(26 days)
TubeClear Clearing Stem Model TC-1018 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type and size (French and length).
· 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).
TubeClear Clearing Stem Model TC-0812 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.
· TC-0812, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in).
TubeClear Clearing Stem Model TC-0608 is indicated for use ONLY and SOLELY in clearing occlusion / cloas in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.
- 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).
The Proposed Device, the TubeClear Control Box and Clearing Stem, is comprised of Control Box Model 101 and Clearing Stem Models TC-0608, TC-0812, and TC-1018. The Control Box is reusable and the Clearing Stems are single use. The Operator manually inserts the Clearing Stem into the feeding and/or decompression tube (i.e., Tube), while the Tube remains in the Patient, 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.
Three (3) new Clearing Stem Models are proposed. The additional Clearing Stem Models expand the specific indications for use.
This document describes the TubeClear Control Box and Clearing Stem (referred to as the "Proposed Device") and its substantial equivalence to a previously marketed device, also called TubeClear (referred to as the "Predicate Device"). This is a summary from a 510(k) premarket notification to the FDA. The information provided focuses on the non-clinical performance data to demonstrate substantial equivalence, as no clinical data was collected.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with numerical acceptance criteria and reported device performance. Instead, it uses qualitative statements about conformance and substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance (Proposed Device) |
|---|---|
| Technical Testing | |
| Product Specifications | Met all product specifications. |
| Wire Tip Flexibility | Assessed, results contribute to substantial equivalence. |
| Forces on Clearing Stem | Assessed, results contribute to substantial equivalence. |
| Distal Wire Pull Force | Assessed, results contribute to substantial equivalence. |
| Accelerated Shelf Life | Met all acceptance criteria for 12 months storage. Ongoing testing for longer shelf life. |
| Packaging Integrity / Transportation Vibration | Met all acceptance criteria for US highway truck. |
| Efficacy Testing | |
| Human Factors Validation | Successfully completed by certified and licensed healthcare practitioners. Results support substantial equivalence of effectiveness. |
| Device Effectiveness | Effectiveness during simulated use was compared to Predicate Device; results support substantial equivalence. |
| Safety Testing | |
| Tube Integrity (scratches, nicks, tears, abrasions, punctures) | Assessed; found to be substantially equivalent to Predicate Device. |
| Tube Heating | Found to be negligible and substantially equivalent to Predicate Device. |
| Tube Movement | Found to be substantially equivalent to Predicate Device. |
| General Medical Electrical Equipment Safety (IEC-60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)) | Conformance tested and found by third party (Intertek Group). |
| Usability Engineering (IEC 60601-1-6: 2010, IEC 62366: 2007) | Conformance tested and found by third party (Intertek Group). |
| Risk Management (ISO 14971-compliant system) | Conformance tested and found by third party (Intertek Group). |
| Electromagnetic Compatibility (IEC 60601-1-2:2001 +A1:2004) | Conformance tested and found by third party (Intertek Group). |
| Intestinal Lining Puncture (Animal Testing - worst case over-insertion) | Results support that the Proposed Clearing Stem Design is safe for its intended use and substantially equivalent to the Predicate Device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- Technical Testing: Not explicitly stated for each test, but implied to be sufficient for verification and adherence to product specifications (e.g., "Verification confirmed that the Clearing Stem Models met product specifications").
- Efficacy Testing (Human Factors Validation & Device Effectiveness): The number of participants for human factors validation is not specified, but they are described as "certified and licensed healthcare practitioners." The number of simulated uses or cases for device effectiveness testing is also not explicitly stated.
- Safety Testing: Not explicitly stated for each test (e.g., number of tubes tested for integrity, heating, or movement).
- Animal Testing: Not explicitly stated, but performed "on porcine jejunum tissue."
- Data Provenance: The document does not specify the country of origin of the data. It indicates the testing was "in-house" for much of the technical, efficacy, and safety testing, with some safety tests conducted by a "third-party organization (Intertek Group (Boxborough, MA))" in the US.
- Retrospective or Prospective: All testing described appears to be prospective as it's designed to evaluate the new device for market clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Human Factors Validation: "Certified or Licensed Healthcare Practitioners" were involved. The specific number or their detailed qualifications (e.g., years of experience, specific specialty) are not provided. They were the "users" in this context, and their performance likely contributed to the "ground truth" of usability.
- Other Testing: For the bench and animal testing, the "ground truth" was established by objective measurements and assessments against predefined criteria, rather than expert consensus on interpretation. For instance, "Verification confirmed that the Clearing Stem Models met product specifications," implies internal testing against engineering specifications forming the ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the context of expert review, as the testing primarily involves objective performance metrics and human factors validation rather than interpretive tasks.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. This device is a mechanical tool for clearing clogs, not an AI-assisted diagnostic or interpretive system. The "Human Factors Validation and comparison of device effectiveness testing" focused on the performance of the device itself and user interaction, not on improving human "reading" or diagnostic skills with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the TubeClear system, as it is a mechanical device that inherently requires "human-in-the-loop" operation (an operator manually inserts and directs the clearing stem). There is no "algorithm only" component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for evaluating the TubeClear device was primarily based on:
- Engineering Specifications/Objective Measurements: For technical aspects like product specifications, wire tip flexibility, forces, shelf life, and packaging.
- Simulated Use Performance: For efficacy, where the ability to clear occlusions in simulated tubes was measured.
- Direct Observation/Measurement of Physical Effects: For safety, assessing tube integrity, heating, and movement directly.
- Controlled Animal Study: For assessing the risk of puncture in worst-case scenarios.
- Conformance to Consensus Standards: For basic safety, usability engineering, risk management, and electromagnetic compatibility.
8. The sample size for the training set
This question is not applicable as the TubeClear device is a mechanical device and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.