(267 days)
TubeClear Clearing Stem Model GJ-1422 is indicated for use ONLY and SOLELY in clearing occlusions/clogs in adults that have the following Tube type and size (French and length).
- GJ-1422, for G-Jet®, MIC®, and MIC-KEY® Gastro-jejunostomy tubes that are size 14-22 Fr and have a jejunal length of 15-45 cm (6-18 in).
The TubeClear System is comprised of a reusable Control Box and a single use Clearing Stem. Control Box Model 101 is used to actuate all Clearing Stem models. The Clearing Stem for the predicate device is TubeClear Clearing Stem Model TC-0608 (TC-0608). The Clearing Stem for the subject device is TubeClear Clearing Stem Model GJ-1422 (GJ-1422). GJ-1422 is connected to the Control Box. The Operator then coats GJ-1422 with Coconut Oil and manually inserts it into the gastro-jejunostomy (GJ) tube (Tube) and directs the progression of the Clearing Stem inside the Tube. The Control Box actuates the Clearing Stem Wire. The Clearing Stem Wire Tip mechanically clears the occlusion to restore Tube patency. Sixteen (16) Clearing Stem Models are currently marketed to accommodate different types, sizes, and materials of feeding tubes. This submission adds a seventeenth (17th) Clearing Stem model (GJ-1422) for use in a specific set of gastro-jejunostomy (GJ) tubes. Use of TubeClear Clearing Stem Model GJ-1422 requires coating the Clearing Stem with Coconut Oil prior to introduction into a patient's feeding tube.
The provided text describes the submission for a new model of the TubeClear System, GJ-1422, which is essentially an updated version of the previously cleared TC-0608. The document focuses on demonstrating substantial equivalence rather than presenting an entirely new study with rigorous acceptance criteria and standalone performance for a novel AI device. Therefore, some of the requested information, particularly regarding AI-specific studies (e.g., MRMC, training set details, ground truth for training), is not applicable or not present in this regulatory submission.
However, based on the non-clinical performance data provided, we can infer and construct a table of acceptance criteria and reported performance for the mechanical device (TubeClear System), not an AI algorithm.
Here's the breakdown of the available information:
Acceptance Criteria and Reported Device Performance (Non-Clinical Benchtop Testing for Mechanical Device)
The document specifies that the acceptance criteria for the new GJ-1422 model were "the same as that used for the legally marketed TC-0608 model". It also states that both models "passed their respective a priori acceptance criteria for each test, which reflects clinically acceptable success rates." While specific numerical values for the acceptance criteria are not explicitly stated, the text indicates that the device met these criteria.
| Test Category | Acceptance Criteria (Implied / Inferred) | Reported Device Performance (GJ-1422) |
|---|---|---|
| Benchtop Efficacy | Effectively clear worst-case artificial clogs in indicated tubes. (Same as TC-0608, ensuring clinically acceptable success rates) | Effectively cleared the required occluded Tubes (G-Jet®, MIC®, and MIC-KEY® Gastro-jejunostomy tubes, 14-22 Fr, 15-45 cm jejunal length, silicone) when used in accordance with IFU. The device met the a priori acceptance criteria, indicating substantial equivalence to TC-0608 in clearing occluded tubes. |
| Clearing Stem Removal Forces | Force required to remove the Clearing Stem should be below a pre-defined maximum to prevent tube dislodgement or component strength exceedance. (Same as TC-0608) | Had lower forces than the a priori acceptance criteria when used in accordance with IFU. This indicates substantial equivalence to TC-0608 regarding removal forces. |
| Feeding Tube Integrity | No signs of damage (scratching, marring) to the feeding tube after repeated use and contact with kinks. | No signs of scratching or marring observed under a microscope after the test (simulated clog cleared, then 70 minutes of contact with a kink in ex vivo porcine tissue). Supports substantial equivalence to TC-0608. |
| Flow Rate (Post-Use) | Repeated use with Coconut Oil should not negatively alter the tube's subsequent flow rate or lead to accumulated residue. | Showed a statistically significant higher amount of water collected in worst-case testing (repeated introduction of GJ-1422 coated in Coconut Oil into smallest French size/maximal length tube). This demonstrates that Coconut Oil does not lead to residue accumulation or reduce tube patency. Supports substantial equivalence to TC-0608. |
| Coconut Oil Safety (USP & Toxicology) | Coconut Oil should meet USP specifications and present no unacceptable adverse risks to patients. | Nineteen (19) of twenty-one (21) analytes met USP 42 specification. Literature review of 8 clinical trials found no negative effects from coconut oil consumption, even at significantly higher doses than the worst-case potential administration with GJ-1422 (140-378 times higher). Indicates no unacceptable adverse risks to the patient. |
Study Details:
This document is a 510(k) Premarket Notification, not a detailed research study publication. Therefore, some granular details typically found in a scientific paper's methodology section are not fully elaborated.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single number. The tests involved "series of indicated Tubes" for Benchtop Efficacy, "artificially created clogged Tube" for Removal Forces, and "different geometry and materials used in indicated Tubes" (GJ tubes) with ex vivo porcine tissue for Tube Integrity. Flow Rate testing involved "feeding tube of the smallest French size and maximal length." The specific number of tubes tested for each scenario is not quantified.
- Data Provenance: This is
- Benchtop/Laboratory Data: The tests were performed in a controlled laboratory setting (benchtop efficacy, removal forces, tube integrity, flow rate).
- Ex Vivo Data: Feeding Tube Integrity test used "ex vivo porcine tissue model."
- Literature Review: Toxicity assessment relied on a "literature review found eight (8) clinical trials exploring the effects of consuming coconut oil."
- Geographic Source: Not specified, but generally, regulatory submissions for US markets involve testing conducted in the US or in compliance with US standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a mechanical device performance submission, not an AI diagnostic device. Therefore, no "ground truth" in the diagnostic sense (e.g., radiology interpretation) was established by human experts for a test set. The "ground truth" for these tests comes from objective measurements (e.g., cleared tube patency, measured forces, visual inspection for damage, flow rates, chemical analysis).
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Adjudication method for the test set:
- Not applicable as this is not a subjective interpretation task (like image reading) requiring adjudication. The outcomes were direct measurements or observations based on predefined objective criteria.
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If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This device is a mechanical tool for clearing occlusions, not an AI-assisted diagnostic device where human reader performance is compared with and without AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. The "performance" described is the ability of the physical device to clear clogs and its safety.
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The type of ground truth used:
- Objective Benchtop Measurements: Patency (clearing of artificial clogs), force measurements, visual microscopic inspection for damage, flow rate measurements.
- Chemical Analysis: USP monograph testing for Coconut Oil.
- Literature-based Evidence: For toxicological risk assessment of Coconut Oil.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The engineering design and testing are based on traditional medical device development.
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How the ground truth for the training set was established:
- Not applicable. (See #7).
§ 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.