FUJIFILM ENDOSCOPIC CO2 REGULATOR

K133976 · Fujifilm Medical System U.S.A., Inc. · FCX · Sep 9, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133976
• Device Name: FUJIFILM ENDOSCOPIC CO2 REGULATOR
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: FCX · Gastroenterology, Urology
• Decision Date: Sep 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.

Device Story

The Fujifilm Endoscopic CO2 Regulator GW-100 is an accessory device used during gastrointestinal endoscopy. It functions by supplying CO2 gas for insufflation of the gastrointestinal tract and water for cleaning the endoscope lens. The device operates via a solenoid/decompression valve mechanism, drawing CO2 from either a gas cylinder or a facility's main supply. It is designed for use in clinical settings by medical professionals as part of a Fujifilm endoscopy system, which includes video processors, light sources, and other peripheral endoscopic equipment. By providing controlled gas insufflation and lens irrigation, the device assists the clinician in maintaining clear visualization and patient comfort during endoscopic examinations.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18), electromagnetic compatibility (IEC 60601-1-2), software validation (IEC 62304), and biocompatibility (ISO 10993-1, -5, -10).

Technological Characteristics

The device utilizes a solenoid/decompression valve mechanism for CO2 regulation. It is a medical electrical device compliant with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, and IEC 60601-2-18. Materials with indirect patient contact were evaluated per ISO 10993-1, -5, and -10. Software is classified as a Minor Level of Concern per IEC 62304.

Indications for Use

Indicated for use in patients undergoing gastrointestinal endoscopic procedures requiring CO2 insufflation and lens cleaning.

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

• Olympus Endoscopic Insufflation Unit, Model XECR-2 (K063786)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 9, 2014

Fujifilm Medical System, USA, Inc. Mary K. Moore Senior Director, Regulatory Affairs and Quality Assurance 10 High Point Drive Wayne, NJ 07470

Re: K133976

> Trade/Device Name: Fujifilm Endoscopic CO2 Regulator GW-100 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX Dated: August 14, 2014 Received: August 15, 2014

Dear Mary K. Moore,

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. 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.

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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); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K133976

Device Name Fujifilm Endoscopic CO2 Regulator GW-100

Indications for Use (Describe)

This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.

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)

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# 510(k) Summary

Date: September 8, 2014

## Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293

## Contact Person:

Mary K. Moore Senior Director, Regulatory Affairs and Quality Assurance Telephone: [phone] Facsimile: [phone] E-Mail: [e-mail]

## Identification of the Subject Device:

| Proprietary/Trade Name: | Fujifilm Endoscopic CO₂ Regulator GW-100 | |
|--------------------------------------------------------|------------------------------------------|--------------|
| Common Name: | Endoscopic CO₂ Regulator | |
| Device Class: | Class II | |
| Review Panel: | Gastroenterology/Urology | |
| Classification Information: | | |
| Classification Name | CFR Section | Product Code |
| Insufflator, Automatic Carbon-Dioxide for<br>Endoscope | 21 CFR 876.1500 | FCX |

#### l. INDICATIONS FOR USE

The Fujifilm Endoscopic CO2 Regulator GW-100 is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.

#### II. DEVICE DESCRIPTION

The Fujifilm Endoscopic CO2 Regulator GW-100 supplies CO2 gas to insufflate the gastrointestinal tract and water to wash the endoscope lens during an examination. The GW-100 is similar to Olympus' XECR-2 Endoscopic Insufflation Unit. The scientific fundamental technology and operating principle of the subject and predicate devices are similar. Both devices utilize a solenoid/decompression valve mechanism to dispense CO2. CO2 can either be supplied from a CO2 gas cylinder or from a facility's main CO2 supply.

The GW-100 can be used with any Fujnon/Fujifilm gastrointestinal endoscope, Fujinon/Fuiifilm Video Processor/Light Source system, video monitor, footswitch, cart, endoscopic accessories, electrosurgical unit and other peripheral devices used for endoscopy.

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#### . SUMMARY OF NON-CLINICAL STUDIES

The Fujifilm Endoscopic CO2 Regulator GW-100 has been subjected to and passed electrical safety, EMC and software testing requirements.

Fuilfilm Endoscopic CO2 Requlator GW-100 was evaluated in accordance with the following voluntary standards as applicable to the device.

- > IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- > IEC 60601-1-1 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
- > IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- > IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic Compatibility -Requirements and tests
- > IEC 60601-1-4 Medical Electrical Equipment Safety Standards Series
- > IEC 62304 Medical device software — Software life cycle processes
- ISO 10993-1* Biological evaluation of medical devices - Part 1: A Evaluation and testing within a risk management process > ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- > ISO10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

*Evaluation to ISO 10993-1was conducted for indirect patient contact materials for the WT-04G.

Software validation was performed. The device software is considered a "Minor Level of Concern."

The reprocessing instructions were validated.

No clinical testing was conducted.

#### IV. SUBSTANTIAL EQUIVALENCE

Fujifilm Endoscopic CO2 Regulator GW-100 is substantially equivalent to the following device:

| Subject Device | Predicate Device | 510(k) # |
|---------------------------|---------------------------------|----------|
| , Fuiifilm Endoscopic CO2 | Olympus Endoscopic Insufflation | K063786 |
| Regulator GW-100 | Unit, Model XECR-2 | |

#### V. CONCLUSION

Fujifilm Endoscopic CO2 Regulator GW-100 is substantially equivalent to the legally marketed device and conforms to applicable medical device safety and performance standards.