(91 days)
The device is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.
The device is intended for the optical visualization of the gastrointestinal tract. This includes the recturn, large and small intestine. It is intended for observation, diagnosis, and endoscopic treatment.
The Fujinon double balloon enteroscopy system utilizes specialized balloons and over-tube to ensure complete positioning of the colonoscope. The tip of the scope can be smoothly inserted to reach the area of diagnosis. This allows for access to hard to reach areas within the bottom portion of the small intestine.
The EC-450B15 consists of the following portions / parts:
- . Control portion - to provide grip for holding the endoscope and for the operation of the endoscope.
- LG Flexible Portion Contains the light guide, air/water supply tube, suction tube, . and cables.
- Bending Portion .
- Distal End Contains objective lens, air/water nozzles, forceps channel. .
The EC-450Bl5 is used with balloons (BS-1 or BS-2) and an Over-Tube (TS-13101), as well as the balloon pump. The balloon pump, balloons and over-tube were introduced and included as part of the Double Balloon Enteroscopy 510(k).
The EC-450BI5 is used with a Processor (4400) and other peripheral items such as VCR, Television Monitor, and Printers.
The provided text is a 510(k) summary for the Fujinon EC-450BI5 Colonoscope. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not directly applicable or present in this specific 510(k) summary.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission. The implicit acceptance criterion is that the new device is "as safe and effective as the predicate device" and shares "the same indications for use, material composition, characteristics, reprocessing/sterilization method."
- Reported Device Performance: The document states, "The materials in the endoscope are identical to the materials used in the predicate device. Additionally, the device contains the same electrical configurations as the predicate devices." This implies that the performance is expected to be identical to the predicate given the design similarities. No specific performance metrics (e.g., sensitivity, specificity, accuracy) are provided, as would be expected for a de novo device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or performance study data with human subjects or cases is mentioned. The submission relies on the established safety and effectiveness of the predicate devices and the similarity of the new device's design.
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 ground truth establishment by experts is described as no new performance study was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
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
- Not Applicable. This is a medical device (colonoscope), not an AI-based diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device; there is no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is established for a new clinical performance claim. The basis for approval is substantial equivalence to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, and no training set is mentioned or implied.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth establishment for a training set is described.
Summary of what the document DOES state regarding performance:
The basis for the Fujinon EC-450BI5 Colonoscope's approval relies on its substantial equivalence to two predicate devices: Fujinon EG-450HL5 (K041903) and Fujinon EN-450P5/20 (K040048).
The key performance claims and rationale for substantial equivalence are:
- Same Indications for Use: "The device is intended for the optical visualization of the gastrointestinal tract... It is intended for observation, diagnosis, and endoscopic treatment." This is identical to the predicates.
- Identical Materials: "The materials in the endoscope are identical to the materials used in the predicate device."
- Same Electrical Configurations: "the device contains the same electrical configurations as the predicate devices."
- Same Processor and Peripherals: "The subject device uses the same processor and peripherals as the predicate device."
- Minor Changes: The main difference mentioned is the "use of a colonoscope for with the double balloon enteroscopy accessories or retrograde application of the double balloon enteroscopy system." The submitter concludes these changes are minor and do not alter the safety or effectiveness.
In the context of a 510(k) for a physical medical device demonstrating substantial equivalence, the "acceptance criteria" are effectively that the device functions as intended (optical visualization, diagnosis, treatment within the GI tract) and is as safe and effective as its predicates, primarily due to shared design characteristics and materials. No specific quantitative performance study is typically required or presented for such a submission if the changes are deemed minor and do not raise new questions of safety or effectiveness.
§ 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.