FUJIFILM Video Bronchoscopes

K182253 · Fujifilm Corporation · EOQ · Apr 4, 2019 · Ear, Nose, Throat

Device Facts

• Record ID: K182253
• Device Name: FUJIFILM Video Bronchoscopes
• Applicant: Fujifilm Corporation
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Apr 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Flexible video bronchoscope; consists of control portion, insertion tube, and umbilicus. Inputs: visual data captured via distal CCD image sensor; illumination provided by internal glass fiber bundles. Operation: physician manipulates control portion to steer distal end; insertion tube delivers air/suction and accommodates accessories (e.g., forceps). Output: real-time video displayed on external monitor via connected video processor and light source. Used in clinical settings by physicians for airway visualization and intervention. Benefits: enables minimally invasive diagnostic and therapeutic access to bronchial tree.

Clinical Evidence

Bench testing only. Performance evaluated via field of view, bending capability, suction rate, working length, forceps channel diameter, viewing direction, resolution, and light output. Electrical safety verified per ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009. Biocompatibility adopted from predicate testing per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. All tests met pre-defined acceptance criteria.

Technological Characteristics

Flexible endoscope with CCD image sensor, glass fiber illumination, and working channels. Materials include new epoxy resin. Connectivity: proprietary interface to FUJIFILM video processors/light sources. Standards: IEC60601-1 ed 3.1, ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, IEC 60601-2-18:2009, ISO 10993 series. Environmental specs: -20°C to 60°C, 10-85% RH.

Indications for Use

Indicated for patients requiring observation, diagnosis, or endoscopic treatment of the trachea and bronchial tree.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• Video Processor VP-7000 (K163675)
• Light Source BL-7000 (K163675)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 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: [phone] Facsimile: [phone] E-Mail: [e-mail]

## 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:

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

{1}------------------------------------------------

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.

{2}------------------------------------------------

## 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.

{3}------------------------------------------------

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

{4}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{5}------------------------------------------------

# Please wait...

If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.