(248 days)
The Fujifilm Double Balloon Endoscopes 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.
The Fujifilm Double Balloon Endoscopes, Models EN-530T and EN-580T and related accessories consist of double balloon endoscopes (models EN-530T and EN-580T), a hood (model DH-17EN), a balloon (model BS-2), an over-tube (model TS-13140), and a balloon controller (model PB-20).
The endoscopes are comprised of three general sections; an operation section, an insertion portion and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion contains glass fiber bundles, several channels and a charged couple device (CCD) image sensor. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the gastrointestinal cavity. This provides adequate light to the CCD image sensor to capture an image and display it on the monitor. The endoscope also contains several channels such as an air/water channel, a suction channel, a balloon channel and a forceps channel. The balloon controller is used to inflate or deflate the balloons on the distal end of the endoscope and on the over-tube through the balloon channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps for endoscopic procedures. The umbilicus section consists of electronic components needed to operate the endoscope when plugged to the video processor and the light source. The subject models are used in combination with Fujifilm's video processor, light source and peripheral devices (water tank, endoscope accessories, monitor, printer, DVD recorder, electrosurgical instruments, foot switch, and cart). The hood is an optional accessory that is attached to the distal end of the endoscopes and is intended to maintain the field of view during the endoscopic procedure.
The minor modifications to the endoscopes were made for the purpose of overall product enhancement and general technological advancement.
This 510(k) summary describes an endoscopic device, and as such, it does not fit the typical format for AI/ML device evaluations. Therefore, many of the requested bullet points, such as MRMC studies, effect size, and specific ground truth details for AI models, are not applicable.
However, based on the provided document, I can extract the following information about the device's performance evaluation against established criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various performance specifications that were tested, comparing the subject devices (EN-530T and EN-580T) to predicate devices (EN-450P5/20 and EC-450BI5). The statement "Subject devices met performance specifications of the following additional testing" implies that the new devices achieved acceptable performance for each listed criterion.
| Acceptance Criteria / Performance Metric | Predicate Device (EN-450P5/20) Performance | Predicate Device (EC-450BI5) Performance | Subject Device (EN-580T) Performance | Subject Device (EN-530T) Performance |
|---|---|---|---|---|
| Resolution (Distance: 5mm/4mm) | 0.09mm pitch chart recognizable (5mm) | 0.07mm pitch chart recognizable (4mm) | 0.056mm pitch chart recognizable (4mm) | 0.063mm pitch chart recognizable (4mm) |
| Resolution (Distance: 100mm) | 1.6mm pitch chart recognizable (100mm) | 1.25mm pitch chart recognizable (100mm) | 1.6mm pitch chart recognizable (100mm) | 1.4mm pitch chart recognizable (100mm) |
| Field of View | 120 degrees | 140 degrees | 140 degrees | 140 degrees |
| F number | 6.21 | 7.05 | 7.2 | 7.2 |
| Distal end diameter | 8.5mm | 9.4mm | 9.4mm | 9.4mm |
| Flexible portion diameter | 8.5mm | 9.3mm | 9.3mm | 9.3mm |
| Max diameter of insertion portion | 9.0mm | 10mm | 10mm | 10mm |
| Number of Light guide fiber | 900x2 | 1200x2 | 650x2 | 650x2 |
| Forceps channel diameter | 2.2mm | 2.8mm | 3.2mm | 3.2mm |
| Forceps channel length | 2100mm | 1620mm | 2100mm | 2100mm |
| Working length | 2000mm | 1520mm | 2000mm | 2000mm |
| Total length | 2300mm | 1820mm | 2300mm | 2300mm |
| Processor | VP-4400, VP-4400HD, VP-4440HD | VP-4400, VP-4400HD, VP-4440HD | VP-4440HD | VP-4400, VP-4400HD, VP-4440HD |
| LG Connector | 400 series connector | 400 series connector | 500 series connector | 500 series connector |
| Video Connector | 400 series connector | 400 series connector | 500 series connector | 500 series connector |
| Location of Balloon inlet | On the control portion | On the control portion | On the LG connector | On the LG connector |
Additional Performance Tests for which "Subject devices met performance specifications":
- Time for inflation
- Operating pressure
- Frictional resistance
- Bending capability
- Rate of air supply
- Rate of water supply
- Rate of suction
- Viewing direction
- Pump air feed pressure
- Pump air evacuation pressure
- Pump air flow rate
2. Sample size used for the test set and the data provenance:
The document states that "Bench testing data demonstrated that the subject endoscopes have substantially equivalent performance to the predicates." However, it does not specify the sample size for this bench testing.
The data provenance is internal bench testing conducted by the manufacturer, Fujifilm Medical Systems, U.S.A., Inc. It is retrospective in the sense that it's testing against established specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The performance tests appear to be objective measurements based on engineering and performance specifications, rather than expert interpretation of images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and is generally not applicable to bench testing of endoscopic devices which relies on objective measurements against engineering specifications.
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:
This is not applicable as the device is an endoscope and not an AI/ML-driven diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is an endoscope and not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance specifications is based on pre-defined engineering and functional specifications and measurements as outlined by relevant consensus standards (e.g., ISO 8600 series) and the manufacturer's internal criteria. For example, resolution is measured by recognizing a pitch chart at a specific distance.
8. The sample size for the training set:
This is not applicable as this is not an AI/ML device requiring a training set in that context.
9. How the ground truth for the training set was established:
This is not applicable as this is not an AI/ML device requiring a training set.
§ 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.