(159 days)
The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults only.
The PUMA-G System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using the Sachs-Vine PUSH technique.
The provided text describes the CoapTech PUMA-G System and its substantial equivalence determination, but it does not contain the detailed information requested for acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states that "Bench and animal performance data were collected to support a substantial equivalence determination" and lists the types of testing performed (balloon performance, magnetic force characterization, coupling strength, capture reliability, biocompatibility, and sterilization). However, it does not provide:
- A table of specific acceptance criteria and reported device performance values. It only gives a high-level summary that the "PUMA-G System can effectively bring together the stomach and anterior abdominal wall while maintaining healthy tissue" and "reliably captures and retains the guidewire."
- Sample sizes, data provenance, or details of the test sets.
- Information about experts used for ground truth, adjudication methods, or MRMC studies.
- Details about standalone algorithm performance if it were an AI device (which it is not).
- The type of ground truth used (beyond implying animal and bench testing results).
- Training set information, as this is a medical device, not an AI/ML algorithm that requires a training set in the conventional sense.
Therefore, I cannot fulfill the request with the provided text. The document focuses on demonstrating substantial equivalence to a predicate device based on functional and safety performance, but not on detailed performance metrics against predefined acceptance criteria in the format requested.
§ 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.