(337 days)
This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement. The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24 hours.
The Feeding Tube consists of the following main components: a feeding tube single lumen catheter and an enteral only connector hub with integral tethered connection closure plug. The catheter tubing is made of Polyurethane or PVC. The catheter tubing has an orange or purple radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration. The proposed Feeding Tube is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
This document is a 510(k) premarket notification decision letter from the FDA to Anhui Tiankang Medical Technology Co., Ltd. regarding their "Feeding Tube" device. It primarily focuses on the device's substantial equivalence to a predicate device and outlines the non-clinical performance data provided to support this claim.
Based on the provided text, the device is a medical feeding tube, and the "acceptance criteria" and "proof" relate to demonstrating its safety and effectiveness through non-clinical performance testing and biocompatibility testing, rather than a study involving human subjects or an AI algorithm. Thus, many of the typical elements of AI/ML device acceptance criteria (e.g., sample size for test set, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable here as this is a traditional medical device submission.
Here's an analysis of the acceptance criteria and the study (non-clinical testing) that proves the device meets them, based only on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to recognized international standards and successful completion of specific physical and biological tests. The "reported device performance" indicates that the subject device met these standards and test requirements.
| Acceptance Criteria (Test/Standard) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility Testing | |
| In Vitro Cytotoxicity Test (ISO 10993-5:2009) | Performed, result not explicitly stated but implied to be acceptable as "does not show any adverse effect" for the material difference. |
| Intracutaneous Reactivity Test (ISO 10993-10:2010) | Performed, result not explicitly stated but implied to be acceptable as "does not show any adverse effect" for the material difference. |
| Skin Sensitization Test (ISO 10993-10:2010) | Performed, result not explicitly stated but implied to be acceptable as "does not show any adverse effect" for the material difference. |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Performed, result not explicitly stated but implied to be acceptable as "does not show any adverse effect" for the material difference. |
| Subacute Toxicity (ISO 10993-11:2017) | Performed, result not explicitly stated but implied to be acceptable as "does not show any adverse effect" for the material difference. |
| Implantation Effects (ISO 10993-6:2017) | Performed, result not explicitly stated but implied to be acceptable as "does not show any adverse effect" for the material difference. |
| Sterilization & Shelf Life Testing | |
| Sterilization Validation (ISO 11135) | Validated to achieve a SAL of 10-6. |
| EO Residue (ISO 10993-7:2008) | Performed, result not explicitly stated but compliant. |
| ECH Residue (ISO 10993-7:2008) | Performed, result not explicitly stated but compliant. |
| Ageing Test (ASTM F1980-16 for 3-year shelf life) | Shelf life of three years determined based on stability studies. |
| Package Integrity (ASTM F88/F88M-15, ASTM F1929-2015, ASTM F1886/F1886M-16) | All packaging deemed acceptable for protection of product and sterility maintenance after testing (Seal strength, Blue Dye Penetration, Visual Inspection). |
| Performance Testing (Mechanical/Physical) | |
| Radiopacity Verification (ISO 20695:2020) | Compliant with ISO 20695:2020. |
| Tube Markings (ISO 20695:2020) | Compliant with ISO 20695:2020. |
| Liquid Leakage Testing (ISO 20695:2020, 50-60 kPa internal pressure) | "Feeding tube set shall not show signs of leakage sufficient to form a falling drop of water" - stated as tested and met the updated standard. |
| Fluid Leakage - Connector (ISO 80369-3 and ISO 80369-20, 300-330 kPa) | "The connector shall not leak" at applied pressure - stated as tested and met the standards. |
| Stress Cracking - Connector (ISO 80369-3 and ISO 80369-20) | "The connector shall have adequate resistance to stress cracking" - stated as tested and met the standards. |
| Resistance to Separation from Axial Load - Connector (ISO 80369-3 and ISO 80369-20) | "The connector shall not separate from the reference connector" - stated as tested and met the standards. |
| Resistance to Separation from Unscrewing - Connector (ISO 80369-3 and ISO 80369-20, |
§ 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.