RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4

K182102 · Olympus Medical Systems Corp. · EOB · Feb 6, 2019 · Ear, Nose, Throat

Device Facts

• Record ID: K182102
• Device Name: RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
• Applicant: Olympus Medical Systems Corp.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Feb 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).

Device Story

Rhino-laryngo videoscopes (ENF-VH2, ENF-V4) are flexible endoscopes used for visualization of nasal lumens and airway anatomy. Devices connect to an Olympus video system center, light source, and monitor. Illumination is provided via optical fiber bundle; reflected light is captured by a distal CCD sensor, converted to electrical signals, and transmitted to the video system for display. Physicians operate the device using a pistol-grip control section with an angulation lever for distal tip bending and three switches for system control. The device is used in clinical settings for endoscopic diagnosis. Output allows real-time visualization of anatomy to assist clinical decision-making. Benefits include improved ergonomics, reduced handling mass, and expanded reprocessing compatibility compared to the predicate.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing, reprocessing validation, biocompatibility testing, and software verification/validation. Clinical claims were supported by meta-analysis and evaluation of existing evidence.

Technological Characteristics

Flexible rhino-laryngo videoscopes with CCD imaging sensors. Features pistol-grip control section, 3-switch layout, and reduced weight. Compatible with OTV-S190/CV-170 systems. Complies with ANSI/AAMI ES 60601-1, IEC 60601-2-18, and IEC 60601-1-2. Biocompatibility per ISO 10993-1. Supports STERRAD and V-PRO sterilization and OER-Pro reprocessing.

Indications for Use

Indicated for endoscopic diagnosis within nasal lumens and airway anatomy, including nasopharynx and trachea, in patients requiring visualization of these areas.

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

• VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2 (K061313)

Reference Devices

• OTV-S190 (K111425)
• CV-170 (K122831)
• CLV-S190 (K111425)
• OEV262H (K102379)
• OEV261H (K954451)
• OEV191H (K954451)

Submission Summary (Full Text)

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February 6, 2019

Olympus Medical Systems Corp. % Sheri Musgnung Regulatory Affairs Manager Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

Re: K182102

Trade/Device Name: Rhino-laryngo Videoscope Olympus ENF-VH2, Rhino-laryngo Videoscope Olympus ENF-V4 Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB, NWB Dated: January 4, 2019 Received: January 7, 2019

Dear Sheri Musgnung:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182102

#### Device Name RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2 RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4

Indications for Use (Describe)

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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February 4, 2019

# 510(k) Summary

# 1 GENERAL INFORMATION

- 510(k) Submitter: OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
- Contact Person: Sheri L. Musgnung Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: [phone] Fax: [phone] Email: [e-mail]

## 2 DEVICE IDENTIFICATION

- Device Name RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2 RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 ■ Common Name RHINO-LARYNGO VIDEOSCOPE ■ Regulation Number 874.4760, 876.1500 ■ Regulation Name Nasopharyngoscope (flexible or rigid) and accessories, Endoscope and accessories. ■ Regulatory Class II ■ Product Code EOB. NWB
- Classification Panel Ear Nose & Throat

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#### 3 PREDICATE DEVICE

#### ■ Predicate device

| Device name | 510(k) Submitter | 510(k) No. |
|--------------------------------------------------------------------------------------------|----------------------------------|------------|
| VISERA RHINO-LARYNGO<br>VIDEOSCOPE PLYMPUS ENF<br>TYPE V2<br>(EVIS EXERA II CV-180 SYSTEM) | OLYMPUS MEDICAL<br>SYSTEMS CORP. | K061313 |

#### 4 DEVICE DESCRIPTION

- General Description of the subject device
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).

It mainly consists of four functional parts:

- video connection section including a video connector and video cable that connects the endoscope to the video system center for displaying images on compatible video monitors.
- light guide connector section that links the endoscope with light source and transmits light to the distal end of the endoscope.
- control section that operates endoscope such as controlling angulation to guide insertion and observation.
- insertion section that goes through and contacts with the nasal lumens and airway anatomy (including nasopharynx and trachea) under light guide.

### Principle of Operation

- a. Basic principle

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#### - Illumination light supply

The endoscope receives the illumination light from the light source by light guide connector connected to the light source device. The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end.

#### - Image construction

The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in CCD at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers the image signal and displays the observation image on the screen.

### - Bending operation

The UP/DOWN angulation control lever and bending section are connected with each other by 2 independent wires. It is possible to bend the bending section to the UP/DOWN direction by operating the UP/DOWN angulation control lever.

### b. Technological characteristics

### - New control section

The new control section of ENF-VH2 and ENF-V4 consists of a pistol grip shape. The new control section reduces the angle of the wrist and enables the insertion section to be directed to the nasal cavity of sitting patient even when the wrist and arm of the physician is in a relaxed situation.

### - New layout of switches

By arranging the 3 switches of new ENT control section, physicians can easily push the 3 switches with only an index finger

### - Reduced total weight

Newly developed configuration of control section and thinner and lighter universal cord leads to a reduction in the handling mass of the endoscope control section.

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#### List of compatible equipment -

| | Model name | 510(k) number |
|----------------------------------|------------|------------------------------------|
| Endoscopes | ENF-V4 | K182102 (this submission) |
| | ENF-VH2 | K182102 (this submission) |
| VISERA ELITE video system center | OTV-S190 | K111425 |
| Video system center | CV-170 | K122831 |
| VISERA ELITE xenon light source | CLV-S190 | K111425 |
| Strobe LED Light source | CLL-S1 | EXEMPT from Premarket Notification |
| Video monitors | OEV262H | K102379 |
| | OEV261H | K954451 |
| | OEV191H | K954451 |

Table 1 Compatible equipment

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## 5 INDICATIONS FOR USE

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).

# 6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE

The ENF-VH2 and ENF-V4 have the same technological characteristics and design as the predicate device except for the following new features:

- Changes on optical system parameters (total number of pixels, resolution, etc.) -
- Configuration modification of control section to improve operability -
- -Dimensional and material changes on the insertion section
- Extension of reprocessing methods -
- Software implementation to correct the pixel defect -

All other technological characteristics of both the subject and predicate devices are identical.

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

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| Features | <Subject Device1><br>RHINO-LARYNGO<br>VIDEOSCOPE<br>OLYMPUS<br>ENF-VH2<br>#K182102 | <Subject Device2><br>RHINO-LARYNGO<br>VIDEOSCOPE<br>OLYMPUS ENF-V4<br>#K182102 | <Predicate Device><br>VISERA<br>RHINO-LARYNGO<br>VIDEOSCOPE<br>OLYMPUS ENF<br>TYPE V2<br>#K061313 |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | This instrument is<br>intended to be used<br>with an Olympus<br>video system center,<br>light source,<br>documentation<br>equipment, display<br>monitor, and other<br>ancillary equipment<br>for endoscopic<br>diagnosis.<br>This instrument is<br>indicated for use<br>within the nasal<br>lumens and airway<br>anatomy (including<br>nasopharynx and<br>trachea). | This instrument is<br>intended to be used<br>with an Olympus<br>video system center,<br>light source,<br>documentation<br>equipment, display<br>monitor, and other<br>ancillary equipment<br>for endoscopic<br>diagnosis.<br>This instrument is<br>indicated for use<br>within the nasal<br>lumens and airway<br>anatomy (including<br>nasopharynx and<br>trachea). | This instrument has<br>been designed to be<br>used with an Olympus<br>video system center,<br>light source,<br>documentation<br>equipment, display<br>monitor, and other<br>ancillary equipment<br>for endoscopic within<br>the nasal lumens and<br>airway anatomy<br>(including<br>nasopharyngeal and<br>trachea). |
| Field of View | 110° | 90° | 90° |
| Depth of Field | 5-50mm | 3.5-50mm | 5-50mm |
| Direction of<br>Forward View | 0°(Forward viewing) | 0°(Forward viewing) | 0°(Forward viewing) |
| Outer Diameter<br>of Distal End | φ3.9mm | φ2.6mm | φ3.2mm |
| Outer Diameter<br>of Insertion<br>Tube | φ3.6mm | φ2.9mm | φ3.4mm |
| Bending<br>Section<br>Angulation | UP:130°<br>DOWN:130° | UP:130°<br>DOWN:130° | UP:130°<br>DOWN:130° |
| Working<br>Length of<br>insertion | 300mm | 300mm | 300mm |
| Features | <Subject Device1><br>RHINO-LARYNGO<br>VIDEOSCOPE<br>OLYMPUS<br>ENF-VH2<br>#K182102 | <Subject Device2><br>RHINO-LARYNGO<br>VIDEOSCOPE<br>OLYMPUS ENF-V4<br>#K182102 | <Predicate Device><br>VISERA<br>RHINO-LARYNGO<br>VIDEOSCOPE<br>OLYMPUS ENF<br>TYPE V2<br>#K061313 |
| Configuration<br>of Control<br>section and<br>location of<br>scope switch | Image: Subject Device 1 control section | Image: Subject Device 2 control section | Image: Predicate Device control section |
| NBI<br>observation | Available | Available | Available |
| Reprocess with<br>OER-Pro | available | available | unavailable |
| Sterilization<br>with<br>STERRAD | available | available | unavailable |
| Sterilization<br>with V-PRO | available | available | unavailable |

Table 2 Device Comparison Table

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#### K182102 Traditional 510(k) Notification RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, ENF-V4

#### 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 for the ENF-VH2 and ENF-V4 were conducted and documentation was 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 for the ENF-VH2 and ENF-V4 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of

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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 Colony Assay ।
- Intracutaneous Study in Rabbits ।
- Guinea Pig Maximization Sensitization Test ।

#### 3) Software verification and validation testing

Software verification and validation testing for the ENF-VH2 and ENF-V4 were conducted and documentation was provided as 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 on the ENF-VH2 and ENF-V4. The system complies with the ANSVAAMI 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 for the ENF-VH2 and ENF-V4 as listed below was conducted to ensure that the subject device performs as intended and meet design specifications.

- Thermal safety test
- Mechanical durability test
- Optical performance test
- Color performance test

#### 6) Performance testing - Animal

No animal study was performed to demonstrate substantial equivalence.

#### 7) Performance testing - Clinical

Clinical testing for ENF-VH2 and ENF-V4 as listed below was conducted to support the market claims.

- Evaluation for supporting evidence of marketing claim
- Meta-analysis

### 8) Risk analysis

Risk analysis for the ENF-VH2 and ENF-V4 was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result

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of this risk analysis assessment.

### 8 CONCLUSIONS

Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the ENF-VH2 and ENF-V4 raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.