Search Results

The Insufflation Retention Device (IRD) is an accessory to an endoscope. The IRD is a single balloon accessory intended for use with any standard endoscope that has a distal tip outer diameter of 9.2-13.2 mm. The device is indicated to assist with optical visualization in the large intestine during endoscopic procedures.

The IRD is a non-sterile accessory for a colonoscope which provides an adjustable seal between a colonoscope and a patient's anus. This seal retains introduced insufflation air introduced during a colonoscopy. The retained insufflation air provides increased visibility and facilitates the advancement of the colonoscope. The IRD contains a split section which allows it to be placed over the continuous shaft of the colonoscope. The adjustable seal is inflated and deflated manually with a non-sterile syringe.

The provided text is a 510(k) summary for the Insufflation Retention Device (IRD), a medical device accessory. This document details the device's characteristics, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria for clinical performance and the detailed study that proves the device meets those criteria.

Specifically, the document focuses on:

• Device Identification and Description: Trade name, common name, device class, regulation number, product code, and a description of the IRD's function and physical characteristics.
• Indications for Use: The IRD is a single balloon accessory intended for use with standard endoscopes to assist with optical visualization in the large intestine during endoscopic procedures.
• Predicate Device Comparison: A detailed table comparing the IRD to the predicate device (Lumendi DiLumen Endolumenal Interventional Platform) based on various attributes like device class, indications for use, technology, design, and principles of operation.
• Substantial Equivalence Argument: An explanation of why the IRD is substantially equivalent to the predicate device, highlighting similarities and addressing differences in balloon count and the absence of a balloon extension/retraction mechanism in the IRD.
• Non-clinical Tests: A list of non-clinical tests performed, including biocompatibility (Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity) and various performance tests (Device Placement, Insertion Force, Pressure Leak, Scope diameter testing, Balloon diameter testing, Scope movement, Scope articulation, Device Removal, Device security, Device Shelf life, Multiple use testing, Package integrity, Glove usability, Use time, Attachment force, Balloon feedback, Connector leakage, Balloon burst).

Missing Information:

The document does not provide:

1. A table of acceptance criteria for device performance and reported performance metrics. While it lists performance tests, it does not specify the quantitative or qualitative acceptance criteria for these tests nor the results achieved against those criteria.
2. Details about specific studies (Clinical or otherwise) that prove the device meets acceptance criteria. The "Performance Testing" section lists types of tests, but not a study design, methodology, or results for any of them.
3. Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods related to any clinical performance evaluation. The document only mentions non-clinical testing.
4. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
5. Information about standalone algorithm performance (human-in-the-loop performance is irrelevant as this is a physical device, not an AI/software device).
6. Type of ground truth used for performance evaluation.
7. Sample size for the training set (not applicable for this type of device submission).
8. How the ground truth for the training set was established (not applicable for this type of device submission).

In summary, the provided text describes a 510(k) clearance for a physical medical device based on non-clinical testing and substantial equivalence to a predicate. It does not include the detailed clinical performance acceptance criteria or studies that would be relevant for a device, especially an AI/software device, meeting specific performance metrics as commonly understood in the context of your request.

Ask a specific question about this device