Search Results

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.

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.

1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable. (See #7).

Ask a specific question about this device

TubeClear System Clearing Stem Models are indicated for use ONLY and SOLELY in clearing occlusions/clogs in Feeding and Decompression Tubes in adult patients that have the following Tube type and size (French and length):

· TC-0608: for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 - 140 cm (15 - 55 in);

· TC-0812: for Nasoenteral and Nasogastric Tubes composed of Polyviny1 Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in);

· TC-1018: for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 91 - 140 cm (36 - 55 in); and Gastrostomy and Jejunostomy Tubes that are size 10 - 18 Fr and have a length of 20 - 36 cm (8 - 14 in);

• · NE-1036: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 91 cm (36 in);
• NE-1042: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 107 cm (42 in);
• NE-1043: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 109 cm (43 in);
• NE-1045: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 114 cm (45 in);
• · NE-1048: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 122 cm (48 in);
• NE-1050: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 127 cm (50 in);
• NE-1055: for Nasoenteral and Nasogastric Tubes that are of size 10 18 Fr and have a length of 140 cm (55 in);
• · G-1008: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 20 cm (8 in);
• · G-1009: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 23 cm (9 in);
• · G-1010: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 25 cm (10 in);
• · G-1011: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 28 cm (11 in);
• · G-1012: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 30 cm (12 in); and
• · G-1014: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 36 cm (14 in).

The TubeClear System is comprised of a reusable Control Box and a single use Clearing Stem. The Clearing Stem is connected to the Control Box. The Operator then manually inserts the Clearing Stem into the Feeding and Decompression Tube (i.e., 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. Control Box Model 101 is used to actuate all Clearing Stem models. Sixteen (16) Clearing Stem Models are proposed to accommodate the different types, sizes, and materials of Tubes.

The provided text describes the Actuated Medical, Inc. TubeClear System (K172556), a device intended for clearing occlusions in feeding and decompression tubes.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions "Performance bench testing used to support substantial equivalence was water ingress testing of the o-ring." This suggests that the testing was likely conducted in a lab environment.

3. Number of Experts and Qualifications for Ground Truth
Not applicable. The study described is bench testing (water ingress), not a clinical study involving human assessment or expert review for ground truth.

4. Adjudication Method for the Test Set
Not applicable. This was a bench test, not a study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. The submission focuses on bench testing for a material change, not a comparative study of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance
Not applicable. The TubeClear System is a physical medical device, not an AI algorithm. The performance evaluation was for the physical properties of a component (o-ring).

7. Type of Ground Truth Used
The ground truth for the performance testing was based on direct physical measurements: "water ingress testing of the o-ring." This is a measure of the o-ring's ability to prevent water from entering the control box.

8. Sample Size for the Training Set
Not applicable. This device is not an AI/algorithm-based device and therefore does not have a "training set" in the context of machine learning. The "training" for this device would refer to its design, engineering, and manufacturing processes.

9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI algorithm.

Ask a specific question about this device