(223 days)
No
The document describes a standard bronchoscope with a CMOS image sensor and channels for accessories, but there is no mention of AI, ML, or advanced image processing beyond basic capture and display. The performance studies focus on physical characteristics, safety, and reprocessing, not algorithmic performance.
Yes
The device is described as "intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus," indicating its use extends beyond mere observation to include therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus". The term "diagnosis" directly indicates its use as a diagnostic device.
No
The device description clearly outlines hardware components including an insertion portion with glass fiber bundles, channels, and a CMOS image sensor, a control portion, and a connector portion with electronic components. It is used in combination with other hardware peripherals like video processors, light sources, and monitors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "observation, diagnosis and endoscopic treatment of the trachea and bronchus". This involves direct visualization and intervention within the body, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a bronchoscope with an insertion portion, control portion, and connector. It describes how it captures images within the body and facilitates procedures. This aligns with an endoscopic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly visualize and interact with internal anatomy.
N/A
Intended Use / Indications for Use
FUJIFILM Endoscope Model EB-71 OP is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.
Never use this product for any other purposes.
Product codes
EOQ
Device Description
FUJIFILM Endoscope Model EB-710P is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion is flexible and contains glass fiber bundles, several channels, and a complementary metal-oxide semiconductor (CMOS) image sensor in its distal end. 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 CMOS image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea and bronchus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians at medical facilities
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)
Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, published March 17, 2015.
Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2018, 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 September 4, 2020.
Software of the proposed device was evaluated in accordance with IEC 62304:2006 and the FDA guidance, Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, issued May 11, 2005, and, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014.
Electrical safety and EMC of the proposed device was evaluated using following standards: ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-2-18:2009
Laser safety and photobiological safety of the proposed device was evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.
Endoscope specific testing was conducted according to ISO 8600-1: 2015
The proposed device met performance specifications in the following additional testing:
- Field of view
- Bending capability .
- Working length Diameter of forceps channel .
- Resolution
- LG output
- . Rate of suction
- Viewing direction .
- Optical and color performance of the proposed device was evaluated. In all cases, the proposed device demonstrated substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
November 10, 2022
FUJIFILM Corporaton % Kotei Aoki Senior Regulatory Affairs Specialist FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue. Suite 300 Lexington, Massachusetts 02421
Re: K220957
Trade/Device Name: FUJIFILM Endoscope Model EB-710P Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOQ Dated: October 13, 2022 Received: October 13, 2022
Dear Kotei Aoki:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Joyce C. Lin-S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT 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
Indications for Use
510(k) Number (if known) K220957
Device Name FUJIFILM Endoscope Model EB-710P
Indications for Use (Describe)
FUJIFILM Endoscope Model EB-71 OP is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.
Never use this product for any other purposes.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
FUJIFILM Corporation
FUJIFILM Endoscope Model EB-710P
Date: March 31, 2022
Submitter's Information:
FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN
Contact Person:
Kotei Aoki Senior Regulatory Affairs Specialist E-Mail: kotei.aoki@fujifilm.com Telephone: (765) 246-2931
ldentification of the Proposed Device:
| Device Name: | FUJIFILM Endoscope Model EB-710F |
|---|---|
| Common Name: | Bronchoscope |
| Product Code: | EOQ |
| Device Class: | Class 2 |
| Regulation Number: | 874.4680 |
| Regulation Description: | Bronchoscope |
| Review Panel: | Ear Nose & Throat |
Predicate Device:
- FUJIFILM Endoscope Model EB-580S (K183607) .
Reference Devices:
Intended Use / Indications for Use:
FUJIFILM Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.
Never use this product for any other purposes.
Device Description:
FUJIFILM Endoscope Model EB-710P is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion is flexible and contains glass fiber bundles, several channels, and a complementary metal-oxide semiconductor (CMOS) image sensor in its distal end. 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 CMOS
4
image sensor to capture an image and display it on the monitor. The channels in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation and rotation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart.
Comparison of Technological Characteristics:
The comparison is summarized in the tabular format in Tables below.
5
Table 1
| | Proposed Device
FUJIFILM Endoscope
Model EB-710P
(to be assigned) | Predicate Device
FUJIFILM Endoscope
Model EB-580S
(K183607) | Reference Device 1
FUJIFILM Endoscope
Model EC-760S-V/L
(K190649) | Reference Device 2
OLYMPUS Endoscope
Model BF-P190
(K201758) | method) | (optical communication) | (electrical contact) | (optical communication) | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------|-------------------------------------------------------|-----------------------------------|-------------------------------------------------------|-----------------|--|
| Indications for Use (IFU) | FUJIFILM Endoscope Model EB-710P is a bronchoscope intended for the observation, diagnosis and endoscopic treatment of the trachea and bronchus at medical facilities under the management of physicians.
Never use this product for any other purposes. | The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree. | | | Connector power supply
method | electromagnetic induction
(non-electrical contact) | electrical contact | electromagnetic induction
(non-electrical contact) | | |
| Viewing direction | | Forward / 0° | | | Connector CPU/Software | Installed | N/A | Installed | | |
| Observation range | 2mm - 50mm | 2mm - 100mm | | 2mm - 50mm | | Suction Channel Brush (WB7025DC) | | | | |
| Acceptance Criteria of Resolution | At 2mm of working distance:0.08mm of line pair on the square wave chart is readable.
At 50mm of working distance:1.25mm of line pair on the square wave chart is readable. | At 4mm of working distance: 0.1mm of line pair on the square wave chart is readable.
At 100mm of working distance: 1.6mm of line pair on the square wave chart is readable. | | | | Cylinder/Inlet Brush (WB11003DV) | | | | |
| Field of View | | 120° | | | Standard Accessories | Suction Valve (SB-607) | Suction button (SB-500B/D) | | | |
| Bending
capability | Vertical | Up 210° / Down 130° | | | | Forceps Valve (FOV-BU1) | Forceps Valve (FOV-DV7) | | | |
| | Horizontal | Right N/A / Left N/A | | | | Cleaning Adapter
(CA-616) | Cleaning Adapter Kit
(CA-500C) | | | |
| Rotation capability
(Insertion portion) | | Right:120° / Left:120° | N/A | | Right:120° / Left:120° | | Ventilation Adapter (AD-7) | | | |
| Image sensors | | CMOS | CCD | CMOS | | | Air leak tester (LT-7F) | | | |
| Distal end diameter | | 4.1mm | 5.3mm | | 4.2mm | Optional Accessories | Suction Valve (SB-606) | Suction Valve (SB-602) | | |
| Flexible portion diameter | | 4.1mm | 5.1mm | | 4.1mm | | Forceps Valve (FV-003) | | | |
| Maximum insertion diameter | | 4.9mm | 6.5mm | | | Light Source/Video
Processor | | XL-4450/VP-4440HD | | |
| Forceps channel diameter | | 2.0mm | 2.2mm | | 2.0mm | | | EPX-3500HD | | |
| Working length | | | 600mm | | | | BL-7000/VP-7000 | BL-7000/VP-7000 | BL-7000/VP-7000 | |
| Total length | | 880mm | 870mm | | 880mm | | | EP-6000 | | |
| Connector (communication | | Scope Connector | LG connector/Video connector | Scope Connector | | Peripherals | Endoscopic Accessories | | | |
| Electrosurgical Instruments | | | | | | | | | | |
| Control Portion | New control portion | G5 control portion | | | | | | | | |
| STERRAD Sterilization | Yes | No | | | | | | | | |
6
7
Performance Data:
Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, published March 17, 2015.
Biocompatibility of the proposed device was evaluated using the following consensus standards: ISO 10993-1:2018, 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 September 4, 2020.
Software of the proposed device was evaluated in accordance with IEC 62304:2006 and the FDA guidance, Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, issued May 11, 2005, and, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued October 2, 2014.
Electrical safety and EMC of the proposed device was evaluated using following standards: ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010/AMD1:2013, and IEC 60601-2-18:2009
Laser safety and photobiological safety of the proposed device was evaluated using the following standards: IEC 60825-1:2007 and IEC 62471:2006.
Endoscope specific testing was conducted according to ISO 8600-1: 2015
The proposed device met performance specifications in the following additional testing:
- Field of view
- Bending capability .
- Working length Diameter of forceps channel .
- Resolution
- LG output
- . Rate of suction
- Viewing direction .
- Optical and color performance of the proposed device was evaluated. In all cases, the proposed device demonstrated substantial equivalence to the predicate device.
Conclusions:
The proposed device FUJIFILM Endoscope Model EB-710P shares the same intended use and indications for use as, similar technological characteristics to, the same principles of operation as, and similar materials to the predicate device and the reference devices. The remaining differences in EB-710P. compared to the predicate device. have either 1) been cleared in the reference devices or 2) been evaluated for the biocompatibility, the electrical safety, the EMC testing, and the bench testing. The testing demonstrates that the proposed device remains as safe and effective as the predicate device and there is no new concern regarding the safety and effectiveness. FUJIFILM Endoscope Model EB-710P is substantially equivalent to the predicate device, FUJIFILM Endoscope Model EB-580S (K183607).