Search Results
Found 1 results
510(k) Data Aggregation
(92 days)
NEOMED Enteral FEEDING TUBE
The NeoMed Enteral Feeding Tube is intended for nasogastric or orogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
The NeoMed Enteral Feeding Tube is a silicone single lumen catheter that is used to deliver liquid nutritional media. The device consists of the following main components: a feeding tube or catheter, a hub with a plug, and either an enteral only, luer lock and/or universal connector.
The provided text describes a 510(k) premarket notification for the NeoMed Enteral Feeding Tube. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies. Therefore, many of the requested details about acceptance criteria, ground truth, sample sizes for training/test sets, expert qualifications, adjudication methods, and MRMC studies are not applicable or not provided in this document.
The "study" that proves the device meets acceptance criteria in this context is the bench testing demonstrating functional equivalence, which is a common approach for 510(k) submissions of this nature.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | "Bench testing has demonstrated that the NeoMed Enteral Feeding Tube is functionally equivalent to predicate feeding tubes currently on the market and that any minor differences do not affect safety or effectiveness." |
| "Functional test results demonstrate that the NeoMed Enteral Feeding Tube performs its intended use of supplying liquid media and is equivalent to the predicate device." | |
| Material Biocompatibility ("Safety") | "The NeoMed Enteral Feeding Tube materials that come in direct contact with the patient have a long history of use in catheter and feeding tube manufacture and are biocompatible." |
| Intended Use Fulfillment ("Effectiveness") | "The NeoMed Enteral Feeding Tube performs its intended use of supplying liquid media..." (This is confirmed by the functional equivalence to the predicate, which is already established to perform this intended use). |
| Method of Operation | "Both devices have the same method of operation, delivery of liquid nutrition media through a single lumen catheter." (This is a statement of design equivalence, an inherent part of establishing functional equivalence and safety/effectiveness for this type of device.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "bench testing" without providing details on the number of tubes tested.
- Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering bench tests comparing the NeoMed device to an existing predicate device. No patient data (retrospective or prospective) is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For bench testing of functional equivalence, "ground truth" is typically established by engineering specifications, validated test methods, and comparison to a known standard (the predicate device). It does not involve expert clinical review of test results in the way, for example, an imaging AI would.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Bench testing generally follows pre-defined protocols and acceptance criteria based on engineering and performance standards, not a clinical adjudication process.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (e.g., imaging AI) to compare the performance of human readers with and without AI assistance. The NeoMed Enteral Feeding Tube is a medical device for delivery of nutritional media, and its evaluation focuses on functional performance and material safety, not diagnostic accuracy requiring human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical device, not a software algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. Its performance is inherent in its physical properties and functional testing.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "study" (bench testing), the ground truth is effectively functional specifications and performance of the predicate device. The NeoMed tube's performance was compared against the known and accepted performance characteristics of the CATCO Nutritional Catheter (K945012) to demonstrate equivalence. Material biocompatibility relies on a "long history of use" for the materials, implying a well-established safety profile.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1