(108 days)
The device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
The Fujinon G5 Duodenoscopes are medical endoscopes used for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
The G5 Duodenoscopes are offered in a 200 and 400 series. The ED-250XT5 represents the G5 Duodenoscope 200 series and the ED-450XT5 represents the G5 Duodenoscope 400 series.
The G5 Duodenoscopes 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.
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. 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 Duodenoscopes 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 Duodenoscopes are used with the same processors, monitors, hard copy units, and 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 Duodenoscopes 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
The provided document is a 510(k) summary for the Fujinon G5 Duodenoscopes, which discusses minor design changes and compares them to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing or clinical trials.
The document states:
- "The subject device has been subjected to and passed EMC testing requirements." - This is a general statement about electromagnetic compatibility testing, not a detailed performance study related to the device's primary function (visualization, diagnosis, endoscopic treatment).
- "The patient contact materials in the Duodenoscopes are identical to the materials used in the predicate device." - This is about material equivalence, not performance.
- "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices." - This is a conclusion based on the minor nature of the changes and substantial equivalence to existing devices, not on a new study demonstrating specific performance metrics.
Therefore, I cannot provide the requested table or information regarding a study proving the device meets acceptance criteria, as such details are absent from the provided text. The submission relies on demonstrating substantial equivalence to predicate devices for its safety and effectiveness claims, rather than presenting a de novo performance study with defined acceptance criteria.
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NOV 18 2004
510 (k) Summary
Date Prepared (21 CFR 807.92(a)(1){
July 29, 2004 [Amended 10/27/04]
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)|
The device trade names are: Fujinon G5 Duodenoscopes Common Name: Duodenoscopes Classification: Class II, 21 CFR 876.1500, FAK
Predicate Device | 21 CFR 807.92(a)(3)|
The G5 changes were described and cleared by FDA in the 510(k) submission for the Fujinon Double Balloon Enteroscopy System - K040048.
This 510(k) captures some minor design changes that have occurred during the evolution of the product line resulting in the G5 family of scopes. Although the changes are believed to be minor, the 510(k) is being submitted to account for "design creep" and to ensure that FDA has the most current information concerning the Fujinon Duodenoscopes.
The subject devices have the same indications for use, composition of patient contact materials, viewing direction, length, and reprocessing/sterilization method as the predicates. The subject devices use the same processors and peripherals as the predicate device.
The main differences between the subject devices and predicate devices are as follows:
- Minor differences with observation range, field of view, diameter, and bending capacity. ◆
- . The subject device includes the G5 upgrade, which is characterized by the following minor differences:
- The L-Port has been eliminated. 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.
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K. L. L. L.
13. 1. 1.
This function was eliminated because demand was low and it was rarely used by the surgeons.
- A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber ೧ A OF foreeps mice port and rubber cap help increase suction and reduce leakage.
- The jet wash line check valve was removed. Internal check valves were removed to elimi-਼ I he jet wasn'tine cheek farro has research 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.
- of the FOV, which is the rubber forceps inlet valve cover. This helps create a wa-0 tertight seal when the endoscope is used.
- terright sour when the eleaning adaptor. The cleaning adaptor allows the scope to be con-ಂ nected to tubes for cleaning.
Description of the Device |21 CFR 807.92(a)(4)|
The Fujinon G5 Duodenoscopes are medical endoscopes used for the visualization of the duodenum and upper I he f unitor US Duodenosoppe are mosevation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
The G5 Duodenoscopes are offered in a 200 and 400 series. The ED-250XT5 represents the G5 Duodenoscope 200 series and the ED-450XT5 represents the G5 Duodenoscope 400 series.
The G5 Duodenoscopes 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.
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. 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 Duodenoscopes 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 Duodenoscopes are used with the same processors, monitors, hard copy units, and 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 Duodenoscopes are used in conjunction with other peripherals specified in the Operation Manual such as:
- . Light Source
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- Processor .
- Cart .
- . Data Keyboard
- Foot Switch .
- . Monitor
- Video Printer .
- Camera and Hard Copy Unit .
- VCR .
- ElectroSurgical Instruments .
Specifications for ED-450XT5 and ED-250XT5
| ED-450XT5 | ED-250XT5 | |
|---|---|---|
| Viewing Direction | Lateral (15 degrees retro) | Lateral (15 degrees retro) |
| Observation Range | 3-60mm | 5-60mm |
| Field of View | 100 degrees | 100 degrees |
| Image Size | Super Image | Super Image |
| Distal End Diameter | 13.5mm | 13.5mm |
| Flexible Portion Diameter | 12.6mm | 12.6mm |
| Bending Capacity UP | 130 degrees | 130 degrees |
| Bending Capacity DOWN | 90 degrees | 90 degrees |
| Bending Capacity LEFT | 90 degrees | 90 degrees |
| Bending Capacity RIGHT | 110 degrees | 110 degrees |
| Forceps Channel Diameter | 4.2mm | 4.2mm |
| Working Length | 1250mm | 1250mm |
| Total Length | 1550mm | 1550mm |
A 8 4 2 16
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K-mmer
77 444
| ED-450XT5 | ED-250XT5 | ||
|---|---|---|---|
| Material of Outer Lines (GI) | LaSf-n17 | LaSf-n17 | |
| Lens Diameter (mm) | 2.2 | 2.2 | |
| Electronic Video Imaging System | Total Pixels | 411,988 | 411,988 |
| Pixels per square millimeter | 83,892 | 83,892 | |
| Size of Pixel (H*V mm) | 0.0032*0.003725 | 0.0032*0.003725 | |
| Active area of CCD chip (H*V mm) | 2.458*1.840 | 2.458*1.840 | |
| Type of CCD chip | Interline Color Chip | Interline Color Chip | |
| Image Quality Resolution (lines / mm) - Near Point | 15.9 lines/mm(6mm) | 14.3 lines/mm(7mm) | |
| Image Quality Resolution (lines/mm) - Far Point | 2.00 lines/mm(60mm) | 1.59 lines/mm(60mm) | |
| Magnification (specify monitor size and type used for this specification) | 26 (5m) at 14inch monitor | 31 (5m) at 14 inchmonitor | |
| Focal Length | 1.459mm | 1.459mm |
Intended Use [21 CFR 807.92(a)(5)]
The device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
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, composition of patient contact material, viewing direction, length, device nave ne same indications for abs, bettredicate. The subject devices use the same processors and peripherals as the predicate devices.
The main differences are the minor changes associated with the G5 upgrade. The G5 changes were previ-The nam offerences are the 510(k) submission for the Fujinon Double Balloon Enteroscopy System -K040048.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed EMC testing requirements. The patient contact materials in the Duodenoscopes 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.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2004
Fujinon, Inc. c/o Mr. Joseph M. Azary Azary Technologies™ LLC 543 Long Hill Avenue SHELTON CT 06484
Re: K042076
Trade/Device Name: G5 Duodenoscopes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDT Dated: October 27, 2004 Received: October 28, 2004
Dear Mr. Azary:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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/dsmadsmam.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K.4 2076
510(k) Number (if known):
Device Name: Fujinon Inc. G5 Duodenoscopes
The device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
(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
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 042016 510(k) Number.
Over-The-Counter Use ____________
(Optional Format 1-2-96)
Page 4
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.