FUJIFILM Video Bronchoscopes EB-530H, EB-530T are comprised of three general sections: a control portion, an insertion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) image sensor in its distal end. The insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is 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 a 510(k) summary for the FUJIFILM Video Bronchoscopes EB-530H, EB-530S, and EB-530T. The scope of this document is a substantial equivalence determination based on minor modifications to an already cleared predicate device.

Here's an analysis of the requested information based only on the provided text:

1. Table of acceptance criteria and reported device performance

The document states that the devices met pre-defined acceptance criteria, but it does not explicitly list the specific quantitative acceptance criteria for each performance test. It only states that the devices "met the pre-defined acceptance criteria for the test."

Performance Test	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Implied)
Field of view	Pre-defined acceptance criteria	Met acceptance criteria
Bending capability	Pre-defined acceptance criteria	Met acceptance criteria
Suction rate	Pre-defined acceptance criteria	Met acceptance criteria
Working length	Pre-defined acceptance criteria	Met acceptance criteria
Forceps channel diameter	Pre-defined acceptance criteria	Met acceptance criteria
Viewing direction	Pre-defined acceptance criteria	Met acceptance criteria
Resolution	Pre-defined acceptance criteria	Met acceptance criteria
LG output	Pre-defined acceptance criteria	Met acceptance criteria

In addition, the following were evaluated for compliance, not performance:

Evaluation Area	Standard	Reported Status
Electrical safety	ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009	Evaluated using these standards. (Implied compliance for substantial equivalence)
Biocompatibility	ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010	Adopted into testing conducted on predicate devices. (Implied compliance for substantial equivalence)

2. Sample size used for the test set and the data provenance

The document does not provide information regarding sample sizes for the test set or data provenance (e.g., country of origin, retrospective/prospective). The performance testing described appears to be bench testing on the physical devices rather than clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The performance tests mentioned (field of view, bending capability, etc.) are objective technical measurements of the device itself, not assessments requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication method for the test set

This information is not provided in the document. As noted above, the tests described are objective technical measurements, not clinical assessments requiring adjudication.

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

An MRMC comparative effectiveness study was not performed because this submission is for minor modifications to a bronchoscope, not an AI-enabled device. The document does not mention any AI components.

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

A standalone algorithm performance test was not performed because this device is a bronchoscope, not an algorithm or AI system.

7. The type of ground truth used

For the performance tests conducted (field of view, bending capability, etc.), the "ground truth" would be established by objective engineering specifications and measurement standards. It's not a ground truth derived from expert consensus, pathology, or outcomes data, as these are technical performance measurements of the physical device.

8. The sample size for the training set

This information is not provided in the document. As this is not an AI/algorithm-based device, a "training set" in that context is not applicable.

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

This information is not provided in the document. As this is not an AI/algorithm-based device, there is no "training set" with associated ground truth to establish in this context.

Summary

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510(k) SUMMARY

FUJIFILM Video Bronchoscopes EB-530H, EB-530S, and EB-530T

Date: March 25, 2019

Submitter's Information:

FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928

Contact Person:

Jeffrey Wan Specialist, Regulatory Affairs Telephone: (201) 675-8947 Facsimile: (201) 995-2452 E-Mail: jeffrey.wan@fujifilm.com

Identification of the Proposed Device:

Proprietary/Trade Name:	FUJIFILM Video Bronchoscopes EB-530H, EB-530S, and EB-530T
Common Name:	Bronchoscope
Device Class:	Class II
Review Panel:	Ear, Nose & Throat
Classification:	Bronchoscope and accessories, 21 C.F.R. § 874.4680
Product Code:	EOQ

Predicate Device:

FUJIFILM Video Bronchoscopes EB-530H, EB-530S, and EB-530T (K122535)

Intended Use / Indications for Use:

EB-530H, EB-530S, and EB-530T are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

Device Description:

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the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.

Technological Characteristics:

The proposed devices EB-530H, EB-530S, and EB-530T differ from the predicate devices in the following minor modifications:

Compatibility with Video Processor VP-7000 and Light Source BL-7000 (K163675). ●
Compliance to IEC60601-1 edition 3.1 to support compatibility with VP-7000 and BL-7000. .
. Expansion of transport and storage conditions to a temperature range of -20°C to 60°C and a humidity range of 10 to 85% RH.
. Use of a new epoxy resin in the manufacturing process. Both the new and original epoxy resins can be used for repair.

Performance Data:

Electrical safety of the proposed devices were evaluated using the following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.

The proposed devices EB-530H, EB-530S, and EB-530T were adopted into biocompatibility testing conducted on the predicate devices EB-530H, EB-530T using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Fujifilm conducted the following performance testing on the proposed devices EB-530H, EB-530S, and EB-530T to ensure that the modified devices perform equivalently to the predicate devices:

. Field of view
Bending capability
. Suction rate
. Working length
Forceps channel diameter
. Viewing direction
Resolution
. LG output

In all cases, the devices met the pre-defined acceptance criteria for the test.

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Substantial Equivalence:

The company's EB-530H, EB-530S, and EB-530T have the same intended use and indications for use as the previously cleared predicates EB-530H, EB-530T (K122535). In addition, the proposed devices have similar technological characteristics and principles of operation as the predicates. The minor differences between the proposed devices and their predicate devices do not raise new or additional questions of safety or effectiveness of the proposed devices. Thus, the proposed devices EB-530H, EB-530S, and EB-530T are substantially equivalent to their predicate devices.

Conclusions:

The modified EB-530H, EB-530S, and EB-530T are substantially equivalent to the predicate EB-530H, EB-530S, and EB-530T and conform to applicable medical device safety and performance standards.

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Image /page/3/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 4, 2019

FUJIFILM Corporation % Jeffrey Wan Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A, Inc. 10 High Point Drive Wayne, New Jersey 07470

Re: K182253

Trade/Device Name: FUJIFILM Video Bronchoscopes Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: March 1, 2019 Received: March 4, 2019

Dear Jeffrey Wan:

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

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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 mediation-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,

for Malvina 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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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.