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510(k) Data Aggregation
(225 days)
ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e. an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.
ENDORAIL is a colonoscopy add-on device developed to be used without any modification to colonoscopes and peripheral devices currently utilized. It is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. The device works as a magnetic anchor that allows the operator to guide the colonoscope and to straighten colon curves and loops. ENDORAIL includes a Balloon Guide that can be introduced, when needed, through the endoscope instrument channel during the colonoscopy, if this procedure becomes challenging. The system does not require to be premounted and does not interfere with the normal colon examination process. The Balloon Guide is advanced beyond the colonoscope tip where the balloon is filled with a ferromagnetic fluid and magnetically anchored to a magnetic Handpiece placed on the patient's abdomen. Once anchored, the colonoscope can be easily straightened and guided along the device, allowing a fast and safe inspection of the entire colon. Once the challenging segment of the colon is resolved, or the colonoscopy procedure is completed, the Balloon Guide can be retrieved.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance (ENDORAIL) |
|---|---|
| Efficacy: Colonoscopy incompletion rate ≤ 10% in long-lasting colonoscopies. | 0% colonoscopy incompletion rate. All 100% of patients successfully completed the colonoscopy. |
| Safety: No increase in colonoscopy serious adverse events (SAEs) (i.e., absence of any device-related SAEs). | No AE/SAE, no abnormal findings, and no overall change in the health status of any patient undergoing colonoscopy with ENDORAIL were observed in the study. |
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size: 38 patients were enrolled and included in the statistical analysis.
- Data Provenance: Prospective, multi-center clinical trial conducted in Italy, Germany, and Belgium.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used to establish the ground truth for the test set cases or their specific qualifications beyond being "specialized medical staff" and "Principal Investigators" at the trial centers. However, the study involved:
- Principal Investigator: Prof. Alessandro Repici (IRCCS Humanitas Research Hospital, Milan, Italy)
- Principal Investigator: Prof. Helmut Neumann (GastroZentrum Lippe, Germany, affiliated with Universität Mainz)
- Principal Investigator: Prof. Raf Bisschops (University Hospitals Leuwen, Belgium)
These individuals are implied to be highly qualified gastroenterologists or endoscopists.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set cases, such as "2+1" or "3+1." The evaluation of outcomes (completion rate, adverse events) was directly reported as observed during the clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a single-arm interventional study.
6. Standalone Algorithm Performance
This section is not applicable as ENDORAIL is a physical accessory to an endoscope, not a software algorithm or AI-driven device intended for standalone performance.
7. Type of Ground Truth Used
The ground truth for the acceptance criteria (colonoscopy completion and adverse events) was based on clinical observation and outcomes data from the prospective clinical trial. Colonoscopy completion was defined as caecal intubation being achieved. Adverse events were observed and classified by medical staff.
8. Sample Size for the Training Set
This section is not applicable. As ENDORAIL is a physical medical device accessory and not a machine learning algorithm, there is no "training set" in the context of AI/ML. The device's design and functionality were developed and validated through non-clinical testing and then evaluated in a clinical trial.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for a physical device.
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(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. | " |
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