RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

Device Description

AI/ML Overview

This document describes the premarket notification (510(k)) for the RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP. The device is a flexible nasopharyngoscope indicated for endoscopic diagnosis within the nasal and nasopharyngeal lumen, to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Item	Acceptance Criteria (Compliance to Standards / Bench Performance)	Reported Device Performance
Regulatory & Safety
Intent (Predicate Equivalence)	Substantially equivalent to predicate device (ENF-GP2, K181240)	Claimed Substantially Equivalent: The device is claimed to be substantially equivalent based on similarities in indications for use, design, materials, technological characteristics, and operational characteristics.
Thermal Safety	Compliance to IEC 60601-2-18:2009-08	Thermal safety performance test verified compliance.
Photobiological Safety	Compliance to IEC 62471:2006-07	Test confirmed light emitted is low enough not to cause injury to skin and eye.
Biocompatibility	Compliance to ISO 10993 series and FDA Guidance	Testing conducted per guidance; deemed acceptable for intended use.
Sterilization (EO)	Compliance to ISO 11135:2014 & ISO 10993-7:2008 & FDA Guidance	Validated as safe and effective for reprocessing with EO Gas.
Reprocessing Methods	Compliance to FDA guidance: "Reprocessing Medical Devices..."	Validated as safe and effective for manual cleaning, manual disinfection, and with OER-Pro/Mini/Elite.
Electrical Safety	Compliance to IEC 60601-1:2005+A1:2012 & IEC 60601-2-18:2009	Found to be in compliance with relevant requirements.
Risk Analysis	Compliance to ISO 14971:2007	Performed in accordance with ISO 14971:2007; risks considered acceptable and mitigated.
Imaging Performance
Composite Durability	Device retains safety and effectiveness against expected stresses	Durability test against composite stress demonstrates the device retains its safety and effectiveness against the stresses expected in its use-life.
Color Performance	Substantially equivalent to predicate devices	Confirmed as substantially equivalent to the predicate devices.
Image Intensity Uniformity	Substantially equivalent to predicate devices	Confirmed as substantially equivalent to the predicate devices.
Resolution	Similar to predicate device, no new safety/effectiveness issues	Resolution is similar to predicate device and does not raise new issues of safety or effectiveness.
Direction of View	Compliance to ISO 8600-1, consistent with design specs	Test verified compliance and confirmed consistency with design specifications, introducing no new safety/effectiveness questions.
Field of View	Compliance to ISO 8600-1, consistent with design specs	Test verified compliance and confirmed consistency with design specifications, introducing no new safety/effectiveness questions. (Note: different from PD but area adjustable and difference does not affect safety/effectiveness).
Depth of Field	Covers predicate device's depth of field	Increased range covers the predicate's depth of field. Not affected by variations in compatible systems.
Compatibility	Compatibility with new processors, light sources, monitors, camera heads does not raise new safety/effectiveness questions	Demonstrated with bench performance testing in Section 18 (not fully detailed here), confirming no new safety or effectiveness questions for OTV-S200/S300, OEV-262H, LMD-X310ST, CH-S200-XZ-EA/EB.

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

The document focuses on "Non-Clinical Bench Testing" for the device, which typically involves testing of the physical device components and its performance characteristics in a controlled environment. It does not mention specific 'test sets' in the context of clinical images or patient data. Therefore, information regarding sample size used for a test set (e.g., number of cases/images) and data provenance (country of origin, retrospective/prospective) is not provided as it is not applicable to the type of testing described (bench testing on the physical device).

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

This information is not provided and is not applicable, as the evaluation described is non-clinical bench testing of a physical medical device (fiberscope), not an AI or diagnostic software based on image interpretation by experts.

4. Adjudication Method:

This information is not provided and is not applicable for the same reason mentioned in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

An MRMC comparative effectiveness study was not done. The device is a RHINO-LARYNGOFIBERSCOPE, a physical medical device for visualization, not an AI or software intended to assist human readers in interpretation or diagnosis.

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

A standalone performance study was not done. This refers to an algorithm's performance without human-in-the-loop, which is relevant for AI/software devices. The device in question is a hardware endoscopic tool.

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

The "ground truth" for the performance criteria in this submission is established through objective measurements and assessments against specified engineering and safety standards. For example:

Thermal Safety: Adherence to temperature limits set by IEC 60601-2-18.
Photobiological Safety: Adherence to light emission limits set by IEC 62471.
Imaging Parameters (Resolution, Field of View, Depth of Field, Color Performance, Image Intensity Uniformity): Measured values are compared against design specifications and predicate device performance to ensure similarity and adequate functionality.
Biocompatibility: Results of laboratory tests (e.g., cytotoxicity, irritation, sensitization) are compared against established biological evaluation criteria in ISO 10993 standards.
Sterilization and Reprocessing: Demonstrated efficacy of cleaning/disinfection/sterilization methods through validated protocols according to FDA guidance and ISO 11135.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable for this physical medical device. Training sets are relevant for machine learning algorithms, which this device does not utilize (it "does not contain any software").

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

This information is not provided and is not applicable for the same reason mentioned in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 28, 2022

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

Re: K221660

Trade/Device Name: Rhino-Laryngofiberscope Olympus ENF Type XP Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: November 21, 2022 Received: November 21, 2022

Dear Steven Keenan:

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.

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

{1}------------------------------------------------

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 (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 mediation-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,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221660

Device Name

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP

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)

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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image displays the word "OLYMPUS" in a bold, sans-serif font. The text is a dark blue color, which contrasts with the white background. A registered trademark symbol is located to the right of the word.

K221660 - 510(k) Summary

For

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP

General Information
Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan192-8507Phone: (+81) 42-642-2694Fax: (+81) 42-642-2307Establishment Registration Number: 8010047
Manufacturer:	Aizu Olympus Co., Ltd.,500 Muranishi, Niidera, Monden-machi,Aizuwakamatsu-shi, Fukushima 965-8520,JapanPhone: (+81) 242-28-2111Fax: (+81) 242-26-4234Establishment Registration Number: 9610595
510(k) Submitter:	Olympus Corporation of the Americas800 West Park DriveWestborough, MA 01518 USA
Establishment Registration Number:	2429304
Contact Person:	Steven KeenanProgram ManagerMobile: (508)-523-5004Email: Steven.Keenan@olymus.com
Date Prepared:	June 3, 2022

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. A registered trademark symbol is located to the right of the letter "S".

Device Description

Model No.	Device/Trade Name	Product Classification
ENF-XP	RHINO-LARYNGOFIBERSCOPEOLYMPUS ENF TYPE XP	EOB (874.4760)

Classification Name: Generic/Common Name: Regulation Number: Regulatory Class: Product Codes: Review Panel:

Nasopharyngoscope (flexible or rigid) and accessories Rhino-Laryngo Fiberscope 874.4760 Class II EOB Ear Nose & Throat

Predicate Device

Predicate Device	510(k) No.
RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2	K181240

Product Description

Comparison of Technological Characteristics

Table 5-1 compares RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP 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.

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

Feature/TechnologicalCharacteristics	Subject DeviceENF-XP	Predicate DeviceENF-GP2	Comparison
Regulatory
Device Name	RHINO-LARYNGOFIBERSCOPEOLYMPUS ENFTYPE XP	Rhino-LaryngoFiberscope ENF-GP2	Different model names.
Regulatory Decision	This submission	K181240	N/A
Feature/TechnologicalCharacteristics	Subject DeviceENF-XP	Predicate DeviceENF-GP2	Comparison
Product Code	EOB	EOB	Same as predicate.
Regulation Number	874.4760	874.4760	Same as predicate.
Regulation Name	Nasopharyngoscope (flexible orrigid) andaccessories	Nasopharyngoscope (flexible orrigid) andaccessories	Same as predicate.
Intended Use	RHINO-LARYNGOFIBERSCOPEOLYMPUS ENFTYPE XP isintended to beused with anOlympus videosystem center,documentationequipment,display monitor,and otherancillaryequipment forendoscopicdiagnosis.RHINO-LARYNGOFIBERSCOPEOLYMPUS ENFTYPE XP isindicated for usewithin the nasalandnasopharyngeallumen.	This instrument isintended to beused with anOlympus lightsource,documentationequipment,display monitorand otherancillaryequipment forendoscopicdiagnosis. Thisinstrument isindicated for usewithin the nasalandnasopharyngeallumen.	Similar to predicate. Device nameand model number are nowincluded in the Indications for Usestatement. The intended use isidentical to predicate.
Feature/TechnologicalCharacteristics	Subject DeviceENF-XP	Predicate DeviceENF-GP2	Comparison
Mode of Action	When observingnasal ornasopharyngeallumen, the lightemitted from lightsource enters intothe fiberscope viaapparatus onconnector sectionand is eventuallytransmitted andreleased fromexamination lightoutlet in the distalend to supplylight by opticalfiber bundles.Subsequently theilluminated imagereflected intoobjective lens issent to theeyepiece sectionby image fiberbundles. Theobserver canobserve the imagedirectly in theeyepiece sectionor alternatively,the image can beobserved on amonitor generatedby a videoprocessor and acamera headattached on theeyepiece.	When observingnasal ornasopharyngeallumen, the lightemitted from lightsource enters intothe fiberscope viaapparatus onconnector sectionand is eventuallytransmitted andreleased fromexamination lightoutlet in the distalend to supply lightby optical fiberbundles.Subsequently theilluminated imagereflected intoobjective lens issent to theeyepiece sectionby image fiberbundles. Theobserver canobserve the imagedirectly in theeyepiece sectionor alternatively,the image can beobserved on amonitor generatedby a videoprocessor and acamera headattached on theeyepiece.	Same as predicate.
Optical System Parameters
Field of View	75°	85°	Although the field of view isdifferent from PD, the area withinthe view can be adjusted by theadvance or retreat of the endoscope.Therefore, the difference in FOVdoes not affect the safety andeffectiveness of the subject device.
Direction of View	0° (Forwardviewing)	0° (Forwardviewing)	Same as predicate.
Feature/TechnologicalCharacteristics	Subject DeviceENF-XP	Predicate DeviceENF-GP2	Comparison
Depth of Field	2.5-50 mm	5-50 mm	The increased range of depth offield covers the PD's depth of field.In addition, although the subjectdevice is compatible with variousprocessors, light sources, andcamera heads, this specification isnot affected by the variation of thesystems.
	Bending Section
Angulation range	Up 130° / Down130°	Up 130° / Down130°	Same as predicate.
	Insertion section
Insertion TubeDiameter – DistalEnd	1.8 mm	3.1 mm	The difference in tube diameter ofthe distal end for the subjectdevice does not alter or change theindications for use or result in anew intended use.
Insertion TubeDiameter –Flexible OuterDiameter	2.2mm	3.5mm	The difference in flexible outerdiameter of the insertion tube forthe subject device does not alter orchange the indications for use orresult in a new intended use.
Insertion SectionWorking Length	300 mm	300 mm	Same as predicate.
	Connection to Light Source
Configuration	Light Guide (LG)cable is notdetachable	LG cable isdetachable	Cable configuration does notdirectly affect the safety andeffectiveness of the subject device.
	Venting Connector
VentingConnectorPosition	On LG connector	On control body	Venting connector position doesnot directly affect the safety andeffectiveness of the subject device.
	Sterilization
EO	Available	Available	Same as predicate.
	Other
Suction Function	Not provided	Not provided	Same as predicate.
Total Length	530 mm	550 mm	Due to the difference in the shapeof the control section, the subjectdevice has a 20mm shorter totallength compared with the predicatedevice. This difference does notalter or change the indications foruse or result in a new intended use.
Feature/TechnologicalCharacteristics	Subject DeviceENF-XP	Predicate DeviceENF-GP2	Comparison
CompatibleProcessor	OTV-S200/S300(with light sourcefunction)	OTV-SC/SC2OTV-S7VCV-170OTV-S7ProOTV-S190	Compatibility of ENF- XP with OTV-S200/S300 was demonstrated withbench performance testing in Section18 confirm that these additionalprocessors do not raise any newquestions of safety or effectiveness.
Compatible LightSource	OTV-S200/S300(with light sourcefunction)	CLV-S190CLV-S40ProCLH-SCCLL-V1CLL-S1CV-170	Compatibility of ENF- XP with OTV-S200/S300 (with light sourcefunction) was demonstrated withbench performance testing in Section18 confirm that these additional lightsources do not raise any newquestions of safety or effectiveness.
CompatibleMonitor	OEV-262HLMD-X310ST**This can only becombined withOTV-S300.	OEV-141OEV-142OEV-143OEV-201OEV-202OEV-203OEV-181HOEV-191OEV-191HOEV-261H	Compatibility of ENF- XP with OEV-262H and LMD-X310ST wasdemonstrated with bench performancetesting in Section 18 confirm thatthese additional monitors do not raiseany new questions of safety oreffectiveness.
CompatibleCamera Head	CH-S200-XZ-EACH-S200-XZ-EB	OTV-S7H-1NA-10E/12EOTV-S7H-1N/1NAOTV-S7ProH-HD-10E/12E	Compatibility of ENF- XP with CH-S200-XZ-EA and CH-S200-XZ-EBcamera heads was demonstrated withbench performance testing in Section18 confirm that these additionalcamera heads do not raise any newquestions of safety or effectiveness.

{5}------------------------------------------------

OLYMPUS®

Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP

{6}------------------------------------------------

OLYMPUS®

Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are closely spaced together, creating a solid block of text. A registered trademark symbol is located to the right of the word.

{8}------------------------------------------------

Traditional 510(k) Notification RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP

Indications for Use

RHINO-LARYNGOFIBROSCOPE OLYMPUS ENF TYPE XP is intended to be used with an Olympus video system center, documentation equipment, display monitor, and other ancillary equipment for endoscopic diagnosis. RHINO-LARYNGOFIBROSCOPE OLYMPUS ENF TYPE XP is indicated for use within the nasal and nasopharyngeal lumen.

Compliance to Voluntary Standards

The following voluntary standards have been applied to the subject devices respectively:

Standard
ANSI AAMI ES 60601-1:2005+A1:2012	Medical electrical equipment – Part 1: Generalrequirements for basic safety and essential performance
IEC 60601-2-18:2009	Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC 62471:2006	Photobiological safety of lamps and lamp systems
ISO 10993-1:2009	Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009	Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010	Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
ISO 10993-12:2012	Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
ISO 10993-17:2002	Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18:2020	Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process
ISO 11135:2014	Sterilization of health care products – Ethylene Oxide – requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-7: 2008	Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)
ISO 14971:2007	Medical Devices – Application of risk management to medical devices
FDA Device Specific Guidance
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff
FDA Guidance Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Guidance for the Content of Premarket Submissions for Software contained in Medical Devices
FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices

{9}------------------------------------------------

Summary of Performance Testing

The following performance testing was conducted in support of the substantial equivalence determination.

1. Non-Clinical Bench Testing

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced together. There is a registered trademark symbol to the right of the letter "S". The background is white.

Item	Contents
Thermal Safety	Thermal safety performance test verified compliance to Protectionagainst excessive temperature and other safety hazards of IEC 60601-2-18:2009-08.
Composite Durability	The durability test against composite stress of mechanical and chemicalstress demonstrates the subject device retains its safety and effectivenessagainst the stresses expected in its use-life.
Color Performance	The color performance of the subject devices is confirmed assubstantially equivalent to the predicate devices.
Image IntensityUniformity	The image intensity uniformity of the subject devices is confirmed assubstantially equivalent to the predicate devices.
Resolution	The resolution of the subject device is similar to predicate device anddoes not raise new issues of safety or effectiveness.
Photobiological Safety	The photobiological safety test verified compliance to IEC 62471:2006-07 and confirms the light emitted from subject devices connected to eachlight source is low enough not to cause injury to the skin and eye.
Direction of View	The direction of view test verified compliance to ISO 8600-1 andconfirms that the subject device is consistent with the designspecifications and does not introduce new questions related to safety andeffectiveness.
Field of View	The field of view test verified compliance to ISO 8600-1 and confirmsthat the subject device is consistent with the design specifications anddoes not introduce new questions related to safety and effectiveness.

2. Animal Test

Animal testing was not applicable and not performed.

3. Biocompatibility Evaluation

Biocompatibility testing was 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". There have been no changes that have impacted the established biocompatibility profile and the Biological Risk associated with this device is acceptable for intended use.

4. Sterilization, Shelf Life, Reprocessing

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP and its reusable accessories are not sterilized before shipment. Before using the instrument for the first time and after using the endoscopes, the devices are reprocessed according to the instructions given in the subject endoscope's companion Reprocessing Manual. All cleaning, disinfection, and sterilization methods were validated pursuant to the FDA guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015. The reprocessing validation was conducted

{11}------------------------------------------------

pursuant to the same FDA guidance document. ENF-XP is validated as safe and effective for reprocessing with the following:

Manual Cleaning using FlexClean895 ●
Manual Cleaning using Endozime AW ●
Manual Cleaning with pre-soaking using Endozime AW
. Manual Disinfection (2-3.5% glutaraldehyde)
OER-Pro (K103264)
. OER-Mini (K120357)
OER-Elite (K201920)
Sterilization with EO Gas

5. Electrical Safety

Electrical safety testing has been confirmed for the subject devices. RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP was found to be in compliance with the relevant requirements as noted below. Electromagnetic compatibility (EMC) testing was not applicable and not performed.

IEC 60601-1:2005+A1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
. IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

6. Software Verification and Validation Testing

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP does not contain any software and therefore software testing was not performed.

7. Risk Analysis

Risk management has been performed in accordance with ISO 14971:2007. In the risk management process, Olympus determined that additional human factors validation testing was not required for the subject device in accordance with the FDA Guidance. "Applying Human Factors and Usability Engineering to Medical Devices" since the risk analysis made to the currently marketed device did not identify any unacceptable use-related risks. Refer to the risk management table for the RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP. To date, with respect to perceivable conditions in which the device would be subjected to a worst-case environment for human error scenario, Olympus believes that the outcomes of these risks are considered acceptable within the context of ISO 14971:2007 and that all potential risks have been mitigated to the lowest form.

8. Clinical Testing

Clinical testing was not applicable and not performed.

Substantial Equivalence

{12}------------------------------------------------

OLYMPUS

RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP is substantially equivalent to the legally marketed predicate device, ENF-GP2 (K181240). Olympus claims substantial equivalence to the predicate devices based on evaluation of the on similarities in indications for use, design, materials, technological characteristics, and operational characteristics. Differences are summarized in Table 5-1 above.

Conclusion

In summary, the indications for use and technological characteristics of the RHINO-LAR YNGOFIBERSCOPE OLYMPUS ENF TYPE XP device do not raise different questions of safety and effectiveness as compared to the predicate device. The performance testing demonstrate that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device.

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.