(49 days)
The Gyrus ACMI BiCOAG Hemostasis Probe is intended for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract during endoscopic procedures.
The BiCOAG Hemostasis Probe is a single use disposable high frequency RF accessory to be used in conjunction with a generator with bipolar frequency energy rated up to 500Vp-p. The BiCOAG Hemostasis Probe is intended to be used for coagulation of active bleeding lesions in the upper or lower gastrointestinal tract. It contains a central irrigation port. The probe is to be available in 10 Fr and 7 Fr (3.3mm and 2.3mm respectively) outer diameter configurations to allow its use through a minimum 3.7mm and 2.8mm endoscope working channel, respectively. The device is intended to be passed through the working channel of an endoscope to provide hemostasis throughout the gastrointestinal tract.
The BiCOAG Hemostasis Probe enables irrigating fluid (sterile water) to be delivered at the electrode tip. This fluid enables the clearing of blood and other substances that often impede vision and coagulation of the surgical site.
The probe is bipolar with electrodes that spiral down the tip in a uniform manner. These electrodes carry desiccating RF current to a site where bleeding is occurring and allows for coagulation at the target site. The hole at the end of the probe allows for irrigating water to clean the surgical site as required when used in conjunction with a bipolar generator and endoscope. The system thus provides endoscopic control and hemostasis of upper and lower GI bleeding by the application of bipolar energy.
Here's a breakdown of the acceptance criteria and study information for the Gyrus ACMI BiCOAG Hemostasis Probe, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Performance (Meeting Acceptance Criteria) |
|---|---|---|
| Physical & Mechanical Integrity | Physical dimensions | Achieved (all passing results) |
| Flow rates | Achieved (all passing results) | |
| Pull testing | Achieved (all passing results) | |
| Leak testing | Achieved (all passing results) | |
| Packaging | Achieved (all passing results) | |
| Shelf life | Achieved (all passing results) | |
| Electrical Performance | Electrical testing | Achieved (all passing results) |
| Biocompatibility | Biocompatibility testing | Achieved (all passing results) |
| Functional Performance (Comparative) | Coagulation performance on porcine tissue | Substantially equivalent to predicate and market competitors |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "a non-clinical bench study was carried out by a trained user on porcine tissue."
- Sample Size: The exact sample size for the test set (number of porcine tissue samples or individual tests) is not specified in the provided text.
- Data Provenance:
- Country of Origin: Not specified, but implied to be internal testing by Gyrus ACMI.
- Retrospective or Prospective: Prospective (bench study specifically designed and conducted for this submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document states "a trained user" conducted the non-clinical bench study. This implies one expert/user was involved in performing the coagulation tests.
- Qualifications of Experts: The specific qualifications of the "trained user" are not detailed beyond being "trained."
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the coagulation performance assessment. It appears the "trained user" directly evaluated the coagulation on porcine tissue. Therefore, the adjudication method was: None specified for expert consensus; direct evaluation by a single trained user.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not reported. The study described is a non-clinical bench study and does not involve human readers evaluating images or clinical outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the device described. The BiCOAG Hemostasis Probe is a physical medical device (electrosurgical accessory), not an algorithm or AI. The performance testing was for the device itself, not for an algorithm designed to perform a task.
7. The Type of Ground Truth Used
For the non-clinical bench study on coagulation, the ground truth was based on the direct observation and evaluation of coagulation effectiveness on porcine tissue by a "trained user." This can be considered a form of direct experimental observation rather than an expert consensus on a subjective measure, pathology, or outcomes data in a clinical setting.
8. The Sample Size for the Training Set
This question is not applicable. The BiCOAG Hemostasis Probe is a physical device, not an AI or algorithm that requires a training set. The descriptions of "training set" and "testing set" are typically used for machine learning models.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as the device is not an AI/algorithm requiring a training set.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).