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The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract.

The Kangaroo Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatic patients that require enteral feeding, medication administration, or decompression through a Kangaroo Skin Level Device.

The Kangaroo ™ Skin Level Balloon Gastrostomy Kit will be comprised of one Kangaroo™ Skin Level Device and one of each of the feed sets. The feed sets, continuous and bolus, are also available in Feed Set Kits packaged individually and then boxed as a 10-pack.

The Kangaroo™ SLD is constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. The tip of the shaft is filled with radiopaque barium RTV. At the distal end, a silicone subsumed tip balloon is reverse bonded to the shaft using a silicone RTV. This subsumed tip balloon accomplishes patient comfort by not exposing the tip of the shaft to the patient as well as being in line with the shaft. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque barium stripe present. Accessories for the Kangaroo™ SLD include two feed extension set confiqurations (ENFit bolus and continuous), an inflation syringe, a feeding syringe (ENFit), and gauzes.

The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the feed set valve connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.

The device is available in the configurations per determined market needs shown below in Table 5.5-2.

The feed extension sets have a valve connector end that inserts into the Kangaroo™ SLD reflux valve. For these ENFit Feed Sets, the opposite end has an ENFit-compatible connector complying with ISO 80369-3 (for prevention of misconnections with nonenteral feeding devices). The extension set can then connect to any ENFit-compatible enteral giving sets or ENFit-compatible syringes. Finally, both the Kangaroo™ Skin Level Device and the Kangaroo™ Feed Sets are compatible with competitor devices currently on the market.

This document is a 510(k) summary for the Kangaroo Skin Level Balloon Gastrostomy Kit and associated feed sets. It does not describe a study involving an AI/ML device, but rather a traditional medical device (gastrostomy kit). Therefore, many of the requested categories related to AI/ML device studies, such as the use of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable.

However, I can extract information regarding the device's acceptance criteria and how its performance was demonstrated through non-clinical testing.

Here's the summary of the acceptance criteria and study information that is applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical performance results directly in the format requested. Instead, it states that results from all tests "met the acceptance criteria for each test."

However, it lists the types of performance tests conducted based on relevant standards. The "acceptance criteria" can be inferred as the requirements set by these standards:

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (number of devices) used for each specific test mentioned under "Performance Testing Bench." It only indicates that "all the above tests met the acceptance criteria," implying that sufficient units were tested to demonstrate compliance.

The data provenance is from non-clinical bench testing conducted by the manufacturer, Xeridiem Medical Devices, on the proposed devices, or leveraged from previously conducted tests on the identified predicate and reference devices. There is no mention of country of origin for data; it is assumed to be from the manufacturer's internal testing. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable, as this is for a traditional medical device and not an AI/ML diagnostic or interpretive device. The "ground truth" here is the performance of the device against engineering and safety standards, directly measured through physical tests.

4. Adjudication Method for the Test Set

Not applicable. Device performance was assessed against predefined engineering and safety standards, not through human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/ML device, and therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Not applicable. This is for a traditional medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this traditional medical device is based on established engineering and safety standards (e.g., ISO 80369-3, EN1615, ISO 20695, ASTM F2528-06, ISO 10993-1). The device's physical and functional characteristics are directly measured and compared against the requirements specified in these standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set.

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The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication or decompression through an established gastrointestinal stoma tract.

The Entuit LP Patient Care Kit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Balloon Retention Feeding Tube.

The Entuit LP Patient Care Kit with ENFit Connection is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube.

The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract.

The PromaX LP Patient Care Kit with ENFit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration, or decompression through a PromaX Low Profile Gastrostomy Feeding Tube.

The proposed low profile devices are constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. At the distal end, a silicone balloon is bonded to the shaft using a silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the extension set connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.

In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque barium stripe present.

Accessories for the proposed devices include two extension set configurations (bolus and continuous, each available in both ENFit-compatible version and non-ENFit compatible version due to ENFit market transition status), an inflation syringe, a feeding syringe (similarly available in both ENFit compatible and non-ENFit compatible versions), gauzes, and a stoma measuring device (for the Entuit offering) to facilitate device placement and use.

This document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of new medical devices to legally marketed predicate devices. As such, it does not contain the information requested regarding acceptance criteria and a study proving device meets acceptance criteria for an AI/ML powered medical device. The document pertains to physical medical devices (gastrostomy feeding tubes and kits).

Therefore, I cannot provide the requested information based on the given text.

The typical structure for a 510(k) submission for a physical device like a feeding tube involves demonstrating:

• Substantial equivalence to a predicate device already on the market.
• Performance testing (bench testing, e.g., tensile strength, leak testing, biocompatibility, sterilization validation) to show the device meets specifications and is safe and effective for its intended use.
• Clinical tests (if applicable): Often not required for Class II devices like these if bench data and substantial equivalence is strong.

The document you provided outlines exactly this:

• It identifies predicate and reference devices (Section 5.3, 5.4).
• It describes the proposed devices and their technological characteristics, comparing them to the predicate (Section 5.5, 5.7, 5.7a).
• It lists non-clinical tests performed (biocompatibility, sterilization, performance bench testing like tensile, leak, connector strength, dimensional testing per ISO standards, pinch clamp testing, and resistance to chemical exposure) (Section 5.8.1).
• It explicitly states that animal and clinical tests were not required (Section 5.8.2, 5.8.3), which is common for devices demonstrating substantial equivalence through robust bench testing.

Essentially, for these types of physical devices, the "acceptance criteria" are the specifications and performance standards met during the non-clinical bench testing, and the "study that proves the device meets the acceptance criteria" refers to the results of these bench tests demonstrating compliance with the standards and equivalence to the predicate. There is no AI/ML component described, so terms like "test set," "training set," "ground truth," "expert consensus," "MRMC study," or "standalone algorithm performance" are not applicable.

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The Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector are indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract.

The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is intended to provide gastric access for enteral feeding, medication administration and decompression through an established gastrointestinal stoma tract.

The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.

The Gastrostomy Feeding Tube (G-tube) consists of two product versions (models): a Bi-Funnel G-Tube and a Tri-Funnel G-Tube. Each G-Tube version is offered in varying shaft French (FR) sizes and balloon sizes. Both versions are offered in the same functional length. The overall difference between the Bi-Funnel and Tri-Funnel G-tubes is that the Tri-Funnel G-Tube allows for simultaneous delivery of feeding solutions and medications while the Bi-Funnel G-Tube allows for delivery of either feeding solutions or medications at a time. Both Bi-Funnel and Tri-Funnel G-Tubes consist of a silicone funnel, shaft, adjustable external bolster and balloon. The funnel for the Bi-Funnel G-Tube has two ports: one port houses the balloon inflation valve which allows for balloon inflation and deflation, and the other port houses the male ENFit connector which allows for delivery of feeding solutions and medication. The funnel for the Tri-Funnel G-Tube has three ports: one port houses the balloon inflation valve, the center port houses the male ENFit connector which allows for delivery of feeding solutions, and the last (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The same ENFit connector, tether and cap components are used for both Bi-Funnel and Tri-Funnel G-Tubes. The remaining components (shaft, adjustable bolster and balloon) are commonly shared for the Bi-Funnel and Tri-Funnel G-Tubes and are identical in both versions.

The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shaft. At the proximal end, a silicone balloon is bonded to the shaft using silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated to the rated volume using sterile or distilled water and the bolster adjusted down to the skin to secure the device in place. The funnel has three ports. One port contains the inflation valve and used for inflation of the balloon. The center port houses the male ENFit connector which allows for the delivery of feeding solutions. The third (side) port houses another male ENFit connector which allows for delivery of medications. Attached to the ENFit connectors are a tether and a cap. The cap is intended to cover the ENFit connector when the device is not in use and the tether is intended to secure the cap to the connector when the device is in use. The funnel configuration and ENFit connectors/caps are identical to the Tri-Funnel Gastrostomy Feeding Tube with ENFit connector discussed in 5.4.1 above.

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for medical devices. It describes the devices, their intended use, and substantial equivalence to previously marketed devices. However, it does not include details on acceptance criteria and a study proving that the device meets those criteria, as it relates to performance metrics in terms of sensitivity, specificity, or similar statistical measures. It also does not contain information on sample size, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

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The Entuit The Thrive Balloon Retention Gastrostomy Feeding Tube is indicated in adult and pediations for use in percutaneous placement of an Enteral feeding tube for feeding tube feeding and/or administration of medication in conjunction with an established GI stoma to act The replacement tube may also be used for gastric decompression.

The Entuit™ Thrive I.P Balloon Retention Gastrostomy Feeding Tube is constructed primarily of silicone. The low profile device consists of a hub which is overmolded onto a previously extruded bilumen shaft. At the proximal end, a silicone balloon is bonded to the shaft using a silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated with 5mL sterile or distilled water to secure the device in place. Accessories for the Low Profile device include two extension set configurations, an inflation syringe, a catheter tip syringe, gauzes and a stoma measuring device to facilitate device placement and use.

This document describes the 510(k) submission for the Entuit™ Thrive LP Balloon Retention Gastrostomy Feeding Tube, comparing it to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to a single performance test with multiple sub-components. The acceptance criteria were primarily based on a standard, and where not explicitly defined, the device's performance was compared to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample size for the test set used for performance testing (e.g., number of devices tested for each parameter). The data provenance is not explicitly mentioned in terms of country of origin or retrospective/prospective, but it is clear that these were bench tests conducted in a laboratory setting as part of the 510(k) submission, not clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The performance testing described is bench testing against an ASTM standard and comparison to a predicate device, not clinical evaluation requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This was bench testing, not a clinical study requiring adjudication of expert interpretations.

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. This is a medical device (gastrostomy feeding tube), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. As noted above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The "ground truth" for the performance testing was adherence to the specified ASTM F2528-06 standard and comparative performance against a legally marketed predicate device.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, not for the engineering and design of a gastrostomy tube.

9. How the Ground Truth for the Training Set Was Established:

Not applicable (as above).

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The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is intended to provide gastric access for enteral feeding, medication and decompression through an established gastrointestinal stoma tract.

The Entuit™ Thrive Balloon Retention Gastrostomy Feeding Tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.

The Entuit The Thrive Balloon Retention Gastrostony Feeding Tube is constructed primarily of silicone. The device consists of a tri-port funnel which is overmolded onto a previously extruded bi-lumen shaft. A retention bolster is molded separately and placed over the shall. At the proximal end, a silicone balloon is bonded to the shaft using silicone RTV. The tip of the shaft is filled with radiopaque barium RTV. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach lumen. The balloon is then inflated to the rated volume using sterile or distilled water and the bolster adjusted down to the skin to secure the device in place.

The acceptance criteria and study proving the device meets them are described below:

1. Acceptance Criteria and Reported Device Performance

• Balloon Burst Volume
• Balloon Volume Maintenance
• Balloon Concentricity
• Balloon Over Shaft Size
• Balloon Integrity
• Balloon Integrity in simulated gastric fluid | All tests were conducted in accordance with ASTM F2528-06 (Procedures A through G). Where specific acceptance criteria were not defined in the standard, the candidate device's performance was required to be equivalent to or better than the predicate device. | The candidate device met all performance requirements. Where acceptance criteria were not defined in the standard, the candidate device performed equivalent to or better than the predicate device. |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily bench testing of the physical device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study involved bench testing of a medical device against a technical standard (ASTM F2528-06), not a diagnostic study requiring human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the study involved bench testing against a technical standard, not a diagnostic study requiring human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was mentioned. The study described is bench testing comparing the performance of the submitted device to a predicate device and a technical standard.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable as the device is a physical medical device (gastrostomy feeding tube), not an AI algorithm. The performance evaluation was standalone in the sense that the device's technical specifications were tested in a controlled environment.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established by adherence to a recognized international standard, ASTM F2528-06 (Procedures A through G), for medical gastrostomy tubes. For aspects where the standard did not define specific criteria, the predicate device's performance served as the benchmark for equivalence.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical medical device, not an AI model that requires a training set with established ground truth.

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