(162 days)
The Endolumik Fluorescence Guided Gastric Callbration Tube (FG Bougie) is indicated for use in gastric and bariatric 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 and measurement guide.
The Endolumik Fluorescence Guided Gastric Calibration Tube is a flexible gastric tube for use in 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 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 suction regulator. An additional squeeze bulb with pressure gauge may be attached to the end of the regulator.
The Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is a flexible gastric tube for use in gastric and bariatric surgery. The device is intended for 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.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Visigi 3D) through various non-clinical tests. The "acceptance criteria" implicitly are that the device performs comparably to the predicate or meets established safety standards.
| Acceptance Criteria (Implied by equivalence testing) | Reported Device Performance (Summary from Non-clinical Test Summary) |
|---|---|
| Biocompatibility: No cytoxicity, sensitization, or irritation. | Passed Cytotoxicity Test (ISO 10993-5), Skin Sensitization Study (ISO 10993-10), Acute Irritation/Intracutaneous Reactivity (ISO 10993-10). |
| Electromagnetic Compatibility (EMC): Adherence to relevant standards. | Passed EMC Evaluation (IEC 60601-1-2 and 60601-2-18). |
| Electrical Safety: Adherence to relevant standards. | Passed Electrical Safety Evaluation (IEC 60601-1). |
| Light Safety: Adherence to relevant standards. | Passed Light Safety Evaluation (IEC 62471). |
| Packaging Integrity: Maintains sterility and integrity. | Passed Packaging Integrity (ASTM D4169). |
| Physical/Mechanical Characteristics: | |
| - Dimensional Accuracy | Passed Dimensional Analysis. |
| - Tip Connection Strength | Passed Tip Connection to Tube Joint Strength Test. |
| - Deflection Resistance | Passed Fixed Deflection Testing. |
| - Torsion Resistance | Passed Torsion Testing. |
| - Buckling Resistance | Passed Buckling Testing. |
| - Kink Resistance | Passed Kink Testing. |
| Functional Performance: | |
| - Drainage Capability | Passed Drainage Testing. |
| - Irrigation Capability | Passed Irrigation Testing. |
| - Suction Capability | Passed Suction Testing. |
| - Leak Testing Capability | Passed Leak Testing. |
| - Bulb Compatibility | Passed Bulb Compatibility. |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical bench testing, not a clinical study on human subjects with a "test set" as typically understood in AI/ML performance evaluation. Therefore, there is no information about sample size for a test set of data or its provenance (country of origin, retrospective/prospective). The "samples" would refer to the number of devices or components tested in the various non-clinical evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device underwent non-clinical testing rather than expert-adjudicated performance evaluation based on clinical cases. The "ground truth" for these tests would be the established scientific and engineering principles and the performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There was no clinical test set requiring adjudication of findings.
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. The device is a physical medical instrument (gastric calibration tube), not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests was established by:
- Compliance with recognized international and national standards: e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical and EMC safety, IEC 62471 for light safety, ASTM D4169 for packaging.
- Bench test results demonstrating functional equivalence to the predicate device for aspects like suction, drainage, irrigation, leak testing, and mechanical integrity.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.