(134 days)
Medline Quick-Clear Wand is intended to be used by health care providers to restore and maintain patency of gastrostomy tubes (G-Tubes), jejunostomy tubes (J-Tubes), and percutaneous endoscopic (PEG) tubes that may be used in infant patients over 10kg, children, adolescents, and adults.
The Medline Quick-Clear Wand is a single use device intended for use in clearing occlusions/clogs from gastrostomy tubes (G-Tubes) and Percutaneous Endoscopic Gastrostomy tubes (PEG tubes) – tubes that are placed through the abdomen wall and rest in the stomach of the patient, and jejunostomy tubes (J-Tubes) - tubes that are placed through the abdomen wall and rest in the jejunum of the patient. The proposed device is manually inserted into the feeding tube, directed along the inside of the tube to reach the blockage, and a rotating motion of the device (manually generated by the operator) mechanically acts on the occlusion to restore the tube patency. All Medline Quick-Clear Wand are offered non-sterile and are prescription only.
Here's a breakdown of the acceptance criteria and the study information for the Medline Quick-Clear Wand, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values for the Medline Quick-Clear Wand. Instead, it states that "the results demonstrate that all acceptance criteria were met" for various performance tests without specifying the exact criteria or quantitative results.
However, based on the "Performance Testing (Bench)" section, we can infer the aspects that were evaluated and for which acceptance criteria were implicitly met:
| Performance Characteristic | Reported Device Performance |
|---|---|
| Flexural strength | Acceptance criteria met |
| Seal strength | Acceptance criteria met |
| Marking accuracy | Acceptance criteria met |
| Stem tensile strength | Acceptance criteria met |
| Handle connection strength | Acceptance criteria met |
| Metrology | Acceptance criteria met |
| Simulated use testing | Acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the non-clinical performance and biocompatibility tests. It also does not provide information on data provenance (e.g., country of origin) or whether the tests were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The non-clinical testing appears to be primarily bench testing and simulated use, which would typically rely on engineering and laboratory standards rather than expert clinical consensus for "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document, as the testing described focuses on objective measurements and established standards rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or reported. The device is a physical tool for clearing occlusions, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical, manually operated tool, not an algorithm.
7. The Type of Ground Truth Used
For the performance testing, the ground truth was based on established engineering and material standards (e.g., ASTM D790-17 for flexural testing, ASTM F88/F88M-15 for seal strength testing). For biocompatibility, the ground truth was based on international standards such as ISO 10993-5 and ISO 10993-10.
8. The Sample Size for the Training Set
This information is not applicable. The Medline Quick-Clear Wand is a mechanical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a mechanical device.
§ 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.