The FUJIFILM Bronchoscope Model EB-530P is comprised of three general sections: a control/ operating section, an insertion and an umbilicus. The control/operating section controls the angulation (up/down) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary charged coupled device (CCD) image sensor in its distal end. The channels in 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 subject device is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K122535.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the FUJIFILM Bronchoscope Model EB-530P. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria for a new clinical indication.

The document does not describe acceptance criteria in the way one would typically find for a medical device that uses artificial intelligence (AI) or requires a clinical performance study with defined metrics like sensitivity, specificity, or accuracy. It's a bronchoscope, which is a physical instrument for observation, diagnosis, and endoscopic treatment.

Therefore, many of the requested bullet points, such as those related to AI performance, ground truth, expert adjudication, and MRMC studies, are not applicable to this type of device submission.

However, I can extract information related to performance testing and comparison to the predicate device, which serves as the basis for the FDA's substantial equivalence determination.

Based on the provided document, here's what can be extracted and what cannot:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the typical sense of clinical performance metrics. Instead, the "acceptance" is implicitly that the device performs functionally as intended and safely, similar to or better than the predicate device.
Reported Device Performance: The document lists several characteristics and states implicitly that the device "met performance specifications" or "has substantially equivalent performance" to the predicate. The "Performance Data" section (page 4) lists the types of tests conducted:
- Electrical safety
- Biocompatibility
- Cleaning, high-level disinfection, and EO sterilization reprocessing validation
- Endoscope specific testing (ISO standards)
- Additional testing: Field of view, Bending capability, Rate of suction, Working length, Diameter of forceps channel, Viewing direction, LG Output.

Table (Reconstructed from "Performance Data" and "Table 7.1: Comparison"):

Acceptance Criteria Category/Characteristic	Device Performance (How it meets "acceptance")	Unclear if specific quantitative thresholds were used beyond "met specifications" or "comparable to predicate."
Electrical Safety	Evaluated using ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.	Implied "met standards."
Biocompatibility	Evaluated using ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.	Implied "met standards" and "material changes...raise no new concerns."
Reprocessing Validation	Cleaning, high-level disinfection, and EO sterilization were performed.	Implied "validated reprocessing instructions."
Endoscope Specific Testing	Conducted using ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.	Implied "met standards."
Field of View	120 degrees (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
Bending Capability (Up)	180 degrees (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
Bending Capability (Down)	130 degrees (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
Rate of Suction	"Met performance specifications"	Not quantified in document.
Working Length	600mm (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
Diameter of Forceps Channel	1.2mm (Predicate: 2.0mm)	Although different, implied "met performance specifications" for the new design without raising safety/effectiveness issues.
Viewing Direction	Forward/ 0 degree (Same as predicate)	Implicitly, "Same as predicate device" means it meets performance.
LG Output	"Met performance specifications"	Not quantified in document.
Distal End Diameter	3.8mm (Predicate: 4.9mm)	Different, but considered "minor dimensional differences" that "raise no new issues of safety or effectiveness."
Flexible Portion Diameter	3.8mm (Same as predicate for proposed, but 4.9mm for predicate)	Different, but considered "minor dimensional differences."
Maximum Insertion Diameter	4.2mm (Predicate: 5.9mm)	Different, but considered "minor dimensional differences."
Total Length	890mm (Predicate: 870mm)	Different, but considered "minor dimensional differences."

Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified quantitatively for any of the performance tests (e.g., how many bronchoscopes were tested for bending capability). These are likely bench tests of physical characteristics.
- Data Provenance: The tests are "bench testing data" (page 7), implying laboratory testing of the device itself, not clinical data from patients. No country of origin for data is specified, as it's not typical patient data. The tests are prospective as they are conducted for the specific submission.
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):
- Not Applicable. This is a physical bronchoscope, not an AI or diagnostic imaging device that requires expert ground truth establishment for clinical performance. The "ground truth" for its physical specifications comes from engineering measurements and adherence to international standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication of results in the sense of clinical interpretation is described. Physical and electrical tests are verified against defined standards and specifications.
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:
- Not Applicable. This is not an AI device or a diagnostic device where human perception is assisted by AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm mentioned in this submission.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For a physical device like a bronchoscope, the "ground truth" for performance is based on engineering specifications, physical measurements, and adherence to established international standards (e.g., ISO, IEC).
The sample size for the training set:
- Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

January 19, 2018

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

Re: K171291

Trade/Device Name: FUJIFILM Bronchoscope Model EB-530P Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOO Dated: December 18, 2017 Received: December 19, 2017

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. The general controls provisions of the Act include requirements for annual registration. Isting 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 requirements, including, but not limited to: registration and listing

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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 the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Eric A. Mann -S

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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Indications for Use

510(k) Number (if known) K171291

Device Name FUJIFILM Bronchoscope Model EB-530P

Indications for Use (Describe)

The FUJIFILM Bronchoscope Model EB-530P is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

FUJIFILM Medical Systems U.S.A., Inc.'s FUJIFILM Bronchoscope Model EB-530P

Date: January 15, 2018

Submitter's Information

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

Contact Person:

Jeffrey Wan Specialist, Regulatory Affairs Telephone: (973) 709-2219 Facsimile: (201) 995-2452 E-Mail: jeffrey.wan@fujifilm.com

Identification of the Proposed Device:

Proprietary/Trade Name:	FUJIFILM Bronchoscope Model EB-530F
Common Name:	Bronchoscope
Device Class:	Class II
Review Panel:	Ear, Nose, and Throat

Classification Information:

Classification Name	CFR Section	Product Codes
Bronchoscope (flexible or rigid) and accessories	21 CFR 874.4680	EOQ

Predicate Devices

Fujinon/Fujifilm EB-530 Series Bronchoscopes Model EB-530S (K122535) ●

Intended Use / Indications for Use

The FUJIFILM Bronchoscope Model EB-530P is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

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Device Description

Technological Characteristics

A comparison of the technological characteristics between the subject and predicate devices is provided in the Table 7-1 below.

Performance Data

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

Biocompatibility of the subject devices was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.

Cleaning, high-level disinfection, and EO sterilization were performed to validate the reprocessing instructions recommended in the labeling.

Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.

Subject devices met performance specifications in the following additional testing:

. Field of view
. Bending capability
Rate of suction
Working length
Dianeter of forceps channel .
Viewing direction
. LG Output

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K171291

Table 7.1: Comparison of FUJIFILM Bronchoscope Model EB-530P with its predicate device Fujinon/Fujifilm EB-530 Series Bronchoscope Model EB-530S (K122535)

		Predicate DeviceFujinon/Fujifilm EB-530 SeriesBronchoscopes Model EB-530S (K122535)	Proposed DeviceFUJIFILM Bronchoscope Model EB-530P
Device Name		FUJIFILM Video Bronchoscope	FUJIFILM Video Bronchoscope
		EB-530S	EB-530P
510(k) Number		K122535	K171291
Indications for Use (IFU)		The device is intended for the observation,diagnosis, and endoscopic treatment oftrachea and bronchial tree.	Same as predicate device
Viewing direction		Forward/ 0 degree	Same as predicate device
Observation range		3mm - 100mm	Same as predicate device
Field of View		120 degrees	Same as predicate device
Distortion characteristics		Orthogonal Projection	Same as predicate device
Image sensors		CCD	Same as predicate device
Distal end diameter		4.9mm	3.8mm
Flexible portion diameter		4.9mm	3.8mm
Maximum insertion diameter		5.9mm	4.2mm
Bending capability	Up	180 degrees	Same as predicate device
	Down	130 degrees	Same as predicate device
Forceps channel diameter		2.0mm	1.2mm
Working length		600mm	Same as predicate device
Total length		870mm	890mm
Video Processor		EPX-2500EPX-4400EPX-4400HDEPX-4440HD	EPX-4440HD
	Predicate DeviceFujinon/Fujifilm EB-530 SeriesBronchoscopes Model EB-530S (K122535)	Proposed DeviceFUJIFILM Bronchoscope Model EB-530P
Peripherals	Endoscopic Accessory (i.e. Forceps)	Endoscopic accessory i.e. forceps caliberunder φ1.2mm
	Monitor	Same as predicate device
	Printer	Same as predicate device
	Electrosurgical Instruments	N/A
Peripherals	Foot Switch	Same as predicate device
	Cart	Same as predicate device
Standard Accessories	Channel Cleaning brushWB3212FW2WB3503FW	Channel Cleaning BrushWB2212FW2WB3503FW
	Valve Cleaning brush(WB11002FW2)	Same as predicate device
	Cleaning Adapter Kit (CA-500C)	Same as predicate device
	Forceps Valve(FOV-DV7)	Same as predicate device
	Suction button(SB-500B/D)	Same as predicate device
	Ventilation Adapter(AD-7)	Same as predicate device
Optional Accessories	Air leak tester LT-7F	Same as predicate device
	Sterile Suction button(SB-602)	Same as predicate device

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Substantial Equivalence

FUJIFILM Bronchoscope Model EB-530P has the same intended use and indications for use, as well as similar technological characteristics and principles of operation as its predicate device Fujinon/Fujifilm EB-530 Series Bronchoscopes Model EB-530S (K122535). The modifications done to the subject device include changes in number of light quide fiber bundles, dimensions, accessories, transport and storage conditions, and materials.

These minor dimensional and material differences between the FUJIFILM Bronchoscope Model EB-530P and its predicate device Fujinon/Fujifilm EB-530 Series Bronchoscopes Model EB-530S were made for the purpose of overall product enhancement and general technological advancement, and raise no new issues of safety or effectiveness. The material changes in the subject device do not raise new concerns regarding biocompatibility as discussed in section XVII. Performance data demonstrated that the FUJIFILM Bronchoscope Model EB-530P has substantially equivalent performance to the predicate device Fujinon/Fujifilm EB-530 Series Bronchoscopes Model EB-530S (K122535). The subject device is successfully validated for the electrical safety and reprocessing instructions, supporting their safety equivalent to the predicate device.

Conclusions

The subject device, Bronchoscope Model EB-530P is substantially equivalent to its predicate device Fujinon/Fujifilm EB-530 Series Bronchoscopes Model EB-530S (K122535), based on the same intended use/indications for use and similar technological characteristics. The differences in the dimensions and materials between the subject device and its predicate device raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject device has substantially equivalent performance to the predicate. Thus, the subject device FUJIFILM Bronchoscope Model EB-530P is substantially equivalent to its predicate device Fujinon/Fujifilm EB-530 Series Bronchoscopes Model EB-530S (K122535).

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.