Search Results

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."
}

Ask a specific question about this device