K Number
K221690
Device Name
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
Date Cleared
2022-12-29

(202 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

Not Found

No
The summary describes a standard endoscope and its components, focusing on physical characteristics, intended use, and performance testing related to safety and basic functionality. There is no mention of AI, ML, image processing beyond basic visualization, or data analysis capabilities that would suggest the use of such technologies.

Yes
The intended use statement explicitly mentions "treatment" as one of the purposes for which the device is designed, along with diagnosis.

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed for "endoscopic diagnosis and treatment within the bladder, urethra and kidney."

No

The device description explicitly states it consists of three physical parts: the control section, the insertion section, and the eyepiece section, indicating it is a hardware device. The performance studies also include hardware-specific testing like reprocessing validation, biocompatibility, electrical safety, and bench testing for physical characteristics.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "endoscopic diagnosis and treatment within the bladder, urethra and kidney." This involves direct visualization and intervention within the body, not the examination of samples taken from the body.
  • Device Description: The description details the physical components of an endoscope (control section, insertion section, eyepiece section), which is consistent with a device used for internal examination.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the hallmarks of an IVD.

Therefore, the OES CYSTONEPHROFIBERSCOPEs OLYMPUS CYF-5 and CYF-5R are medical devices used for endoscopic procedures, not in vitro diagnostics.

N/A

Intended Use / Indications for Use

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.

Product codes

FAJ

Device Description

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. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bladder, urethra and kidney

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare facility/hospital

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

  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. 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.

Key Metrics

Not Found

Predicate Device(s)

K133538

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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.

1

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

2

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)

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.

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 name510(k) Submitter510(k) No.
VISERA CYSTO-NEPHRO VIDEOSCOPE
OLYMPUS CYF TYPE V2, CYF TYPE
VA2, CYF TYPE V2R
(EVIS EXERA II 180 SYSTEM)OLYMPUS MEDICAL
SYSTEMS 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

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.

5

■ 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-411BSingle Use Combination Cleaning Brush
MAJ-1413Light guide adapter
MB-156ETO 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 DevicePredicate Device
ItemOLYMPUS CYF-5, CYF-5ROLYMPUS CYF
TYPE V2, VA2, V2R
(K133538)
Indications for
UseOES
CYSTONEPHROFIBERSCOPEs
OLYMPUS CYF-5 and CYF-5R
have been 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.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
bladder, urethra, ureter, and
kidney.
Regulation
Number21CFR 876.150021CFR 876.1500
Regulation NameEndoscope and accessoriesEndoscope and accessories
Regulatory ClassClass IIClass II
Product CodeFAJFAJ
Classification
PanelGastroenterology/UrologyGastroenterology/Urology
Use EnvironmentHealthcare facility/hospitalHealthcare 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 of contact | Surface-contacting device in contact
    with mucosal membranes. The
    contact duration is limited exposure
    (