FUJIFILM Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.

Never use this product for any other purposes.

Device Description

FUJIFILM Endoscope Model EB-710P is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion is flexible and contains glass fiber bundles, several channels, and a complementary metal-oxide semiconductor (CMOS) image sensor in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the FUJIFILM Endoscope Model EB-710P. It details the device, its intended use, comparison to predicate/reference devices, and performance data. However, the document does not describe an AI/ML-driven device or a study involving human readers and AI assistance.

Therefore, many of the requested criteria related to AI/ML performance, human reader studies, ground truth establishment for AI models, and sample sizes for training/test sets for AI are not applicable to this document. This document pertains to a traditional medical device (an endoscope) and its clearance based on substantial equivalence.

I will address the applicable criteria based on the information provided in the document.

Analysis of Acceptance Criteria and Device Performance (FUJIFILM Endoscope Model EB-710P)

This document describes the 510(k) premarket notification for a physical medical device, the FUJIFILM Endoscope Model EB-710P, not an AI or software-as-a-medical-device (SaMD) product. Therefore, the acceptance criteria and study described are for the physical performance and safety of the endoscope itself, primarily through bench testing and compliance with recognized standards, rather than clinical performance metrics of an AI model like sensitivity, specificity, or reader improvement.

The "acceptance criteria" here refer to meeting performance specifications and regulatory standards demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance specifications and states that the proposed device met them. It does not present a formal "acceptance criteria vs. reported performance" table in the way one might for an AI model's accuracy metrics, but rather as statements of compliance.

Criterion/Test Type	Acceptance Standard/Method Used	Reported Device Performance
Resolution	For Proposed Device: At 2mm working distance: 0.08mm line pair readable; At 50mm working distance: 1.25mm line pair readable (on square wave chart). For Predicate Device: At 4mm working distance: 0.1mm line pair readable; At 100mm working distance: 1.6mm line pair readable.	Met performance specifications, demonstrating substantial equivalence to the predicate device. (The document states "The proposed device met performance specifications...Resolution...Optical and color performance of the proposed device was evaluated. In all cases, the proposed device demonstrated substantial equivalence to the predicate device.")
Cleaning, Disinfection, Sterilization	Validation in accordance with FDA guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015).	Validation performed in accordance with guidance.
Biocompatibility	Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Conducted in accordance with FDA guidance, "Use of International Standard ISO 10993-1..." (September 4, 2020).	Biocompatibility testing conducted successfully.
Software	Evaluated in accordance with IEC 62304:2006, FDA guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (May 11, 2005), and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" (October 2, 2014).	Evaluated in accordance with standards and guidance documents.
Electrical Safety & EMC	Evaluated using ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-2-18:2009.	Evaluated using specified standards.
Laser Safety & Photobiological Safety	Evaluated using IEC 60825-1:2007 and IEC 62471:2006.	Evaluated using specified standards.
Endoscope Specific Testing	Conducted according to ISO 8600-1:2015.	Conducted successfully.
Other Performance Specs	Field of view, Bending capability, Working length, Diameter of forceps channel, LG output, Rate of suction, Viewing direction.	The proposed device met performance specifications in these additional testing areas and demonstrated substantial equivalence to the predicate device.

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

The document does not specify a "sample size" in the context of clinical studies for diagnostic accuracy, as it is a device clearance for an endoscope based on engineering and bench testing, and demonstrating substantial equivalence. The "test set" here refers to the physical units and materials used for various engineering and safety tests. No patient data or clinical imagery is referenced for performance testing in this document.

Sample Size: Not applicable in the context of a clinical test set for AI/ML. The tests are performed on the device itself and components.
Data Provenance: Not applicable in the context of clinical data. The tests are laboratory/bench tests on the device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth for an AI/ML model for diagnostic purposes is not relevant for the clearance of a physical endoscope itself. The "ground truth" for this device's performance would be the objective measurements and accepted standards in engineering and medical device testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where human readers interpret medical images, often to establish ground truth or evaluate reader performance. This is not describing such a study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not mention an MRMC study. MRMC studies are typically performed for AI-assisted diagnostic devices to assess how AI affects reader performance.

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

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's regulatory clearance is established by:

Performance Specifications: The defined objective measurements and technical requirements for the endoscope's functions (e.g., resolution, field of view, bending capability).
Consensus Standards: Adherence to recognized national and international standards for medical device safety, biocompatibility, electrical safety, software, and reprocessing (e.g., ISO, IEC, ANSI/AAM).
Predicate Device Performance: The performance characteristics of the previously cleared predicate device, which the proposed device must be substantially equivalent to.
Bench Testing Data: Direct measurements obtained from laboratory testing of the device.

8. The Sample Size for the Training Set

Not applicable. This is not describing an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process as defined for AI/ML.

Summary

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November 10, 2022

FUJIFILM Corporaton % Kotei Aoki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue. Suite 300 Lexington, Massachusetts 02421

Re: K220957

Trade/Device Name: FUJIFILM Endoscope Model EB-710P Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: October 13, 2022 Received: October 13, 2022

Dear Kotei Aoki:

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

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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

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Indications for Use

510(k) Number (if known) K220957

Device Name FUJIFILM Endoscope Model EB-710P

Indications for Use (Describe)

FUJIFILM Endoscope Model EB-71 OP is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.

Never use this product for any other purposes.

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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510(k) Summary

FUJIFILM Corporation

FUJIFILM Endoscope Model EB-710P

Date: March 31, 2022

Submitter's Information:

FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN

Contact Person:

Kotei Aoki Senior Regulatory Affairs Specialist E-Mail: kotei.aoki@fujifilm.com Telephone: (765) 246-2931

ldentification of the Proposed Device:

Device Name:	FUJIFILM Endoscope Model EB-710F
Common Name:	Bronchoscope
Product Code:	EOQ
Device Class:	Class 2
Regulation Number:	874.4680
Regulation Description:	Bronchoscope
Review Panel:	Ear Nose & Throat

Predicate Device:

FUJIFILM Endoscope Model EB-580S (K183607) .

Reference Devices:

. FUJIFILM Endoscope Model EC-760S-V/L (K190649)
OLYMPUS Endoscope Model BF-P190 (K201758) ●

Intended Use / Indications for Use:

Never use this product for any other purposes.

Device Description:

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image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart.

Comparison of Technological Characteristics:

The comparison is summarized in the tabular format in Tables below.

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Table 1

	Proposed DeviceFUJIFILM EndoscopeModel EB-710P(to be assigned)	Predicate DeviceFUJIFILM EndoscopeModel EB-580S(K183607)	Reference Device 1FUJIFILM EndoscopeModel EC-760S-V/L(K190649)	Reference Device 2OLYMPUS EndoscopeModel BF-P190(K201758)	method)	(optical communication)	(electrical contact)	(optical communication)
Indications for Use (IFU)	FUJIFILM Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.Never use this product for any other purposes.	The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree.			Connector power supplymethod	electromagnetic induction(non-electrical contact)	electrical contact	electromagnetic induction(non-electrical contact)
Viewing direction		Forward / 0°			Connector CPU/Software	Installed	N/A	Installed
Observation range	2mm - 50mm	2mm - 100mm		2mm - 50mm		Suction Channel Brush (WB7025DC)
Acceptance Criteria of Resolution	At 2mm of working distance:0.08mm of line pair on the square wave chart is readable.At 50mm of working distance:1.25mm of line pair on the square wave chart is readable.	At 4mm of working distance: 0.1mm of line pair on the square wave chart is readable.At 100mm of working distance: 1.6mm of line pair on the square wave chart is readable.				Cylinder/Inlet Brush (WB11003DV)
Field of View		120°			Standard Accessories	Suction Valve (SB-607)	Suction button (SB-500B/D)
Bendingcapability	Vertical	Up 210° / Down 130°				Forceps Valve (FOV-BU1)	Forceps Valve (FOV-DV7)
	Horizontal	Right N/A / Left N/A				Cleaning Adapter(CA-616)	Cleaning Adapter Kit(CA-500C)
Rotation capability(Insertion portion)		Right:120° / Left:120°	N/A		Right:120° / Left:120°		Ventilation Adapter (AD-7)
Image sensors		CMOS	CCD	CMOS			Air leak tester (LT-7F)
Distal end diameter		4.1mm	5.3mm		4.2mm	Optional Accessories	Suction Valve (SB-606)	Suction Valve (SB-602)
Flexible portion diameter		4.1mm	5.1mm		4.1mm		Forceps Valve (FV-003)
Maximum insertion diameter		4.9mm	6.5mm			Light Source/VideoProcessor		XL-4450/VP-4440HD
Forceps channel diameter		2.0mm	2.2mm		2.0mm			EPX-3500HD
Working length			600mm				BL-7000/VP-7000	BL-7000/VP-7000	BL-7000/VP-7000
Total length		880mm	870mm		880mm			EP-6000
Connector (communication		Scope Connector	LG connector/Video connector	Scope Connector		Peripherals	Endoscopic Accessories
Electrosurgical Instruments
Control Portion	New control portion	G5 control portion
STERRAD Sterilization	Yes	No

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Performance Data:

Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, published March 17, 2015.

Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was conducted in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", issued September 4, 2020.

Software of the proposed device was evaluated in accordance with IEC 62304:2006 and the FDA guidance, Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, issued May 11, 2005, and, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014.

Electrical safety and EMC of the proposed device was evaluated using following standards: ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-2-18:2009

Laser safety and photobiological safety of the proposed device was evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.

Endoscope specific testing was conducted according to ISO 8600-1: 2015

The proposed device met performance specifications in the following additional testing:

Field of view
Bending capability .
Working length Diameter of forceps channel .
Resolution
LG output
. Rate of suction
Viewing direction .
Optical and color performance of the proposed device was evaluated. In all cases, the proposed device demonstrated substantial equivalence to the predicate device.

Conclusions:

The proposed device FUJIFILM Endoscope Model EB-710P shares the same intended use and indications for use as, similar technological characteristics to, the same principles of operation as, and similar materials to the predicate device and the reference devices. The remaining differences in EB-710P. compared to the predicate device. have either 1) been cleared in the reference devices or 2) been evaluated for the biocompatibility, the electrical safety, the EMC testing, and the bench testing. The testing demonstrates that the proposed device remains as safe and effective as the predicate device and there is no new concern regarding the safety and effectiveness. FUJIFILM Endoscope Model EB-710P is substantially equivalent to the predicate device, FUJIFILM Endoscope Model EB-580S (K183607).

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.