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510(k) Data Aggregation
(138 days)
ViSiGi® LUX is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing quide.
VISIGi® LUX is a non-sterile, single patient use device for use in gastric and bariatric surgery. It is used to apply suction, decompress the stomach, drain gastric fluids, irrigate and to serve as a sizing guide. The design is derived from the predicate by addition of battery-powered LED lights. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end includes a slide valve, integral suction regulator and a battery case. The non-rechargeable batteries power up an array of LEDs enclosed within the distal end of the tube. The purpose of the LED lights is to aid visualization of the tube by tissue transillumination during insertion and surgery under laparoscopic vision. The device is inserted by an anesthesiologist under supervision of the surgeon. The added lights do not change the intended use and are not required for the surgery to proceed safely.
The provided text describes the 510(k) premarket notification for the ViSiGi LUX device. However, it does not contain information about acceptance criteria, device performance against specific metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/algorithm-driven device.
The document focuses on demonstrating substantial equivalence of a physical medical device (a gastrointestinal tube with added LED lights) to a predicate device. The tests mentioned are for physical and electrical safety, biocompatibility, and functional performance (suction, drainage, irrigation) of the tube itself.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI or algorithmic performance against specific metrics, as this information is not present in the provided text.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not available for an AI/algorithm. The document lists general tests like "Suction Testing," "Drainage Testing," etc., and states "Passing these tests demonstrates substantial equivalence." It doesn't define quantitative acceptance criteria or specific performance numbers for these tests.
- 2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/algorithm for this device. The tests mentioned are laboratory bench tests on physical devices.
- 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): Not applicable, as this is a physical device submission, not an AI/imaging algorithm.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device does not involve human readers or AI assistance in image interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI/algorithm. Ground truth for a physical device typically refers to engineering specifications and performance benchmarks.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The device, ViSiGi LUX, is a gastrointestinal tube with an added LED light subassembly. Its primary function is mechanical (suction, drainage, irrigation, sizing guide). The LED lights are for visualization, not for generating or processing diagnostic data that would typically involve AI or complex algorithmic performance evaluation metrics as requested in the prompt.
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(28 days)
ViSiGi 3D 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, and to serve as a sizing guide.
VISIG1® 3D is a non-sterile, single patient use device comprises a tube with a closed, rounded tip, and holes at the distal end. The tubes are supplied in three separate diameters: 32 French, 36 French, and 40 French. The proximal end of ViSiGi® 3D includes an integral suction regulator and vented On/Off slide valve. The device is supplied packaged in a sealed, labeled, poly bag. A squeeze bulb with an integral pressure gauge that can connect to the proximal end of the ViSiGi® 3D tube is an optional component compatible with the ViSiGi® 3D.
The medical device in question is the Boehringer Laboratories ViSiGi® 3D Gastric Sizing Tube. The Special 510(k) submission (K234145) is for adding "to test for leaks" to the indications for use.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" for the safety and effectiveness of the device for the added indication. Instead, it mentions that "Performance Data was collected to support the risk assessment associated with the addition of 'to test for leaks' to the indications for use." The performance data focused on accessory compatibility and functionality rather than the device's ability to detect leaks itself.
| Acceptance Criteria (Inferred from study scope) | Reported Device Performance |
|---|---|
| Bulb Compatibility | Not explicitly detailed, but implied to be compatible for the functionality testing, as the device is specified to be "compatible with the ViSiGi® 3D" |
| Bulb Functionality (e.g., pressure generation) | Not explicitly detailed, but implied to be functional for its intended purpose of supporting leak testing, as it was considered in the risk assessment. |
Important Note: The current submission for K234145 is a Special 510(k). This type of submission is used when a modification to a legally marketed device does not require a new 510(k) submission, meaning the changes are well-defined and do not significantly affect the safety or effectiveness of the device. In this case, the change is only to expand the indications for use. The manufacturer is essentially leveraging the existing clearance (K130483) of the primary predicate device and the fact that a similar indication ("to test for leaks") is included in a reference device (K222880, Endolumik Fluorescence Guided Gastric Calibration Tube). They argue that the existing technological characteristics are sufficient for this added indication.
Therefore, the "studies" conducted for this specific submission focused on demonstrating that the modification (addition of a new indication) does not alter the fundamental safety and effectiveness of the existing device design.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance data cited ("Bulb Compatibility" and "Bulb Functionality") appears to be internal verification of accessory functionality rather than a clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. This type of assessment is typically used for AI/ML-based devices or image interpretation, which is not the primary focus of this device's change in indication.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as there's no indication of a test set with multiple interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or referenced. This device is not an AI/ML-based diagnostic tool where human reader performance with and without AI assistance would be relevant.
6. Standalone (Algorithm Only) Performance:
No standalone algorithm performance study was conducted. The device is a physical gastric sizing tube, not a software algorithm. The "performance data" mentioned (bulb compatibility and functionality) relates to the physical accessories and their mechanical function, not an algorithm.
7. Type of Ground Truth Used:
No external ground truth (like pathology or outcomes data) is mentioned as being specifically used for evaluating the "to test for leaks" indication. The submission relies on the established safety and effectiveness of the device for its existing indications and the technological similarity to a predicate device that already includes the "to test for leaks" indication.
8. Sample Size for the Training Set:
No training set is mentioned. This is not an AI/ML device that requires a training set.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned.
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