(405 days)
The intended use is for the prophylaxis of pulmonary aspirations during induction and termination of general anesthesia.
The Aspisafe Gastric Tube is designed to be used for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia.
The provided text describes a 510(k) premarket notification for the Aspisafe Gastric Tube. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data or detailed performance studies with acceptance criteria in the way a novel therapeutic device might.
Based on the provided text, the device Aspisafe Gastric Tube is a Class II medical device intended for the prophylaxis of pulmonary aspiration during induction and termination of general anesthesia. The submission seeks to prove substantial equivalence to Gastric Sump Tubes (K935688) by Andersen Products.
Here's an analysis of the provided information against your requested points:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (from text) |
|---|---|
| Material Composition | "Composed of materials that have been tested in accordance with Tripartite Guidance for biocompatibility and determined to be suitable for the intended use of this product." |
| Physical Performance | "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to: physical testing, visual examination (in process and to: finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
| Intended Use | "Identical... to the Gastric Sump Tubes currently... There are no new issues of safety or effectiveness raised by Aspisafe Gastric Tube." (Demonstration of substantial equivalence to predicate) |
| Safety and Effectiveness | "NO new issues of safety or effectiveness raised by Aspisafe Gastric Tube" (vs. predicate) |
Note: The document does not provide specific numerical acceptance criteria (e.g., tensile strength minimums, flow rate ranges, specific biocompatibility thresholds) or quantitative performance data. Instead, it refers to internal quality control procedures and adherence to existing guidance documents, which is common for 510(k) submissions focusing on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or provide details on data provenance (country of origin, retrospective/prospective). The "testing" mentioned refers to internal manufacturing quality control and material biocompatibility, not clinical or comparative performance studies in a "test set" in the sense of a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The submission is for a medical device (a gastric tube), not an AI or diagnostic algorithm requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document, as no clinical test set adjudication is described.
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
This information is not applicable and not provided in the document. The device is a physical medical device (gastric tube), not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document, as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not provided in the document. The concept of "ground truth" as used in algorithm validation is not relevant to this type of device submission. The "truth" here is compliance with material safety, manufacturing specifications, and functional equivalence to the predicate device.
8. The sample size for the training set
This information is not applicable and not provided in the document. There is no mention of a "training set" as this is not an AI/algorithm submission.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the document, as there is no training set described.
§ 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.