EB-530US is intended for the observation, diagnosis, and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with a FUJIFILM ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

Device Description

FUJIFILM Ultrasonic Endoscope EB-530US is an ultrasonic bronchoscope that emits ultrasound waves and scans the reflected signals to provide ultrasonic images when used in combination with an ultrasonic processor.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Parameter	Reported Device Performance	Study Type
Electrical Safety	ANSI/AAMI ES 60601-1:2012	Met pre-defined criteria	Non-clinical
	IEC 60601-1-2:2007	Met pre-defined criteria	Non-clinical
	IEC 60601-1-6:2013	Met pre-defined criteria	Non-clinical
	IEC 60601-2-18:2009	Met pre-defined criteria	Non-clinical
	IEC 60601-2-37:2015	Met pre-defined criteria	Non-clinical
Biocompatibility	ISO 10993-1:2009	Met pre-defined criteria	Non-clinical
	ISO 10993-5:2009	Met pre-defined criteria	Non-clinical
	ISO 10993-10:2010	Met pre-defined criteria	Non-clinical
Storage & Transportation	Expanded temperature range (-20°C to 60°C)	Validated	Non-clinical
	Expanded humidity range (10 to 85% RH)	Validated	Non-clinical
Performance Testing	Field of view	Met pre-defined criteria	Non-clinical
	Forceps channel diameter	Met pre-defined criteria	Non-clinical
	Axial resolution	Met pre-defined criteria	Non-clinical
	Bending capability	Met pre-defined criteria	Non-clinical
	Viewing direction	Met pre-defined criteria	Non-clinical
	Lateral resolution	Met pre-defined criteria	Non-clinical
	Suction rate	Met pre-defined criteria	Non-clinical
	Resolution	Met pre-defined criteria	Non-clinical
	Penetration depth	Met pre-defined criteria	Non-clinical
	Working length	Met pre-defined criteria	Non-clinical
	LG output	Met pre-defined criteria	Non-clinical

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

The document does not specify human clinical trials or a "test set" in the context of patient data. The performance testing appears to be entirely non-clinical (engineering and laboratory tests), likely using a sample of the manufactured device itself or components. Therefore, information about human data provenance is not applicable.

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

Not applicable. The reported performance testing is non-clinical and does not involve expert evaluation for ground truth in a clinical context.

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

Not applicable, as no clinical test set requiring adjudication by experts is described.

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 MRMC comparative effectiveness study was done, and the device is an ultrasonic endoscope, not an AI-assisted diagnostic tool. Therefore, the effect size of human readers improving with AI assistance is not applicable.

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

This is not an AI algorithm. The device is a medical instrument. Therefore, this question is not applicable.

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

For the non-clinical performance tests, the "ground truth" would be established by objective measurements against engineering specifications, calibrated instruments, and established safety and performance standards (e.g., IEC standards for electrical safety, ISO standards for biocompatibility).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device requiring a training set.

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

Not applicable, as this is not an AI/machine learning device.

Summary

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February 22, 2019

FUJIFILM Corporation % Jeffrev Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 419 West Ave. Stamford, Connecticut 06902

Re: K182825

Trade/Device Name: FUJIFILM Ultrasonic Endoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ, ITX Dated: January 22, 2019 Received: January 23, 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.

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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 (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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510(k) Number (if known)	K182825
Device Name	FUJIFILM Ultrasonic Endoscope EB-530US
Indications for Use (Describe)	EB-530US is intended for the observation, diagnosis, and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with a FUJIFILM ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.
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 Ultrasonic Endoscope EB-530US

Date: October 3, 2018

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 E-Mail: jeffrey.wan@fujifilm.com

Identification of the Proposed Device:

Proprietary/Trade Name:	FUJIFILM Ultrasonic Endoscope EB-530US
Common Name:	Ultrasonic Endoscope
Device Class:	Class II
Review Panel:	Ear, Nose & Throat
Classification:	Bronchoscope and accessories, 21 C.F.R. § 874.4680Diagnostic ultrasonic transducer, 21 C.F.R. § 892.1570
Product Code:	EOQ, ITX

Predicate Device:

Fujifilm Ultrasonic Endoscope EB-530US (K121035)

Reference Device:

Fujifilm Video Colonoscope Model EC-600WL v2 (K160196)

Intended Use / Indications for Use:

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Device Description:

Technoloqical Characteristics:

The proposed devices EB-530US differ from the predicate devices in the following minor modifications:

. Compatibility with Video Processor VP-7000 and Light Source BL-7000 (K163675).
Compatibility with Ultrasonic Processor SU-1 (K153206). ●
. Compliance to IEC60601-1 edition 3.1 and IEC60601-2-37 edition 2.1 to support compatibility with VP-7000, BL-7000, and SU-1.
. 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 device was evaluated using the following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, IEC 60601-2-18:2009, and IEC 60601-2-37:2015.

The proposed device EB-530US was adopted into biocompatibility testing conducted on reference device EC-600WL v2 using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Storage and transportation testing was conducted on the proposed device EB-530US to validate the expanded storage and transportation conditions.

Fujifilm conducted the following performance testing on the proposed device EB-530US to ensure that the modified device performs equivalently to the predicate device:

. Field of view
.
Forceps channel diameter .
. Axial resolution
. Bending capability
Viewing direction ●
Lateral resolution .
Suction rate
- . Resolution
Penetration depth
Working length .
LG output ●

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

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Substantial Equivalence:

The company's EB-530US has the same intended use and indications for use as the previously cleared predicate EB-530US (K121035). In addition, the proposed device has similar technological characteristics and principles of operation as the predicate. The minor differences between the proposed device and their predicate device do not raise new or additional questions of safety or effectiveness of the proposed device. Thus, the proposed device EB-530US is substantially equivalent to the predicate device.

Conclusions:

The modified EB-530US is substantially equivalent to the predicate EB-530US and conforms to applicable medical device safety and performance standards.

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.