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510(k) Data Aggregation
(58 days)
XNY Disposable Gastric Calibration Tube
XNY Disposable Gastric Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.
The XNY Disposable Gastric Calibration Tubes are indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch. The device has the advantages of accurately determining residual gastric capacity and easy positioning, and it can be connected to a suction device to extract the gas or liquid in the patient's stomach.
The XNY Disposable Gastric Calibration Tube is a Class II medical device used in gastric and bariatric surgical procedures. The 510(k) summary provides information on the device's acceptance criteria and performance through various bench tests.
1. Acceptance Criteria and Reported Device Performance:
| Test Performed | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Firmness of the balloon | Evaluate the firmness of the balloon. | Greater than 60N. | Pass |
| Firmness between the suction port and the catheter | Evaluate the firmness of this connection. | Greater than 5N. | Pass |
| Catheter aspiration function | Evaluate the catheter's ability to aspirate liquid. | Able to draw out 500ml of liquid within 1 minute. | Pass |
| Firmness between suction port 2 (adapter) and catheter | Evaluate the firmness of this connection. | Greater than 30N. | Pass |
| Firmness of the inflation valve | Evaluate the firmness of the inflation valve. | Greater than 20N. | Pass |
| Balloon leakage test | Evaluate for balloon leakage. | Can tolerate double the working pressure of 80 ml gas without leakage or damage. | Pass |
| Biocompatibility Testing | Evaluate the device to meet ISO 10993 for biological evaluation. | No cytotoxicity, no sensitization, no irritation. | Pass |
| Balloon Inspection | Evaluate the appearance of the balloon. | Colorless and transparent. Tightly connected to the tube, with a homogeneous connection without twisting. | Pass |
| Tube Dimension | Evaluate the tube length and diameter. | Meet the required measurements. | Pass |
| Tube scale mark inspection | Evaluate the appearance of the tube scale marks. | Clear and not faded. | Pass |
| Tube resistance to bend and break | Evaluate the tube's resistance to bending and breaking. | Hold the tube at both ends and bend the tube so that the 1cm of long tube at both ends are parallel and in contact, hold for 15 seconds, then release, ensuring that no creases form at the bend of the catheter. | Pass |
| Firmness of insertion tip and tube | Evaluate the firmness of the connection between the insertion tip and the tube. | The connection between the Insertion tip and the tube should be able to withstand a static axial pull of 15N for 15S without breaking or falling off. | Pass |
| Firmness between suction port 1 (Adapter 1) and suction port 2 (Adapter 2) | Evaluate the firmness between adapters. | Greater than 5N. | Pass |
| Pipe Clip Sealability Test | Evaluate the Pipe Clip sealability of disposable gastric calibration tubes. | When the Pipe Clip is closed, no bubbles are generated at the catheter port. | Pass |
2. Sample size used for the test set and the data provenance:
The provided document does not specify the exact sample size used for each individual test or the overall test set. The tests performed are bench studies ("non-clinical assessments") which are typically conducted in a laboratory setting. There is no information provided about the country of origin or whether the data is retrospective or prospective, as these are not relevant for bench testing of this type of device.
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 to the provided data. The listed tests are objective, performance-based bench tests that do not involve expert interpretation or subjective ground truth establishment like in clinical image analysis or diagnostic studies. The acceptance criteria are based on measurable physical properties and functional performance, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies where subjective interpretations or disagreements among experts need to be resolved to establish a ground truth. The tests performed for this device are objective bench tests with pass/fail criteria.
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. The device is a "Disposable Gastric Calibration Tube," which is a physical surgical tool and not an AI-powered diagnostic or assistive technology that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a passive physical medical instrument, not an algorithm or software-based system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests of this device is based on objective, measurable physical and functional properties as defined by the acceptance criteria. For example, the firmness is measured in Newtons, aspiration function by volume and time, and dimensions by standard measurements. Biocompatibility relies on established ISO standards.
8. The sample size for the training set:
This information is not applicable. This device is a physical medical instrument, not a machine learning model, and therefore does not have a "training set" in the context of AI development. The "training" for a manufacturing process would involve quality control and process validation, which is distinct from an AI training set.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" for this type of medical device as described in the context of AI.
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