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This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.

The proposed Cook Device is assembled by the end user from three component pieces: a handle with a threaded piston and directional arrow, a sterile needle cannula with an attached pressure gauge to track pressure in the event of needle kinks/bends in the tortuous GI anatomy and a sterile 10 cc syringe filled with a mixture of sterile water and sodium CMC. Blue colorant may or may not be added to enhance endoscopic visibility. After creation of a starter bleb below affected tissue, the gel is then injected into the starter bleb. The bleb will then stay elevated from the muscle layer to allow for endoscopic dissection or resection with a separately supplied endoscopic electrosurgical device. After excision and retrieval of affected tissue, the bleb will dissolve and pass out of the body naturally.

The prompt describes a medical device called the "Cook GI Endoscopic Injection Gel Kit," which is intended for submucosal lift of polyps or other gastrointestinal mucosal lesions prior to excision. The provided text is a 510(k) summary for this device, outlining its intended use, description, comparison to predicate devices, and performance data.

However, the provided text does not contain the information requested in the prompt regarding acceptance criteria and a detailed study proving the device meets those criteria. Specifically, the prompt asks for:

1. A table of acceptance criteria and reported device performance: This is not present. The document states "Pre-clinical testing verified the biological safety of the injection media and validated the performance capabilities of the GI Endoscopic Injection Gel Kit to meet its design criteria through a series of bench and animal testing." This is a general statement, not a table of specific criteria and results.
2. Sample size for the test set and data provenance: No specific sample sizes for tests are given, nor is the data provenance detailed beyond "bench and animal testing."
3. Number of experts and qualifications for ground truth: No information on expert involvement or ground truth establishment is provided for testing.
4. Adjudication method: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. This is typically for AI/imaging devices, which this is not.
6. Standalone performance study (algorithm only): Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not specified, beyond the general "bench and animal testing."
8. Sample size for the training set: Not applicable, as this is a physical device, not an AI model requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The document discusses the "PERFORMANCE DATA" in a very high-level manner, stating that "Pre-clinical testing verified the biological safety of the injection media and validated the performance capabilities of the GI Endoscopic Injection Gel Kit to meet its design criteria through a series of bench and animal testing." It also highlights a key characteristic: "The viscosity of the subject gel overcomes the limitation of injection of saline and other low viscosity materials with respect to time the bleb remains elevated from the muscularis and other mechanical mucosal separation techniques that may result in muscle layer involvement." This implies a performance benefit related to longer bleb elevation, but specific metrics and acceptance criteria for this are not detailed.

In conclusion, based only on the provided text, it is not possible to answer the detailed questions about acceptance criteria and specific study methodologies because that information is not present in the 510(k) summary. The summary focuses on regulatory substantial equivalence rather than a detailed report of all performance testing and its corresponding acceptance criteria.

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