(35 days)
The Epix® Suction Irrigation System is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, and laparoscopic and open urologic surgery. This device delivers sterile irrigant solution and serves as a conduit for suction.
The Epix Irrigation Pump (model C7000) is reusable and operates outside of the sterile field. The Epix Suction Irrigation Tubing Set (model C7100) is a sterile, single use device, used in conjunction with the Epix Irrigation Pump and the house vacuum to deliver sterile irrigation fluids and to evacuate blood, tissue debris, and smoke from the surgical site.
Here's a breakdown of the acceptance criteria and study information for the Epix® Suction Irrigation System, based on the provided 510(k) summary:
This device is a suction irrigator, not an AI/ML powered device. As such, many of the typical categories for AI/ML device studies (such as MRMC studies, training set details, or ground truth establishment for a diagnostic algorithm) are not applicable. The study predominantly focuses on benchtop performance testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary doesn't explicitly state quantitative acceptance criteria with numerical targets for each test. Instead, the "acceptance criteria" are implied to be that the subject device performs comparably to the predicate device in the specified functional tests, demonstrating substantial equivalence. The reported device performance is that these tests confirmed substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Subject device performs comparably to predicate in Irrigation Fluid Flow. | Testing demonstrated substantial equivalence to the predicate. |
| Subject device performs comparably to predicate in Irrigation Fluid Leak. | Testing demonstrated substantial equivalence to the predicate. |
| Subject device performs comparably to predicate in Aspiration Fluid Flow. | Testing demonstrated substantial equivalence to the predicate. |
| Subject device performs comparably to predicate in Smoke Evacuation Flow. | Testing demonstrated substantial equivalence to the predicate. |
| Subject device meets tubing collapse requirements based on ISO 10079-3. | Device was evaluated by a tubing collapse test based on ISO 10079-3. |
2. Sample Size Used for the Test Set and Data Provenance
The summary describes "bench top tests" where "the devices were tested side-by-side." It does not specify a numerical sample size (e.g., number of devices tested, number of trials). The data provenance is a laboratory setting from Applied Medical Resources Corporation. This is a prospective test, as the protocol was created specifically to confirm substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a functional performance test for a physical device, not an AI/ML diagnostic device requiring expert ground truth for classification or interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is a functional performance test for a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is not an AI/ML device. The "standalone" test refers to the device's functional performance in a laboratory setting, as described in the benchtop tests.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is the expected physical and functional performance according to engineering and safety standards (e.g., IEC 60601-1, ISO 10993, ISO 10079-3) and by comparison to the established performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.