This instrument is intended to be used with an Olympus light source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis. This instrument is indicated for use within the nasal and nasopharyngeal lumen.

Device Description

ENF-GP2 is mainly consisted of four functional parts:

eyepiece section that observes endoscopic images
control section that operates endoscope such as controlling angulation to guide insertion and observation
connector section that links with light source -
insertion section that goes through and contacts with nasal and nasopharyngeal lumen under light guide.

When observing nasal or nasopharyngeal lumen, the light emitted from light source comes into fiberscope via apparatus on connector section and is eventually transmitted and released from examination light outlet in the distal end to supply light by optical fiber bundles. Subsequently the enlighten image reflexed into objective lens is grasped and sent to evepiece section by image fiber bundles, and observer can observe the image in eyepiece section or alter the imaging position by means of operations on control section, such as manipulation by UP/DOWN angulation control lever to adjust the bending section. Each section works collectively to perform observation within nasal and nasopharyngeal lumen.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2, asserting its substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo clinical or standalone performance studies against predefined acceptance criteria for novel claims.

Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning standalone diagnostic performance, multi-reader multi-case studies, and detailed ground truth data for training/test sets, is not present in this document. The document details bench and reprocessing validation tests for the device itself, rather than its diagnostic performance in a clinical setting against specific analytical or clinical performance metrics.

Here's an analysis of the provided text based on your request, highlighting what is and isn't available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with "acceptance criteria" for diagnostic performance and "reported device performance" against those criteria in the context of an AI/algorithm-driven device. Instead, it describes performance testing focused on device safety and functionality.

Acceptance Criteria Type	Acceptance Criteria (from document)	Reported Device Performance (from document)
Reprocessing Validation	As recommended by "Guidance for Industry and Food and Drug Administration Staff, 'Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling'".	Conducted and documentation provided.
Biocompatibility	In accordance with FDA's Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'".	Conducted.
Electrical Safety	Compliance to ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC60601-2-18:2009.	Performed to verify compliance.
Thermal Safety	Compliance to "PROTECTION AGAINST EXCESSIVE TEMPARATURES AND OTHER SAFETY HAZARDS" of IEC 60601-2-18:2009-08.	Performed to verify compliance.
Mechanical Durability	Safety and effectiveness considering the supposed usage and operating environment.	Performed to verify safety and effectiveness.
Optical Performance	Safety and effectiveness from optical perspective.	Performed to verify safety and effectiveness.
Risk Analysis	In accordance with established in-house acceptance criteria based on ISO 14971:2007 and human factors validation in accordance with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices".	Conducted, and design verification tests and acceptance criteria were identified and performed as a result.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. The document refers to testing of the physical medical device (fiberscope), not an AI/algorithm where a "test set" of data would be used for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text. No ground truth establishment for a diagnostic test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text. No test set adjudication is mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "No clinical study was performed to demonstrate substantial equivalence." This device is a fiberscope, not an AI-assisted diagnostic tool discussed in the context of MRMC studies.

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

This information is not applicable/available for this device submission. The device is a physical rhinopharyngoscope, not a standalone AI algorithm. The performance tests mentioned in the document relate to the physical and functional aspects of the scope itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided text. Ground truth, in the context of diagnostic performance, is not discussed for this device.

8. The sample size for the training set

This information is not applicable/available for this device submission. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable/available for this device submission. There is no mention of a "training set" or its ground truth establishment.

Summary

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October 4, 2018

Olympus Medical Systems Corp. % Sheri L. Musgnung Regulatory Affairs Manager Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610

Re: K181240

Trade/Device Name: Rhino-Larvngo Fiberscope Olympus ENF-GP2 Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: August 31, 2018 Received: September 4, 2018

Dear Sheri L. 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.

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 yours,

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) K181240

Device Name RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2

October 1, 2018

1 General Information

■ Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507,JapanEstablishment Registration No: 8010047
■ Official Correspondent:	Sheri L. MusgnungManager, Regulatory AffairsOlympus Corporation of the Americas3500 Corporate Parkway PO Box 610Center Valley, PA 18034-0610, USAPhone: 484-896-3147FAX: 484-896-7128Email: sheri.musgnung@olympus.com
■ Manufacturer:	Aizu Olympus Co., Ltd.500 Muranishi, Niidera, Monden-Machi,Aizuwakamatsu- Shi, Fukushima, 965-8520, JapanEstablishment Registration No.: 9610595

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2 Device Identification

■ Device Trade Name:	RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2
■ Common Name:	RHINO-LARYNGO FIBERSCOPE
■ Regulation Number:	874.4760
■ Regulation Name:	Nasopharyngoscope (flexible or rigid) and accessories
■ Regulatory Class:	II
■ Classification Panel:	Ear Nose and Throat
■ Product Code:	EOB

3 Predicate Device Information

■ Device Name:	XENF-TP Rhino-Laryngofiberscope, its accessories andancillary equipment
■ Common Name:	Fiber Scope for Rhino-Laryngo
■ Applicant	OLYMPUS MEDICAL SYSTEMS CORP.
■ 510(k) No.	K013591

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4 Device Description

ENF-GP2 is mainly consisted of four functional parts:

eyepiece section that observes endoscopic images
control section that operates endoscope such as controlling angulation to guide insertion and observation
connector section that links with light source -
insertion section that goes through and contacts with nasal and nasopharyngeal lumen under light guide.

5 Indications for Use

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6 Comparison of Technological Characteristics

Compared to the predicate device, the subject device RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 has similar technological characteristics except for the following differences:

Changes on optical system parameters
Configuration modification and material change of eyepiece section and control section
Dimension and material change on insertion section
Removal of instrumental channel structure
Extension of reprocessing methods

Detailed information is provided in the following table.

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OLYMPUS MEDICAL SYSTEMS CORP. 510(k) Premarket Notification RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2, K181240

Features	RHINO-LARYNGO FIBERSCOPEOLYMPUS ENF-GP2	XENF-TP Rhino-Laryngofiberscope,its accessories and ancillaryequipment, K013591
Indications for use	This instrument is intended to be usedwith an Olympus light source,documentation equipment, displaymonitor and other ancillary equipmentfor endoscopic diagnosis. Thisinstrument is indicated for use withinthe nasal and nasopharyngeal lumen.	This instrument has been designed tobe used with an Olympus light sourceor an Olympus miniature light source,documentation equipment, displaymonitor. Endotherapy accessories andother ancillary equipment forendoscopic diagnosis and treatmentwithin the nasal and nasopharyngeallumen. Do not use this instrument forany purpose other than its intendeduse.
Field of view	85°	85°
Direction of view	0°(forward viewing)	0°(forward viewing)
Depth of field	5-50mm	3-50mm
Configuration andmaterial change ofeyepiece and controlsection	Image: RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 eyepiece and control section	Image: XENF-TP Rhino-Laryngofiberscope eyepiece and control section
Features	RHINO-LARYNGO FIBERSCOPEOLYMPUS ENF-GP2	XENF-TP Rhino-Laryngofiberscope,its accessories and ancillaryequipment, K013591
Outer diameter of distal end	φ3.1mm	φ4.8mm
Outer diameter of insertion tube	φ3.5mm	φ5.0mm
Working length of insertion section	300mm	365mm
Angulation angle	130°	130°
Channel for therapy accessories	none	Incorporated
Construction of objective lens and light guide lens	Image: Diagram of objective lens and light guide lens with labels 1. objective lens and 2. light guide lens	Image: Diagram of light guide lenses, objective lens, and instrument channel with labels 1. light guide lenses, 2. objective lens, and 3. instrument channel
Total length	550mm	620mm
Reprocess with OER-Pro	available	unavailable
Sterilization with STERRAD	available	unavailable
Sterilization with V-PRO	available	unavailable

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OLYMPUS MEDICAL SYSTEMS CORP. 510(k) Premarket Notification RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2, K181240

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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 RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 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 RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

3) Performance testing - Bench

Bench testing for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 as listed below was conducted. Electrical safety test has been performed to verify the compliance to ANSVAAMI ES 60601-1:2005/(R)2012 and A1:2012. IEC60601-2-18:2009, thermal safety test has been performed to verify the compliance to "PROTECTION AGAINST EXCESSIVE TEMPARATURES AND OTHER SAFETY HAZARDS" of IEC 60601-2-18:2009-08, durability test has been performed to verify the safety and effectiveness considering the supposed usage and operating environment and optical performance test has been performed to verify the safety and effectiveness from optical perspective.

Electrical Safety followed by ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC60601-2-18:2009
Thermal safety test
Mechanical durability test
Optical performance test

4) Performance testing - Animal

No animal study was performed to demonstrate substantial equivalence.

5) Performance testing - Clinical

No clinical study was performed to demonstrate substantial equivalence.

6) Risk analysis

Risk analysis for the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 was

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conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007 and the human factors validation was conducted in accordance with the FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices". The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

8 Conclusion

When compared to the predicate device, the RHINO-LARYNGO FIBERSCOPE OLYMPUS ENF-GP2 does not cause any significant changes in intended use and technical characteristics that could affect the safety or effectiveness of the 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.