(59 days)
CONOD Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a piercing spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults.
The CONOD Enteral Feeding Sets have three models, CONOD safety spike plus pump set, CONOD gravity feeding set and CONOD feeding pump set. The CONOD Feeding Pump Set (1200ml) and gravity feeding set both have a structure of a 1200ml formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. CONOD Safety spike plus Pump Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device.
I am sorry, but based on the provided text, there is no information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML performance.
The document is a 510(k) premarket notification for "CONOD Enteral Feeding Sets," which is a medical device for dispensing liquid nutrition. The provided sections detail:
- Submission Information: Company, contact, device name, regulation, product code.
- Device Description: Models (pump set, gravity set, safety spike plus pump set), single-use, non-sterile.
- Indications for Use: Dispensing liquid nutrition at a user-controlled rate, interfacing with a feeding tube, for infants, children, adolescents, and adults.
- Comparison to Predicate Device (K150286, Medline Enteral Feeding Sets): Highlights similarities in intended use, product code, classification, design features (non-DEHP material, ISO 80369-3:2016 connector), materials, prescription use, disposability, intended use time (no longer than 24 hours), non-sterility, shelf-life, and available tube lengths.
- Performance Data: This section describes biocompatibility testing (cytotoxicity, sensitization, skin irritation, 10993-1, 10993-5, 10993-10 standards) and performance testing (fluid leakage, stress cracking, resistance to separation (axial load, unscrewing), resistance to overriding, disconnection by unscrewing, tensile properties, liquid leakage, flow rate, bioburden, usability), all conducted according to various ISO/EN/IEC standards.
- Animal Study/Clinical Study: States that neither was required.
- Conclusion: The device is substantially equivalent to the predicate based on non-clinical data and performance testing.
The "performance data" discussed refers to engineering and material safety tests for the medical equipment itself, not the performance of an AI/ML algorithm. Therefore, I cannot extract the information requested about AI/ML acceptance criteria, study details, sample sizes, expert involvement, or ground truth for an AI/ML device.
§ 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.