(262 days)
Not Found
No
The summary describes a standard bronchoscope with optical imaging and mechanical controls. There is no mention of AI, ML, image processing for analysis, or any data related to training or testing of algorithms.
Yes
The device is intended for "endoscopic treatment" of the trachea and bronchial tree, which indicates a therapeutic purpose.
Yes
Explanation: 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 bronchial tree."
No
The device description clearly outlines physical components like a control/operating section, insertion portion with glass fiber bundles, channels, a CCD image sensor, and an umbilicus. It also mentions being used in combination with hardware like video processors and light sources.
No, 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 involves directly visualizing and potentially treating structures within the body.
- Device Description: The description details a bronchoscope, which is an instrument used to look inside the airways. It describes components like fiber bundles, channels for air/suction and accessories, and a CCD image sensor for capturing images within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device operates in vivo (within the living body) for direct visualization and intervention, not in vitro (in glass or outside the body) for testing samples.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
EOO, EOQ
Device Description
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.
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 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
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.
Fujinon/Fujifilm EB-530 Series Bronchoscopes Model EB-530S (K122535)
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.
Not Found
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 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
1
(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)
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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
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.
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
5
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 Device
Fujinon/Fujifilm EB-530 Series
Bronchoscopes Model EB-530S (K122535) | Proposed Device
FUJIFILM 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 of
trachea 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-2500
EPX-4400
EPX-4400HD
EPX-4440HD | EPX-4440HD |
| | Predicate Device
Fujinon/Fujifilm EB-530 Series
Bronchoscopes Model EB-530S (K122535) | Proposed Device
FUJIFILM Bronchoscope Model EB-530P | |
| Peripherals | Endoscopic Accessory (i.e. Forceps) | Endoscopic accessory i.e. forceps caliber
under 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 brush
WB3212FW2
WB3503FW | Channel Cleaning Brush
WB2212FW2
WB3503FW | |
| | 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).