(276 days)
The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.
The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician. Accessories to be offered alongside the MED-RX Pediatric Feeding Tubes include MED-RX Enteral Extension Sets of various configurations. The MED-RX Enteral Extension Set is intended to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tubes and Enteral Extension Sets feature non-luer enteral only connectors to decrease the risk of accidental misconnection. All devices are sterile, single-use, and latex free. The MED-RX Pediatric Feeding Tube and Accessories are for pediatric use only. Accessories may be sold with MED-RX Pediatric Feeding Tubes or separately.
The provided document is a 510(k) premarket notification for a medical device (MED-RX Pediatric Feeding Tube and Accessories). It describes non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets clinical acceptance criteria with respect to AI/algorithm performance. Therefore, many of the requested points, such as those related to AI/algorithm performance, ground truth, expert review, and MRMC studies, are not applicable to this document.
However, I can extract information related to the device's non-clinical acceptance criteria and the summary results of those tests.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Feeding Tube Tensile Strength Test | Withstand tensile force of: 2 lbf (OD ≤ 2 mm), 4 lbf (OD > 2 mm) | PASS, PASS |
| Extension Set Tensile Strength Test | Withstand tensile force of 4 lbf | PASS |
| Leakage under Pressure | No leakage or separation under 50 kPa | PASS |
| Leakage under Vacuum | No leakage or separation under vacuum | PASS |
| Connector Separation | Withstand tensile force of 3.37 lbf (15 N) | PASS |
| Device Compatibility | Incompatible with other recognized non-luer medical devices | PASS |
| Latex Content | Contain less than 0.04% natural rubber latex | Less than 0.04% |
| Sterility Assurance Level | Validated to a Sterility Assurance Level of 1 x 10⁻⁶ (ANSI/AMMI/ISO 11135:1994) | Validated to 1 x 10⁻⁶ |
| EO Sterilization Residuals | Pass (ISO 10993-7: 2008) | Pass |
| Bacterial Endotoxins | Pass (ANSI/AAMI ST72:2002) | Pass |
| Cytotoxicity | Non-toxic (ISO 10993-5: 2009) | Non-toxic |
| Intracutaneous Reactivity | Non-irritant (ISO 10993-10: 2010) | Non-irritant |
| Guinea Pig Maximization Sensitization | No sensitization response (ISO 10993-10:2002) | No sensitization response |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It states "The MED-RX Pediatric Feeding Tubes and MED-RX Enteral Extension Sets have successfully completed all required performance testing."
The data provenance is not explicitly stated in terms of country of origin of the data or retrospective/prospective nature. These are non-clinical bench tests performed by the manufacturer and a contract lab (Wuxi AppTec for Latex Content).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes non-clinical, physical, and biocompatibility testing, not a study involving expert human review or ground truth derived from clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this pertains to non-clinical testing.
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 document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document does not describe an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" or reference for passing/failing is defined by established regulatory standards (e.g., ISO, ANSI/AAMI standards) and specific quantitative criteria (e.g., tensile force in lbf, pressure in kPa, latex percentage).
8. The sample size for the training set
Not applicable. There is no "training set" as this is a non-AI/algorithm device submission.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or corresponding ground truth as this is a non-AI/algorithm device submission.
§ 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.