(88 days)
The feeding tube is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication, or decompression through an established gastrointestinal stoma tract.
The Kangaroo Skin Level Gastrostomy Device Feed Set Kit with ENFit® Connection is indicated for use in adult and pediatic patients that require enteral feeding, medication administration, or decompression through a Kangaroo Skin Level Device.
The Kangaroo ™ Skin Level Balloon Gastrostomy Kit will be comprised of one Kangaroo™ Skin Level Device and one of each of the feed sets. The feed sets, continuous and bolus, are also available in Feed Set Kits packaged individually and then boxed as a 10-pack.
The Kangaroo™ SLD is constructed primarily of silicone and consists of a hub which is overmolded on to a previously extruded bi-lumen shaft. The tip of the shaft is filled with radiopaque barium RTV. At the distal end, a silicone subsumed tip balloon is reverse bonded to the shaft using a silicone RTV. This subsumed tip balloon accomplishes patient comfort by not exposing the tip of the shaft to the patient as well as being in line with the shaft. In use, the balloon end of the catheter is inserted through a gastrointestinal stoma tract and into the stomach. The balloon is then inflated with sterile or distilled water (per the recommended volume for the specific device size) to secure the device in place. To confirm placement of the device in the stomach, fluoroscopic procedures are typically used since the catheter shaft tip has radiopaque barium stripe present. Accessories for the Kangaroo™ SLD include two feed extension set confiqurations (ENFit bolus and continuous), an inflation syringe, a feeding syringe (ENFit), and gauzes.
The hub has two ports. The top (center) port contains a reflux valve assembly which is keyed to accept the feed set valve connectors. Leaks are prevented by the reflux valve assembly (with cross-slit valve design). The second port is the inflation port and contains the inflation valve.
The device is available in the configurations per determined market needs shown below in Table 5.5-2.
The feed extension sets have a valve connector end that inserts into the Kangaroo™ SLD reflux valve. For these ENFit Feed Sets, the opposite end has an ENFit-compatible connector complying with ISO 80369-3 (for prevention of misconnections with nonenteral feeding devices). The extension set can then connect to any ENFit-compatible enteral giving sets or ENFit-compatible syringes. Finally, both the Kangaroo™ Skin Level Device and the Kangaroo™ Feed Sets are compatible with competitor devices currently on the market.
This document is a 510(k) summary for the Kangaroo Skin Level Balloon Gastrostomy Kit and associated feed sets. It does not describe a study involving an AI/ML device, but rather a traditional medical device (gastrostomy kit). Therefore, many of the requested categories related to AI/ML device studies, such as the use of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable.
However, I can extract information regarding the device's acceptance criteria and how its performance was demonstrated through non-clinical testing.
Here's the summary of the acceptance criteria and study information that is applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with numerical performance results directly in the format requested. Instead, it states that results from all tests "met the acceptance criteria for each test."
However, it lists the types of performance tests conducted based on relevant standards. The "acceptance criteria" can be inferred as the requirements set by these standards:
| Acceptance Criteria Category (Inferred from Standards) | Reported Device Performance |
|---|---|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Met acceptance criteria (deemed applicable from predicate device) |
| Sterilization (EO residuals) | Met acceptance criteria (deemed applicable from predicate device) |
| Resistance to device migration (hub or balloon) | Met acceptance criteria |
| Enteral feeding devices testing (ASTM F2528-06(2014)) | Met acceptance criteria |
| Tensile testing (EN 1615:2000 and EN 1618:1997) | Met acceptance criteria |
| Leak testing (EN1615:2000, EN 1618:1997, ISO 20695:2020) | Met acceptance criteria |
| Valve connector insertion/removal force testing (ISO 20695:2020) | Met acceptance criteria |
| Low profile device-valve connector torque testing | Met acceptance criteria |
| Feed/extension set pinch clamp testing (stop fluid flow) | Met acceptance criteria |
| Resistance to expected chemical exposure | Met acceptance criteria |
| Distribution simulation testing | Met acceptance criteria |
| Design validation testing (simulated use, blenderized diet) | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (number of devices) used for each specific test mentioned under "Performance Testing Bench." It only indicates that "all the above tests met the acceptance criteria," implying that sufficient units were tested to demonstrate compliance.
The data provenance is from non-clinical bench testing conducted by the manufacturer, Xeridiem Medical Devices, on the proposed devices, or leveraged from previously conducted tests on the identified predicate and reference devices. There is no mention of country of origin for data; it is assumed to be from the manufacturer's internal testing. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as this is for a traditional medical device and not an AI/ML diagnostic or interpretive device. The "ground truth" here is the performance of the device against engineering and safety standards, directly measured through physical tests.
4. Adjudication Method for the Test Set
Not applicable. Device performance was assessed against predefined engineering and safety standards, not through human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/ML device, and therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a traditional medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this traditional medical device is based on established engineering and safety standards (e.g., ISO 80369-3, EN1615, ISO 20695, ASTM F2528-06, ISO 10993-1). The device's physical and functional characteristics are directly measured and compared against the requirements specified in these standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set.
§ 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.