Search Results

The Endolumik Gastric Calibration Tube is indicated for use in gastric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids,irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.

The Endolumik Fluorescence Guided Gastric Calibration Tube is a flexible gastric tube for use in esophageal, gastric, and bariatric surgery. It may be used for the following: the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.
The Endolumik Gastric Calibration Tube is a non-sterile, single patient use device. The tube is 80 cm long and is available in 2 different diameters: 36 and 40 French. It has a rounded tip and small side holes at the distal end. The proximal end includes a handle with an integral suctionregulator. An additional squeeze bulb with pressure gauge may be attached to the end of the

The provided text describes a 510(k) premarket notification for a medical device called the "Endolumik Gastric Calibration Tube M Series." It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information on acceptance criteria and a study proving those criteria are met for the device's primary function of gastric calibration.

However, the document does list several non-clinical tests that were performed to evaluate the substantial equivalence of the new device (M Series) to the predicate device. These tests primarily relate to electrical safety and electromagnetic compatibility standards, suggesting that the acceptance criteria for these aspects were met by passing the listed standards.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

Information Present or Inferable:

• Acceptance Criteria and Reported Device Performance:

  • Acceptance Criteria (Inferred): The device (Endolumik Gastric Calibration Tube M Series) must pass the requirements of the following international standards:
    • IEC 60601-2
    • IEC 60601-2 Section 5 (Likely refers to a specific section or part of IEC 60601-2)
    • IEC 60601-1
    • IEC 60601-2-18
    • IEC 62471
  • Reported Device Performance: "All tests passed." This indicates that the device met the requirements of the listed standards.

• Type of Ground Truth Used: Not applicable for the electrical safety and electromagnetic compatibility tests listed. These are objective engineering standard tests.

Missing Information:

The document does not provide information for most of the requested categories because it's a 510(k) summary focused on substantial equivalence to a predicate device, rather than a detailed clinical or performance study of the device's functional efficacy in gastric calibration. Specifically, the following are not mentioned:

• Sample size used for the test set and the data provenance: Not applicable for the engineering tests listed. There's no "test set" of clinical cases.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical gastric calibration tube, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary Table of Available Information:

• IEC 60601-2
• IEC 60601-2 Section 5
• IEC 60601-1
• IEC 60601-2-18
• IEC 62471

Reported Device Performance: "All tests passed." |
| 2. Sample size for test set and data provenance | Not applicable (engineering standard testing, no clinical test set described). |
| 3. Number of experts and qualifications for ground truth | Not applicable. |
| 4. Adjudication method for test set | Not applicable. |
| 5. MRMC comparative effectiveness study and effect size (AI assistance) | Not applicable (device is a physical gastric calibration tube, not AI software). |
| 6. Standalone (algorithm only without human-in-the-loop performance) study | Not applicable. |
| 7. Type of ground truth used | Objective engineering standards (for electrical safety, electromagnetic compatibility, etc.). |
| 8. Sample size for the training set | Not applicable. |
| 9. How the ground truth for the training set was established | Not applicable. |

Ask a specific question about this device