(240 days)
No
The description focuses on the hardware components and basic image capture/display, with no mention of AI/ML terms or image processing capabilities beyond basic illumination and capture.
No
The device is described as being for "observation, diagnosis, and endoscopic treatment" but the description of its function only supports observation and diagnosis. The "treatment" aspect is through the use of accessories, such as forceps, suggesting the bronchoscope itself is not therapeutic but rather a delivery system for therapeutic tools.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are "intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree." The inclusion of "diagnosis" confirms its role as a diagnostic device.
No
The device description explicitly details hardware components including a control portion, insertion portion with glass fiber bundles, channels, a CCD image sensor, and an umbilicus with electronic components. It also mentions being used in combination with other hardware like video processors, light sources, monitors, printers, foot switches, and carts.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree." This describes a procedure performed directly on the patient's body, not on a sample taken from the body.
- Device Description: The description details a device that is inserted into the body to visualize and interact with internal structures. It mentions components like glass fiber bundles, channels for suction and accessories, and a CCD image sensor to capture images from within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or performing tests on these samples outside of the body. The device's function is to provide visual information and facilitate interventions in vivo.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device does not fit that description.
N/A
Intended Use / Indications for Use
FUJIFILM Bronchoscopes EB-580S and EB-580T are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.
Product codes
EOQ
Device Description
FUJIFILM Bronchoscopes EB-580S and EB-580T are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering 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 portion 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 into the video processor and light source. The endoscopes are 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.
EB-580S and EB-580T can be used with Video Processor VP-7000 and Light Source BL-7000. However, LCI, FICE, and BLI imaging modes are not compatible with the subject devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea and bronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was conducted in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
Cleaning, high-level disinfection, and sterilization of the subject device were evaluated according to the following consensus standards: AAMI TIR12:2010, AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's quidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
The subject device met performance specifications in the following additional testing: Field of view, Working length, Viewing direction, Bending capability, Diameter of forceps channel, Resolution, LG output, Rate of suction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
August 23, 2019
FUJIFILM Corporation % Jeffrey Wan Specialist. Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue Lexington, Massachusetts 02421
Re: K183607
Trade/Device Name: FUJIFILM Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOO Dated: July 24, 2019 Received: July 25, 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.
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | | See PRA Statement below. |
| 510(k) Number (if known) | K183607 | |
| Device Name | FUJIFILM Bronchoscopes EB-580S and EB-580T | |
| Indications for Use (Describe) | FUJIFILM Bronchoscopes EB-580S and EB-580T are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
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3
510(k) SUMMARY
FUJIFILM Corporation's FUJIFILM Bronchoscopes EB-580S and EB-580T
Date: August 14, 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: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com
ldentification of the Proposed Devices:
| Proprietary/Trade Name: | FUJIFILM Bronchoscopes EB-580S and EB-580T |
|---|---|
| Common Name: | Bronchoscope |
| Device Class: | Class II |
| Review Panel: | Ear, Nose & Throat |
Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Bronchoscope (flexible or rigid) and accessories | 21 CFR 874.4680 | EOQ |
Predicate Devices:
- . FUJIFILM Video Bronchoscopes EB-530S and EB-530T (K122535)
Intended Use / Indications for Use
FUJIFILM Bronchoscopes EB-580S and EB-580T are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.
4
Device Description
FUJIFILM Bronchoscopes EB-580S and EB-580T are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering 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 portion 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 into the video processor and light source. The endoscopes are 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.
EB-580S and EB-580T can be used with Video Processor VP-7000 and Light Source BL-7000. However, LCI, FICE, and BLI imaging modes are not compatible with the subject devices.
Comparison of Technological Characteristics
FUJIFILM Bronchoscopes EB-580S and EB-580T differ from the predicate devices EB-530S and EB-530T in terms of technological characteristics and materials. The subject and predicate devices share the same mode of operation and intended use.
A summary of major differences between the subject devices EB-580S and EB-580T and the predicate devices EB-530S and EB-530T is provided as follows:
- . The subject devices are compatible with Video Processor VP-7000 and Light Source BL-7000 (K163675).
- . The subject devices are compatible with the disposable cleaning brushes WB11003DV and WB7025DC
- . The epoxy resin used in both insertion and non-insertion of the subject devices has been modified.
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 device was evaluated using the following consensus standards: ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. Biocompatibility testing was conducted in accordance with the FDA guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016.
5
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014.
Cleaning, high-level disinfection, and sterilization of the subject device were evaluated according to the following consensus standards: AAMI TIR12:2010, AAMI TIR30:2011. Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's quidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17, 2015.
The subject device met performance specifications in the following additional testing:
-
. Field of view
. -
Working length .
-
. Viewing direction
-
Bending capability ●
-
Diameter of forceps channel
-
. Resolution
-
LG output ●
Substantial Equivalence
Rate of suction
The subject devices FUJIFILM Bronchoscopes EB-580T are substantially equivalent to the predicate devices, FUJIFILM Video Bronchoscopes EB-530T (K122535). The subject devices have the same intended use/indications for use and substantially similar technological characteristics and principles of operation as that of the predicate devices. Material changes to the predicate devices have been validated through biocompatibility testing. Thus, the subject devices FUJIFILM Bronchoscopes EB-580T are substantially equivalent to the predicate devices.
Conclusions
The subject devices FUJIFILM Bronchoscopes EB-580T are substantially equivalent to the predicate devices based on the same intended use, indications for use, similar technological characteristics and materials. The differences in technological characteristics and materials between the subject and predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the predicate devices. The difference in materials between subject and predicate devices has been validated through biocompatibility testing. Thus, the subject devices FUJIFILM Bronchoscopes EB-580S and EB-580T are substantially equivalent to the predicate devices, FUJIFILM Video Bronchoscopes EB-530S and EB-530T (K122535).