(164 days)
The Kangaroo™ Feeding Tube Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications.
The device is intended for neonates and infants who require enteral feeding.
The Kangaroo™ Feeding Tube Extension Sets with ENFit small bore connectors are sterile, disposable medical devices designed to deliver nutrition to patients who cannot obtain nutrition or liquid by mouth, are unable to swallow safely, or need nutritional supplementation. The proposed set is intended as a conduit between the enteral feeding formula container (mostly enteral feeding syringe) and feeding tube. The device is designed with a single lumen microbore PVC tube with ENFit small bore connectors at both ends. During enteral feeding therapy, mainly for neonates and infants, there are situations when the feeding tube extension set is required to connect the syringe to patient feeding tube when the distance between the patient and the source of enteral feeding demands additional length of tube.
This document is a 510(k) Summary for a medical device called "Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors." As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria in the way generally understood for AI/ML device performance studies (e.g., diagnostic accuracy, sensitivity, specificity against a clinical ground truth).
The information provided describes non-clinical testing performed to show that the new device (with ENFit connectors) is functionally equivalent and safe compared to the predicate device and compliant with relevant ISO standards for small-bore connectors.
Therefore, the requested information elements (especially those related to AI/ML performance, ground truth, expert adjudication, MRMC studies, and training sets) are not directly applicable or available in this type of FDA submission. I will extract the closest available information based on the context of this document.
Here's an attempt to answer your questions based on the provided text, reinterpreting "acceptance criteria" as compliance with ISO standards and functional performance metrics for a hardware device:
Acceptance Criteria and Study for Kangaroo™ Feeding Tube Extension Sets
This document describes the non-clinical testing performed to demonstrate that the Kangaroo™ Feeding Tube Extension Sets with ENFit Small Bore Connectors are substantially equivalent to a legally marketed predicate device (Covidien Kangaroo™ Enteral Feeding Extension Sets, K9733409) and meet relevant international standards for safety and performance.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this device are primarily defined by compliance with ISO 80369-3 (Small-bore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications) and ISO 80369-20 (Common test methods), as well as biocompatibility, stability, and functional equivalence (flow testing). The document states the device conforms to these requirements.
| Acceptance Criteria (Defined in ISO 80369-3 / FDA expectations) | Reported Device Performance (as stated in submission) |
|---|---|
| Biocompatibility | Demonstrated biological safety. |
| Stability (to support expiration date) | Evaluated properties after accelerated aging; supports product expiration date. |
| Dimensional Analysis (ISO 80369-3, Table B.2) | Conforms to criteria in Table B.2 of ISO 80369-3. |
| Fluid Leakage (ISO 80369-3 Clause 6.2, Test Method Annex C of ISO 80369-20) | Conforms to requirements of ISO 80369-3. |
| Stress Cracking (ISO 80369-3 Clause 6.3, Test Method Annex E of ISO 80369-20) | Conforms to requirements of ISO 80369-3. |
| Resistance to separation from axial load (ISO 80369-3 Clause 6.4, Test Method Annex F of ISO 80369-20) | Conforms to requirements of ISO 80369-3. |
| Resistance to separation from unscrewing (ISO 80369-3 Clause 6.5, Test Method Annex G of ISO 80369-20) | Conforms to requirements of ISO 80369-3. |
| Resistance to overriding (ISO 80369-3 Clause 6.6, Test Method Annex H of ISO 80369-20) | Conforms to requirements of ISO 80369-3. |
| Disconnection by unscrewing (ISO 80369-3 Clause 6.7, Test Method Annex I of ISO 80369-20) | Conforms to requirements of ISO 80369-3. |
| Flow Performance (compared to predicate) | Substantially equivalent to the performance of the predicate device. |
| Risk Management (related to misconnection of ENFit connector) | Assessed and captured in various documents (e.g., FMEA, Misconnection Assessment, Risk Management Report). |
| Usability/Human Factors (related to ENFit connector) | Conducted as part of design, captured in Human Factors Validation Study. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of extension sets tested for fluid leakage, stress cracking, etc.). It generally refers to "the proposed extension sets" or "the proposed devices" being tested.
- Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer (Covidien). The country of origin of the data is not specified, but the manufacturer is based in Mansfield, MA, USA. The studies are prospective in the sense that they were designed and executed to test the new device's compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this submission. For a hardware device, "ground truth" is typically defined by adherence to objective engineering and chemical standards (e.g., ISO dimensional tolerances, flow rates, material composition, breakage forces) rather than expert consensus on a subjective outcome like image interpretation. The testing was performed in accordance with established international standards (ISO).
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., by radiologists) to reach a consensus ground truth. For the described tests (fluid leakage, dimensions, etc.), the results are objectively measured against defined criteria within the ISO standards; there is no subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance with an AI device compares to their performance without one. This device is a physical medical device (feeding tube extension set), not an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- International Standards: Specifically, the requirements and test methods defined in ISO 80369-3 (for enteral connectors) and ISO 80369-20 (common test methods for small-bore connectors).
- Biocompatibility Standards: General standards for material safety in contact with biological systems.
- Functional Equivalence: Direct comparison of key performance characteristics (like flow) to the predicate device, which is already legally marketed and established as safe and effective.
8. The Sample Size for the Training Set
This question is not applicable. This device is a physical medical device, not an AI algorithm developed through machine learning. Therefore, there is no "training set" in the context of an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI/ML model.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.