(257 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.
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.
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.
§ 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.