The Fujinon/Fujifilm Ultrasonic Endoscope 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 Fujinon/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

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. EB-530US is used in combination with the Fujinon/Fujifilm's ultrasonic processor, video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EB-530US emits ultrasound wave and scans the reflected signals to provide ultrasonic images. For ultrasound procedure, EB-530US can be used with a single-patient-use balloon inflated with sterile water for an ultrasonic endoscope eliminates air between the ultrasonic transducer and target tissue so that the ultrasound wave can travel with little interference. Additionally EB-530US supports ultrasound guided needle aspiration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Fujinon/Fujifilm Ultrasonic Endoscope EB-530US, based on the provided 510(k) summary:

This device did not conduct clinical testing to prove its performance against acceptance criteria. Instead, it demonstrated substantial equivalence to a legally marketed predicate device (OLYMPUS BF type UC160F-OL8, K042140) by comparing technical features and conforming to relevant safety and performance standards.

Therefore, many of the requested fields related to clinical study design and performance metrics will be marked as "Not Applicable (N/A)" or "Not Reported" because the submission relies on a different pathway for clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Since no clinical testing was conducted to establish performance metrics against specific acceptance criteria for diagnostic accuracy, the acceptance criteria here are derived from the device's conformance to recognized standards and its equivalence to a predicate device. The "Reported Device Performance" refers to the technical specifications of the proposed device.

Acceptance Criterion (Implicit)	Reported Device Performance (Technical Specification)
Conformance to IEC 60601-1 (General safety)	Device conforms to IEC 60601-1
Conformance to IEC 60601-1-1 (System safety)	Device conforms to IEC 60601-1-1
Conformance to IEC 60601-1-2 (EMC)	Device conforms to IEC 60601-1-2
Conformance to IEC 60601-2-18 (Endoscopic equipment safety)	Device conforms to IEC 60601-2-18
Conformance to IEC 60601-2-37 (Ultrasonic equipment safety)	Device conforms to IEC 60601-2-37
Conformance to ISO 10993-1 (Biological evaluation)	Device conforms to ISO 10993-1
Sterility of balloon (B20BU)	Balloon conforms to applicable internal and international IEC testing requirements for Sterility
Validated Reprocessing Instructions	Reprocessing instructions were validated
Substantial Equivalence to Predicate Device (K042140)	Technical specifications are comparable (e.g., viewing direction, observation range, field of view, diameters, bending capabilities, working length, scanning method) and materials are the same as previously-cleared Fujinon/Fujifilm endoscopes.

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

Sample Size for Test Set: Not Applicable (No clinical performance or diagnostic accuracy study reported for this device in the 510(k) summary).
Data Provenance: Not Applicable (No clinical data set used for performance evaluation).

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

Number of Experts: Not Applicable (No clinical performance or diagnostic accuracy study reported).
Qualifications of Experts: Not Applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not Applicable (No clinical performance or diagnostic accuracy study reported).

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

MRMC Study Done: No.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not Applicable (No AI component, no MRMC study).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Standalone Study Done: No. This device is an endoscope, not an algorithmic device requiring standalone performance evaluation in the context of AI. The performance is assessed through its physical and electrical specifications and safety standards.

7. The Type of Ground Truth Used

Type of Ground Truth: Not Applicable. For this 510(k) pathway, the "ground truth" for substantial equivalence is derived from compliance with recognized consensus standards and direct comparison of design and technological characteristics to a legally marketed predicate device.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not Applicable (No AI/machine learning component requiring a training set was reported for this device).

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

How Ground Truth was Established: Not Applicable (No AI/machine learning component, therefore no training set or associated ground truth for such a set).

Summary

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K121035

FUJIFILM

JUN - 4 2012

510(k) Summary

Date: June 4, 2012

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wavne, NJ 07470 USA FDA Establishment Registration Number: 2431293

Contact Person:

Name:	Gina Walljasper
Title:	Director, Quality and Regulatory Compliance
Telephone:	(973) 633-5600 Ext. 484
Facsimile:	(973) 633-8818
E-Mail:	gwalljasper@fujifilm.com

Identification of the Proposed Device:

Proprietary/Trade Name: Common Name: Device Class: Review Panel:

Fuiinon/Fuiifilm Ultrasonic Endoscope EB-530US Ultrasonic Bronchoscope Class 2 Ear Nose & Throat

Classification Information:

Classification Name	CFR Section	Product Codes
Bronchoscope (flexible or rigid) and accessories	21 CFR 874.4680	EOQ
Diagnostic Ultrasonic Transducer	21 CFR 892.1570	ITX

INDICATIONS FOR USE l,

DEVICE DESCRIPTION II.

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K12/035

FUJKFILM

single-patient-use balloon inflated with sterile water for an ultrasonic endoscope eliminates air between the ultrasonic transducer and target tissue so that the ultrasound wave can travel with little interference. Additionally EB-530US supports ultrasound guided needle aspiration.

SUMMARY OF STUDIES lll.

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US conforms to the following internal and international IEC testing requirements in addition to the applicable quality system regulations:

IEC 60601-1	Medical electrical equipment - Part 1: General requirements for safety
IEC60601-1-1	Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC60601-1-2	Medical electrical equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and tests
IEC60601-2-18	Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment
IEC 60601-2-37	Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO10993-1	Biological evaluation of medical devices

The balloon, B20BU for the Fujinon/Fujifilm Ultrasonic Endoscope EB-530US conform to the applicable internal and international IEC testing requirements for Sterility.

The reprocessing instructions were validated.

No clinical testing was conducted.

SUBSTANTIAL EQUIVALENCE IV.

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is substantially equivalent to the following device:

Legally Marketed Device(s)	510(k) #
EVIS EXERA Ultrasonic Bronchofibervideoscope	K042140
OLYMPUS BF type UC160F-OL8

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FUJIFILM

Comparison is outlined in the table below.

	Legally Marketed DeviceK042140	Proposed DeviceModel EB-530US
Viewing direction	35 degree forward oblique	10 degree forward oblique
Observation range	2-50 mm	3-100 mm
Field of view	80 degree	120 degree
Distal end diameter	6.9 mm	6.7 mm
Flexible portion diameter	6.2 mm	6.3 mm
Bending capability Up	120 degree	130 degree
Bending capability Down	90 degree	90 degree
Forceps channel diameter	2.0 mm	2.0 mm
Working length	600 mm	610 mm
Total length	890 mm	880 mm
Scanning method	Electrical curved linear array	Electrical curved linear array
Scanning range	50 degree	60 degree (with SU-7000)65 degree (with SU-8000)
Ultrasonic operating frequency	7.5 MHz	5 MHz, 7.5 MHz, 10 MHz,12 MHz

All patient contact materials used in the proposed EB-530US remain the same as the previously-cleared Fujinon/Fujifilm endoscopes.

V. CONCLUSION

Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is substantially equivalent to the legally marketed device and conforms to applicable medical device safety and performance standards.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FUJIFILM Medical Systems U.S.A., Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

Re: K121035

Trade/Device Name: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ, ITX Dated: April 4, 2012 Received: April 5, 2012

Dear Mr. Job:

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. 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.

JUN - 4 2012

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Page 2 - Mr. Mark Job

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K121035

Indications for Use

510(k) Number (if known): __

Device Name: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US To be used with Fujinon/Fujifilm Ultrasonic Processor (SU-7000/SU-8000)]

Indications for Use:

The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, . The Tighton't ajimm Oneonent of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

. Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

121035

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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i2 10 35

Diagnostic Ultrasound Indications For Use

510(k) Number (If Known):

Fujinon/Fujifilm Ultrasonic Processor (SU-7000/SU-8000) System Name: Ultrasonic Endoscope EB-530US Transducer:

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application		Mode of Operation
General	Specific .	B	M	PWD	CWD	ColorDoppler	Combined¹	Other
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intra-operative
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ(Thyroid, Breast, Testes, etc.)
	Neonatal Cephalic
General	Adult Cephalic
Application	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Tran-esoph. (non-Card.)	N	N	N		N	N¹
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular						N¹
	Other (Specify)	N	N	N		N	N¹
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Tran-esoph. (Cardiac)
	Intra-cardiac
	Other (Specify)
Peripheral	Peripheral vessel
Vascular	Other (Specify)

vessel

Combined modes includes B+M, B+CD, B+PWD, B+CD+PWD modes

Other (Specify): Trachea, bronchial tree and surrounding organs

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

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.