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510(k) Data Aggregation
(28 days)
Gastrointestinal Boundary Identifier (GIBI HD)
The GIBI HD™ is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.
The Gastrointestinal Boundary Identifier, or GIBI HD™, is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
The dual lumen GIBI HD utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate/deflate the balloon. The catheter is attached to a 32-inch suction tubing and a 6inch tubing with a stopcock for filling the balloon.
The provided document is a 510(k) premarket notification for the Gastrointestinal Boundary Identifier (GIBI HD™). It describes the device, its indications for use, and a comparison to a predicate device, including performance data from bench tests.
Acceptance Criteria and Device Performance Study for the Gastrointestinal Boundary Identifier (GIBI HD™)
The document primarily focuses on bench testing to demonstrate substantial equivalence, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the typical questions regarding AI-driven medical devices (like MRMC studies, ground truth establishment for complex imaging, training set details, or expert adjudication) are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Balloon leakage test | The balloon component of the GIBI HD shall inflate to a minimum volume of 100 cc without exhibiting fluid leak or air egress. | Samples retained 100 cc of fluid at least 1 minute without leakage. | Pass |
| Fluid removal test | The GIBI HD shall remove a minimum of 500 cc of saline or clean water in under 1 minute. | Samples evacuated a minimum of 500 cc of fluid in under 1 minute. | Pass |
| Balloon bond joint strength test | The mated joint between the GIBI HD 's Balloon and Tubing shall withstand a minimum of 13 lbf prior to separation. | Samples did not exhibit balloon separation under 13 lbf. | Pass |
| Distal tip bond joint strength test | The mated joint between the GIBI HD 's distal tip and Tubing shall withstand a minimum of 19.5 lbf prior to separation. | Samples did not exhibit sensor tip separation under 19.5 lbf. | Pass |
| Stopcock separation test | The stopcock component of the GIBI HD shall withstand a minimum of 1 lbf prior to separation from the fill tube. | Samples did not exhibit stopcock separation under 1 lbf. | Pass |
| Fill tube separation test | The fill tube attached to the stopcock of the GIBI HD shall withstand a minimum of 1 lbf prior to separation from the y connector. | Samples did not exhibit fill tube separation under 1 lbf. | Pass |
| Adapter tubing separation test | The proximal tubing of the GIBI HD shall withstand a minimum of 1 lbf prior to separation from the y connector. | Samples did not exhibit adapter tube separation under 1 lbf. | Pass |
| Adapter separation test | The adapter of the GIBI HD shall withstand a minimum of 1 lbf prior to separation from the adapter tube. | Samples did not exhibit adapter separation under 1 lbf. | Pass |
| Visual Inspection and Measurement verification test (Length) | The dual lumen catheter component of the GIBI HD, from the distal edge of the Y connector to the end of the dual lumen catheter, shall have a minimum length of 75 cm. | Minimum length of measured sample is 75 cm. | Pass |
| Visual Inspection and Measurement verification test (Indicator Marks) | The dual lumen catheter component of the GIBI HD shall include indication marks on the surface of the tube at 30, 35, 40, 45, 50, 55 and 60 cm with respect to the distal portion of the component. | Indicator marks are located 30, 35, 40, 45, 50, 55, and 60 cm with respect to distal portion of the component. | Pass |
| Visual Inspection and Measurement verification test (Outer Diameter) | The dual lumen catheter component of the GIBI HD shall have three size configurations: 0.42" (32 Fr), 0.47" (36 Fr) and 0.53" (40 Fr). | Outer diameter of 32Fr, 36Fr and 40Fr samples are 0.42", 0.47" and 0.53", respectively. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Samples" for the performance tests, but does not specify the exact sample size (N) used for each test. The tests are bench tests, meaning they were performed in a lab setting, not on patient data. Therefore, the concept of "country of origin of the data" or "retrospective/prospective" study design in the context of clinical data does not apply here. The data provenance is from in-house bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is based on engineering specifications and measurable physical properties (e.g., fluid retention volume, force required for separation, length, diameter, and presence of markings) as evaluated during bench testing. This does not involve expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As the tests are physical measurements and functional evaluations, there is no need for expert adjudication in the classic sense. The "ground truth" is determined by the Pass/Fail criteria directly from the physical 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
Not applicable. This device is a mechanical surgical instrument, not an AI-driven diagnostic or interpretative tool. No MRMC study was conducted or is relevant for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is defined by the engineering specifications and physical requirements for the device's components and functionality. This is a technical ground truth based on measurable physical properties rather than clinical outcomes, pathology, or expert consensus on medical images.
8. The Sample Size for the Training Set
Not applicable. This is a manufactured physical good, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this device does not involve a training set for an AI model, this question is not relevant.
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