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510(k) Data Aggregation
(256 days)
The BaroSense EGT is indicated for use with an endoscope where multiple endoscopic intubations are anticipated.
The BaroSense EGT is a single use, disposable, overtube used in hospitals or surgery centers to provide a channel for the delivery and removal of endoscopic devices from the mouth to the stomach. It is intended for use when multiple endoscopic intubations, or endoscopic instrument/tool exchanges, are anticipated.
The EGT is supplied non-sterile and is provided with a removable, flexible introducer with a tapered tip that assists in introduction of the EGT through the mouth and esophagus.
The provided text is a 510(k) Summary for the BaroSense Endogastric Tube (EGT). This document primarily focuses on establishing substantial equivalence to existing predicate devices based on device description, indications for use, and biocompatibility.
Crucially, the document does NOT contain information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), or any study that directly reports on such performance data. It briefly mentions "bench tests" but does not detail their methodology, results, or specific acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as these details are not present in the provided text.
Based on the available information, here's what can be extracted:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| However, based on the context of a 510(k) for an overtube, implicit performance criteria would likely include: | Implicitly, the device successfully met these criteria, as substantial equivalence was determined. |
| Biocompatibility requirements per ISO 10993 | "All patient contacting components of the EGT are composed of materials of known biocompatibility tested to the requirements of ISO 10993." (Stated as met) |
| Functional performance characteristics (e.g., ease of insertion, ability to create a channel for endoscopic devices, durability during intended use, compatibility with endoscopes, prevention of kinking/collapse) | "The safety and effectiveness of the device was further established through a series of bench tests. All testing yielded acceptable results." (Stated as met, but no specific results are provided) |
| Dimensional specifications (length, diameter, compatibility with typical endoscopes) | Not explicitly stated as an acceptance criterion, but would be assessed in bench testing. |
| Sterilization (if applicable, though stated as non-sterile) | Not applicable as the device is supplied non-sterile. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "a series of bench tests," but provides no details on sample size or data provenance.
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/Not specified. This device is an Endogastric Tube (overtube), not an AI/imaging diagnostic device that would typically involve expert ground truth for performance evaluation in the context of the questions asked. Its evaluation relied on engineering bench tests and biocompatibility testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. See point 3.
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. This is not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/imaging diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Adherence to ISO 10993 standards and material conformance.
- For functional performance: Engineering specifications and testing protocols for items like material strength, flexibility, dimensions, and ease of use in simulated environments. The "ground truth" would be whether the device met its pre-defined engineering specifications and performed as intended in bench simulations.
8. The sample size for the training set:
- Not applicable. This is a hardware medical device (an overtube), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
Summary of Device and 510(k) Logic:
The BaroSense Endogastric Tube (EGT) is a single-use, disposable overtube intended to provide a channel for endoscopic procedures requiring multiple intubations or instrument exchanges. Its 510(k) clearance (K082589) was based on demonstrating substantial equivalence to existing predicate devices (Guardus™ Disposable Overtube, NDO Surgical Overtube, CR Bard Endoscopic Overtube).
The evidence for substantial equivalence primarily relied on:
- Similar Indications for Use: "use with an endoscope where multiple endoscopic intubations are anticipated."
- Similar Device Description: Single-use, disposable overtube with an introducer.
- Biocompatibility: Confirmation that all patient-contacting components met ISO 10993 requirements.
- Bench Testing: A series of unspecified "bench tests" were performed, with acceptable results, presumably demonstrating functional performance characteristics consistent with predicate devices and safety for intended use.
The 510(k) process for this device focused on confirming that it did not raise new safety or effectiveness concerns compared to already marketed devices, rather than establishing novel performance metrics or conducting clinical trials as might be seen for a new drug or high-risk implant.
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