(38 days)
Fujinon EB-310S (K954707)
No
The device description focuses on mechanical and ergonomic improvements to the bronchoscope and does not mention any software, image processing, or AI/ML capabilities.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "endoscopic treatment of the trachea and bronchial tree," which implies a therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "observation, diagnosis, and endoscopic treatment."
No
The device description explicitly details physical hardware components such as endoscopes, ports, valves, and cleaning adaptors, indicating it is a hardware device, not software-only.
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 device used directly on or in the patient for visualization and intervention.
- Device Description: The description details a medical endoscope, which is a device used to visualize internal body cavities. It describes its physical components, how it's used with other equipment (light source, processor, monitor, etc.), and its function in procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly a medical device used for direct visualization and treatment within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The device 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)
EOQ
Device Description
The Fujinon G5 Bronchoscopes are medical endoscopes used for the observation, diagnosis, and endoscopic treatment of the trachea and broncho.
The G5 Bronchoscopes are offered in a 200 and 400 series. The EB-250S represents the G5 Bronchoscope 200 series and the EB-470S represents the G5 Bronchoscope 400 series.
The G5 Bronchoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons.
The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage.
The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable.
The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same.
The G5 Bronchoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning.
The G5 Bronchoscopes are used with the same processors, monitors, hard carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual.
The Fujinon G5 Bronchoscopes are used in conjunction with other peripherals specified in the Operation Manual such as:
- Light Source
- Processor
- Cart
- Data Keyboard
- Foot Switch
- Monitor
- Video Printer
- Camera and Hard Copy Unit
- VCR
- ElectroSurgical Instruments
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)
The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in 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.
Fujinon EB-310S (K954707)
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.
K042076 Fujinon G5 Duodenoscopes, K042043 Fujinon G5 Gastroscopes, K041903 Fujinon G5 Colonoscopes
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
510(k) Notification Fujinon G5 Bronchoscopes MAY 1 9 2005
õ50907
510 (k) Summary
Date Prepared [21 CFR 807.92(a)(1)]
March 31, 2005
Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary C/o Fujinon Inc. 543 Long Hill Avenue Shelton, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor Fujinon Inc. 10 High Point Drive, Wayne, NJ 07470, Establishment Registration# 2431293.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Names: Fujinon G5 Bronchoscopes Models: EB-470S, EB-250S, and EB-270P
Common Name: Bronchoscope Classification: Class II, 21 CFR 874.4680, EOQ
Predicate Device [21 CFR 807.92(a)(3)]
-
Fujinon EB-310S (K954707) .
The G5 Technology has received FDA marketing clearance in the following 510(k) Premarket Notifications: -
K042076 Fujinon G5 Duodenoscopes .
-
K042043 Fujinon G5 Gastroscopes .
-
K041903 Fujinon G5 Colonoscopes .
The subject device have the same indications for use, material composition, viewing direction, image size, bending, reprocessing/sterilization method, and working dimensions as the predicate. The subject device uses the same processor and peripherals as the predicate device.
The main differences between the subject device and predicate device are as follows:
- Minor differences with observation range, field of view, diameter, and length. .
- The subject device includes the G5 upgrade, which is characterized by the following minor differ-. ences:
- The L-Port has been eliminated. The L-port functioned as a lens wash port . Doctors had o the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens.
1
This function was eliminated because demand was low and it was rarely used by the surgeons.
- o The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
- A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber O cap. The smaller port and rubber cap help increase suction and reduce leakage.
- The jet wash line check valve was removed. Internal check valves were removed to elimio nate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable.
- The suction and air/water cylinders and valves were upgraded. They were updated to ac-0 commodate the new valves. The function of the valves is the same.
- Addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a wao tertight seal when the endoscope is used.
- Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be cono nected to tubes for cleaning.
A chart comparing the subject device to the predicate device can be found in Annex 8. Additional information regarding the predicate device can be found in Annex 4.
Description of the Device [21 CFR 807.92(a)(4)}
The Fujinon G5 Bronchoscopes are medical endoscopes used for the observation, diagnosis, and endoscopic treatment of the trachea and broncho.
- The G5 Bronchoscopes are offered in a 200 and 400 series. The EB-250S represents the G5 . Bronchoscope 200 series and the EB-470S represents the G5 Bronchoscope 400 series.
The G5 Bronchoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons.
The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging.
A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage.
The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable.
The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same.
2
The G5 Bronchoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning.
The G5 Bronchoscopes are used with the same processors, monitors, hard carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual.
The Fujinon G5 Bronchoscopes are used in conjunction with other peripherals specified in the Operation Manual such as:
- Light Source .
- . Processor
- Cart .
- Data Keyboard .
- Foot Switch .
- Monitor .
- Video Printer .
- Camera and Hard Copy Unit .
- VCR .
- . ElectroSurgical Instruments
Specifications Chart:
| EB-250S | EB-470S | EB-270P | |
|---|---|---|---|
| Viewing Direction | Forward | Forward | Forward |
| Observation Range | 3-50mm | 3-100mm | 3-100mm |
| Field of view | 120 degrees | 120 degrees | 120 degrees |
| Image size | Super Image | Super Image | Super Image |
| Distal end diameter | 5.3 mm | 4.9mm | 3.8 mm |
| Flexible portion diameter | 5.3 mm | 4.9mm | 3.5 mm |
| Bending capability | |||
| Up | 180 degrees | 180 degrees | 180 degrees |
| Down | 130 degrees | 130 degrees | 130 degrees |
| Left | N/A | N/A | N/A |
| Right | N/A | N/A | N/A |
| Forceps channel diameter | 2.0mm | 2.0mm | 1.2 mm |
| Working length | 600mm | 600mm | 600mm |
| Total length | 870mm | 870mm | 870mm |
| Processor | 200 Series | 400 Series | 200 Series |
3
510(k) Notification Fujinon G5 Bronchoscopes
Intended Use [21 CFR 807.92(a)(5)]
The device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.
Technological Characteristics [21 CFR 807.92(a)(6)]
Fujinon, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device have the same indications for use, material composition, image size, bending, reprocessing/sterilization method, and working dimensions as the prodicate. The subject device uses the same processor and peripherals as the predicate device.
The main technological differences are the minor changes associated with the G5 upgrade.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.
4
Image /page/4/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird or abstract design, consisting of three curved lines that resemble wings or feathers.
MAY 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fujinon, Inc. c/o Joseph Azary Azary Technologies, LLC 543 Long Hill Avenue Shelton, CT 06484
Re: K050907
KU50907
Trade/Device Name: Fujinon G5 Bronchoscopes, Models EB-407S, EB-250S and EB-270P Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and Accessories Regulatory Class: Class II Product Code: EOQ Dated: March 31, 2005 Received: April 11, 2005
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to trg. 3 the enactment date of the Medical Device Amendments, or to commerce prior to 1125 2011-11-11 accordance with the provisions of the Federal Food, Drug, de vices that have been recussions in ausire approval of a premarket approval application (PMA). and Cosmetic Free (. rece) that be nevice, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls pro reseries, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassined (600 above) als. Existing major regulations affecting your device can may of subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ooscements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dri a lossants of our device complies with other requirements of the Act that I Dri has made a abinistered by other Federal agencies. You must of any I catal statutes and regaranents, including, but not limited to: registration and listing (21 comply with an the rece stequirements)01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable the electronic forth in the quality by wills (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in your a FDA finding of substantial equivalence of your device to a legally premaince noticated on "The classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you a the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golferal micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Notification Fujinon G5 Bronchoscopes
5 10(k) Number (if known):
Device Name: Fujinon Inc. G5 Bronchoscopes
Indications For Use: The device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.
KOSO907
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Anatolub
(Optional Format 1-2-96)
(Division Nose and
510(k) Number
Page 3