(89 days)
The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.
This device, with the exception of length, is identical to the TFX Medical Safety Needle with Introducer cleared by the FDA in K000665. The working length of the needle has been increased, due to the intended gastrointestinal use, and will be available in 2F - 6F sizes with lengths ranging between 2.50″ - 4.0″. The Modified TFX Medical Safety Needle with Introducer will allow placement of guidewires ranging from 0.015″ - 0.052″. The variance in sizes and lengths is due to specific procedure, physician preference and patient body type.
This product consists of two components:
- Safety Needle (Needle with Passive Sharps Protection)
- Peelable Splitable Introducer
The provided text is a 510(k) summary for a medical device (Modified TFX Medical Safety Needle with Introducer) and a determination letter from the FDA. It does not contain information about acceptance criteria, study methodologies, or test performance data for this device.
The document states that the device is "substantially equivalent in design and materials" to previously cleared devices and mentions the use of a "guidance document, 'Supplementary Guidance on the Content of Premarket Notification Submissions for Medical Devices with Sharps (510 (k) | Injury Protection Features)', was used in the design and verification of the function of the Safety Needle." However, it does not detail the specific acceptance criteria or the results of any testing done to prove the device meets them.
Therefore, I cannot provide the requested information from the given input. The requested details would typically be found in a more comprehensive study report or a different section of a 510(k) submission that elaborates on design verification and validation testing.
§ 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.