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510(k) Data Aggregation
(90 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 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. | "< 10 Minutes" (Table 1) |
| Overall Safety and Effectiveness | Reasonable assurance of safety and effectiveness, substantially equivalent to predicate device. | "These data suggest the PUMA-G System is as safe and as effective as the identified predicate device." and "Based upon analysis and valid scientific evidence, reasonable assurance of safety and effectiveness is apparent, therefore concluding that the PUMA-G System is substantially equivalent to its predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Bench performance data were collected..." and refers to "Functional Testing" and "Magnetic Characterization." It also mentions "Post-Market Analysis" for the subject device and "GLP Animal Safety" for the predicate in Table 1. However, specific sample sizes for any test set are not provided in the document. The data provenance seems to be internal company testing, as it's presented as "Bench performance data." The document does not specify country of origin or whether the studies were retrospective or prospective, though bench testing is inherently prospective for the device being tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not describe any studies involving human experts establishing ground truth for a test set. The performance data discussed appears to be primarily technical/mechanical bench testing.
4. Adjudication Method for the Test Set:
Not applicable, as no expert-based test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided text. The evaluation method appears to be focused on the device's technical performance and comparison to a predicate device based on technological characteristics and bench testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
The PUMA-G System is a physical medical device (catheter, guidewire, external magnet), not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device facilitates a procedure for human users.
7. The Type of Ground Truth Used:
For the bench performance tests mentioned, the "ground truth" would be established by:
- Physical measurements and engineering standards: For magnetic force characterization, coupling strength, and mechanical performance.
- Biocompatibility standards: ISO 10993 for materials.
- Sterilization validation standards: ISO 11135 for ethylene oxide sterilization.
- Animal safety data: Referenced for the predicate device ("GLP Animal Safety"), likely pathological or physiological outcomes.
8. The Sample Size for the Training Set:
The concept of a "training set" typically applies to machine learning or AI algorithms. Since the PUMA-G System is a mechanical device, there is no training set in the traditional sense of AI algorithm development. Device development likely involves iterative design, prototyping, and testing, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established:
As there is no training set for an AI algorithm, this question is not applicable.
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