC60601-2-18) likely cover the electrical safety aspects of such an addition.

Conclusion:

Based on the provided document, I cannot fill out the requested table or provide most of the study details because the document is a 510(k) premarket notification for an endoscope, not a clinical study report for an AI-driven device or one requiring extensive clinical performance data in this format. The acceptance is based on demonstrating substantial equivalence to predicate devices and adherence to recognized safety standards.

Summary

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Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle, with its wings spread and its head turned to the left.

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

The Olympus Optical Company % Robert Schiff, Ph.D., RAC, CQA (ASQC) President Schiff & Company 1129 Bloomfield Avenue West Caldwell, NJ 07006

JUL 2 7 2015

Re: K993041

Trade/Device Name: Olympus XCYF - 1T3 OES Cystofiberscope/Nephrofiberscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ, FGA, FDI, KGE, KNS, FCL Dated (Date on orig SE ltr): March 14, 2000 Received (Date on orig SE ltr): March 15, 2000

Dear Dr. Schiff,

This letter corrects our substantially equivalent letter of March 30, 2000.

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. 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

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Page 2 -

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 device-related 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

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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K993041

OLYMPUS!

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Not assigned yet Oiympus XCYF-1 T3 OES CYSTOFIBESCOPE/ Device Name: NEPHROFIBERSCOPE, accessories and ancillary equipment.

Indications for Use:

Do not use this instrument for any purpose other than its intended use.

(Please Do Not WRITE BELLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ASE BO NOT WARE BEES AND A BELLE - SE - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Concurrence of CDRH, Office of Device Evaluation(ODE)

Prescription Use
(Per 21 CFER 801.109) OR Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993041

OLYMPUS OPTICAL CO., LTD.

2951, Ishikawacho, Hachioji, Tokyo, Japan TEL. (426)42-5101 FAX (426)46-2786

011

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MAR 3 0 2000

510(k) Premarket Notification Olympus Optical Co., Ltd. OES Cystofiberscope/Nephrofiberscope

K993041
pg 1 of 3

510(k) SUMMARY

OLYMPUS XCYF-1T3

OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE

Submitter's Name, Address, Phone and Fax Numbers A.

Name & Address of manufacturer:

Olympus Optical Co., Ltd.

22-2 Nishi-Shinjuku, 1-Chome,

Shinjuku-ku, Tokyo 163-8610

Japan

Registration No:

8010047

Address, Phone and Fax Numbers:

2951 Ishikawa-Cho,

Hachioji-shi, Tokyo 192-8507, Japan

R&D Department, Endoscope Division

Tel: 81-426-42-5101

Fax: 81-426-46-2786

B. Name of Contact Person

Tadahiko Ogasawara

Prepared by Schiff & Company

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C. Trade Name, Common Name, Classification Number, Classification

Trade Name :

Olympus XCYF - 1T3

OES Cystofiberscope/Nephrofiberscope

Accessories and Ancillary Equipment

Common Name:

Classification Number:

Cystofiberscope/Nephrofiberscope

21 CFR 876.1500 Endoscopes and

Accessories

Predicate Device

Classification :

K843084 Olympus Nephroscope/Cystoscope K904940 Infant Resectoscope & Accessories

Description of the Device D.

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K993041

510(k) Premarket Notificatio Olympus Optical Co., L OES Cystofiberscope/Nephrofiberscope

pg 3 of 3

predicate device, XCYF-1T3. These characteristics facilitate operation under endoscopic-surgery including high-frequency treatment within the bladder, urethra and kidnev.

E. Intended Use of the Device(s)

The Olympus XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE, accessories and ancillary equipment have been specifically designed to be used in endoscopic diagnosis and treatment within the bladder, urethra and kidney. Do not use these instruments for any purpose other than their intended use.

F. General Safety

The Olympus XCYF-1T3 OES Cystofiberscope/Nephrofiberscope is manufactured and tested according to voluntary safety standards IEC60601-1 and IEC60601-2-18. XCYF-1T3 is designed for electrosurgical treatment within the bladder, urethra and kidney. When compared to the predicate device, the Olympus Nephroscope/Cystoscope Model CHF-P10, except for the electrosurgical treatment, does not incorporate any significant change in operation, material or design that could affect safety or effectiveness.

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.