(217 days)
The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend the abdomen, colon or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflation is intended to use in hospital. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.
There are 3 operating modes:
- Flow Mode (1) delivers a fixed flow, settable between 0 and 15 standard liters per minute (SLPM)
- Pressure Modes (2) -
- Intermittent Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).
The tubeset is a sterile, single-use product. The tubeset is made of PVC and polyethylene. The A VA 15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation, respectively.
The provided text describes the EVA15 Insufflator, a medical device, and its 510(k) submission to the FDA. However, it does not contain information about a study involving AI assistance for human readers, nor does it detail a study for an AI algorithm's standalone performance. The document focuses on the substantial equivalence of the EVA15 Insufflator to a predicate device (SurgiQuest AirSeal iFS System) based on non-clinical performance testing of mechanical and electrical aspects.
Therefore, many of the requested details, especially those related to AI model evaluation (like sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable or present in this document.
Here's an analysis of the available information based on your request:
Acceptance Criteria and Device Performance (Bench Testing Summary):
The document provides a summary of non-clinical performance testing. The "acceptance criteria" are generally stated as "predefined acceptance criteria" without specific numerical thresholds, and the "reported device performance" is a qualitative statement that the device met these criteria.
| Category | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Bench Testing | ||
| Pressure delivery accuracy | Predefined acceptance criteria | Device met criteria |
| Flow delivery accuracy | Predefined acceptance criteria | Device met criteria |
| Simulated Leak | Predefined acceptance criteria | Device met criteria under conditions |
| Smoke Evacuation | Predefined acceptance criteria | Device met criteria |
| Smoke Evacuation Filter | Predefined acceptance criteria | Device met criteria |
| Software Validation | Adherence to Guidance for Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) | Software was validated |
| Electrical / EMC | ||
| Electrical Safety | Requirements of IEC 60601-1 standards | Device met requirements |
| EMC | Requirements of IEC 60601-1-2:2014 | Device met requirements |
| Sterility & Aging | ||
| Tubeset Sterilization | ISO 11135:2014/Amd.1:2018 Annex E (Half cycle) | Validated |
| Shelf-life | ISO 10993-7:2008/Amd 1:2019, ASTM D4169-16, ASTM F1886 (visual), ASTM F2096 (leak), ASTM F88 (seal), ASTM F-1980-16 (aging) | Supported 1 year |
Information Not Available in the Document:
-
Sample size used for the test set and the data provenance: The document details bench testing, which implies a test set, but it does not specify the sample size (e.g., number of units tested, number of simulated scenarios). It also does not discuss data provenance in the sense of patient data (e.g., country of origin, retrospective/prospective), as this is a physical device rather than an AI/imaging diagnostic.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the testing involves objective measurements of pressure, flow, and filtration, not expert human interpretation for establishing ground truth like in medical imaging.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for engineering bench testing.
-
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 document is for a medical device (insufflator) approval, not an AI diagnostic/assistance tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance testing consists of physical measurements against engineering specifications and validated standards (e.g., pressure readings, flow rates, filtration efficiency).
-
The sample size for the training set: Not applicable as this is not an AI/machine learning model that undergoes training.
-
How the ground truth for the training set was established: Not applicable.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.