K Number

Device Name

FUJIFILM Endoscopic CO2 Regulator GW-100

Manufacturer

FUJIFILM Corporation

Date Cleared

2018-05-25

(67 days)

Product Code

FCX

Regulation Number

876.1500

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133976

Reference Devices

K172916

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and electrical components (solenoid/decompression valve) and standard performance testing, with no mention of AI, ML, or image processing.

Therapeutic

No
The device is used to insufflate the gastrointestinal tract with CO2 and supply water to clean endoscope lenses during an examination, which are diagnostic and procedural support functions, not therapeutic.

Diagnostic

The device is described as supplying CO2 gas and water for cleaning lenses and insufflating the gastrointestinal tract during endoscopic procedures. Its function is to facilitate the endoscopy, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components (Main Unit, Water Tank, Gas Tube) and the performance studies include electrical safety and biocompatibility testing, which are relevant to hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract during endoscopy. This is a direct interaction with the patient's body for a procedural purpose, not for examining specimens in vitro (outside the body).
Device Description: The description details how the device delivers CO2 and water into the body cavity via the endoscope. This confirms its function as an accessory for an in vivo procedure.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostic testing.

Therefore, the FUJIFILM Endoscopic CO2 Regulator GW-100 is a medical device used in vivo during endoscopic procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

FCX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

gastrointestinal tract

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)

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.

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.

K133976

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.

K172916

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

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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

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 2 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.

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.

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
Endoscope
Manufacturer	Same as K133976	FUJIFILM Corporation
510(k) number	Same as K133976	K133976
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.	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.
Power supply	Same as K133976	100-240VAC 50/60Hz
Current
consumption	Same as K133976	0.3A
Dimensions	Same as K133976	W145 x H170 x D390 mm
Mass	Same as K133976	7kg
Gas supply
method	Same as K133976	Supply by carbon dioxide gas cylinder or
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
setting	Same as K133976	Normal, Low
Feeding pressure
indicator	Same as K133976	Six level indication
Compatible Water
Tank	WT-04G(standard accessory)
WT-604G(optional accessory)	WT-04G(standard accessory)
Compatible
Gas/Water Valve	AW-500(standard accessory)
AW-604G(optional accessory)	AW-500(standard accessory for applicable
endoscopes)

| Compatible Gas

Tube	Same as K133976	CT-11G
Electrical Safety
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:

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.

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.