(123 days)
TubeClear is indicated for use ONLY and SOLELY in clearing occlusions / clogs in Feeding and Decompression Tubes in adult patients that have a Tube of size 10 to 18 Fr.
The Clearing Stem Models are indicated for use as follows:
- 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).
- G-1014, for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 36 cm (14 in).
The Proposed Device, TubeClear, is comprised of Control Box Model 101 and Clearing Stem Models NE-1036, NE-1042, NE-1043, NE-1045, NE-1048, NE-1050, NE-1055, G-1008, G-1009, G-1010, G-1012, and G-1014. 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) 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 Mire. The motion at the Wire Tip mechanically acts on the occlusion and restores Tube patency.
The provided document details the 510(k) summary for the TubeClear device, specifically focusing on the new Clearing Stem Models. The submission claims substantial equivalence to its predicate device, also named TubeClear. The core of the device is to clear occlusions in feeding and decompression tubes using a reciprocating wire.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for each individual criterion. Instead, it describes various tests and states whether they were "successfully completed," "passed acceptance criteria," or found to be "equivalent" to the predicate device.
Below is a synthesized table based on the descriptions provided:
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Technical Testing | Product Specifications Verification | Meet product specifications | "Confirmed that the Clearing Stem Models met product specifications passing all acceptance criteria." |
| Transportation Vibration | Pass acceptance criteria for US highway truck | "Transportation testing successfully passed acceptance criteria for US highway truck." | |
| Shelf Life | Pass 24-month storage | "Shelf life was tested via accelerated life testing and passed 24 month storage." | |
| Efficacy Testing | Usability | Successfully reviewed by licensed healthcare practitioners | "Usability testing by licensed healthcare practitioners was successfully completed." |
| Effectiveness (Simulated Use) | Equivalent to Predicate Clearing Stem Models | "Found to be of equivalent effectiveness" to predicate devices. | |
| Safety Testing | Tube Damage (scratches, nicks, tears, abrasions, punctures) | Equivalent to Predicate Clearing Stem Models | "Found to be equivalent for the Proposed and Predicate Devices." |
| Tube Heating during Operation | Negligible and equivalent to Predicate Clearing Stem Models | "Negligible and equivalent for the Proposed and Predicate Devices, thus the Devices have equivalent safety in terms of heating." | |
| Tube Movement during Operation | Same magnitude as Predicate Clearing Stem Models | "Measured and found to be of the same magnitude, thus equivalent for both Devices." | |
| Control Box Testing | Electrical Safety (IEC 60601-1 3rd Edition) | Compliance with IEC 60601-1 3rd Edition | "Successfully completed in December, 2012." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the test sets in any of the described tests (Technical, Efficacy, Safety). It mentions "Clearing Stem Models" in plural, implying multiple units were tested, but no concrete numbers.
The data provenance is from bench testing performed by the manufacturer (Actuated Medical, Inc.) and a third-party lab (Intertek Group for electrical safety). All testing appears to be retrospective in the sense that it's performed on manufactured devices for regulatory submission. There is no mention of country of origin for the data; however, the testing entity (Intertek Group, Boxborough, MA) suggests the testing itself occurred in the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For the "Usability testing," it states "Usability testing by licensed healthcare practitioners was successfully completed." However, it does not specify the number of these practitioners or their specific qualifications (e.g., years of experience, specialty). Therefore, the number and qualifications of experts for establishing ground truth are not provided.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (e.g., 2+1, 3+1, none) for the test results. The assessment of equivalence and success appears to be based on direct measurement and comparison to the predicate device or established standards, rather than expert consensus on individual cases that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted or reported. This submission primarily focuses on the technical and safety equivalence of the device itself through bench testing, not on the improvement of human readers' performance with or without the device. The device is a tool used by practitioners, not an AI diagnostic aid for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device described, "TubeClear," is a physical medical device that requires direct human operation to insert and advance the clearing stem. It is not an algorithm or AI system that can perform without human-in-the-loop. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed. The "Control Box" provides electromechanical actuation, but the device's function is inherently human-assisted.
7. The Type of Ground Truth Used
The ground truth for the efficacy and safety tests appears to be based on:
- Product Specifications: For technical verification.
- Simulated Use Conditions: For efficacy testing, where successful clearing of occlusions in simulated tubes would be the "ground truth."
- Measurement and Observation: For safety tests like tube damage, heating, and movement, where direct measurement of these parameters against acceptable ranges or predicate device performance constitutes the "ground truth."
- Licensed Healthcare Practitioner Evaluation: For usability, where their feedback on the device's ease of use and performance in a simulated environment serves as the "ground truth."
There is no mention of pathology, biological outcomes data, or patient outcomes data being used as ground truth for this submission, as it explicitly states "No clinical data was collected."
8. The Sample Size for the Training Set
Since "No clinical data was collected" and the device is a mechanical tool rather than an AI/ML algorithm, there is no concept of a "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, the question of how its ground truth was established is not applicable.
§ 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.