(22 days)
TubeClear™ is indicated for use only and solely in clearing occlusions / clogs in nasogastric (NG) tubes (i.e., tubes that are placed through the nose and reside in the stomach) of adult patients. Clearing Stem Model NG-1036 is indicated for use in nasogastric tubes that are of size 10 - 14 French and have a length of 36 - 42 inches (91 - 108 cm). Clearing Stem Model NG-1043 is indicated for use in nasogastric tubes that are of size 10 - 18 French and have a length of 43 - 50 inches (109 - 127 cm).
The Proposed Device is TubeClear. TubeClear is composed of a reusable Control Box and single use Clearing Stem. One Control Box model. Model 101 is used to actuate all Clearing Stem models. TubeClear has two Clearing Stem models, Models NG-1036 and NG-1043.
The Operator manually inserts the Clearing Stem into the feeding or decompression tube (i.e., Tube) and directs the Clearing Stem's advancement along the inside of the Tube. The Control Box Motor via electromechanical actuation creates a linear reciprocating motion. The linear reciprocating motion is transferred to the proximal end of the Clearing Stem which contains a Wire that also reciprocates. Because the Wire is continuous throughout the Clearing Stem, the reciprocating motion is further transferred to the distal Tip of the Wire. The motion at the Wire Tip mechanically acts on the occlusion, breaks up the occlusion and restores Tube patency.
Because the Control Box remains outside of the patient and it functions only to provide actuation to the Clearing Stem when the two are attached, the Clearing Stem is considered to be the primary element of TubeClear.
Here’s a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Usability Testing | Passed all acceptance criteria |
| Retainability Testing | Passed all acceptance criteria |
| Operation and performance of the Control Box | Unaffected by design modification (removal of centimeter marks) |
| Performance of the Clearing Stem | Unaffected by design modification (removal of centimeter marks) |
| Shelf Life | Unaffected by design modification (removal of centimeter marks) |
| Biocompatibility | Unaffected by design modification (removal of centimeter marks) |
| Packaging and Transportation | Unaffected by design modification (removal of centimeter marks) |
| Software / Firmware | Unaffected by design modification (removal of centimeter marks) |
| Electromagnetic Compatibility / Electrical Safety | Unaffected by design modification (removal of centimeter marks) |
2. Sample Size and Data Provenance for Test Set
The document mentions "Usability and Retainability testing by end users" but does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts and Qualifications for Ground Truth of Test Set
The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The testing described is "Usability and Retainability testing by end users," implying a user-centric evaluation rather than expert ground truthing in a diagnostic context.
4. Adjudication Method for Test Set
The document does not describe an adjudication method for the test set. Given the nature of the testing (usability and retainability), a formal adjudication process as seen in diagnostic studies would likely not be relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was done, nor does it mention any effect size for human readers improving with or without AI assistance. This device is a mechanical medical device (TubeClear™), not an AI-powered diagnostic tool, so such a study would not be applicable.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone performance study. This device is a mechanical clearing system, not an algorithm, so a "standalone" or "algorithm only" performance study is not applicable.
7. Type of Ground Truth Used
The ground truth for the usability and retainability testing was based on "acceptance criteria" being met by "end users." This implies a subjective or objective assessment of the device's functionality and user interaction rather than a diagnostic accuracy ground truth like pathology or outcomes data.
8. Sample Size for Training Set
The document does not mention a training set as this device is a mechanical medical device and does not involve machine learning or AI models that require training data.
9. How Ground Truth for Training Set was Established
Not applicable, as there is no training set for this type of medical 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.