(30 days)
The MIC-KEY® G™ Low Profile Gastrostomy Replacement Kit is designed as a replacement Gastrostomy tube. It can be used in any well formed gastric tract where a low profile device is considered desirable.
Gastrostomy tube feeding may be indicated for patients needing long term enteral support, including but not limited to, feeding, hydrating, medication delivery, and decompressing, secondary to a primary condition relating to the head or neck. These conditions may include:
Stroke Cancer Head or neck tumors, injuries, or trauma Neurological disorders resulting in a chewing or swallowing disorder.
The MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit is intended to be used for patients requiring enteral support or decompression via a gastrostomy and is designed to be a balloon - secured replacement gastrostomy tube. A tapered distal tip eases insertion through the gastric tract and the balloon is then inflated to assure secure placement. The tapered tip makes the tube less traumatic to place than skin level tubes with mushroom type tips.
Device modification: The modification to this device is a change in balloon material formulation.
The device is packaged sterile and is marketed with a number of accessories; reference page 19 - Kit Certification, "Special" 510(k) Premarket Notification.
The provided text describes a "Special" 510(k) premarket notification for a device modification. The modification is a change in the balloon material formulation of the MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit. The submission focuses on demonstrating substantial equivalence to a predicate device, as such it relies on non-clinical data for performance evaluation.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (from predicate device) | Reported Device Performance (Proposed Device) |
|---|---|---|---|
| Material Integrity | Visual/Dimensional Inspection | Identical to predicate device | Passed inspection |
| Functional Performance | Balloon Burst Strength | Identical to predicate device | Met acceptance criteria |
| Durability | High Acid Balloon Life Study | Identical to predicate device | Met acceptance criteria |
Note: The document explicitly states: "The testing of and acceptance criteria of the proposed device was identical to the testing and acceptance criteria of the predicate device." However, the specific numerical or qualitative criteria for each test are not detailed in the provided text. It only indicates that the proposed device met these unspecified criteria which were identical to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the non-clinical tests (Visual/Dimensional Inspection, Balloon Burst Strength, High Acid Balloon Life Study). It mentions "the proposed MIC-KEY® 'G'™ Gastrostomy Tube" as the subject of testing, implying that samples of the modified device were used.
The data provenance is retrospective, as it refers to comparing the modified device's performance to an already legally marketed predicate device (MIC-KEY® "G"™ Low Profile Gastrostomy Tube -510(k) K922667/B). The tests were conducted "in vitro".
The country of origin for the data is implicitly the United States, as Ballard Medical Products is located in Draper, UT, and the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is a non-clinical, in-vitro performance evaluation of a device modification, not a study involving human subjects or expert assessment of clinical data. The "ground truth" for these engineering tests would be the established specifications and performance characteristics of the predicate device.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
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
This information is not applicable. The device is a medical tube for enteral feeding, not an imaging or diagnostic device that would involve "human readers" or AI assistance in the context of interpretation.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was Done
This information is not applicable for the reasons stated in point 5.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests was the established performance specifications and acceptance criteria of the legally marketed predicate device. The goal was to demonstrate that the modified device performed identically to the predicate device in terms of these engineering benchmarks.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in 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.