(61 days)
EN-580T, EN-450P5/20 and EN-450T5 are intended for the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.
EC-450B15 is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestines. It is intended for observation, diagnosis, and endoscopic treatment.
FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 are comprised of three general sections: a control portion, an insertion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary Charge-Coupled Device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when pluqged in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
The document describes the regulatory submission for FUJIFILM Double Balloon Endoscopes, focusing on modifications made to existing devices. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Performance Data" section (pages 4-5).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that a series of performance tests were conducted to ensure the modified devices perform equivalently to the predicate devices. The acceptance criteria were "pre-defined," and in all cases, the devices met these criteria. However, the specific quantitative acceptance criteria for each test and the precise reported device performance values are not explicitly detailed in the provided text. Instead, a list of tested parameters is given.
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Field of view | Met pre-defined criteria |
| Bending capability | Met pre-defined criteria |
| Rate of air supply | Met pre-defined criteria |
| Rate of water supply | Met pre-defined criteria |
| Suction rate | Met pre-defined criteria |
| Working length | Met pre-defined criteria |
| Forceps channel diameter | Met pre-defined criteria |
| Viewing direction | Met pre-defined criteria |
| Resolution | Met pre-defined criteria |
| LG output | Met pre-defined criteria |
| Electrical Safety | Met ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009 standards |
| Biocompatibility | Met ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 standards |
| Reprocessing Validation | Met AAMI TIR12:2010, AAMI TIR30:2011, and FDA's guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size (number of devices or tests performed) for the performance testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these performance studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable and not provided in the document. The performance tests described (e.g., field of view, bending capability, electrical safety, biocompatibility) are objective engineering and material science evaluations, not assessments requiring expert interpretation of clinical data to establish ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. The performance tests described are objective and do not involve adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of modified endoscopes to predicate devices through technical and physical performance metrics, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm-only) performance study was not done. This device is an endoscope, a physical instrument, and does not involve AI algorithms for diagnosis or analysis.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests was based on established engineering specifications, consensus standards (e.g., ISO, AAMI, IEC), and regulatory guidance documents. For instance, electrical safety was measured against specific IEC standards, and biocompatibility against ISO standards. The validation of reprocessing instructions was performed in accordance with FDA guidance.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. The studies described are performance tests of physical devices against pre-defined specifications, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided for the reason mentioned above.
§ 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.