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

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.

AI/ML Overview

The provided document is a 510(k) summary for the Fujifilm Endoscopic CO2 Regulator GW-100. It details the device's intended use and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets those criteria, as typically found for AI/ML-based devices.

This document describes a medical device seeking clearance based on substantial equivalence, which is a different regulatory pathway than proving performance against specific clinical acceptance criteria for new AI/ML-based diagnostic or therapeutic devices. The studies mentioned are primarily related to electrical safety, electromagnetic compatibility (EMC), software validation, and biocompatibility, not clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered, with notes explaining the absence of other details:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The device's "acceptance" is based on its substantial equivalence to a predicate device and meeting safety/performance standards (electrical safety, EMC, software, biocompatibility).
Reported Device Performance: Performance is demonstrated through compliance with safety and engineering standards. No clinical performance metrics (e.g., accuracy, sensitivity, specificity) are reported.

Acceptance Criteria (Implied)	Reported Device Performance (as per non-clinical studies)
Compliance with IEC 60601-1 (Medical electrical equipment)	Passed
Compliance with IEC 60601-1-1 (Safety for medical systems)	Passed
Compliance with IEC 60601-2-18 (Endoscopic equipment)	Passed
Compliance with IEC 60601-1-2 (EMC)	Passed
Compliance with IEC 60601-1-4 (Safety Standards Series)	Passed
Compliance with IEC 62304 (Medical device software)	Software validation performed; "Minor Level of Concern"
Compliance with ISO 10993-1, -5, -10 (Biological evaluation)	Passed (for indirect patient contact materials)
Validated reprocessing instructions	Validated

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this type of submission. This submission relies on substantial equivalence and non-clinical engineering tests, not a clinical test set with patient data for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical ground truth was established for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a hardware device (CO2 regulator), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a hardware accessory for an endoscopy system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical performance ground truth was established. The "ground truth" here is compliance with established engineering and safety standards.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no concept of a training set for an algorithm. Device validation was based on testing against design specifications and international standards.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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: (973) 686-2498 Facsimile: (973) 686-2616 E-Mail: mkmoore@fujifilm.com

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 forEndoscope	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

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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.

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.