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The sterile overtubes are intended to be used as accessories with the Fujinon Enteroscopes and Colonoscopes cleared for use with overtubes. The overtubes are used to assist with the movement of the scopes inside the upper or lower digestive tract.

The sterile overtubes are intended to be used as accessories with the Fujinon Double Balloon Enteroscopy system, which is used for the optical visualization of the gastrointestinal tract

The Fujinon double balloon enteroscopy system (K040048) and EC-450B15 (K090116) utilize specialized overtubes to ensure complete positioning of the enteroscope or colonoscope in the digestive tract and to ensure the tip of the scope can be smoothly inserted to reach the area of diagnosis.

The overtube (TS-12140) was included in the original 510(k) K040048 and the overtube (TS-13101) was included in 510(k) K090116 with the EC-450BI5.

This submission includes the following items:
TS-12140 Over Tube Originally included in the K040048 as non-sterile.
TS-13140 Over Tube
TS-13101 Over Tube Including in K090016.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Acceptance Criteria for Fujinon Sterile Overtubes",
    "headers": ["Acceptance Criteria (Performance Standard)", "Reported Device Performance"],
    "rows": [
      ["Biocompatibility requirements (per ISO standards)", "Passed"],
      ["Sterilization process validation (per ISO standards)", "Validated"],
      ["Same indications for use as predicate devices", "Met"],
      ["Same dimensions as predicate devices", "Met"],
      ["Same material composition as predicate devices", "Met"]
    ]
  },
  "study_details": {
    "sample_size_test_set": "Not applicable, as the submission describes a change to a sterile version of an existing device, not a new diagnostic algorithm using a test set.",
    "data_provenance": "Not applicable.",
    "number_of_experts_ground_truth_test_set": "Not applicable.",
    "qualifications_of_experts": "Not applicable.",
    "adjudication_method": "Not applicable.",
    "mrmc_comparative_effectiveness_study": false,
    "effect_size_human_readers_ai_vs_without_ai": "Not applicable.",
    "standalone_performance_study": false,
    "type_of_ground_truth_used": "Not applicable. The study focuses on demonstrating sterility and biocompatibility, not diagnostic accuracy requiring a ground truth.",
    "sample_size_training_set": "Not applicable.",
    "ground_truth_for_training_set_establishment": "Not applicable."
  },
  "additional_information": "This 510(k) submission ([K091773](https://510k.innolitics.com/search/K091773)) is for Fujinon Sterile Overtubes, which are a sterile version of previously cleared non-sterile overtubes ([K040048](https://510k.innolitics.com/search/K040048) and [K090116](https://510k.innolitics.com/search/K090116)). The submission aims to establish substantial equivalence by demonstrating that the sterile devices meet biocompatibility and sterilization standards, and maintain the same intended use, dimensions, and material composition as their non-sterile predicates. The document does not describe a study involving diagnostic performance, AI algorithms, or human readers, but rather focuses on the safety and effectiveness aspects related to the sterilization of the device."
}

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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 visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb.

The Fujinon GS Gastroscopes are medical endoscopes used for visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The G5 Gastroscopes are offered in a 200 and 400 series. The EG-250WR5 represents the G5 Gastrooscope 200 series and the EG-450WR5 represents the G5 Gastroscope 400 series. The G5 Gastroscopes 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. 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. 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 Gastroscopes 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 Gastroscopes are used with the same processors, monitors, hard copy units, and carts as the predicate devices. Each Gastroscope 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 Gastroscopes are used in conjunction with other perified 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 Gastroscopes, focusing on minor design changes compared to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI performance or diagnostic accuracy.

The submission aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic system. The changes are described as "minor" and related to usability, ergonomics, and cleaning, not to the fundamental diagnostic or treatment capabilities that would typically require extensive performance studies with defined acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be extracted based on the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• No specific, quantitative performance acceptance criteria are mentioned (e.g., sensitivity, specificity, accuracy for a detection task).
• No quantitative device performance metrics (e.g., specific accuracy rates) are provided.

2. Sample size used for the test set and the data provenance: Not applicable. This submission is about minor design changes to an existing device, not a performance study on a test set (clinical or imaging data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No such performance study was conducted or described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No such performance study was conducted or 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 submission is for a gastroscope, not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This submission is for a gastroscope, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established as part of a performance study described in this document. The "ground truth" for the clearance is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device.

9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set or ground truth establishment for such a set.

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The device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

The Fujinon G5 Duodenoscopes are medical endoscopes used for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

The G5 Duodenoscopes are offered in a 200 and 400 series. The ED-250XT5 represents the G5 Duodenoscope 200 series and the ED-450XT5 represents the G5 Duodenoscope 400 series.

The G5 Duodenoscopes 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.

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. 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 Duodenoscopes 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 Duodenoscopes are used with the same processors, monitors, hard copy units, and 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 Duodenoscopes 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 document is a 510(k) summary for the Fujinon G5 Duodenoscopes, which discusses minor design changes and compares them to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing or clinical trials.

The document states:

• "The subject device has been subjected to and passed EMC testing requirements." - This is a general statement about electromagnetic compatibility testing, not a detailed performance study related to the device's primary function (visualization, diagnosis, endoscopic treatment).
• "The patient contact materials in the Duodenoscopes are identical to the materials used in the predicate device." - This is about material equivalence, not performance.
• "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices." - This is a conclusion based on the minor nature of the changes and substantial equivalence to existing devices, not on a new study demonstrating specific performance metrics.

Therefore, I cannot provide the requested table or information regarding a study proving the device meets acceptance criteria, as such details are absent from the provided text. The submission relies on demonstrating substantial equivalence to predicate devices for its safety and effectiveness claims, rather than presenting a de novo performance study with defined acceptance criteria.

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The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

The Fujinon G5 Colonoscopes are medical endoscopes used for visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. The G5 colonoscopes include minor changes that improve the useability, ergonomics, and cleaning of the devices. The G5 Scopes do not have a lens wash port. The J-Port was repositioned. A G5 forceps inlet port was modified. The jet wash line check valve was removed. The suction and air/water cylinders and valves were upgraded. The G5 colonoscopes also feature the addition of the FOV, which is the rubber forceps inlet valve cover. Upgrade to CA-500 cleaning adaptor. The G5 colonoscopes are used with a processor (EPX-201 for EC-250HL5 and VP-402 for EC-450HL5), a colonoscopy unit, and a cart. Each colonoscope is packaged in a protective carrying case with lens cleaner, silicon oil, forceps valve, waterproof cap, S connector cap, adapters, valves, and the Operation Manual. The Fujinon G5 colonoscopes 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fujinon G5 Colonoscopes:

Overview:

The provided document is a 510(k) summary for the Fujinon G5 Colonoscopes. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies will differ significantly from what would be found in a PMA (Premarket Approval) application.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit acceptance criteria defined in a quantitative, measurable manner for the performance of the Fujinon G5 Colonoscopes as a standalone device. Instead, the entire submission hinges on demonstrating substantial equivalence to existing predicate devices.

The "performance" is implicitly defined by the device's technological characteristics and its similarity to the predicate.

2. Sample Size for Test Set and Data Provenance

The document does not describe a "test set" in the traditional sense of evaluating a new device's performance against ground truth data. Instead, it relies on demonstrating equivalence to predicate devices which have already been cleared.

• Sample Size: Not applicable in the context of this 510(k) submission for direct performance testing. The "sample" is the device itself and its technical specifications compared to the predicate.
• Data Provenance: Not applicable for performance data generation. The data provenance relevant here refers to the previous clearance of the predicate devices (K944620 and K944759), and the previous clearance of the G5 upgrade in K040048. These are regulatory clearances, not clinical study data provenance.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. Ground truth, in the context of clinical performance, was not established for this 510(k) submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess reader performance with and without an AI aid, or to compare different diagnostic methods. The Fujinon G5 Colonoscopes are endoscopes, primarily tools for visualization and intervention, not an AI-assisted diagnostic system.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone performance study was not done. This device is a physical endoscope with minor design changes, not a standalone algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for this 510(k) submission. The "ground truth" for the predicate devices' safety and effectiveness would have been established through their initial clearances (which might have involved clinical data, engineering analyses, etc.), but this document relies on similarity to those cleared devices. For the G5 colonoscopes themselves, the "truth" being established is their equivalence to the predicate via technical specifications and existing regulatory clearances.

8. Sample Size for Training Set

• Sample Size: Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable.

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