FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5

K042043 · Fujinon, Inc. · FDS · Nov 24, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042043
• Device Name: FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
• Applicant: Fujinon, Inc.
• Product Code: FDS · Gastroenterology, Urology
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.

Device Story

Fujinon G5 Gastroscopes are flexible endoscopes used by physicians for visualization, diagnosis, and treatment of the upper digestive tract (esophagus, stomach, duodenal bulb). The device captures optical images via a distal CCD chip and transmits them to a processor/monitor for real-time viewing. The G5 series introduces design refinements to the 200 and 400 series scopes, including removal of the L-port (lens wash), modification of the forceps inlet port with a rubber cap for improved suction/seal, and relocation of jet wash line check valves to an external, removable position to facilitate cleaning. The device is used in clinical settings alongside standard endoscopic peripherals (light source, processor, electrosurgical instruments). By providing high-resolution visualization and access for instruments, the device enables minimally invasive diagnostic and therapeutic procedures, benefiting patients by reducing the need for more invasive surgical interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including EMC testing, and comparison of design specifications and materials to predicate devices.

Technological Characteristics

Flexible endoscope with forward viewing direction; 9.4mm distal/flexible diameter; 140-degree field of view; 2.8mm forceps channel. Imaging system uses an interline color CCD chip (411,988 pixels). Materials of outer lines: LaSf-n17. Connectivity: compatible with standard Fujinon processors/monitors. Reprocessing: compatible with CA-500 cleaning adaptor; externalized check valves facilitate cleaning/sterilization. No software algorithm described.

Indications for Use

Indicated for patients requiring visualization, diagnosis, or endoscopic treatment of the upper digestive tract, including the esophagus, stomach, and duodenal bulb.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Fujinon EG-400HR (K944620)
• Fujinon EG-200FP (K944759)

Reference Devices

• Fujinon Double Balloon Enteroscopy System (K040048)

Submission Summary (Full Text)

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K042043

# 510 (k)

NOV 2 4 2004

## Date Prepared [21 CFR 807.92(a)(1)]

July 21, 2004 [Amended October 29, 2004]

## 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 Gastroscopes Common Name: Gastroscope Classification: Class II, 21 CFR 876.1500, FDS

## Predicate Device [21 CFR 807.92(a)(3)]

- Fujinon EG-400HR - K944620
- Fujinon EG-200FP K944759 .

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 Fuiinon Gastroscopes.

The subject devices have the same indications for use, composition of patient contact materials, viewing direction, image size, 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, bending capacity, and length.
- . The subject device includes the G5 upgrade, which is characterized by the following minor differences:
- o 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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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 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 elimi-0 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 aco 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 con-0 nected to tubes for cleaning.

## Description of the Device [21 CFR 807.92(a)(4)]

The Fujinon GS Gastroscopes are medical endoscopes used for visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.

The G5 Gastroscopes are offered in a 200 and 400 series. The EG-250WR5 represents the G5 Gastrooscope 200 series and the EG-450WR5 represents the G5 Gastroscope 400 series.

The G5 Gastroscopes 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 Gastroscopes 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 Gastroscopes are used with the same processors, monitors, hard copy units, and carts as the predicate devices. Each Gastroscope 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 Gastroscopes are used in conjunction with other perified in the Operation Manual such as:

- Light Source / Processor / Cart / Data Keyboard / Foot Switch / Monitor / Video Printer .

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- • Camera and Hard Copy Unit / VCR / Electrosurgical Instruments
ons for EG-450WR5 and EG-250WR5

| Specifications for EG-450WR5 and EG-250WR5 | | | |
|---------------------------------------------------------------------------|----------------------------------|--------------------------------|--------------------------------|
| | EG-450WR5 | EG-250WR5 | |
| Viewing Direction | Forward | Forward | |
| Observation Range | 5-100mm | 7-100mm | |
| Field of View | 140 degrees | 140 degrees | |
| Image Size | Super Image | Super Image | |
| Distal End Diameter | 9.4mm | 9.4mm | |
| Flexible Portion Diameter | 9.4mm | 9.4mm | |
| Bending Capacity UP | 210 degrees | 210 degrees | |
| Bending Capacity DOWN | 90 degrees | 90 degrees | |
| Bending Capacity LEFT | 100 degrees | 100 degrees | |
| Bending Capacity RIGHT | 100 degrees | 100 degrees | |
| Forceps Channel Diameter | 2.8mm | 2.8mm | |
| Working Length | 1100mm | 1100mm | |
| Total Length | 1400mm | 1400mm | |
| | | EG-450WR5 | EG-250WR5 |
| Material of Outer Lines (G1) | | 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<br>Chip | Interline Color<br>Chip |
| Image Quality Resolution (lines / mm) - Near Point | | 11.1 lines/mm<br>(6mm) | 10.0 lines/mm<br>(7mm) |
| Image Quality Resolution (lines/mm) - Far Point | | 0.91 lines/mm<br>(100mm) | 0.91 lines/mm<br>(100mm) |
| Magnification (specify monitor size and type used for this specification) | | 24 (5mm) at 14<br>inch monitor | 24 (5mm) at 14<br>inch monitor |
| Focal Length | | 1.206 | 1.206 |

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## Intended Use [21 CFR 807.92(a)(5)]

A 24 2043
pg 4 of 7

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.

## 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, image size, and reprocessing/sterilization method as the predicate. 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 previously cleared by FDA in 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 Gastroscopes 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

Fujinon, Inc. c/o Joseph M. Azary Azary Technologies™, LLC P.O. Box 2156 HUNTINGTON CT 06484

Re: K042043

Trade/Device Name: Fujinon Inc. G5 Gastroscopes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FDS Dated: October 28, 2004 Received: November 1, 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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510(k) Number (if known):

Device Name: Fujinon Inc. G5 Gastroscopes

The device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.

(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

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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