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 Description

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.

AI/ML Overview

The provided text describes the regulatory clearance for the Olympus RHINO-LARYNGO VIDEOSCOPE ENF-VH2 and ENF-V4 devices and details various performance tests conducted. However, it does not contain specific acceptance criteria, reported device performance metrics (such as sensitivity, specificity, or accuracy), or explicit details about a study designed to prove the device meets such criteria in the quantifiable manner typically seen for AI/ML medical devices.

The document focuses on demonstrating substantial equivalence to a predicate device (VISERA RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF TYPE V2, K061313) through non-clinical and some clinical testing, primarily for safety, durability, and basic functionality of an endoscope.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests but does not provide a table with quantifiable acceptance criteria or reported performance metrics (like sensitivity, specificity, or accuracy) for the device's diagnostic capabilities. The tests are generally focused on safety, functionality, and manufacturing compliance.

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (from text)	Reported Device Performance (from text)
Reprocessing	Reprocessing Validation Testing	"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'"	Implied: Complies with relevant guidance for reprocessing.
Biocompatibility	Cytotoxicity Study	"conducted in accordance with FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1..."	Implied: Complies with ISO 10993-1.
	Intracutaneous Study in Rabbits	"conducted in accordance with FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1..."	Implied: Complies with ISO 10993-1.
	Guinea Pig Maximization Sensitization Test	"conducted in accordance with FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1..."	Implied: Complies with ISO 10993-1.
Software	Software Verification and Validation	"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'."	Implied: Complies with relevant FDA software guidance.
Electrical Safety & EMC	Electrical Safety Testing	"The system complies with the ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-18:2009 standards for safety"	Complies with listed standards.
	EMC Testing	"and the IEC 60601-1-2:2014 standards for EMC."	Complies with listed standard.
Bench Performance	Thermal Safety Test	"conducted to ensure that the subject device performs as intended and meet design specifications."	Implied: Meets design specifications.
	Mechanical Durability Test	"conducted to ensure that the subject device performs as intended and meet design specifications."	Implied: Meets design specifications.
	Optical Performance Test	"conducted to ensure that the subject device performs as intended and meet design specifications."	Implied: Meets design specifications.
	Color Performance Test	"conducted to ensure that the subject device performs as intended and meet design specifications."	Implied: Meets design specifications.
Clinical Performance	Evaluation for supporting evidence of marketing claim	"conducted to support the market claims."	Implied: Supports market claims. (No specific quantifiable metrics given).
	Meta-analysis	"conducted to support the market claims."	Implied: Supports market claims. (No specific quantifiable metrics given).
Risk Analysis	Risk analysis based on ISO 14971:2007	"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 of this risk analysis assessment."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Clinical testing for ENF-VH2 and ENF-V4... was conducted to support the market claims" including an "Evaluation for supporting evidence of marketing claim" and "Meta-analysis." However, no specific sample sizes for the test set or information about the country of origin of the data, or whether it was retrospective or prospective, are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The general nature of the clinical testing ("Evaluation for supporting evidence of marketing claim") doesn't specify how ground truth was established or if experts were involved in a quantifiable assessment.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. 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

The document does not indicate that an MRMC comparative effectiveness study was done, nor does it mention AI. The device described is an endoscope, not an AI-powered diagnostic tool in the sense of image interpretation software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is a videoscope, which is a physical instrument for visualization, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document generically states "Clinical testing... was conducted to support the market claims" and a "Meta-analysis" was performed. It does not specify the type of ground truth used for these clinical evaluations. Given the nature of an endoscope, the "ground truth" for its performance would likely relate to visualization quality, ability to identify anatomical structures, or successful completion of procedures, rather than a diagnostic 'truth' established by pathology in the context of an AI device.

8. The Sample Size for the Training Set

This question is not applicable as the device is a videoscope and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as the device is a videoscope and not an AI/ML algorithm that requires a training set.

Summary of Missing Information:

The provided document is a 510(k) summary for a videoscope, demonstrating substantial equivalence to a predicate device. It focuses on the safety and basic functional performance of the hardware. The type of rigorous quantitative performance evaluation (e.g., sensitivity, specificity, ground truth establishment with expert consensus, sample sizes for test/training sets) typically associated with AI/ML-powered diagnostic devices is not present in this document. The "clinical testing" mentioned is generic and lacks the detail required to answer most of your specific questions about acceptance criteria and study design for a diagnostic algorithm.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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: 484-896-3147 Fax: 484-896-7128 Email: sheri.musgnung@olympus.com

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-LARYNGOVIDEOSCOPE PLYMPUS ENFTYPE V2(EVIS EXERA II CV-180 SYSTEM)	OLYMPUS MEDICALSYSTEMS 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

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	RHINO-LARYNGOVIDEOSCOPEOLYMPUSENF-VH2#K182102	RHINO-LARYNGOVIDEOSCOPEOLYMPUS ENF-V4#K182102	VISERARHINO-LARYNGOVIDEOSCOPEOLYMPUS ENFTYPE V2#K061313
Indications for use	This instrument isintended to be usedwith an Olympusvideo system center,light source,documentationequipment, displaymonitor, and otherancillary equipmentfor endoscopicdiagnosis.This instrument isindicated for usewithin the nasallumens and airwayanatomy (includingnasopharynx andtrachea).	This instrument isintended to be usedwith an Olympusvideo system center,light source,documentationequipment, displaymonitor, and otherancillary equipmentfor endoscopicdiagnosis.This instrument isindicated for usewithin the nasallumens and airwayanatomy (includingnasopharynx andtrachea).	This instrument hasbeen designed to beused with an Olympusvideo system center,light source,documentationequipment, displaymonitor, and otherancillary equipmentfor endoscopic withinthe nasal lumens andairway anatomy(includingnasopharyngeal andtrachea).
Field of View	110°	90°	90°
Depth of Field	5-50mm	3.5-50mm	5-50mm
Direction ofForward View	0°(Forward viewing)	0°(Forward viewing)	0°(Forward viewing)
Outer Diameterof Distal End	φ3.9mm	φ2.6mm	φ3.2mm
Outer Diameterof InsertionTube	φ3.6mm	φ2.9mm	φ3.4mm
BendingSectionAngulation	UP:130°DOWN:130°	UP:130°DOWN:130°	UP:130°DOWN:130°
WorkingLength ofinsertion	300mm	300mm	300mm
Features	RHINO-LARYNGOVIDEOSCOPEOLYMPUSENF-VH2#K182102	RHINO-LARYNGOVIDEOSCOPEOLYMPUS ENF-V4#K182102	VISERARHINO-LARYNGOVIDEOSCOPEOLYMPUS ENFTYPE V2#K061313
Configurationof Controlsection andlocation ofscope switch	Image: Subject Device 1 control section	Image: Subject Device 2 control section	Image: Predicate Device control section
NBIobservation	Available	Available	Available
Reprocess withOER-Pro	available	available	unavailable
SterilizationwithSTERRAD	available	available	unavailable
Sterilizationwith 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.

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.