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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.

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The device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

The Fujinon G5 Bronchoscopes are medical endoscopes used for the observation, diagnosis, and endoscopic treatment of the trachea and broncho. The G5 Bronchoscopes are offered in a 200 and 400 series. The EB-250S represents the G5 Bronchoscope 200 series and the EB-470S represents the G5 Bronchoscope 400 series. The G5 Bronchoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 scopes do not have an L-Port. The L-port functioned as a lens wash port. Doctors had the option to take a syringe to inject a fluid to use it as a high pressure wash for the lens. This function was eliminated because demand was low and it was rarely used by the surgeons. The J-Port was repositioned. The J-Port is used as a jet water wash port. The J-Port was repositioned based on doctor feedback. The port was moved from the bottom part to the top (end) of the scope. There was also a desire to eliminate check valves to facilitate reprocessing and cleaning, as well as prevent clogging. A G5 forceps inlet port was modified. The new port is smaller and comes with a rubber cap. The new design helps increase suction and reduces leakage. The jet wash line check valve was removed. Internal check valves were removed to eliminate the potential for clogging and to facilitate cleaning, disinfection, and sterilization. The valves are now external and removable. The suction and air/water cylinders and valves were upgraded. They were updated to accommodate the new valves. The function of the valves is the same. The G5 Bronchoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. This helps create a watertight seal when the endoscope is used. Upgrade to CA-500 cleaning adaptor. The cleaning adaptor allows the scope to be connected to tubes for cleaning. The G5 Bronchoscopes are used with the same processors, monitors, hard carts as the predicate devices. Each Duodenoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, protective cap, adapters, valves, and the Operation Manual. The Fujinon G5 Bronchoscopes are 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 Instruments.

The provided text describes a 510(k) submission for Fujinon G5 Bronchoscopes (Models EB-470S, EB-250S, and EB-270P). However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on demonstrating substantial equivalence to a predicate device (Fujinon EB-310S, K954707) by outlining changes and similarities in technical characteristics, indications for use, and material composition.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided text.
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): This information is not present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided text.
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 information is not present in the provided text. The device is an endoscope, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present in the provided text. The device is an endoscope, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present in the provided text.
8. The sample size for the training set: This information is not present in the provided text.
9. How the ground truth for the training set was established: This information is not present in the provided text.

The document states under "Performance Data [21 CFR 807.92(b)(1)]":
"The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are identical to the materials used in the predicate device."

This indicates that some performance testing was conducted, but it's limited to electrical safety, thermal, and EMC, and the specific acceptance criteria and detailed results of these tests are not provided in the summary. The core of the submission is demonstrating equivalence, not necessarily a new performance study against specific criteria beyond safety and basic physical characteristics.

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