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510(k) Data Aggregation
(161 days)
BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
The G-Tube is indicated for placement in adult populations that require enteral feeding, medication or gastric 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-Tube 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 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 (also known as PG Lock* connector) which allows for delivery of feeding solutions and medication. 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 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 identical in both versions.
The document describes a 510(k) submission for the Bi-Funnel Gastrostomy Feeding Tube and Tri-Funnel Gastrostomy Feeding Tube, hereafter referred to as "the device". The submission aims to demonstrate substantial equivalence to a predicate device, the Flow-Thru (Compat®) Balloon Replacement Gastrostomy Tubes (K885339).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with pass/fail thresholds for each test. Instead, it describes the types of performance characteristics tested and generally concludes that the proposed device performed "equivalent to or better than" the predicate device.
| Performance Characteristic Tested | Reported Device Performance | Acceptance Criteria (Implied) |
|---|---|---|
| ASTM F2528 Testing | Performed equivalent to or better than the predicate device. | Device meets or exceeds the performance of the predicate device for these critical functional aspects. |
| O Flow rate | Performed equivalent to or better than the predicate device. | |
| O Balloon burst volume | Performed equivalent to or better than the predicate device. | |
| O Balloon volume maintenance | Performed equivalent to or better than the predicate device. | |
| O Balloon concentricity | Performed equivalent to or better than the predicate device. | |
| O Balloon size over shaft size | Performed equivalent to or better than the predicate device. | |
| O Balloon integrity in water | Performed equivalent to or better than the predicate device. | |
| O Balloon integrity in simulated gastric fluid | Performed equivalent to or better than the predicate device. | |
| ENFit Performance Testing | Performed equivalent to or better than the predicate device. | Ensures safety and efficacy related to enteral connections, preventing misconnections. |
| O Falling drop test | Performed equivalent to or better than the predicate device. | |
| O Stress cracking | Performed equivalent to or better than the predicate device. | |
| O Resistance to axial load | Performed equivalent to or better than the predicate device. | |
| O Resistance to separation from unscrewing | Performed equivalent to or better than the predicate device. | |
| O Resistance to overriding | Performed equivalent to or better than the predicate device. | |
| O Disconnection by unscrewing | Performed equivalent to or better than the predicate device. | |
| Tensile testing | Performed equivalent to or better than the predicate device. | |
| Leak testing | Performed equivalent to or better than the predicate device. | |
| Simulated use (human factors) | Performed equivalent to or better than the predicate device. | Device is safe and effective in simulated use scenarios. The Human Factors Validation Study confirms this. |
| Shelf life testing | Met required standards. | Device maintains sterility and functionality over its specified shelf life. |
| Sterilization | Met required standards. | Device can be effectively sterilized. |
| Packaging validation | Met required standards. | Packaging maintains sterility and protects the device. |
| Biocompatibility | Met required standards. | Device materials are biocompatible and safe for patient contact. |
| Enteral Connector Misconnection Assessment | Findings contributed to the conclusion of no new issues of safety or effectiveness. | The new ENFit connectors effectively prevent misconnections. |
| Enteral Connector Risk Management Report | Findings contributed to the conclusion of no new issues of safety or effectiveness. | Risks associated with enteral connectors are appropriately managed. |
| ENFit Misconnection data with FMEA | Data supports the safety and effectiveness of the ENFit connectors. | The ENFit system successfully mitigates misconnection risks. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "nonclinical (bench) test results" but does not specify the sample sizes used for any of the individual tests. Similarly, it does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests appear to be laboratory-based bench tests, implying they are prospective in nature, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy or clinical interpretation. The testing described is primarily engineering and performance-based (e.g., physical properties, and functional capabilities). Human factors testing is mentioned, which would involve human users, but the role of "experts" in establishing a ground truth for interpretation is not relevant or described.
4. Adjudication Method for the Test Set
As the testing is primarily bench-based and performance-oriented rather than involving subjective interpretation, an adjudication method for a "test set" in the traditional sense (e.g., 2+1, 3+1 for clinical image review) is not applicable and therefore not described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance testing revolved around the physical and functional characteristics of the device itself and its connectors, rather than diagnostic interpretation by human readers. The mention of "Human Factors Validation Study" implies testing with human users to ensure safe and effective use, but this is distinct from an MRMC study comparing human interpretive performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The device is a medical tube, not an AI algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests would have been established by engineering specifications, validated test methods (like ASTM F2528), and industry standards. For example, a balloon's burst volume would be compared against a predefined specification derived from the predicate device's performance or relevant safety standards.
- For ASTM F2528 and other physical tests: The ground truth would be the defined physical properties (e.g., flow rate, burst volume, tensile strength) as measured by calibrated equipment and compared against established engineering specifications or the predicate device's performance.
- For Biocompatibility: The ground truth is established through validated biological testing methods and compliance with ISO 10993 series standards.
- For Sterilization and Packaging: The ground truth is validated through established sterilization cycles and packaging integrity tests, ensuring sterility assurance levels (SALs) and barrier integrity.
- For Misconnection Assessment: The ground truth in this context would be the successful prevention of misconnections when using the ENFit connectors as designed, as demonstrated through testing scenarios.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical tube, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for this device.
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