(415 days)
The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.
The Stomach Tube is a sterile, single-use tube manufactured in various sizes from medical grade PVC. The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The tube is inserted into a patient's stomach through the patient's nose or mouth.
The Stomach Tube is supplied in French size ranging from 6 to 22, consists of main tube and connector. The stomach tube connector connects to suction device for suctioning, The tube is available in open tip and closed tip form. It is composed of biologically safe materials and supplied sterile and intended for single use only.
The Stomach Tube device, K162340, is a non-AI device. The provided text does not contain information about acceptance criteria and performances related to AI/ML technology. Therefore, the questions related to AI/ML technology (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, how ground truth for training set was established) are not applicable.
Here's the information regarding the device's acceptance criteria and the study proving it meets them:
1. A table of acceptance criteria and the reported device performance
The provided text states that "The Stomach Tube meets all the pre-determined testing and acceptance criteria" but does not explicitly list the specific acceptance criteria and detailed performance results for each test. Instead, it broadly lists the types of tests conducted.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| General Performance Testing | |
| Dimensions | Met pre-determined criteria |
| Leakage | Met pre-determined criteria |
| Flow Rate Test | Met pre-determined criteria |
| Tensile Properties | Met pre-determined criteria |
| Suction Tubing Collapse Test | Met pre-determined criteria |
| Biocompatibility Testing | |
| Cytotoxicity (ISO 10993-5:2009) | Biocompatible |
| Irritation (ISO 10993-10:2010) | Biocompatible |
| Sensitization (ISO 10993-10:2010) | Biocompatible |
2. Sample sized used for the test set and the data provenance
Not applicable as this is not an AI/ML device. The performance testing refers to physical product testing. The document does not specify the sample size used for each physical test or the origin of the test data (e.g., specific country for collecting samples).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is a non-AI/ML device. Ground truth is not established by human experts in this context; performance is determined by established engineering and biological testing methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as this is a non-AI/ML device. Adjudication methods are typically relevant for human expert review in diagnostic studies, not for physical performance testing of a medical device like a stomach tube.
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 as this is a non-AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is a non-AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance testing, the "ground truth" is based on established engineering standards and biological testing protocols. For instance:
- General performance testing (Dimensions, Leakage, Flow Rate, Tensile, Suction Tubing Collapse): The ground truth is determined by the specifications and tolerances defined in relevant engineering standards or internal company specifications for the device's physical properties and functional performance. It is measured objectively using instruments and procedures.
- Biocompatibility testing (Cytotoxicity, Irritation, Sensitization): The ground truth is established by the results of biological assays performed according to ISO 10993 standards, which assess the material's interaction with biological systems. The "truth" is whether the material elicits an adverse biological response according to the defined criteria of these standards.
8. The sample size for the training set
Not applicable as this is a non-AI/ML device.
9. How the ground truth for the training set was established
Not applicable as this is a non-AI/ML 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.