(274 days)
The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
To Aid in Percutaneous Access to the Stomach During Gastrostomy Tube Placement.
The PUMA-G Pediatric 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 Pediatric System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G Pediatric 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 either the Sachs-Vine PUSH technique or the Ponsky PULL technique.
The provided FDA 510(k) clearance letter and summary for the PUMA-G Pediatric System describe a medical device designed to aid in the initial placement of gastrostomy feeding tubes. The summary outlines some performance testing, including a small safety clinical study. However, the document does not contain the detailed acceptance criteria or the specific study design elements (beyond a "small safety clinical study" and "single-center study") that would typically be reported for an AI/software device that needs to meet performance criteria for metrics like sensitivity, specificity, or accuracy based on a test set.
The PUMA-G Pediatric System appears to be a mechanical device with an ultrasound visualization component, not an AI/software-driven diagnostic or assistive device that would rely on a test set with ground truth established by experts and MRMC studies. The "performance data" mentioned focuses on mechanical, biocompatibility, and sterilization aspects, along with a safety study.
Therefore, many of the requested information points (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as they pertain to the rigorous evaluation of AI/software algorithm performance against established ground truth, which is not the primary focus of this device's clearance.
Based on the provided information, here's an attempt to answer the questions, highlighting where information is absent or non-applicable:
Device Description
The PUMA-G Pediatric System is a medical device designed to aid in the initial percutaneous placement of a gastrostomy feeding tube. It utilizes a balloon catheter with an internal magnet and an external magnet to coapt the stomach to the anterior abdominal wall. Users then employ their existing ultrasound for visualization and guided needle placement. The system also includes a guidewire.
Acceptance Criteria and Performance Study Analysis (Based on Provided Document)
Given the nature of the device as a mechanical aid with ultrasound visualization (rather than an AI/software algorithm for diagnosis or image analysis), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on safety, functional performance, and effectiveness in facilitating the procedure, rather than typical AI performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria for performance metrics in the way one would see for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance is described qualitatively and through the outcomes of a safety study.
| Acceptance Criterion (Inferred from Performance Data) | Reported Device Performance |
|---|---|
| Safety: Absence of serious adverse events or device-related adverse events. | "All patients successfully completed the gastrostomy procedure with no serious adverse events or device-related adverse events." |
| Effectiveness/Functionality: Successful completion of the gastrostomy procedure. | "The primary endpoint of safely completing the gastrostomy procedure was met." |
| Coaptation Time: Time taken to affix the stomach to the anterior abdominal wall. | " |
§ 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.