(25 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 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 obturator placed mushroom type tips.
The balloon in this device is mounted (distal cuff) to the distal inner lumen of the feeding tube, the proximal cuff is mounted to the outer diameter of the feeding tube. While the balloon length is equivalent to the predicate MIC-KEY, the overall length of the device has been decreased to facilitate the balloon, when inflated, to surround the device distal tip.
The device is packaged sterile and is marketed with a number of accessories; reference Section 11 - Kit Certification, "Special" 510(k) Premarket Notification.
Here's a breakdown of the acceptance criteria and study information for the MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Balloon Cuff Glue Bond Inspection | Passed (implied; testing was "identical to the testing and acceptance criteria of the predicate device") |
| Visual/Dimensional Inspection | Passed (implied; testing was "identical to the testing and acceptance criteria of the predicate device") |
| Balloon Burst Strength | Passed (implied; testing was "identical to the testing and acceptance criteria of the predicate device") |
Study Information
- Sample sizes used for the test set and the data provenance: Not specified in the provided text. The text only mentions "non-clinical data" and "in vitro tests."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study involved non-clinical, in vitro testing, not expert-adjudicated test sets.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was an in vitro mechanical testing study, not one requiring adjudication by experts.
- 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: Not applicable. This is a medical device, not an AI diagnostic tool. No MRMC study was mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth was established by the in vitro mechanical properties of the device, specifically its balloon cuff glue bond, visual/dimensional characteristics, and balloon burst strength, as compared to a predicate device.
- The sample size for the training set: Not applicable. This was a non-clinical, in vitro study for a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The provided document describes a "Special" 510(k) premarket notification for a modification to an existing medical device, the MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit. The study conducted to demonstrate the device meets acceptance criteria was a non-clinical, in vitro performance testing study.
The core of the study involved comparing the modified device to its predicate device (MIC-KEY® Low Profile Gastrostomy Kit #K922667/B) using identical testing and acceptance criteria. The tests performed were:
- Balloon Cuff Glue Bond Inspection
- Visual/Dimensional Inspection
- Balloon Burst Strength
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." It then concludes that based on the performance testing, the device is "safe and effective for its intended use." This implies that the modified device met the same performance standards as the predicate device for these critical mechanical characteristics. No specific numerical results or sample sizes for these tests are provided in the excerpt.
§ 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.