(168 days)
The Kanqaroo® EntriStar™ Skin-Level Gastrostomy Kit is a sterile, single use device containing a gastrostomy tube and the components needed to insert a low profile qastrostomy tube. The Kangaro® Skin-Level Gastrostomy Kit is a Class II device, Gastrointestinal Tube and Accessories per 21 CFR 876.5980, Procode: 78KNT.
The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as conduit for insertion of enteral access devices such as qastric a decompression catheters or intestinally placed feeding catheters.
The Kanqaroo® EntriStar™ Skin-Level Gastrostomy Kit is a sterile, single use device containing a gastrostomy tube and the components needed to insert a low profile qastrostomy tube. The Kangaro® Skin-Level Gastrostomy Kit is a Class II device, Gastrointestinal Tube and Accessories per 21 CFR 876.5980, Procode: 78KNT.
The Skin-Level Gastrostomy Tube is a replacement gastrostomy tube placed through an existing stoma via the abdomen into the stomach. The tube acts as a conduit to deliver formula to a patient requiring enteral nutrition and as conduit for insertion of enteral access devices such as qastric a decompression catheters or intestinally placed feeding catheters. The stoma tube is designed so that it is a fixed length to correspond to the depth of the stoma. However, a "step-up shim" may be placed between the external retention device and the abdominal wall to customize the fit to the patient.
The Skin-Level Gastrostomy Tube is inserted and removed by inserting the obturator through the inner lumen of the stoma tube. When inserted, the obturator mechanically slenderizes (elongates) the internal retention device, which reduces its diameter to reduce the physical trauma to the stoma inherent in the insertion and removal procedures.
The Skin-Level Gastrostomy Tube is available in various lengths designed to precisely fit the depth of the patient's stoma, which results in a snuq fit between the surface of the external retention device and the patient's abdomen. An insertion/removal accessory is included for use when inserting and removing the gastrostomy tube.
The distal tip of the obturator and the internal retention device are covered in lubricous Hydromer coatinq to reduce the force needed to insert the obturator and qastrostomy tube. Hydromer coating is currently used in several nasoqastric feeding tubes marketed by Sherwood and Biosearch Medical Products which were cleared via the 510(k) process.
This document is a 510(k) summary for a medical device (Kangaroo EntriStar Skin-Level Gastrostomy Feeding Kit) and does not describe a study involving an AI/ML device. Therefore, most of the requested information (acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this submission.
However, based on the provided text, I can extract information related to the device's functional specifications and biocompatibility testing, which serve as its acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Specification | Reported Device Performance (Implied by Submission) |
|---|---|---|
| Biocompatibility | Implantation (7 day) | Will be required to pass prior to release for sale. |
| Cytotoxicity | Will be required to pass prior to release for sale. | |
| Sensitization | Will be required to pass prior to release for sale. | |
| Genotoxicity | Will be required to pass prior to release for sale. | |
| Chronic Toxicity | Will be required to pass prior to release for sale. | |
| Functional Specifications | Snug fit between external retention device and patient's abdomen (due to precise length options) | Designed to achieve a snug fit. |
| Reduced physical trauma during insertion/removal (due to obturator slenderizing internal retention device) | Designed to reduce physical trauma. | |
| Reduced force needed for insertion (due to lubricous Hydromer coating) | Designed to reduce insertion force. | |
| Sterility | Sterile, single-use device. | |
| Substantial Equivalence | Modified version of cleared device K923474 (Low-Profile Gastrostomy Device Kit) | Believed to be substantially equivalent to K923474. |
Study Proving Device Meets Acceptance Criteria:
The document describes that the device will be required to pass a battery of biocompatibility tests (Implantation, Cytotoxicity, Sensitization, Genotoxicity, and Chronic Toxicity) prior to its release for sale, in accordance with ISO 10993 Part-1 Biocompatibility Guidance. This indicates that these tests are the studies proving it meets those specific acceptance criteria.
For functional specifications, the document states (implicitly and explicitly) that Sherwood has established functional specifications to ensure the device is safe and effective. The "study" proving these are met is likely in-house testing and design validation, although details are not provided in this summary. The primary "study" for regulatory clearance is the argument for substantial equivalence to a previously cleared device (K923474). The submission states, "the device covered by this submission is simply a modified version of the design disclosed in K923474." The implication is that since the predicate device met its safety and effectiveness criteria, and this new device is a modified version that maintains core design and function, it also meets the criteria.
Information Not Applicable or Not Provided in the Text (for AI/ML studies):
- 2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 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: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: For biocompatibility, the ground truth is established by the results of the specific biological tests per ISO 10993. For functional specifications, it's established by engineering and design validation tests. For substantial equivalence, the "ground truth" is the performance and clearance of the predicate device.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: 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.