VISERA CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF TYPE V2, CYF TYPE V2R have 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 bladder, urethra, and kidney.

CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF VH, and CYF VHR have 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 bladder, urethra, and kidney.

Device Description

The subject device 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 bladder, urethra, and kidney. The subject devices consist of three parts: the control section section, and the connector section. The basic principle including user interface and operation for the subject device are identical to that of the predicate device.

AI/ML Overview

This FDA 510(k) Summary describes a submission for a new line of endoscopes (VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE V2R, CYF-VH, CYF-VHR). The submission asserts substantial equivalence to a predicate device (OLYMPUS CYF TYPE V2, VA2, V2R [K133538]).

The provided document describes a medical device, specifically a cysto-nephro videoscope used for endoscopic diagnosis and treatment within the bladder, urethra, and kidney. The information focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI model. Therefore, many of the typical acceptance criteria and study details for an AI-powered device are not applicable or not present in this document.

However, I can extract the relevant information regarding performance data that was provided in support of the substantial equivalence determination for this non-AI medical device.

Key takeaway: This document explicitly states that "No clinical study was performed to demonstrate substantial equivalence" and "No animal study was performed to demonstrate substantial equivalence." The performance data focused on bench testing, reprocessing validation, biocompatibility, software verification, electrical safety, and risk management to demonstrate that the new device does not raise new safety or effectiveness concerns compared to the predicate device.

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

A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a traditional medical device (endoscope) and not an AI device, the "acceptance criteria" are not framed in terms of AI metrics (e.g., sensitivity, specificity, AUC). Instead, they relate to functional performance and safety validations.

Acceptance Criteria Type	Reported Device Performance
Reprocessing Validation	Conducted and documented as recommended by FDA guidance ("Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling").
Biocompatibility Testing	Conducted in accordance with FDA guidance (ISO 10993-1). Included Cytotoxicity, ISO Intracutaneous (Rabbits), ISO Guinea Pig Maximization Sensitization, USP Rabbit Pyrogen, and ISO Acute Systemic Toxicity (Mice).
Software Verification & Validation	Conducted and documented as recommended by FDA guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices").
Electrical Safety & EMC	Conducted in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 (safety) and IEC 60601-2-18:2009 (safety) and IEC 60601-1-2:2014 (EMC).
Performance Testing - Bench	Conducted to ensure the device performs as intended and meets design specifications. Specific tests included: Thermal Safety, Composite Durability, Color Performance, Photobiological Safety, Noise and Dynamic Range, Image Intensity Uniformity, Field of View and Direction of View, Resolution, Effectiveness NBI.
Risk Management	Performed in accordance with ISO 14971:2007. Design verification tests and their acceptance criteria were identified as a result of this process.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail specific "test set" sample sizes in the context of an AI model. The performance data listed (e.g., reprocessing, biocompatibility, electrical safety, bench testing) are typically conducted on a representative number of device units or samples of materials, not on a "test set" of patient data as would be for an AI algorithm. No country of origin for such test data or whether it was retrospective/prospective is mentioned, as these are engineering/materials tests.
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. This is not an AI device requiring expert-labeled ground truth from medical images or patient data. The "ground truth" for the tests performed (e.g., biocompatibility, electrical safety) would be established by validated scientific methods and industry standards, not by medical experts interpreting data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no "test set" in the context of AI performance evaluation.
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. The device is an endoscope, not an AI-assisted diagnostic tool. No MRMC study was performed as there is no AI component or human-in-the-loop performance to evaluate. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an endoscope, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" in the context of AI algorithms (e.g., expert consensus for diagnoses) is not applicable here. For the engineering and safety tests performed:
- Reprocessing: Ground truth is defined by successful adherence to validated reprocessing protocols and sterility Assurance Levels (SAL).
- Biocompatibility: Ground truth is established by standardized biological tests (e.g., ISO 10993) demonstrating no an adverse biological reaction.
- Electrical Safety & EMC: Ground truth is compliance with relevant electrical safety and electromagnetic compatibility standards (e.g., IEC 60601 series).
- Bench Testing: Ground truth is defined by meeting pre-specified design requirements and engineering specifications (e.g., resolution targets, field of view).
The sample size for the training set

Not applicable. This device is not an AI model, so there is no training set.
How the ground truth for the training set was established

Not applicable.

Summary

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January 20, 2023

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

Re: K221683

Trade/Device Name: VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE V2R CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH, CYF-VHR Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: December 22, 2022 Received: December 22, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K221683

Device Name

VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, CYF TYPE V2R

Indications for Use (Describe)

VISERA CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF TYPE V2, CYF TYPE V2R have 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 bladder, urethra, and kidney.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K221683

Device Name

CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH, CYF-VHR

Indications for Use (Describe)

CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF VH, and CYF VHR have 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 bladder, urethra, and kidney.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Date Prepared: 01/19/2023

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 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, Nishishirakawa-gun, Fukushima 961-8061, Japan

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

2. DEVICE IDENTIFICATION

■ Trade/Device Name:	VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2,CYF TYPE V2RCYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH, CYF-VHR
■ Model Name:	OLYMPUS CYF-V2, CYF-V2R, CYF-VH, CYF-VHR
■ Common Name:	CYSTO-NEPHRO VIDEOSCOPE
■ Regulation Number:	876.1500
■ Regulation Name:	Endoscope and accessories
■ Regulatory Class:	Class II
■ Product Code:	FAJ (Cystoscope and Accessories, Flexible/Rigid)
■ Classification Panel:	Gastroenterology/Urology

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3. PREDICATE DEVICE

Predicate device

Device name	510(k) Submitter	510(k) No.
VISERA CYSTO-NEPHROVIDEOSCOPE	OLYMPUS MEDICALSYSTEMS CORP.	K133538
OLYMPUS CYF TYPE V2, CYF TYPEVA2, CYF TYPE V2R

4. DEVICE DESCRIPTION

■ General Description of the subject device

Principle of Operation

The subject devices consist of three parts: the control section section, and the connector section. The basic principle including user interface and operation for the subject device are identical to that of the predicate device.

■ List of device components

The VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-V2/V2R will be packed and offered together with the devices listed in the 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
MB-156	ETO Cap

The CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF-VH and CYF-VHR will be packed and offered together with the devices listed in the table below. They can be used with commercially available Olympus devices as described within the Instruction Manual.

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Model No.	Device Name
BW-411B	Single Use Combination Cleaning Brush
MAJ-1538	Sterilization Cap

5. INDICATIONS FOR USE

VISERA CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF TYPE V2, CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF-VH and CYF-VHR have 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 bladder, urethra, and kidney.

6. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE

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

Optical performance
Shape of the distal end

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

Item	Subject Device	Predicate Device
	OLYMPUS CYF-V2, CYF-V2R	OLYMPUS CYFTYPE V2, VA2, V2R(K133538)
Indications for Use	VISERA CYSTO-NEPHROVIDEOSCOPEs OLYMPUS CYF TYPEV2 and CYF TYPE V2R have beendesigned to be used with an Olympusvideo system center, light source,documentation equipment, monitor,EndoTherapy accessories, and otherancillary equipment for endoscopicdiagnosis and treatment within thebladder, urethra, and kidney.	This instrument has been designed tobe used with an Olympus videosystem center, light source,documentation equipment, monitor,EndoTherapy accessories, and otherancillary equipment for endoscopicdiagnosis and treatment within thebladder, urethra, ureter, and kidney.
Regulation Number	21CFR 876.1500	21CFR 876.1500
Regulation Name	Endoscope and accessories	Endoscope and accessories
Regulatory Class	Class II	Class II
	Subject Device	Predicate Device
Item	OLYMPUS CYF-V2, CYF-V2R	OLYMPUS CYFTYPE V2, VA2, V2R(K133538)
Product Code	FAJ	FAJ
Classification Panel	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 and type ofcontact	Surface-contacting device in contact withmucosal membranes. The contact durationis limited exposure (<24 hours).	Surface-contacting device in contactwith mucosal membranes. Thecontact duration is limited exposure(<24 hours).
Depth of Field	3-50mm	3-50mm
Direction of View	0°(Forward viewing)	0°(Forward viewing)
Field of View	120°	120°
Type of CCD	Color CCD	Color CCD
Number of CCD Chip	1	1
Outer Diameter ofDistal End	ø 4.8mm (bullet shape)	ø 4.8mm (bullet shape)
Diameter of InsertionTube	ø 5.4mm	ø 5.4mm
Bending SectionAngulation	Up 210° / Down 120°	Up 210° / Down 120°
Working Length	380mm	380mm
Instrument Channelinner diameter	ø 2.2 mm	ø 2.2 mm
Observation mode	WLI, NBI	WLI, NBI
	Subject Device	Predicate Device
Item	OLYMPUS CYF-V2, CYF-V2R	OLYMPUS CYFTYPE V2, VA2, V2R(K133538)
Patient contactingmaterial	Insertion tube: Forced dry-hard type offluorine resin coat	Insertion tube: Forced dry-hard typeof fluorine resin coat
	Bending section: Fluoro Rubber	Bending section: Fluoro Rubber
	Glue: Epoxy glue	Glue: Epoxy glue
	Distal End: Polyphenylsulfone	Distal End: Polyphenylsulfone
	Objective lens/ Light guide lens: Glass	Objective lens/ Light guide lens:Glass
	Solder: AuSn Solder	Solder: AuSn Solder
	Instrument channel pipe/ Instrumentchannel joint/ Junction/ Instrumentchannel port: Stainless Steel	Instrument channel pipe/ Instrumentchannel joint/ Junction/ Instrumentchannel port: Stainless Steel
	Instrument Channel:Polytetrafluoroethylene	Instrument Channel:Polytetrafluoroethylene
	Rubber seal: Silicone	Rubber seal: Silicone
	Subject Device	Predicate Device
Item	OLYMPUS CYF-VH, CYF-VHR	OLYMPUS CYFTYPE V2, VA2, V2R(K133538)
Indications for Use	CYSTO-NEPHRO VIDEOSCOPEsOLYMPUS CYF-VH and CYF-VHRhave been designed to be usedwith an Olympus video system center,light source, documentationequipment, monitor, EndoTherapyaccessories, and other ancillaryequipment for endoscopic diagnosisand treatment within the bladder,urethra and kidney.	This instrument has been designed tobe used with an Olympus video systemcenter, light source, documentationequipment, monitor, EndoTherapyaccessories, and other ancillaryequipment for endoscopic diagnosisand treatment within the bladder,urethra, ureter, and kidney.
Regulation Number	21CFR 876.1500	21CFR 876.1500
Regulation Name	Endoscope and accessories	Endoscope and accessories
Regulatory Class	Class II	Class II
Product Code	FAJ	FAJ
Classification Panel	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 and type ofcontact	Surface-contacting device in contactwith mucosal membranes. The contactduration is limited exposure (<24hours).	Surface-contacting device in contactwith mucosal membranes. The contactduration is limited exposure (<24hours).
Depth of Field	3-50mm	3-50mm
Direction of View	0°(Forward viewing)	0°(Forward viewing)
Field of View	120°	120°
Type of CCD	Color CCD	Color CCD
Number of CCD Chip	1	1
Outer Diameter ofDistal End	ø 2.7mm (bullet shape)	ø 4.8mm (bullet shape)
Diameter of InsertionTube	ø 5.5mm	ø 5.4mm
Bending SectionAngulation	Up 220° / Down 130°	Up 210° / Down 120°
Working Length	380mm	380mm
	Subject Device	Predicate Device
Item	OLYMPUS CYF-VH, CYF-VHR	OLYMPUS CYFTYPE V2, VA2, V2R(K133538)
Instrument Channelinner diameter	ø 2.2 mm	ø 2.2 mm
Observation mode	WLI, NBI	WLI, NBI
Patient contactingmaterial	Insertion tube: Forced dry-hard type offluorine resin coatBending section: Fluoro RubberGlue: Epoxy glueDistal End/ Light guide lens:PolysulfoneObjective lens: GlassSolder: AuSn SolderInstrument channel pipe/ Instrumentchannel joint/ Junction/ Instrumentchannel port: Stainless SteelInstrument Channel:PolytetrafluoroethyleneRubber seal: Silicone	Insertion tube: Forced dry-hard type offluorine resin coatBending section: Fluoro RubberGlue: Epoxy glueDistal End: PolyphenylsulfoneObjective lens/ Light guide lens: GlassSolder: AuSn SolderInstrument channel pipe/ Instrumentchannel joint/ Junction/ Instrumentchannel port: Stainless SteelInstrument Channel:PolytetrafluoroethyleneRubber seal: Silicone

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

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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:

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) Software verification and validation testing

Software verification and validation testing were conducted, and documentations were provided as

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recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".

4) Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were 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 and the IEC 60601-1-2:2014 standards for EMC.

5) 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
Noise and Dynamic Range
Image Intensity Uniformity
Field of View and Direction of View
Resolution
Effectiveness NBI

6) Performance testing - Animal

No animal study was performed to demonstrate substantial equivalence.

7) Performance testing - Clinical

No clinical study was performed to demonstrate substantial equivalence.

8) Risk management

Risk management was performed in accordance with ISO 14971:2007. The design verification tests and their acceptance criteria were performed and identified 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, VISERA CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF TYPE V2, CYF TYPE V2R, CYSTO-NEPHRO VIDEOSCOPEs OLYMPUS CYF-VH and CYF-VHR 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.