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 for endoscopy systems used in clinical settings. It receives CO2 from a cylinder or medical gas pipeline and water from a tank. The device uses a solenoid/decompression valve mechanism to regulate and dispense CO2 gas for gastrointestinal tract insufflation and to supply water for cleaning the endoscope lens via the air/water channel. Operated by medical staff during endoscopic examinations, the device provides controlled gas flow and water delivery to improve visualization and patient comfort. The output is delivered directly through the endoscope to the patient's body cavity. The device benefits patients by facilitating clearer endoscopic views and managing insufflation during procedures.
Clinical Evidence
Bench testing only. Performance testing included CO2 gas supply and water supply verification, electrical safety (ANSI/AAMI ES60601-1), biocompatibility (ISO 10993), and reprocessing validation for the new accessories. All tests met pre-defined acceptance criteria.
Technological Characteristics
Main unit with solenoid/decompression valve mechanism. Power: 100-240VAC. Dimensions: 145x170x390mm. Mass: 7kg. Max pressure feed: 65kPa. Compatible with CO2 cylinders or medical gas pipelines. Electrical safety: ANSI/AAMI ES60601-1 Edition 3.1. Accessories include water tanks and gas/water valves.
Indications for Use
Indicated for use in the gastrointestinal tract to supply CO2 gas for insufflation and feed water for lens cleaning during endoscopic procedures.
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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
Fujifilm Endoscopic CO2 Regulator GW-100 (K133976)
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May 25, 2018
FUJIFILM Corporation % Jeffrey Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 40 Boroline Road Allendale, New Jersey 07401
Re: K180711
> Trade/Device Name: FUJIFILM Endoscopic CO2 Regulator GW-100 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FCX Dated: April 27, 2018 Received: April 27, 2018
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, 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. 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 of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) 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.
Joyce M. Whang-S
for
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) K180711
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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#### VII. 510(K) SUMMARY
## 510(k) SUMMARY
## FUJIFILM Endoscopic CO2 Regulator GW-100
### Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
### Contact Person:
Jeffrey Wan Specialist, Regulatory Affairs Fujifilm Medical Systems U.S.A., Inc. Endoscopy Division Telephone: (973) 709-2219 Facsimile: (973) 686-8818 E-Mail: jeffrey.wan@fujifilm.com
Date Prepared: March 19, 2018
## ldentification of the Proposed Device:
| Proprietary/Trade Name: | FUJIFILM Endoscopic CO <sub>2</sub> Regulator GW-100 |
|-------------------------|------------------------------------------------------|
| Common Name: | Endoscopic CO2 Regulator |
| Device Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Classification: | Endoscope and accessories, 21 C.F.R. § 876.1500 |
| Product Code: | FCX |
#### Predicate Device:
Fujifilm Endoscopic CO2 Regulator GW-100, Fujifilm Medical Systems U.S.A, K133976
## Reference Device:
FUJIFILM Water Tank WT-603, FUJIFILM Corporation, K172916
#### Intended Use / Indications for 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.
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## Device Description:
FUJIFILM Endoscopic CO2 Regulator GW-100 supplies CO2 gas to insufflate the gastrointestinal tract. The GW-100 supplies water to wash the endoscope lens during an examination.
FUJIFILM Endoscopic CO2 Regulator GW-100 is comprised of the following components: Main Unit, Water Tank, and Gas Tube. The Main Unit utilizes a solenoid/decompression valve mechanism to dispense CO₂ from the Water Tank via the Gas Tube and the air/water channel in the endoscope into the body cavity. The Main Unit also supplies sterile water Tank via the air/water channel in the endoscope.
## Technological Characteristics:
A comparison of the technological characteristics between the modified and predicate devices is provided in the table below. The only modification to the proposed GW-100 is the addition of WT-604G and AW-604G as optional accessories. WT-604G is a class II accessory; AW-604G is a class I accessory.
| | Proposed Device | Predicate Device |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | GW-100 | GW-100 |
| Common name | Same as K133976 | Insufflator, Automatic Carbon-Dioxide For<br>Endoscope |
| Manufacturer | Same as K133976 | FUJIFILM Corporation |
| 510(k) number | Same as K133976 | K133976 |
| Intended<br>Use/Indications<br>for Use | This product is intended to supply CO2 gas<br>and feed water to clean lenses in the<br>gastrointestinal tract when used as an<br>accessory with Fujifilm's endoscopy<br>system. | This product is intended to supply CO2 gas<br>and feed water to clean lenses in the<br>gastrointestinal tract when used as an<br>accessory with Fujifilm's endoscopy system. |
| Power supply | Same as K133976 | 100-240VAC 50/60Hz |
| Current<br>consumption | Same as K133976 | 0.3A |
| Dimensions | Same as K133976 | W145 x H170 x D390 mm |
| Mass | Same as K133976 | 7kg |
| Gas supply<br>method | Same as K133976 | Supply by carbon dioxide gas cylinder or<br>medical gas pipeline system |
| Gas supplied | Same as K133976 | CO2 |
| Max pressure feed | Same as K133976 | 65kPa |
| Feeding method | Same as K133976 | Decompression valve |
| Feeding flow<br>setting | Same as K133976 | Normal, Low |
| Feeding pressure<br>indicator | Same as K133976 | Six level indication |
| Compatible Water<br>Tank | WT-04G(standard accessory)<br>WT-604G(optional accessory) | WT-04G(standard accessory) |
| Compatible<br>Gas/Water Valve | AW-500(standard accessory)<br>AW-604G(optional accessory) | AW-500(standard accessory for applicable<br>endoscopes) |
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| Compatible Gas<br>Tube | Same as K133976 | CT-11G |
|---------------------------------|---------------------------------|---------------------------------|
| Electrical Safety<br>Compliance | ANSI/AAMI ES60601-1 Edition 3.1 | ANSI/AAMI ES60601-1 Edition 3.0 |
Substantial equivalence was determined based on the performance testing described below.
## Performance Data:
Electrical safety testing was conducted on the proposed device GW-100 using the following consensus standards: ANSI/AAMI ES60601-1:2005+AMD1:2012 CSV, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009.
The proposed optional accessory WT-604G was adopted into biocompatibility testing conducted on the reference device WT-603 using the following consensus standards: ISO 10993-1:2009. ISO 10993-5:2009, and ISO 10993-10:2010.
The proposed device GW-100 was adopted into software testing conducted on the predicate device GW-100 according to the consensus standard IEC 62304:2006.
The proposed optional accessory WT-604G was adopted into cleaning, high-level disinfection, and sterilization validation testing conducted on the reference device WT-603 in accordance with the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015).
Fujifilm conducted the following performance testing on the proposed device GW-100 to ensure that the modified device performs equivalently to the predicate device:
- CO2 gas supply
- Water supply .
In all cases, the device met the pre-defined acceptance criteria for the test.
## Substantial Equivalence:
The company's GW-100 has the same intended use as the previously cleared predicate GW-100 (K133976). In addition, the proposed device GW-100 has the same intended use, indications for use, technological characteristics, and principles of operation as its predicate. Although there is a minor difference between the proposed device and its predicate device, namely the addition of compatible accessories, this difference does not raise new or additional questions of safety or effectiveness of the proposed device. Thus, the proposed device GW-100 is substantially equivalent to its predicate device.
## Conclusions:
The modified GW-100 is substantially equivalent to the predicate GW-100 and conforms to applicable medical device safety and performance standards.
