OES CYSTONEPHROFIBERSCOPEs OLYMPUS CYF-5 and CYF-5R have been designed to be used with an Olympus light source, documentation equipment, display monitor. EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

Device Description

The subject device consists of three parts: the control section, the insertion section, the eyepiece section. The basic principle including user interface and operation for the procedure of the subject device are identical to that of the predicate device.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a medical device: OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 and CYF-5R. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on its performance in diagnosing or treating a condition.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria for diagnostic/treatment performance. This is because the device is an endoscope used for diagnosis and treatment within the bladder, urethra, and kidney, and the 510(k) submission primarily addresses the safety and performance of the device itself (e.g., sterilization, biocompatibility, electrical safety, optical performance) compared to a predicate device, not its clinical efficacy in a specific diagnostic task like an AI model would for detecting a disease.

Specifically:

No acceptance criteria or device performance for diagnostic accuracy/effectiveness are mentioned. The performance data section focuses on physical and technical aspects of the endoscope.
No clinical study for demonstrating substantial equivalence was performed. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence." This means there was no study involving human patients to show the device's diagnostic or therapeutic effectiveness in a real-world setting, and thus no related acceptance criteria for such a study.
No information on ground truth establishment, expert consensus, or MRMC studies is provided. These are typically associated with AI/diagnostic software applications.

Here's what is provided regarding acceptance criteria and performance data for the device's physical and technical aspects:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's structure):

The document reports bench testing results to ensure the device performs as intended and meets design specifications. While explicit "acceptance criteria" are not listed in a table, the types of performance tests conducted imply that certain thresholds or standards were met. The "Reported Device Performance" is stated implicitly as having "met design specifications."

Test Category	Specific Tests Conducted	Implied Acceptance Criteria (not explicitly stated as numerical values)	Reported Device Performance (implicit)
Reprocessing	Reprocessing instruction and method validation testing	Compliance with FDA guidance "Reprocessing Medical Devices in Health Care Setting" (e.g., efficacy of cleaning, disinfection, sterilization)	Compliant, documented
Biocompatibility	Cytotoxicity, Intracutaneous, Sensitization, Pyrogen, Acute Systemic Toxicity	Compliance with ISO 10993-1 and specific test standards (e.g., non-toxic, non-irritating, non-pyrogenic)	Compliant
Electrical Safety & EMC	Electrical safety (ANSI/AAMI ES 60601-1, IEC 60601-2-18)	Compliance with standards for patient and user safety	Compliant
Performance (Bench)	Thermal Safety, Composite Durability, Color Performance, Photobiological Safety, Image Intensity Uniformity, Resolution, Field of View / Direction of View	Device performs as intended and meets design specifications (e.g., images are clear, resolution is adequate, components are durable, colors are accurate, no thermal hazards)	Met design specifications
Risk Management	Not a test, but a process followed in accordance with ISO 14971:2007	Identified and mitigated risks; acceptance criteria identified and performed for design verification tests	Performed, led to verification tests

2. Sample Size for Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of diagnostic performance measured by patient cases. The "test set" here refers to the device prototypes or production units that underwent bench, reprocessing, and biocompatibility testing. The exact number of units tested is not specified but is implicitly sufficient for the tests performed.
Data Provenance: The tests are performed on the device itself. Manufacturing sites are in Japan (Shirakawa Olympus Co., Ltd., Aizu Olympus Co., Ltd.). The tests are likely conducted in controlled laboratory environments. No patient data (retrospective or prospective) is involved for this type of submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable as this is a device clearance for an endoscope, not an AI or diagnostic software where ground truth based on expert review of clinical data would be established. The "ground truth" for the device's technical performance is established by standardized engineering and medical device testing protocols and their respective acceptance limits.

4. Adjudication Method for Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are for establishing ground truth in clinical datasets, usually for diagnostic AI.

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

No MRMC study was done. The document explicitly states "No clinical study was performed to demonstrate substantial equivalence." An MRMC study would be relevant for demonstrating the effect of an AI device on human reader performance, which doesn't apply here.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical medical device (an endoscope), not a software algorithm with standalone performance metrics.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on engineering specifications, regulatory standards (e.g., ISO, IEC, FDA guidances), and pre-defined test parameters. For example, a "resolution" test would have a defined target resolution, which serves as the ground truth.

8. Sample Size for Training Set:

Not applicable. This device is not an AI model that requires a training set.

9. How Ground Truth for Training Set was Established:

Not applicable for the same reason as above.

Summary

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December 29, 2022

Olympus Medical Systems Corp. % Teffany Hutto Regulatory Affairs Consultant Olympus Corporation of the Americas 3500 Corporate Parkway, PO Box 610 Center Valley, PA 18034-0610

Re: K221690

Trade/Device Name: OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5R Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ Dated: November 29, 2022 Received: November 29, 2022

Dear Teffany Hutto:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221690

Device Name

OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5R

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. GENERAL INFORMATION

■ 510(k) Submitter:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan
---------------------	-----------------------------------------------------------------------------------------

Contact Person: Teffany Hutto Consultant for Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 512-508-6550 Fax: 484-896-7128 Email: teffany.hutto(@olympus.com
. Manufacturing site: Shirakawa Olympus Co., Ltd. 3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawagun, Fukushima 961-8061, Japan

Aizu Olympus Co., Ltd., 3-1-1 Niiderakita, Aizuwakamatsu-shi, Fukushima 965-8520, Japan

2. DEVICE IDENTIFICATION

Device Name: OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5R
Model Name: CYF-5, CYF-5R
Common Name: CYSTO-NEPHRO FIBERSCOPE
Regulation Number: 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II

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FAJ (Cystoscope And Accessories, Flexible/Rigid) ■ Product Code:
Classification Panel: Gastroenterology/Urology

3. PREDICATE DEVICE

■ Predicate device

Device name	510(k) Submitter	510(k) No.
VISERA CYSTO-NEPHRO VIDEOSCOPEOLYMPUS CYF TYPE V2, CYF TYPEVA2, CYF TYPE V2R(EVIS EXERA II 180 SYSTEM)	OLYMPUS MEDICALSYSTEMS CORP.	K133538

4. DEVICE DESCRIPTION

■ General Description of the subject device

The subject device has been designed to be used with an Olympus light source, documentation equipment, display monitor, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

■ Principle of Operation

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■ List of device components

The OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 and CYF-5R will be packed and offered together as Table below. They can be used with commercially available Olympus devices as described within the Instruction Manual.

Model No.	Device Name
BW-411B	Single Use Combination Cleaning Brush
MAJ-1413	Light guide adapter
MB-156	ETO cap

5. INDICATIONS FOR USE

OES CYSTONEPHROFIBERSCOPEs OLYMPUS CYF-5 and CYF-5R have been has been designed to be used with an Olympus light source, documentation equipment, display monitor, EndoTherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra and kidney.

6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The subject device has the same technological characteristics and design as the predicate device except for the following features:

Optical mechanism
Optical performance

Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.

A side-by-side comparison of the subject device and the predicate device is provided below.

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	Subject Device	Predicate Device
Item	OLYMPUS CYF-5, CYF-5R	OLYMPUS CYFTYPE V2, VA2, V2R(K133538)
Indications forUse	OESCYSTONEPHROFIBERSCOPEsOLYMPUS CYF-5 and CYF-5Rhave been been designed to be usedwith an Olympus light source,documentation equipment, displaymonitor, EndoTherapy accessoriesand other ancillary equipment forendoscopic diagnosis and treatmentwithin the bladder, urethra andkidney.	This instrument has been designedto be used with an Olympus videosystemcenter, light source, documentationequipment, monitor, EndoTherapyaccessories, and other ancillaryequipment for endoscopicdiagnosis and treatment within thebladder, urethra, ureter, andkidney.
RegulationNumber	21CFR 876.1500	21CFR 876.1500
Regulation Name	Endoscope and accessories	Endoscope and accessories
Regulatory Class	Class II	Class II
Product Code	FAJ	FAJ
ClassificationPanel	Gastroenterology/Urology	Gastroenterology/Urology
Use Environment	Healthcare facility/hospital	Healthcare facility/hospital
Reprocessing	[Cleaning]AER and manual[Disinfection]AER and manual[Sterilization]- Ethylene oxide gas- STERRAD NX	[Cleaning]AER and manual[Disinfection]AER and manual[Sterilization]- Ethylene oxide gas- STERRAD NX
Single-Use/Reuse	Reusable	Reusable
Duration andtype of contact	Surface-contacting device in contactwith mucosal membranes. Thecontact duration is limited exposure(<24 hours).	Surface-contacting device incontact with mucosal membranes.The contact duration is limitedexposure (<24 hours).
Depth of Field	3-50mm	3-50mm
Direction of View	0°(Forward viewing)	0°(Forward viewing)
Field of View	120°	120°
Outer Diameter ofDistal End	⌀ 4.6mm (bullet shape)	⌀ 4.8mm (bullet shape)
Diameter ofInsertion Tube	⌀ 5.5mm	⌀ 5.4mm
	Subject Device	Predicate Device
Item	OLYMPUS CYF-5, CYF-5R	OLYMPUS CYFTYPE V2, VA2, V2R(K133538)
Bending SectionAngulation	Up 210° / Down 120°	Up 210° / Down 120°
Working Length	380mm	380mm
InstrumentChannel innerdiameter	⌀ 2.4 mm	⌀ 2.2 mm
Observation mode	WLI	WLI, NBI
Patient contactingmaterial	Insertion tube: Forced dry-hard typeof fluorine resin coatBending section: Fluoro RubberGlue: Epoxy glueDistal End: PolyphenylsulfoneObjective lens/ Light guide lens:GlassObjective lens frame/ Instrumentchannel pipe/ Instrument channeljoint/ Instrument channel port:Stainless SteelInstrument Channel:PolytetrafluoroethyleneRubber seal: Silicone	Insertion tube: Forced dry-hardtype of fluorine resin coatBending section: Fluoro RubberGlue: Epoxy glueDistal End: PolyphenylsulfoneObjective lens/ Light guide lens:GlassSolder: AuSn SolderInstrument channel pipe/Instrument channel joint/ Junction/Instrument channel port: StainlessSteelInstrument Channel:PolytetrafluoroethyleneRubber seal: Silicone

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7 PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

1) Reprocessing validation testing

Reprocessing instruction and reprocessing method validation testing were conducted and documentations were provided as recommended by Guidance for Industry and Food and Drug Administration Staff, "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling".

2) Biocompatibility testing

Biocompatibility testing were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:

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Cytotoxicity Study Using the ISO Elution Method
ISO Intracutaneous Study in Rabbits
ISO Guinea Pig Maximization Sensitization Test
ISO Intracutaneous Study in Rabbits
USP Rabbit Pyrogen Study
ISO Acute Systemic Toxicity Study in Mice

3) Electrical safety and electromagnetic compatibility (EMC)

Electrical safety testing was conducted in accordance with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety.

4) Performance testing - Bench

Bench testing as listed below were conducted to ensure that the subject device performs as intended and meet design specifications.

Thermal Safety
Composite Durability
Color performance
Photobiological Safety
Image Intensity Uniformity
Resolution
Field of View / Direction of View

5) Performance testing - Animal

No animal study was performed to demonstrate substantial equivalence.

6) Performance testing - Clinical

No clinical study was performed to demonstrate substantial equivalence.

7) Risk management

Risk management was performed in accordance with ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk management.

8. CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5 and CYF-5R raise no new issue of

safety and effectiveness and are substantially equivalent to the predicate device in terms of safety, effectiveness and performance.

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.