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The Kimberly-Clark* MIC* G Introducer Kits are intended to
facilitate primary placement of Kimberly-Clark* and Kimberly-
Clark* MIC* brand of Gastrostomy Feeding Tubes.
The Kimberly-Clark* MIC-KEY* G Introducer Kits are intended
to facilitate primary placement of Kimberly-Clark* and
Kimberly-Clark* MIC-KEY* brand of Gastrostomy Feeding
Tubes.
The Kimberly-Clark* MIC* Jejunal and Kimberly-Clark* MIC*
Transgastric-Jejunal Introducer Kit is intended to facilitate
primary placement of Kimberly-Clark* MIC* Jejunal Feeding
Tube and the Kimberly-Clark* MIC* Transgastric-Jejunal
Feeding Tube.
The Kimberly-Clark* MIC-KEY* Jejunal and Kimberly-Clark*
MIC-KEY* Transgastric-Jejunal Introducer Kit is intended to
facilitate primary placement of Kimberly-Clark* MIC-KEY*
Low-Profile Jejunal Feeding Tube and the Kimberly-Clark*
MIC-KEY* Low-Profile Transgastric-Jejunal Feeding Tube.

The Introducer Kits consists of a group of essential components required to facilitate placement of a balloon-retained enteral feeding tube. The kit contains these essential components in an easy to use tray and is configured for use in an interventional radiology and /or endoscopy suite.

This device consists of the following components and accessories:

• 1. Gastropexy
• 2. Dilator with Peel-away sheath
• 3. Syringe
• 4. Hemostat
• 5. Introducer Needle
• 6. Seeking Catheter
• 7. Scalpel
• 8. Guidewire
• 9. Stoma Measuring Device

The provided text describes a 510(k) submission for Kimberly-Clark* Introducer Kits, asserting substantial equivalence to previously cleared devices. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria.

Here's why and what information is available:

• No Acceptance Criteria or Device Performance Table: The document explicitly states, "Bench testing has demonstrated that the new Kimberly-Clark* Introducer Kits performs the same function as the predicate kits, and that any minor differences between the modified device and the predicate device do not affect safety or efficacy." It also mentions, "All components that come in direct contact with the patient have a history of use in medical devices and are biocompatibility, sterilization and functional test results demonstrate that the device is safe and effective for use in humans. Biocompatibility summaries can be found in Attachment D." However, it does not provide specific numerical acceptance criteria (e.g., a "failure rate of less than X%") or a table comparing the device's measured performance against such criteria.
• No Standalone Study details: The document discusses "performance testing" and "bench testing," but it does not describe a formal study with a defined sample size, data provenance, ground truth establishment, or expert involvement as would be required for an AI/device performance study.
• No MRMC Comparative Effectiveness Study: The submission is for an introducer kit, which is a physical medical device, not an AI software. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable and not mentioned.

Information that can be extracted or inferred (though not directly addressing all your questions):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Implied): The device performs the same function as the predicate kits, and any minor differences do not affect safety or efficacy. Biocompatibility, sterilization, and functional test results must demonstrate safety and effectiveness.
   • Reported Device Performance:
     • "Bench testing has demonstrated that the new Kimberly-Clark* Introducer Kits performs the same function as the predicate kits."
     • "Biocompatibility, sterilization and functional test results demonstrate that the device is safe and effective for use in humans."
     • (No specific quantitative performance metrics are provided in the summary.)

2. Sample size used for the test set and the data provenance: Not specified. The document mentions "bench testing" and "performance testing" but does not detail the sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This type of device relies on engineering and biological testing, not expert interpretation of outputs to establish ground truth in the way AI models do.

4. Adjudication method for the test set: Not applicable/specified for this type of device testing.

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: No, this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "bench testing" and "functional test results" which are forms of standalone testing for a physical device, but no specific study details are provided.

7. The type of ground truth used:

   • Implied Ground Truth: Engineering specifications, established performance characteristics of predicate devices, and biological safety standards (e.g., for biocompatibility and sterilization).

8. The sample size for the training set: Not applicable for a physical device.

9. How the ground truth for the training set was established: Not applicable for a physical device.

In summary, the provided text describes a 510(k) submission for a physical medical device (introducer kits) and focuses on establishing substantial equivalence through bench testing and functional comparisons to predicate devices, rather than a clinical or AI-driven performance study with detailed acceptance criteria and expert-adjudicated ground truth as would be relevant for software or AI medical devices.

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