(168 days)
No
The 510(k) summary describes a mechanical device for enteral feeding and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a conduit for delivering formula or for inserting other access devices, rather than directly providing therapy itself.
No
The device is intended for delivering formula and inserting other devices, not for diagnosis.
No
The device description clearly outlines physical components like a gastrostomy tube, obturator, and a "step-up shim," indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Kangaroo® EntriStar™ Skin-Level Gastrostomy Kit is a device used for delivering formula to a patient requiring enteral nutrition and as a conduit for insertion of other enteral access devices. It is a physical tube inserted into the body.
- Lack of Diagnostic Purpose: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its purpose is purely for delivering substances or facilitating the insertion of other devices.
- Classification: The device is classified as a "Gastrointestinal Tube and Accessories" under 21 CFR 876.5980, which is a classification for devices used within the gastrointestinal system, not for in vitro diagnostic testing.
Therefore, the Kangaroo® EntriStar™ Skin-Level Gastrostomy Kit is a medical device used for therapeutic and access purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
78KNT
Device Description
The Skin-Level Gastrostomy 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen into the stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In accordance with ISO 10993 Part-1 Biocompatibility Guidance, the Kangaroo® EntriStar™ Skin-Level Gastrostomy Kit is categorized as an implantable device, of permanent contact, contacting tissue/bone. Based on this classification, the kit will be required to pass the following battery of tests: Implantation (7 day), Cytotoxicity, Sensitization, Genotoxicity and Chronic Toxicity prior to the release of product for sale. In addition to biocompatibility testing, Sherwood has established functional specifications to ensure the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR - 8 996
Kg54429
510(k) Summary of Safety & Efficacy: Kangaroo® EntriStar™ Skin-Level Gastrostomy Feeding Kit
Sherwood Medical Co., 1915 Olive St., Submitted by: St. Louis, MO 63103, (314) 621-7788 Dennis Pozzo, Requlatory Affairs Manager Contact : Date Prepared: September 11, 1995
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.
In accordance with ISO 10993 Part-1 Biocompatibility Guidance, the Kangaroo® EntriStar™ Skin-Level Gastrostomy Kit is categorized as an implantable device, of permanent contact, contacting tissue/bone. Based on this classification, the kit will be required to pass the following battery of tests: Implantation (7 day), Cytotoxicity, Sensitization, Genotoxicity and Chronic Toxicity prior to the release of product for sale. In addition to biocompatibility testing, Sherwood has established functional specifications to ensure the device is safe and effective for its intended use.
Sherwood believes that the Kangaroo® EntriStar™ Skin-Level Gastrostomy is substantially equivalent to the Low-Profile Gastrostomy Device Kit [Biosearch Medical Products, Somerville, NJ] which was cleared as 510K No. K923474. In fact, the device covered by this submission is simply a modified version of the design disclosed in K923474 Both kits utilize the same basic gastrostomy tube design and accessories.