(67 days)
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.
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.
The provided text describes a 510(k) premarket notification for the FUJIFILM Endoscopic CO2 Regulator GW-100. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that an AI/ML powered device meets specific performance criteria.
Therefore, the information required to answer the prompt (acceptance criteria, study details for an AI/ML device, sample sizes, expert involvement, etc.) is not present in this document. This document is for a medical device (a CO2 regulator for endoscopy) that is an accessory and does not appear to involve AI/ML.
The "Performance Data" section (Page 5) describes engineering and safety tests for the device itself and its accessories, not clinical performance or diagnostic accuracy. It mentions:
- Electrical safety testing: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18.
- Biocompatibility testing: ISO 10993-1, ISO 10993-5, ISO 10993-10 for an optional accessory.
- Software testing: IEC 62304 (for the predicate device, with the proposed device adopted into it).
- Cleaning, high-level disinfection, and sterilization validation testing: Per FDA guidance.
- "Performance testing" on CO2 gas supply and Water supply: Stated that "In all cases, the device met the pre-defined acceptance criteria for the test" but does not specify the criteria or the results.
Since the requested information pertains to AI/ML device performance and clinical validation, and this document describes a hardware medical device's engineering and safety testing for substantial equivalence, a complete answer to your prompt cannot be generated from the given input.
However, if we assume, for the sake of demonstrating the structure of the answer you're looking for, that the "CO2 gas supply" and "Water supply" tests were the "performance tests" for this device, a highly speculative and incomplete answer based on the limited provided text would look like this:
Based on the provided document, the device in question (FUJIFILM Endoscopic CO2 Regulator GW-100) is a hardware medical device, not an AI/ML powered device. As such, the comprehensive details typically required for AI/ML device validation (e.g., ground truth establishment, reader studies, effect sizes) are not applicable or provided in this 510(k) submission.
The document states that "performance testing" was conducted for "CO2 gas supply" and "Water supply," and that "In all cases, the device met the pre-defined acceptance criteria for the test." However, the document does not specify what these criteria were or the actual reported device performance values for these parameters.
Therefore, most of the specific questions regarding AI/ML device validation cannot be answered from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| CO2 Gas Supply Performance | "Pre-defined acceptance criteria" (not specified in document) | "Met the pre-defined acceptance criteria for the test" (specific values not reported) |
| Water Supply Performance | "Pre-defined acceptance criteria" (not specified in document) | "Met the pre-defined acceptance criteria for the test" (specific values not reported) |
Note: The document only states that the device "met the pre-defined acceptance criteria" but does not explicitly list the criteria or the quantitative results of the performance.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the "CO2 gas supply" and "Water supply" performance tests. This would typically involve engineering test units rather than patient data.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are engineering/device performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined for AI/ML (e.g., diagnosis, abnormality detection) is not established for this type of device's performance testing. The "ground truth" for the performance tests would be the accurate measurement of CO2 gas and water supply.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring human adjudication of clinical data.
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 not an AI-powered device, and therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used:
- For the "CO2 gas supply" and "Water supply" tests, the "ground truth" would be the engineering specifications and calibrated measurement of the device's output, rather than clinical outcomes or expert consensus.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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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 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.
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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 ForEndoscope |
| Manufacturer | Same as K133976 | FUJIFILM Corporation |
| 510(k) number | Same as K133976 | K133976 |
| IntendedUse/Indicationsfor Use | This product is intended to supply CO2 gasand feed water to clean lenses in thegastrointestinal tract when used as anaccessory with Fujifilm's endoscopysystem. | This product is intended to supply CO2 gasand feed water to clean lenses in thegastrointestinal tract when used as anaccessory with Fujifilm's endoscopy system. |
| Power supply | Same as K133976 | 100-240VAC 50/60Hz |
| Currentconsumption | Same as K133976 | 0.3A |
| Dimensions | Same as K133976 | W145 x H170 x D390 mm |
| Mass | Same as K133976 | 7kg |
| Gas supplymethod | Same as K133976 | Supply by carbon dioxide gas cylinder ormedical gas pipeline system |
| Gas supplied | Same as K133976 | CO2 |
| Max pressure feed | Same as K133976 | 65kPa |
| Feeding method | Same as K133976 | Decompression valve |
| Feeding flowsetting | Same as K133976 | Normal, Low |
| Feeding pressureindicator | Same as K133976 | Six level indication |
| Compatible WaterTank | WT-04G(standard accessory)WT-604G(optional accessory) | WT-04G(standard accessory) |
| CompatibleGas/Water Valve | AW-500(standard accessory)AW-604G(optional accessory) | AW-500(standard accessory for applicableendoscopes) |
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| Compatible GasTube | Same as K133976 | CT-11G |
|---|---|---|
| Electrical SafetyCompliance | 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.
§ 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.