Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3

K221638 · Olympus Medical Systems Corp. · EOB · Sep 19, 2022 · Ear, Nose, Throat

Device Facts

• Record ID: K221638
• Device Name: Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
• Applicant: Olympus Medical Systems Corp.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Sep 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH are intended to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGO VIDEOSCOPEs OLY MPUS ENF-V3 and ENF-VH is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).

Device Story

Rhino-Laryngo Videoscopes (ENF-VH, ENF-V3) are flexible endoscopes used for visualization of nasal lumens and airway anatomy. The device receives illumination light from an external light source via an optical fiber bundle; reflected light from the patient's anatomy is captured by a distal objective lens and a color CCD image sensor. The device connects to an Olympus video system center, light source, and display monitor for real-time endoscopic diagnosis. Operated by physicians in clinical settings, the device features an upright control handle design. Output is displayed on a monitor to assist the clinician in visual diagnosis. The device supports Narrow Band Imaging (NBI) observation. It is a reusable device requiring reprocessing (cleaning, disinfection, or sterilization) between uses.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including thermal safety, composite durability, noise/dynamic range (ISO 15739:2017), color performance, image intensity uniformity, resolution, photobiological safety (IEC 62471:2006), biocompatibility (ISO 10993), and electrical safety/EMC (IEC 60601 series).

Technological Characteristics

Flexible endoscope with color CCD sensor; 110° (ENF-VH) or 90° (ENF-V3) field of view; 0° forward viewing; 5-50 mm (ENF-VH) or 3.5-50 mm (ENF-V3) depth of field. Materials validated per ISO 10993. Sterilization via EO gas, STERRAD NX, or STERRAD 100S. Connectivity to Olympus video system centers (OTV-S200/S300, OTV-S190, CV-170).

Indications for Use

Indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea) for endoscopic diagnosis in patients requiring such procedures.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2 (K182102)
• RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 (K182102)

Reference Devices

• OER-Pro (K103264)
• OER-Mini (K120357)
• OER-Elite (K201920)

Submission Summary (Full Text)

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September 19, 2022

Olympus Medical Systems Corp. % Brenda Geary Manager, Regulatory Affairs Olympus Corporation of the Americas 800 West Park Drive Westborough, Massachusetts 01581

Re: K221638

Trade/Device Name: Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB, NWB Dated: August 9, 2022 Received: August 18, 2022

Dear Brenda Geary:

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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 [phone] or 301-796-7100).

Sincerely,

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and Ear, Nose and Throat Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental 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) TBD

#### Device Name

RHINO-LARYNGO VIDEOSCOPE, OLYMPUS MODEL: ENF-VH RHINO-LARYNGO VIDEOSCOPE, OLYMPUS MODEL: ENF-V3

#### Indications for Use (Describe)

RHINO-LARYNGO VIDEOSCOPEs OLYMPUS ENF-V3 and ENF-VH are intended to be used with an Olympus video system center, light source, document, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGO VIDEOSCOPEs OLY MPUS ENF-V3 and ENF-VH is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) Summary

### RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3

| General Information | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.<br>2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan<br>192-8507<br>Phone: [phone]<br>Fax: [phone]<br>Establishment Registration Number: 8010047 |
| Manufacturer: | Shirakawa Olympus Co., Ltd.<br>3-1 Okamiyama, Odakura, Nishigo-mura,<br>Nishishirakawa-gun, Fukushima 961-8061,<br>Japan<br>Phone: [phone]<br>Fax: [phone]<br>Establishment Registration Number:<br>3002808148 |
| | Aizu Olympus Co., Ltd.,<br>500 Muranishi, Niidera, Monden-machi,<br>Aizuwakamatsu-shi, Fukushima 965-8520,<br>Japan<br>Phone: [phone]<br>Fax: [phone]<br>Establishment Registration Number: 9610595 |
| 510(k) Submitter: | Olympus Corporation of the Americas<br>800 West Park Drive<br>Westborough, MA 01581 USA |
| Establishment Registration Number: | 2429304 |
| Contact Person: | Brenda M Geary<br>Manager, Regulatory Affairs<br>Mobile: [phone]<br>Email: [e-mail] |
| Date Prepared: | 3 June 2022 |

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#### Device Description

| Model No. | Device/Trade Name | Product Classification |
|-----------|--------------------------|------------------------|
| ENF-VH | RHINO-LARYNGO VIDEOSCOPE | EOB (874.4760) |
| ENF-V3 | RHINO-LARYNGO VIDEOSCOPE | NWB |

| Classification Name: | Nasopharyngoscope (flexible or rigid) and accessories,<br>Endoscope and accessories | |
|----------------------|-------------------------------------------------------------------------------------|--|
| Generic/Common Name: | Rhino-Laryngo Videoscope | |
| Regulation Number: | 874.4760 | |
| Regulatory Class: | Class II | |
| Product Codes: | EOB, NWB | |
| Review Panel: | Ear Nose & Throat | |

## Predicate Devices

| Predicate Device | 510(k) No. |
|--------------------------------------------------|------------|
| RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V4 | K182102 |

### Product Description

Rhino-Laryngo Videoscopes Olympus ENF-VH, ENF-V3 are intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. Rhino-Laryngo Videoscopes Olympus ENF-VH, ENF-V3 are indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).

#### Comparison of Technological Characteristics

Table 5-1 compares ENF-VH to the predicate device with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

| Feature/Technological<br>Characteristics | Subject Device<br>ENF-VH | Predicate Device<br>ENF-VH2 | Comparison |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| Device Name<br>(Model) | Rhino-Laryngo<br>Videoscope<br>(ENF-VH) | Rhino-Laryngo<br>Videoscope<br>(ENF-VH2) | Model names differ. |
| Regulatory Decision | This submission | K182102 | N/A |
| Product Code | EOB, NWB | EOB, NWB | Same as predicate |
| Regulation Number | 874.4760, | 874.4760, | Same as predicate |
| Regulation Name | Nasopharyngoscope<br>(flexible or rigid) and<br>accessories, Endoscope<br>and accessories | Nasopharyngoscope<br>(flexible or rigid) and<br>accessories, Endoscope<br>and accessories | Same as predicate |
| Feature/Technological<br>Characteristics | Subject Device<br>ENF-VH | Predicate Device<br>ENF-VH2 | Comparison |
| Intended Use | RHINO-LARYNGO<br>VIDEOSCOPE<br>OLYMPUS ENF-VH<br>is intended to be used<br>with an Olympus video<br>system center, light<br>source, documentation<br>equipment, display<br>monitor, and other<br>ancillary equipment for<br>endoscopic diagnosis.<br>RHINO-LARYNGO<br>VIDEOSCOPE<br>OLYMPUS ENF-VH is<br>indicated for use within<br>the nasal lumens and<br>airway anatomy<br>(including nasopharynx<br>and trachea). | This instrument is intended<br>to be used with an<br>Olympus video system<br>center, light source,<br>documentation equipment,<br>display monitor, and other<br>ancillary equipment for<br>endoscopic diagnosis. This<br>instrument is indicated for<br>use within the nasal lumens<br>and airway anatomy<br>(including nasopharynx<br>and trachea). | Similar to predicate.<br>Device name and model<br>number are now<br>included in the<br>Indications for Use<br>statement. The actual<br>intended use is identical. |
| Mode of Action | The endoscope receives<br>the illumination light<br>from the light source by<br>light guide connector<br>connected to the light<br>source device. The<br>illumination light is<br>transferred to the distal<br>end through the optical<br>fiber bundle inside of the<br>endoscope and<br>illuminates the inside of<br>the patient body through<br>the illumination lens at<br>the distal end. The<br>endoscope receives the<br>reflected light from the<br>inner lumen of a patient<br>by objective lens at the<br>distal end. | The endoscope receives<br>the illumination light from<br>the light source by light<br>guide connector<br>connected to the light<br>source device. The<br>illumination light is<br>transferred to the distal<br>end through the optical<br>fiber bundle inside of the<br>endoscope and illuminates<br>the inside of the patient<br>body through the<br>illumination lens at the<br>distal end. The endoscope<br>receives the reflected light<br>from the inner lumen of a<br>patient by objective lens<br>at the distal end. | Same as predicate |
| Optical System Parameters | | | |
| Field of View | 110° | 110° | Same as predicate |
| Direction of View | 0° forward viewing | 0° forward viewing | Same as predicate |
| Depth of Field<br>(Refer to Attachment<br>12-B for the definition) | 5-50 mm | 5-50 mm | Same as predicate |
| Imaging System | | | |
| Type of Chip | Color CCD | Color CCD | Same as predicate |
| No. of Image Sensor<br>Chip | 1 | 1 | Same as predicate |
| NBI observation | Available | Available | Same as predicate |
| Control Section | | | |
| Feature/Technological<br>Characteristics | Subject Device<br>ENF-VH | Predicate Device<br>ENF-VH2 | Comparison |
| Control Section | Image: Subject Device ENF-VH | Image: Predicate Device ENF-VH2 | The control section of<br>the Rhino-Laryngo<br>Videoscopes (ENF-<br>VH/V3) were designed<br>have the same control<br>mechanism however<br>they are designed to be<br>handled with up-right<br>functionality rather than<br>a pistol and trigger grip.<br>The difference in the<br>ergonomic design does<br>not raise new questions<br>of safety and<br>effectiveness<br>This difference does not<br>alter or change the<br>indications for use or<br>result in a new intended<br>use. |
| Total Length | 510 mm | 500 mm | Similar<br>Total length difference is<br>due to change in design<br>of the control section for<br>the subject device. This<br>difference does not alter<br>or change the indications<br>for use or result in a new<br>intended use. |
| Insertion section | | | |
| Insertion Tube<br>Diameter - Distal End | 3.9 mm | 3.9 mm | Same as predicate |
| Insertion Tube<br>Diameter - Flexible<br>Outer Tube | 3.6 mm | 3.6 mm | Same as predicate |
| Insertion Section Working<br>Length | 300 mm | 300 mm | Same as predicate |
| Bending section | | | |
| Angulation range | Up 130° / Down 130° | Up 130° / Down 130° | Same as predicate |
| Connection to Light Source | | | |
| Configuration | Light guide (LG) cable<br>is not detachable | Light guide (LG) cable<br>is not detachable | Same as predicate |
| Venting Connector | | | |
| Position | On LG connector | On LG connector | Same as predicate |
| Sterilization | | | |
| EO | Available | Available | Same as predicate |
| STERRAD NX | Available | Available | Same as predicate |
| STERRAD 100S | Available | Available | Same as predicate |
| Feature/Technological<br>Characteristics | Subject Device<br>ENF-VH | Predicate Device<br>ENF-VH2 | Comparison |
| Compatible Processor | OTV-S200/S300<br>OTV-S190<br>CV-170 | OTV-S190<br>CV-170 | For VH- qualified<br>additional processors<br>OTV-S200/S300.<br>Compatibility of ENF-<br>VH with OTV-<br>S200/S300 was<br>demonstrated with bench<br>performance testing in<br>Section 18 confirm that<br>these additional<br>processors do not raise<br>any new questions of<br>safety or effectiveness. |
| Compatible Light<br>Source | CLV-S190<br>CLL-S1 | CLV-S190<br>CLL-S1 | Same as predicate |
| Compatible Monitor | OEV262H<br>LMD-X310ST*<br>*This can only be<br>combined with OTV-S300. | OEV262H<br>OEV-261H<br>OEV-191H | For VH- qualified<br>LMD-X310ST.<br>Compatibility of ENF-<br>VH with LMD-<br>XS310ST was<br>demonstrated during<br>electrical safety and<br>electromagnetic<br>compatibility testing<br>described in Section 17<br>confirm that this monitor<br>does not raise new<br>questions of safety or<br>effectiveness. |

#### Table 5-1: Comparison of the technological characteristics of ENF-VH to predicate device

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# RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-VH, ENF-V3

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#### Traditional 510(k) Notification RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH, ENF-V3

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Table 5-2 compares subject device ENF-V3 to the predicate device ENF-V4 with respect to intended use, technological characteristics, and principle of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

| Feature/ Technological<br>Characteristics | Subject Device<br>ENF-V3 | Predicate Device<br>ENF-V4 | Comparison |
|-------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------|
| Regulatory | | | |
| Device Name<br>(Model) | Rhino-Laryngo<br>Videoscope<br>(ENF-V3) | Rhino-Laryngo<br>Videoscope<br>(ENF-V4) | Model names differ |
| Regulatory Decision | This submission | K182102 | N/A |
| Product Code | Same as predicate | EOB, NWB | Same as predicate |
| Regulation Number | Same as predicate | 874.4760 | Same as predicate |
| Regulation Name | Same as predicate | Nasopharyngoscope<br>(flexible or rigid) and<br>accessories, Endoscope<br>and accessories. | Same as predicate |
| Intended Use | RHINO-LARYNGO<br>VIDEOSCOPE | This instrument is<br>intended to be used with |…