(15 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, TubeClear™ is composed of a reusable Control Box and single use Clearing Stem. One Control Box Model, 101, is used to actuate all Clearing Stem models. Two Clearing Stem Models, NG-1036 and NG-1043, are available to accommodate different sizes of Tubes. The Operator manually inserts the Clearing Stem into the feeding or decompression tube (i.e., Tube) and directs the Clearing Stem's progression 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 and restores Tube patency.
The provided text describes the acceptance criteria and the study that proves the TubeClear™ device meets these criteria. Since this is a 510(k) summary for a medical device, the studies are non-clinical (bench testing).
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a single table, but are woven throughout the "NON-CLINICAL PERFORMANCE DATA" section, particularly under Technical, Efficacy, and Safety Testing. The "Reported Device Performance" refers to the results of these tests for TubeClear™. The predicate device, The DeClogger®, is used for comparison in many cases to establish substantial equivalence.
| Acceptance Criteria Category | Specific Criteria / Test | TubeClear™ Performance / Outcome | Comparison to Predicate (DeClogger®) |
|---|---|---|---|
| Technical | Product Specifications | Met all acceptance criteria | N/A (Verification) |
| Control Box Reliability | Passed testing equivalent to one year of operation | N/A (Verification) | |
| Transportation Vibration | Successfully passed acceptance criteria for US highway truck | N/A (Verification) | |
| Shelf Life | Passed 6-month storage (accelerated) | N/A (Verification) | |
| Firmware Validation | Passed all acceptance criteria ('moderate' level) | N/A (Verification) | |
| Efficacy | Usability | Passed all acceptance criteria | Found to be of equivalent effectiveness |
| Effectiveness (simulated use) | Found to be of equivalent effectiveness | Equivalent effectiveness | |
| Safety | Tube Damage | Equivalent for Proposed and Predicate Devices (no significant scratches, nicks, tears, abrasions, punctures) | Equivalent |
| Heating during operation | Negligible (less than resolution of test equipment) | Equivalent | |
| Tube Movement | Same magnitude | Equivalent | |
| Magnetic Field Strength | Passed acceptance criteria for safe operation | N/A (Specific to TubeClear™) | |
| Electrical Safety | Adherence to standards (8 specific standards, e.g., UL 60601-1, IEC 60601-1-2) | Met all requirements | N/A (Specific to TubeClear™) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data, as no clinical data was collected. Instead, the "tests" refer to non-clinical bench testing.
- Sample Size for Test Set: Not specified in terms of number of particular items tested for each bench test. For example, for "Tube Damage," it implies multiple tubes were tested, but the exact number isn't quantified. For "Control Box Reliability," it passed "testing equivalent to one year of operation," suggesting a duration-based test rather than a sample size of distinct control boxes.
- Data Provenance: The data is entirely non-clinical bench testing.
- Country of Origin: Testing was performed by Intertek Group, Inc. (Boxborough, MA) for Electromagnetic Compatibility (EMC) and Electrical Safety Tests. The location of other technical, efficacy, and safety tests is not explicitly stated, but given the company's address (Bellefonte, PA), it is likely conducted within the USA or through US-based labs.
- Retrospective or Prospective: These are prospective tests designed and conducted specifically to validate the device's performance against predefined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the studies are entirely non-clinical (bench testing). There is no "ground truth" established by human experts in the way clinical studies requiring diagnosis or evaluation by medical professionals would. The "ground truth" for these tests is based on objective performance metrics and engineering standards (e.g., passing electrical safety standards, negligible heating, equivalent efficacy in simulated use).
4. Adjudication Method for the Test Set
Not applicable. Since the performance assessment is based on objective bench testing measurements and adherence to engineering specifications, there is no need for expert adjudication in the traditional clinical sense (e.g., 2+1 review for discordant readings).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was collected; therefore, no clinical data is presented in this submission." The effectiveness comparison was performed through "Efficacy testing" in a simulated environment, comparing TubeClear™ with the predicate device, the DeClogger®. This was not a human-in-the-loop study with multiple readers and cases.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable, as no human-in-the-loop clinical studies were conducted, and the device is not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
While the device's function is automated (linear reciprocating motion from a control box), it is not an "algorithm only" device in the sense of software for image analysis or diagnosis. Its performance (efficacy, safety) was evaluated in standalone bench tests without direct human-in-the-loop clinical scenarios. For example, the "efficacy during simulated use" and "safety testing in terms of Tube damage" represent standalone performance evaluations.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the bench testing was based on:
- Engineering Specifications: For technical tests like product specifications, reliability, vibration, and firmware validation.
- Objective Measurements: For safety tests like heating, tube movement, and magnetic field strength (measured by equipment).
- Simulated Performance: For efficacy and tube damage, where performance was observed and compared to the predicate device in a controlled, non-clinical setting.
- Industry Standards: For electrical safety and EMC testing (e.g., UL, CSA, IEC, ISO standards).
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical/electromechanical medical device, not a machine learning or AI-based system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no "training set" for this type of 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.