(147 days)
The device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.
The small intestine is one of the most difficult organs to access in gastro-intestinal (GI) tract endoscopy. The Fujinon double balloon enteroscopy system facilitates diagnosis and treatment of the upper GI tract including the small intestine. The Fujinon double balloon enteroscopy system utilized balloons and over-tube to ensure complete positioning of the enteroscope in the small intestine. The tip of the scope can be smoothly inserted to reach the area of diagnosis. The Fujinon double balloon enteroscopy system includes the following: G5 endoscope / enteroscope (EN-450P5/20), Over-Tube (TS-12140), Balloon (BS-1), Balloon Pump Controller (PB-10). The subject device is used with the Fujinon Series 400 processor, the same processor used with the predicate device. The Fujinon double balloon enteroscopy system is used in conjunction with other peripherals specified in the Operation Manual such as: Light Source, Processor, Cart, Data Keyboard, Foot Switch, Monitor, Video Printer, Camera and Hard Copy Unit, VCR, ElectroSurgical Tastruments.
The provided text is a 510(k) summary for the Fujinon Double Balloon Enteroscopy System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance acceptance criteria and results.
Therefore, much of the requested information (such as specific performance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and adjudication methods) is not present in the provided document. The document emphasizes comparison to a predicate device and safety testing.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device and passing general safety tests. The implicit acceptance criterion is that the new device performs at least as well as the predicate device and is safe for its intended use.
Reported Device Performance: The primary "performance" reported is compliance with regulatory standards and the device's physical specifications.
| Characteristic | Reported Performance (Fujinon Double Balloon Enteroscopy System EN-450P5/20) |
|---|---|
| Viewing Direction | Forward |
| Observation Range | 5~100mm |
| Field of View | 120° |
| Image Size | 130% (super) |
| Distal End Diameter | 8.5mm |
| Flexible Portion Diameter | 8.5mm |
| Bending Capability (Up) | 180° |
| Bending Capability (Down) | 180° |
| Bending Capability (Left) | 160° |
| Bending Capability (Right) | 160° |
| Forceps Channel Diameter | 2.2mm |
| Working Length | 2000mm |
| Total Length | 2300mm |
| Lens Diameter | 2.1mm |
| # of Pixels | 411,988 pixels |
| Pixels per Square mm | 83,892 |
| Pixel Size (H x V) | 0.0032 x 0.003725 |
| Active area of CCD (H x V) | 2.458 x 1.840 |
| Type of CCD Chip | Interline color chip |
| Balloon Pressure (PB-10) | 3.6 kpa - 7.6 kpa (5.6 kpa +/- 2 kpa) |
| Max Pump Flow Rate (PB-10) | 170 ml/10 sec |
| Biocompatibility | Passed (for balloon and overtube materials) |
| Electrical Safety | Passed |
| Thermal Testing | Passed |
| EMC Testing | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document refers to "electrical safety, thermal, and EMC testing requirements" and "biocompatibility testing" but does not give sample sizes for these tests. There is no mention of a clinical test set to evaluate diagnostic or treatment performance compared to the predicate device in terms of image quality or efficacy in patient outcomes.
- Data Provenance: Not specified. The tests are general safety and performance tests typically conducted in a laboratory or engineering setting, not on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The document describes engineering and biocompatibility testing, not a study requiring expert readers to establish ground truth for a diagnostic outcome. The device's substantial equivalence is primarily based on technical specifications and safety profile compared to the predicate.
4. Adjudication Method for the Test Set
- Not Applicable. As no expert reading or diagnostic performance evaluation study is described, no adjudication method would be relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document does not describe an MRMC comparative effectiveness study. The focus is on demonstrating substantial equivalence through technical specifications and safety testing, not on measuring human reader improvement with or without AI assistance. The device itself is an endoscope system, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. The Fujinon Double Balloon Enteroscopy System is a medical device (endoscope), not a standalone algorithm. Its performance is intrinsically linked to human operation.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Not Applicable / Implicit. For the engineering tests mentioned (electrical safety, thermal, EMC), the "ground truth" would be established by passing industry standards and internal specifications. For biocompatibility, the ground truth would be established by complying with recognized biocompatibility standards. There is no mention of ground truth related to diagnostic accuracy (e.g., pathology, outcomes data) because such a study is not described.
8. The Sample Size for the Training Set
- Not Applicable. This device is an endoscope system, not an AI model. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided 510(k) summary.
§ 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.