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510(k) Data Aggregation
(90 days)
PUMA-G System
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 and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).
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 using the guidewire and Seldinger technique.
The provided text describes the PUMA-G System, a medical device intended to affix the stomach to the anterior abdominal wall to facilitate the initial percutaneous placement of a gastrostomy feeding tube.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a formal table or list. However, the "Performance Data" section describes the types of performance data collected and the conclusions drawn regarding effectiveness and safety.
| Acceptance Criteria Category (Derived) | Desired Outcome (Derived) | Reported Device Performance |
|---|---|---|
| Effectiveness (Affixture) | Adequately bring together the stomach and anterior abdominal wall. | "Performance test results demonstrate reasonable assurance that the PUMA-G System can effectively bring together the stomach and anterior abdominal wall..." |
| Safety (Tissue Harm) | Maintain healthy tissue (no harm during affixture). | "...while maintaining healthy tissue." |
| Effectiveness (Guidewire) | Reliably capture and retain the guidewire for gastrostomy tube placement. | "The PUMA-G System also reliably captures and retains the guidewire for eventual completion of the gastrostomy tube placement." |
| Magnetic Force Characterization | Adequate magnetic force for temporary tissue affixture without causing harm. | "The magnetic force was characterized in performance testing to ensure it can adequately create temporary affixture of the tissue (effectiveness) without harming the tissue (safety)." (This is a statement about the purpose of the test rather than the quantitative result, but implies the characteristic was met.) The "Performance Data" section also mentions "magnetic force characterization and coupling strength information," suggesting these were measured and found acceptable. |
| Biocompatibility | Materials are safe for medical use. | "ISO 10993 Compatible" (Table 1) |
| Sterilization | Device can be reliably sterilized. | "Ethylene Oxide ISO 11135 Validated" (Table 1) |
| Time (Procedural) | Procedure time is within acceptable limits. | " |
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(159 days)
PUMA-G System
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.
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