Fulinon/Fuilfilm EB-530 Series Bronchoscopes are intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchial tree. The Fujinon/Fujifilm EB-530 Series Bronchoscopes are used in combination with the Fujinon/Fujifilm's video endoscope processors, light source, monitor, cart, foot switch, endoscopic accessories, other peripheral devices (e.g. printer, keyboard, etc.), and the legally marketed electrosurgical instruments.

There are three models included in this submission:

EB-530S Standard Type
EB-530T Treatment Type (includes 2.8mm forceps channel)
EB-530H Super Image Type (High resolution)

AI/ML Overview

The provided text describes a 510(k) submission for the Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T, and EB-530H). This submission demonstrates substantial equivalence to a legally marketed predicate device, the Fujinon G5 Bronchoscope (K050907), rather than proving that the device meets specific acceptance criteria through a clinical study.

The submission focuses on engineering and performance validation against recognized medical device standards. There is no information provided about a clinical study with acceptance criteria, human readers, ground truth establishment, or training sets as requested in the prompt.

Here's a breakdown of the information that can be extracted based on the provided text, and where information is missing:

No information regarding a study proving acceptance criteria through clinical performance is available in the provided document.

The document details a 510(k) submission that demonstrates substantial equivalence to a predicate device, focusing on engineering performance and safety standards, rather than clinical efficacy measured against acceptance criteria.

Information that can be extracted:

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

Acceptance Criteria: The device was evaluated for compliance with several international and industry standards, which serve as performance "acceptance criteria" for safety and basic non-clinical performance. The "reported device performance" is that it "passed" these requirements.

Standard / Requirement	Acceptance Criteria (Implicit)	Reported Device Performance
IEC 60601-1	General requirements for safety	Passed
IEC 60601-1-1	Safety requirements for medical electrical systems	Passed
IEC 60601-1-2	Electromagnetic Compatibility - Requirements and tests	Passed
IEC 60601-2-18	Requirements for the safety of endoscopic equipment	Passed
ISO 10993-1	Biological evaluation of medical devices	Passed
Pre-sterilized suction button SB-602	Conforms to applicable internal and international ISO testing requirements for Sterility	Conforms
Reprocessing instructions	Validated reprocessing instructions	Updated and validated

Substantial Equivalence Comparison Table (Functional/Physical Characteristics): This table compares the proposed device models to the predicate device. While not "acceptance criteria" in the sense of clinical performance, it shows how the new device performs against a device already cleared by the FDA.

Characteristic	Predicate Fujinon G5 Bronchoscope (EB-470S, K050907)	Proposed Device Model EB-530S	Proposed Device Model EB-530T	Proposed Device Model EB-530H
Viewing direction	Forward/0 degree	Forward/0 degree	Forward/0 degree	Forward/0 degree
Observation range	3-100mm	3-100mm	3-100mm	3-100mm
Field of view	120 degrees	120 degrees	120 degrees	140 degrees
Distal end diameter	4.9mm	4.9mm	5.8mm	5.4mm
Flexible portion diameter	4.9mm	4.9mm	5.9mm	4.9mm
Bending capability (Up)	180 degrees	180 degrees	180 degrees	180 degrees
Bending capability (Down)	130 degrees	130 degrees	130 degrees	130 degrees
Forceps channel diameter	2.0mm	2.0mm	2.8mm	2.0mm
Working length	600 mm	600 mm	600 mm	600 mm
Total length	870mm	870mm	870mm	870mm

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

None provided. The submission explicitly states: "No clinical testing was conducted." The "test set" here refers to physical devices tested against engineering standards.

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):

None provided. No clinical ground truth was established as no clinical study was conducted.

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

None provided. Not applicable as no clinical study was performed.

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 study was done. This device is a bronchoscope, a physical medical instrument for direct observation and intervention, not an AI-assisted diagnostic or imaging interpretation tool.

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

Not applicable. This is a physical bronchoscope, not an algorithm.

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

Not applicable. No clinical ground truth was established as no clinical study was conducted. The "ground truth" for this submission are the established engineering standards (IEC, ISO) and the characteristics of the predicate device.

8. The sample size for the training set:

Not applicable. No training set for an algorithm was used.

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

Not applicable. No training set for an algorithm was used.

Summary: The provided document is a 510(k) summary for a medical device (bronchoscopes) seeking market clearance based on substantial equivalence to a predicate device and compliance with recognized safety and performance standards. It explicitly states that "No clinical testing was conducted." Therefore, the specific types of studies and criteria related to clinical performance, expert consensus, and AI-driven analysis requested in the prompt are not applicable to this submission.

Summary

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FUJIFILM

FUJIFILM Medical Systems U.S.A., Inc. 10 High Paint Drive Vayne: NJ 07470 Tel. (973) 533-5600

510(k) Summary

DEC 1 3 2012

Date: November 1, 2012

K Number: K122535

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, 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:

Fuiinon/Fuiifilm EB-530 Series Bronchoscopes Proprietary/Trade Name: Bronchoscopes Common Name: Device Class: Class 2 Review Panel: Ear Nose & Throat Classification Information:

AND REALERS LE & LEASE & LEA BER ANDCompany Court Call College Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Company Compaties B . FClassification Name	Section	ProductCodesCanadian Career Station Company of Children Company of Children Company of Children
Separation Street Art A.R. P.A. P.O. Box C.C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C.NEW YORK OF CANDRIGURANCE OF STBronchoscope (flexible or rigid) and accessories	ילס ח"מת -4 4680Call of the country of the first and the comments of the comments of the first of the first of the comments of the comments of the comments of the comments of the comments ofand the first from the became of the many would be	and any and

l. INDICATIONS FOR USE

The Fujinon/Fujifilm EB-530 Series Bronchoscopes are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

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K122535'

FUJKFILM

FUJIFILM Medical Systems U.S.A., Inc. 10 High Pors Ony ame NJ 07470 8 1973 6325800

DEVICE DESCRIPTION II.

There are three models included in this submission:

EB-530S Standard Type •
EB-530T Treatment Type (includes 2.8mm forceps channel) .
EB-530H Super Image Type (High resolution) .

lll. SUMMARY OF STUDIES

The subject device has been subjected to and passed electrical safety and EMC test requirements.

Fujinon/Fujifilm EB-530 Series Bronchoscopes were evaluated in accordance with the following safety and performance requirements in addition the applicable quality requlations:

IEC 60601-1	Medical electrical equipment - Part 1: General requirements forsafety
IEC60601-1-1	Medical electrical equipment - Part 1-1: General requirementsforsafety - Collateral standard: Safety requirements for medicalelectrical systems
IEC60601-1-2	Medical electrical equipment - Part 1-2: General Requirementsfor Safety - Collateral standard: Electromagnetic Compatibility -Requirements and tests
IEC60601-2-18	Medical electrical equipment - Part 2-18: Particularrequirements for the safety of endoscopic equipment
ISO10993-1	Biological evaluation of medical devices

New pre-sterilized suction button SB-602 conforms to the applicable internal and international ISO testing requirements for Sterility.

The reprocessing instructions were updated and validated. No clinical testing was conducted.

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FUJIFILM

FUJIFILM Medical Systems U.S.A., Inc. 0 High Point Drive Wavne, NJ 07470 1. (973) 833-5600

SUBSTANTIAL EQUIVALENCE IV.

Fuilnon/Fujifilm EB-530 Series Bronchoscopes are substantially equivalent to the following device:

Legally Marketed Device(s)	510(k) #
Fujinon G5 Bronchoscopes	K050907

Comparison is outlined in the table below.

	Legally marketedFujinon G5BronchoscopeEB-470S (K050907)	Proposed DeviceModel EB-530S	Proposed DeviceModel EB-530T	Proposed DeviceModel EB-530H
Viewingdirection	Forward/0degree	Forward/0degree	Forward/0degree	Forward/0degree
Observationrange	3-100mm	3-100mm	3-100mm	3-100mm
Field of view	120 degrees	120 degrees	120 degrees	140 degrees
Distal enddiameter	4.9mm	4.9mm	5.8mm	5.4mm
Flexible portiondiameter	4.9mm	4.9mm	5.9mm	4.9mm
Bending	Up: 180 degrees	Up: 180 degrees	Up: 180 degrees	Up: 180 degrees
capability	Down: 130 degrees	Down: 130degrees	Down: 130degrees	Down: 130degrees
Forcepschanneldiameter	2.0mm	2.0mm	2.8mm	2.0mm
Working length	600 mm	600 mm	600 mm	600 mm
Total length	870mm	870mm	870mm	870mm

All patient contact materials used in the proposed EB-530 Series Bronchoscopes remain the same as the legally marketed device.

V. CONCLUSION

Fujinon/Fujifilm EB-530 Series Bronchoscopes are substantially equivalent to the legally marketed device and conform to applicable medical device safety and performance: standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three overlapping human figures.

December 13, 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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

Re: K122535

Trade/Device Name: Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530H) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: November 1, 2012 Received: November 2, 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.

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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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric A. Mann

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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K122535

Indications for Use

510(k) Number (if known): K122535

Device Name: Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T AND EB-230H)

Indications for Use: This device is intended for the observation, diagnosis, and endoscopic treatment of the frachea and bronchial tree.

X 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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

510(k) Number __

Prescription Use
(Per 21 CFR 801.109)

K122535; Fujinon/Fujifilm EB-530 Series Bronchoscopes

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.