(120 days)
The GastriSail™ Gastric Positioning System is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.
The GastriSail™ Gastric Positioning System is a 36FR flexible, non-sterile, single-use, dual lumen gastric tube designed to be inserted into the esophagus by an anesthesiologist for use in gastric and bariatric surgical procedures, such as sleeve gastrectomy.
The GastriSail™ Gastric Positioning System consists of a dual lumen flexible tube. One lumen houses the Sail feature and integrated LED guidelights, and the other lumen has rows of distal holes which, when connected to suction provides vacuum to the stomach for evacuation of stomach contents and suction fixation along the lesser curvature of the stomach. This lumen is also used to perform leak testing at the end of the procedure.
The provided text describes a medical device, the GastriSail™ Gastric Positioning System, and its clearance through the FDA's 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device. The document focuses on regulatory approval rather than a detailed study proving the device meets specific quantitative acceptance criteria in a clinical setting.
Therefore, much of the requested information (like effect size of MRMC studies, details of expert adjudication, ground truth for training sets, etc.) is not present in this regulatory document, as it is generally not required for a 510(k) submission unless clinical studies are specifically called for to demonstrate substantial equivalence.
However, I can extract the available information related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for a study in the sense of predefined thresholds for clinical performance metrics. Instead, it lists various non-clinical and comparative tests conducted to demonstrate the device's functionality and substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests.
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance (Summary) |
|---|---|
| Dimensional analysis | Passed (Dimensions are acceptable) |
| Tensile testing of adhered bonds | Passed (Bonds are sufficiently strong) |
| Battery functional testing | Passed (Battery operates as intended) |
| Vacuum relief testing | Passed (Vacuum relief functions correctly) |
| Suction tubing adapter test | Passed (Adapter performs as expected) |
| Decompression of the stomach (Comparative) | Comparable to Realize™ Gastric Calibration Tube |
| Suction fixation and evacuation of stomach contents (Comparative) | Comparable to Realize™ Gastric Calibration Tube |
| Sizing of a Gastric Sleeve (Comparative) | Comparable to Realize™ Gastric Calibration Tube |
| Esophageal insertion test in porcine (In-vivo) | Passed (Safe and effective insertion) |
| Biocompatibility (ISO 10993-1:2009) | Materials tested and passed |
| Electrical Safety Testing (IEC 60601-1: Ed3, IEC 60601-1-2: Ed 4) | Passed (Meets electrical safety standards) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any of the non-clinical or comparative tests. For the in-vivo evaluation, it was performed "in porcine," meaning animal subjects, but the number of animals or procedures is not given.
- Data Provenance: The studies are non-clinical (bench testing) and in-vivo animal testing. It's not human clinical data, so country of origin isn't relevant in the typical sense. The regulatory submission is from the USA (Covidien LLC, North Haven, CT).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided. For non-clinical and comparative performance tests, "ground truth" and "experts" as in a clinical study are not typically applicable in the same way. Performance is measured against engineering specifications or direct comparison with a predicate device. For the in-vivo test, veterinary or surgical expertise would be involved, but specific numbers and qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not applicable/Not specified for the non-clinical and animal performance 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 MRMC or human-in-the-loop study was conducted. This device is a physical medical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is not an algorithm or AI device.
7. The Type of Ground Truth Used
- For non-clinical safety and performance tests: Engineering specifications, direct measurements, and comparison to the predicate device's established performance.
- For biocompatibility: Adherence to ISO 10993-1:2009 standards.
- For electrical safety: Adherence to IEC 60601-1 and 60601-1-2 standards.
- For the in-vivo test: Observed physiological response and device function in a porcine model.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in that context.
9. How the Ground Truth for the Training Set was Established
- Not applicable as there is no training set.
§ 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.