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The BAROnova Access Sheath Kit is used in conjunction with an endoscope for procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract, with or without instruments through the instrument chamel of the endoscope.

The BAROnova Access Sheath Kit is used in conjunction with the TransPyloric Shuttle Delivery Device to facilitate insertion and positioning of the device during TPS delivery and deployment.

The Access Sheath Kit is NOT indicated for foreign body removal or instrument use alongside the endoscope.

The BAROnova Access Sheath Kit includes the following products:

• BAROnova Access Sheath (with obturator)
• Endoscope (Seal) Cap
• Insufflation Syringe

The BAROnova Access Sheath consists of a clean, non-sterile mated Obturator/Access Sheath Assembly. The Access Sheath is composed of thinwalled tubing, a handle and a distal cuff and balloon with an atraumatic tip. The Obturator is made of flexible tubing with an atraumatic tip. The Seal Cap consists of a non-sterile, plastic cap for use with standard endoscopes. A 10cc syringe is also provided with the Access Sheath Kit to enable balloon inflation and deflation.

This document is a 510(k) summary statement for the BAROnova Access Sheath Kit. It's a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. This type of document generally focuses on comparing the new device to existing ones and providing non-clinical performance data (e.g., bench testing) to support safety and effectiveness, rather than detailed clinical study data with acceptance criteria for device performance in a clinical setting.

Therefore, much of the requested information about clinical acceptance criteria, sample sizes, expert ground truth, adjudication methods, and human reader studies is not available in this document. This submission emphasizes technological equivalence and non-clinical performance.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and reported device performance:

Based on the provided text, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) for design verification tests are not explicitly stated in this summary. The document broadly states that the device "meet all requirements."

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are non-clinical (bench testing, simulated use, animal study) and were conducted by BAROnova, Inc. (the manufacturer). The country of origin for the data generation is not explicitly stated but would likely be the location of the manufacturing and testing facilities. It is inherently "retrospective" in the sense that the tests were performed to validate the device's design before submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. For non-clinical tests (dimensional, mechanical, etc.), "ground truth" is typically established by engineering specifications and objective measurements, not expert consensus in the clinical sense. For the animal study, the assessment would be made by veterinary or medical professionals participating in the study, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies with human assessors to resolve discrepancies in diagnoses or interpretations. Non-clinical tests usually involve objective measurements against predefined specifications.

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 document describes a medical device (an access sheath kit), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. As noted above, this is a physical medical device, not a standalone algorithm.

7. The type of ground truth used:

• For non-clinical tests (e.g., dimensional, mechanical, balloon integrity, shaft wall integrity, seal cap functionality), the "ground truth" is typically engineering specifications, design requirements, and quantifiable measurements. Deviations from these specifications are considered failures.
• For the simulated use and animal studies, "ground truth" would relate to the observed functional performance, safety, and any adverse events or complications during the simulated or animal procedures, assessed against expected outcomes and safety profiles.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established:

• Not Applicable. No training set was used.

Summary of what is present:

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Identical Indications for Use.
• Identical Technological Characteristics (design, materials, construction) to the predicate BAROnova Access Sheath, and the included Seal Cap and Syringe being standard components.
• Non-clinical testing: This included dimensional, mechanical, balloon integrity, shaft wall integrity, seal cap functionality, simulated use, animal, and biocompatibility studies. The outcome of these tests was that the devices "met all requirements" and were found to be safe and effective for their intended use.

This 510(k) submission is a device-specific regulatory filing for a physical medical product, not a software or AI-driven product, which explains the absence of information related to clinical studies, expert adjudication, or AI performance metrics.

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The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device.

The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.

The BAROnova Accessory Kit includes the following products:

• BAROnova Insufflation System
• BAROnova Transpyloric Shuttle (TPS) Stand
• Hook Tool

The BAROnova Insufflation System is designed to provide pressure-controlled air to the stomach for insufflation within the gastric space during endoscopic procedures for placement of the BAROnova Transpyloric Shuttle (TPS) device. The Insufflation System is used in conjunction with the BAROnova TPS Delivery Device to facilitate TPS skin expansion during deployment once the Delivery Device is inserted. Prior to initiating TPS coil advancement with the handle controls, the TPS Delivery Device is connected to the reusable Insufflation System using the disposable tubing set provided within the TPS Delivery Device Kit. The reusable components of the Insufflation System are composed of a portable air Compressor, a Power Adapter, and Pressure Regulator Box. The air Compressor and Power Adapter are the identical components as utilized in the PARI Trek S nebulizer (K060357). The Pressure Regulator Box includes a precision low-pressure regulator and redundant pressure relief valves to limit system output pressure. The Box also includes a calibrated pressure gauge for testing and monitoring the performance of the system. The BAROnova Insufflation System allows the physician to deliver pressure-controlled air to the patient in a manner consistent with that being done currently in a routine endoscopic procedure with room air which is supplied by an air pump in the console of the endoscopic equipment.

The TPS Stand (Class I, regulated under 878.4800 – Manual surgical instrument for general use) and Hook Tool (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology Surgical Instrument and Accessories), are optional accessories included in the Accessory Kit for use with the BAROnova TPS Delivery Device. The TPS Stand is a non-sterile, reusable plastic stand with a weighted aluminum base provided for the convenience of the operator, and can be used to support the TPS Delivery Device handle during TPS deployment. The Hook Tool is a stainless steel reusable tool which may be used to facilitate cutting of tension lines for deployment troubleshooting.

The provided text describes the BAROnova Insufflation System and BAROnova Accessory Kit, and the FDA's 510(k) clearance. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (BAROnova Insufflation System and Accessory Kit), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth information as requested.

Therefore, I cannot provide the requested information based on the input text. The text only states:

• "Non-clinical testing of the subject device for functional and simulated use has been performed, as well as testing to applicable standards. The subject device was found to meet all requirements." This is a general statement and does not provide specific acceptance criteria, reported performance, or details of the study.
• "The results of the testing performed demonstrate that the BAROnova Insufflation System is safe and effective when used in accordance with its intended use and labeling." Again, this is a concluding statement without the underlying data or criteria.

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The disposable Overtube is a device used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract.

The Endoscope Caps are intended to keep suitable endoscopic view field during endoscopic procedures.

The BAROnova Retrieval Kit includes the following products:

• BAROnova Overtube Set (Overtube with a mated Obturator and • Seal Cap)
• Endoscope Cap Set (Endoscope Caps, Small and Large) ●
• Push Tube ●

The BAROnova Overtube Set (BAROnova Overtube) consists of a non-sterile, polymer extrusion with a metallic coil reinforcement, atraumatic tip and handle, in addition to a mated Obturator made of flexible PVC with a tapered tip, and a flexible polymer seal cap. The BAROnova Endoscope Cap Set (BAROnova Endoscope Caps) consists of two non-sterile, plastic caps for use with standard endoscopes. The Endoscope Caps are provided in two sizes to accommodate a range of standard endoscope sizes. The Push Tube (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology-Urology Surgical Instrument and Accessories) and the Endoscope Cap Sizing Guide (Class I, regulated under 876.1500 - Endoscope and Accessories), are optional accessories included in the Retrieval Kit for use with the BAROnova Overtube and BAROnova Endoscope Caps respectively. The Push Tube is a non-sterile, plastic probe with a handle, which may be used to facilitate removal of foreign objects through the BAROnova Overtube. The Endoscope Sizing Cap Guide is an optional accessory for the BAROnova Endoscope Caps to assist the user in selecting the correct size Cap.

The provided text describes a 510(k) summary for the BAROnova Retrieval Kit, which includes an Overtube and Endoscope Caps. The purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices.

The information provided does not contain any details about an AI/algorithm-based device, nor does it discuss acceptance criteria and a study that proves an AI device meets those criteria. The document focuses entirely on the physical characteristics, intended use, and performance of traditional medical devices (an overtube and endoscope caps) and their comparison to predicate devices for regulatory clearance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI test set.
• Details on MRMC studies or effect sizes for AI assistance.
• Details on standalone algorithm performance.

The document describes non-clinical testing for mechanical, biocompatibility, and simulated use data for the physical devices (BAROnova Overtube and Endoscope Caps), confirming they "perform as intended and that no new issues of safety and effectiveness are introduced" when compared to their predicates. This is a standard regulatory pathway for physical medical devices and does not involve AI performance metrics.

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